1 July 1995
type: Concept
source: therapeutic-goods-act-1989.pdf, p.397
note: Conditional commencement of Therapeutic Goods Amendment Act 1996
asserts: therapeutic-goods-act-1989-sec-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-1
schema version: 2

1 Mar 2006
type: Concept
source: therapeutic-goods-act-1989.pdf, p.400
note: Remainder: 1 Mar 2006
asserts: therapeutic-goods-act-1989-sec-1-2-norm
asserts: therapeutic-goods-act-1989-sec-1-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-1-2
schema version: 2

therapeutic-goods-act-1989-sec-1-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation
modality: Deontic
operator: Obligation

1 Mar 2010
type: Concept
source: therapeutic-goods-act-1989.pdf, p.403
asserts: therapeutic-goods-act-1989-sec-1-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-1-3
schema version: 2

1 Mar 2010(s 2(1)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.403
note: Therapeutic Goods Amendment (2009 Measures No. 3) Act
asserts: therapeutic-goods-act-1989-sec-1-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-1-4
schema version: 2

1 July 2020 (s 2(1)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.407
note: Therapeutic Goods Amendment (2018 Measures No. 1) Act
asserts: therapeutic-goods-act-1989-sec-1-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-1-5
schema version: 2

1 Mar 2021
type: Concept
source: therapeutic-goods-act-1989.pdf, p.408
note: Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 commencement and application details.
asserts: therapeutic-goods-act-1989-sec-1-6-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-1-6
schema version: 2

10 July
type: Concept
source: therapeutic-goods-act-1989.pdf, p.399
note: July section
asserts: therapeutic-goods-act-1989-sec-10-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-10
schema version: 2

10 Dec
type: Concept
source: therapeutic-goods-act-1989.pdf, p.404
note: Commencement of Sch 5 and Sch 7
asserts: therapeutic-goods-act-1989-sec-10-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-10-2
schema version: 2

10 Sept
type: Concept
source: therapeutic-goods-act-1989.pdf, p.405
note: Consequential Provisions
asserts: therapeutic-goods-act-1989-sec-10-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-10-3
schema version: 2

10 Sept
type: Concept
source: therapeutic-goods-act-1989.pdf, p.405
note: Statute Law Revision Act (No. 1) 2015
asserts: therapeutic-goods-act-1989-sec-10-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-10-4
schema version: 2

10 Sept
type: Concept
source: therapeutic-goods-act-1989.pdf, p.406
note: Statute Law Revision Act (No. 1) 2016
asserts: therapeutic-goods-act-1989-sec-10-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-10-5
schema version: 2

11 Section 11
type: Concept
source: therapeutic-goods-act-1989.pdf, p.355
note: Corporate officers may be personally liable for certain offences.
asserts: therapeutic-goods-act-1989-sec-11-norm
asserts: therapeutic-goods-act-1989-sec-11-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-11
schema version: 2

11 June
type: Concept
source: therapeutic-goods-act-1989.pdf, p.397
asserts: therapeutic-goods-act-1989-sec-11-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-11-2
schema version: 2

11 June 1996 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.397
note: Legislation history for Therapeutic Goods Act 1989
asserts: therapeutic-goods-act-1989-sec-11-3-norm
asserts: therapeutic-goods-act-1989-sec-11-3-logic-n3logic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-11-3
schema version: 2

therapeutic-goods-act-1989-sec-11-3-logic-n3logic-1
type: LogicApplication
conclusion text: 2025-09-05
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::n3_compiler
logic summary: Defines compilation date
modality: N3Logic
operator: Applicable
premise text: Compilation date is defined as the date of publication

11 Nov
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
asserts: therapeutic-goods-act-1989-sec-11-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-11-4
schema version: 2

11 Feb
type: Concept
source: therapeutic-goods-act-1989.pdf, p.406
note: Narcotic Drugs Amendment Act 2016
asserts: therapeutic-goods-act-1989-sec-11-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-11-5
schema version: 2

therapeutic-goods-act-1989-sec-11-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Corporate officers have an obligation to comply with certain regulations.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-11-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 11 Section 11

12 Sept
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: Remains in force until further notice
asserts: therapeutic-goods-act-1989-sec-12-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-12
schema version: 2

12 Dec
type: Concept
source: therapeutic-goods-act-1989.pdf, p.404
note: Conditional commencement of amendments to the Therapeutic Goods Amendment (2013 Measures No. 1) Act
asserts: therapeutic-goods-act-1989-sec-12-2-norm
asserts: therapeutic-goods-act-1989-sec-12-2-logic-alleninterval-1
asserts: therapeutic-goods-act-1989-sec-12-2-logic-ltl-2
asserts: therapeutic-goods-act-1989-sec-12-2-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-12-2-logic-epistemic-4
asserts: therapeutic-goods-act-1989-sec-12-2-logic-paraconsistent-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-12-2
schema version: 2

therapeutic-goods-act-1989-sec-12-2-logic-alleninterval-1
type: LogicApplication
conclusion text: Sch 6 (item 1): 12 Dec 2012 (s 2(1) item 16)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines temporal intervals for commencement of amendments
modality: AllenInterval
operator: Applicable
premise text: Sch 5 (item 98) and Sch 6 (items 15–19): 12 Mar 2014 (s 2(1) items 3, 19)

therapeutic-goods-act-1989-sec-12-2-logic-deontic-3
type: LogicApplication
conclusion text: Sch 6 (item 1): 12 Dec 2012 (s 2(1) item 16)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Classifies amendments as part of a schedule
modality: Deontic
operator: Applicable
premise text: Sch 5 (item 98) and Sch 6 (items 15–19): 12 Mar 2014 (s 2(1) items 3, 19)

therapeutic-goods-act-1989-sec-12-2-logic-epistemic-4
type: LogicApplication
conclusion text: Sch 6 (item 1): 12 Dec 2012 (s 2(1) item 16)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Provides information about amendments
modality: Epistemic
operator: Applicable
premise text: Sch 5 (item 98) and Sch 6 (items 15–19): 12 Mar 2014 (s 2(1) items 3, 19)

therapeutic-goods-act-1989-sec-12-2-logic-ltl-2
type: LogicApplication
conclusion text: Sch 6 (item 1): 12 Dec 2012 (s 2(1) item 16)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines trace for amendments
modality: LTL
operator: Applicable
premise text: Sch 5 (item 98) and Sch 6 (items 15–19): 12 Mar 2014 (s 2(1) items 3, 19)

therapeutic-goods-act-1989-sec-12-2-logic-paraconsistent-5
type: LogicApplication
conclusion text: Sch 6 (item 1): 12 Dec 2012 (s 2(1) item 16)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::paraconsistent
logic summary: None applicable
modality: Paraconsistent
operator: Applicable
premise text: Sch 5 (item 98) and Sch 6 (items 15–19): 12 Mar 2014 (s 2(1) items 3, 19)

12 Dec
type: Concept
source: therapeutic-goods-act-1989.pdf, p.407
note: Conditional commencement of the Therapeutic Goods Amendment (2020 Measures No. 1) Act
asserts: therapeutic-goods-act-1989-sec-12-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-12-3
schema version: 2

13 Apr
type: Concept
source: therapeutic-goods-act-1989.pdf, p.405
note: References Schedule 2 (item 7) and Schedule 7
asserts: therapeutic-goods-act-1989-sec-13-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-13
schema version: 2

14 Sept
type: Concept
source: therapeutic-goods-act-1989.pdf, p.399
asserts: therapeutic-goods-act-1989-sec-14-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-14
schema version: 2

14 Sept
type: Concept
source: therapeutic-goods-act-1989.pdf, p.401
note: Conditional commencement of National Health and Medical Research Council Amendment Act 50, 2006
asserts: therapeutic-goods-act-1989-sec-14-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-14-2
schema version: 2

14 Sept
type: Concept
source: therapeutic-goods-act-1989.pdf, p.401
asserts: therapeutic-goods-act-1989-sec-14-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-14-3
schema version: 2

14 Apr 2015 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.405
note: Amendment of Schedule 7 by Acts and Instruments (Framework Reform) (Consequential Provisions) Act 126, 2015
asserts: therapeutic-goods-act-1989-sec-14-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-14-4
schema version: 2

15 Feb 1991 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.397
note: Community Services and Health Legislation Amendment Act (No. 2) 141, 1990
asserts: therapeutic-goods-act-1989-sec-15-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-15
schema version: 2

15 Dec
type: Concept
source: therapeutic-goods-act-1989.pdf, p.403
note: Schedule and commencement dates
asserts: therapeutic-goods-act-1989-sec-15-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-15-2
schema version: 2

15 Dec
type: Concept
source: therapeutic-goods-act-1989.pdf, p.407
note: Sch 1 (items 57–73): 16 Dec 2020 (s 2(1) item 2)
asserts: therapeutic-goods-act-1989-sec-15-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-15-3
schema version: 2

16 Aug
type: Concept
source: therapeutic-goods-act-1989.pdf, p.400
note: Conditional commencement of Sch 7 (item 7)
asserts: therapeutic-goods-act-1989-sec-16-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-16
schema version: 2

17 Jan 1990
type: Concept
source: therapeutic-goods-act-1989.pdf, p.397
asserts: therapeutic-goods-act-1989-sec-17-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-17
schema version: 2

17 Apr
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
asserts: therapeutic-goods-act-1989-sec-17-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-17-2
schema version: 2

17 Apr 1998 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: Conditional commencement of Therapeutic Goods Legislation Amendment Act 1999
asserts: therapeutic-goods-act-1989-sec-17-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-17-3
schema version: 2

17 Sept
type: Concept
source: therapeutic-goods-act-1989.pdf, p.399
asserts: therapeutic-goods-act-1989-sec-17-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-17-4
schema version: 2

17 Sept 2001 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.399
note: Amendment Act (No. 1)
asserts: therapeutic-goods-act-1989-sec-17-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-17-5
schema version: 2

17 June
type: Concept
source: therapeutic-goods-act-1989.pdf, p.402
note: References Schedule 1, 2 and 5–7.
asserts: therapeutic-goods-act-1989-sec-17-6-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-17-6
schema version: 2

18 June 2009 (s 2(1)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.402
note: June 2009 (s 2(1))
asserts: therapeutic-goods-act-1989-sec-18-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-18
schema version: 2

19 Apr 2011 (s 2(1)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.403
note: Acts Interpretation Amendment Act 2011
asserts: therapeutic-goods-act-1989-sec-19-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-19
schema version: 2

19 June
type: Concept
source: therapeutic-goods-act-1989.pdf, p.406
note: Conditional commencement of certain schedules
asserts: therapeutic-goods-act-1989-sec-19-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-19-2
schema version: 2

19 Feb
type: Concept
source: therapeutic-goods-act-1989.pdf, p.408
note: Conditional commencement
asserts: therapeutic-goods-act-1989-sec-19-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-19-3
schema version: 2

20 Mar
type: Concept
source: therapeutic-goods-act-1989.pdf, p.401
asserts: therapeutic-goods-act-1989-sec-20-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-20
schema version: 2

20 Mar 2008 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.401
note: Statute Law Revision Act 2008
asserts: therapeutic-goods-act-1989-sec-20-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-20-2
schema version: 2

20 May
type: Concept
source: therapeutic-goods-act-1989.pdf, p.406
note: Mandatory amendment of Australian Border Force Amendment (Protected Information) Act 2017
asserts: therapeutic-goods-act-1989-sec-20-3-norm
asserts: therapeutic-goods-act-1989-sec-20-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-20-3
schema version: 2

therapeutic-goods-act-1989-sec-20-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Mandatory amendment
modality: Deontic
operator: MUST AMEND

20 June 2017 (s 2(1)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.406
note: List of items included in certain schedules
asserts: therapeutic-goods-act-1989-sec-20-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-20-4
schema version: 2

21 Dec
type: Concept
source: therapeutic-goods-act-1989.pdf, p.399
asserts: therapeutic-goods-act-1989-sec-21-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-21
schema version: 2

21 Sept
type: Concept
source: therapeutic-goods-act-1989.pdf, p.407
note: Schedule definitions and commencement dates
asserts: therapeutic-goods-act-1989-sec-21-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-21-2
schema version: 2

21 Mar
type: Concept
source: therapeutic-goods-act-1989.pdf, p.408
note: Schedule 1: 21 March 2025 (s2(1) item 2)
asserts: therapeutic-goods-act-1989-sec-21-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-21-3
schema version: 2

22 June 2001 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.399
note: Conditional commencement of the Therapeutic Goods Amendment Act 2001
asserts: therapeutic-goods-act-1989-sec-22-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22
schema version: 2

22 Mar
type: Concept
source: therapeutic-goods-act-1989.pdf, p.399
asserts: therapeutic-goods-act-1989-sec-22-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22-2
schema version: 2

22 Sept 2001
type: Concept
source: therapeutic-goods-act-1989.pdf, p.399
note: Amendment Act 2001
asserts: therapeutic-goods-act-1989-sec-22-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22-3
schema version: 2

22 Feb
type: Concept
source: therapeutic-goods-act-1989.pdf, p.400
note: Conditional commencement of Therapeutic Goods Amendment Act (No. 2)
asserts: therapeutic-goods-act-1989-sec-22-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22-4
schema version: 2

22 Mar
type: Concept
source: therapeutic-goods-act-1989.pdf, p.403
asserts: therapeutic-goods-act-1989-sec-22-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22-5
schema version: 2

22 Sept
type: Concept
source: therapeutic-goods-act-1989.pdf, p.404
asserts: therapeutic-goods-act-1989-sec-22-6-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22-6
schema version: 2

22 Sept 2012
type: Concept
source: therapeutic-goods-act-1989.pdf, p.404
note: Personal Liability for Corporate Fault Reform Act 2012
asserts: therapeutic-goods-act-1989-sec-22-7-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22-7
schema version: 2

23 Nov
type: Concept
source: therapeutic-goods-act-1989.pdf, p.406
asserts: therapeutic-goods-act-1989-sec-23-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-23
schema version: 2

23 Nov 2016 (s 2(1)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.406
note: Therapeutic Goods Amendment (2016 Measures No. 1) Act
asserts: therapeutic-goods-act-1989-sec-23-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-23-2
schema version: 2

24 Dec
type: Concept
source: therapeutic-goods-act-1989.pdf, p.397
asserts: therapeutic-goods-act-1989-sec-24-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-24
schema version: 2

24 Dec 1991 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.397
note: References s 4(2), 10(2) and 13(2)
asserts: therapeutic-goods-act-1989-sec-24-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-24-2
schema version: 2

24 Oct
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: Commences on 1 January 1998
asserts: therapeutic-goods-act-1989-sec-24-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-24-3
schema version: 2

24 June 2014
type: Concept
source: therapeutic-goods-act-1989.pdf, p.404
note: Legislation history
asserts: therapeutic-goods-act-1989-sec-24-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-24-4
schema version: 2

25 Nov
type: Concept
source: therapeutic-goods-act-1989.pdf, p.397
note: Customs, Excise and Bounty Legislation Amendment Act 1995
asserts: therapeutic-goods-act-1989-sec-25-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-25
schema version: 2

25 July
type: Concept
source: therapeutic-goods-act-1989.pdf, p.403
asserts: therapeutic-goods-act-1989-sec-25-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-25-2
schema version: 2

25 Feb
type: Concept
source: therapeutic-goods-act-1989.pdf, p.405
asserts: therapeutic-goods-act-1989-sec-25-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-25-3
schema version: 2

25 Mar 2015 (s 2(1)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.405
note: Endnote 3—Legislation history
asserts: therapeutic-goods-act-1989-sec-25-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-25-4
schema version: 2

25 June
type: Concept
source: therapeutic-goods-act-1989.pdf, p.407
note: Sch 1 (items 1–18): 25 Aug 2020 (s 2(1) item 2)
asserts: therapeutic-goods-act-1989-sec-25-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-25-5
schema version: 2

26 June
type: Concept
source: therapeutic-goods-act-1989.pdf, p.397
note: Conditional commencement of the Therapeutic Goods Amendment Act 1991
asserts: therapeutic-goods-act-1989-sec-26-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26
schema version: 2

26 July 2011 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.403
note: Legislation history
asserts: therapeutic-goods-act-1989-sec-26-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26-2
schema version: 2

27 May
type: Concept
source: therapeutic-goods-act-1989.pdf, p.400
note: Conditional commencement of certain provisions
asserts: therapeutic-goods-act-1989-sec-27-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-27
schema version: 2

27 May 2003 (s 2(1)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.400
note: US Free Trade Agreement Implementation Act
asserts: therapeutic-goods-act-1989-sec-27-2-norm
asserts: therapeutic-goods-act-1989-sec-27-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-27-2
schema version: 2

therapeutic-goods-act-1989-sec-27-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must implement US Free Trade Agreement
modality: Deontic
operator: MUST

27 Aug
type: Concept
source: therapeutic-goods-act-1989.pdf, p.402
note: Sch 1, 3, 6 and Sch 7 (items 1–28): 28 Aug 2009
asserts: therapeutic-goods-act-1989-sec-27-3-norm
asserts: therapeutic-goods-act-1989-sec-27-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-27-3
schema version: 2

therapeutic-goods-act-1989-sec-27-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation
modality: Deontic
operator: Obligation

27 June
type: Concept
source: therapeutic-goods-act-1989.pdf, p.403
asserts: therapeutic-goods-act-1989-sec-27-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-27-4
schema version: 2

27 Dec 2011
type: Concept
source: therapeutic-goods-act-1989.pdf, p.403
note: Therapeutic Goods Amendment (2011 Measures No. 1) Act
asserts: therapeutic-goods-act-1989-sec-27-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-27-5
schema version: 2

27 May
type: Concept
source: therapeutic-goods-act-1989.pdf, p.404
note: May
asserts: therapeutic-goods-act-1989-sec-27-6-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-27-6
schema version: 2

27 June
type: Concept
source: therapeutic-goods-act-1989.pdf, p.409
note: Conditional commencement of certain sections
asserts: therapeutic-goods-act-1989-sec-27-7-norm
asserts: therapeutic-goods-act-1989-sec-27-7-logic-ltl-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-27-7
schema version: 2

therapeutic-goods-act-1989-sec-27-7-logic-ltl-1
type: LogicApplication
conclusion text: commences on July 1, 2024
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines temporal intervals for commencement
modality: LTL
operator: Applicable
premise text: 1 July 2024 (s2(1) items 2-2C)

28 Dec
type: Concept
source: therapeutic-goods-act-1989.pdf, p.397
asserts: therapeutic-goods-act-1989-sec-28-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-28
schema version: 2

28 Feb
type: Concept
source: therapeutic-goods-act-1989.pdf, p.404
asserts: therapeutic-goods-act-1989-sec-28-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-28-2
schema version: 2

28 Feb 2014
type: Concept
source: therapeutic-goods-act-1989.pdf, p.404
note: List of schedules and items for the Statute Law Revision Act (No. 1) 2014
asserts: therapeutic-goods-act-1989-sec-28-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-28-3
schema version: 2

29 Mar
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: Audit (Transitional and Miscellaneous) Amendment Act 1997
asserts: therapeutic-goods-act-1989-sec-29-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-29
schema version: 2

29 Mar
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: Amendment Act 1999
asserts: therapeutic-goods-act-1989-sec-29-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-29-2
schema version: 2

29 Sept
type: Concept
source: therapeutic-goods-act-1989.pdf, p.402
note: Schedule 1 and items 2–7 of Schedule 2 commence on 30 September 2009; Schedule 3 items 8–10 commence on 29 March 2010.
asserts: therapeutic-goods-act-1989-sec-29-3-norm
asserts: therapeutic-goods-act-1989-sec-29-3-logic-alleninterval-1
asserts: therapeutic-goods-act-1989-sec-29-3-logic-ltl-2
asserts: therapeutic-goods-act-1989-sec-29-3-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-29-3-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-29-3
schema version: 2

therapeutic-goods-act-1989-sec-29-3-logic-alleninterval-1
type: LogicApplication
conclusion text: 30 Sept 2009 and 29 Mar 2010
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines commencement dates for schedules
modality: AllenInterval
operator: Applicable
premise text: Sch 1: 1 July 2010 (s 2(1) item 2)

therapeutic-goods-act-1989-sec-29-3-logic-deontic-3
type: LogicApplication
conclusion text: 30 Sept 2009 and 29 Mar 2010
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Classifies commencement dates as undertakings
modality: Deontic
operator: Applicable
premise text: Sch 1: 1 July 2010 (s 2(1) item 2)

therapeutic-goods-act-1989-sec-29-3-logic-deontic-4
type: LogicApplication
conclusion text: 30 Sept 2009 and 29 Mar 2010
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Classifies commencement dates as undertakings
modality: Deontic
operator: Applicable
premise text: Sch 1: 1 July 2010 (s 2(1) item 13)

therapeutic-goods-act-1989-sec-29-3-logic-ltl-2
type: LogicApplication
conclusion text: 30 Sept 2009 and 29 Mar 2010
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines commencement dates for schedules
modality: LTL
operator: Applicable
premise text: Sch 1: 1 July 2010 (s 2(1) item 13)

29 Feb
type: Concept
source: therapeutic-goods-act-1989.pdf, p.406
note: Conditional commencement of Narcotic Drugs Legislation Amendment Act 2016
asserts: therapeutic-goods-act-1989-sec-29-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-29-4
schema version: 2

3 July 2002
type: Concept
source: therapeutic-goods-act-1989.pdf, p.399
note: Therapeutic Goods Amendment Act (No. 1) 2006
asserts: therapeutic-goods-act-1989-sec-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-3
schema version: 2

3 May 2006
type: Concept
source: therapeutic-goods-act-1989.pdf, p.399
note: Conditional commencement of Therapeutic Goods Amendment Act 2007
asserts: therapeutic-goods-act-1989-sec-3-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-2
schema version: 2

3 July 2002
type: Concept
source: therapeutic-goods-act-1989.pdf, p.400
note: Commencement dates for certain provisions of the Therapeutic Goods Amendment Act (No. 1)
asserts: therapeutic-goods-act-1989-sec-3-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-3
schema version: 2

3 Mar 2006
type: Concept
source: therapeutic-goods-act-1989.pdf, p.401
asserts: therapeutic-goods-act-1989-sec-3-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-4
schema version: 2

3 Mar 2006 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.401
note: Therapeutic Goods Amendment Act (No. 1)
asserts: therapeutic-goods-act-1989-sec-3-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-5
schema version: 2

3 May 2006
type: Concept
source: therapeutic-goods-act-1989.pdf, p.401
note: Amendment of therapeutic goods schedule
asserts: therapeutic-goods-act-1989-sec-3-6-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-6
schema version: 2

3 Oct 2007 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.401
note: Conditional commencement of the Therapeutic Goods Amendment (Poisons Standard) Act 2008
asserts: therapeutic-goods-act-1989-sec-3-7-norm
asserts: therapeutic-goods-act-1989-sec-3-7-logic-alleninterval-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-7
schema version: 2

therapeutic-goods-act-1989-sec-3-7-logic-alleninterval-1
type: LogicApplication
conclusion text: Undertaking
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Requires temporal relation between commencement and amendment
modality: AllenInterval
operator: Applicable
premise text: Conditional commencement

3 July 2008
type: Concept
source: therapeutic-goods-act-1989.pdf, p.401
note: Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008
asserts: therapeutic-goods-act-1989-sec-3-8-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-8
schema version: 2

3 Oct 2008
type: Concept
source: therapeutic-goods-act-1989.pdf, p.401
note: Commencement of Sch 1 (items 1–3)
asserts: therapeutic-goods-act-1989-sec-3-9-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-9
schema version: 2

30 June
type: Concept
source: therapeutic-goods-act-1989.pdf, p.397
note: Conditional commencement of Health and Community Services Legislation Amendment Act (No. 2)
asserts: therapeutic-goods-act-1989-sec-30-norm
asserts: therapeutic-goods-act-1989-sec-30-logic-alleninterval-1
asserts: therapeutic-goods-act-1989-sec-30-logic-ltl-2
asserts: therapeutic-goods-act-1989-sec-30-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-30
schema version: 2

30 May
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
asserts: therapeutic-goods-act-1989-sec-30-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-30-2
schema version: 2

30 May 2000 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: Amendment Act (No. 3)
asserts: therapeutic-goods-act-1989-sec-30-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-30-3
schema version: 2

30 June
type: Concept
source: therapeutic-goods-act-1989.pdf, p.405
note: Amendment of Schedule 14 by Public Governance and Resources Legislation Amendment Act (No. 1) 2015
asserts: therapeutic-goods-act-1989-sec-30-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-30-4
schema version: 2

30 Oct
type: Concept
source: therapeutic-goods-act-1989.pdf, p.406
note: Prohibition on certain acts
asserts: therapeutic-goods-act-1989-sec-30-5-norm
asserts: therapeutic-goods-act-1989-sec-30-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30-5
schema version: 2

therapeutic-goods-act-1989-sec-30-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the specified act
modality: Deontic
operator: forbid

therapeutic-goods-act-1989-sec-30-logic-alleninterval-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Requires relation between identifiable temporal intervals for conditional commencement
modality: AllenInterval
operator: Applicable
premise text: s 82–88: 30 Jun 1992 (s (1)) s 83(2)

therapeutic-goods-act-1989-sec-30-logic-deontic-3
type: LogicApplication
conclusion text: Undertaking
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Classifies the legal effect as Undertaking
modality: Deontic
operator: Applicable
premise text: No explicit duty, ban conduct, grant permission, or create a right

therapeutic-goods-act-1989-sec-30-logic-ltl-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Requires ordered or recurring trace for conditional commencement
modality: LTL
operator: Applicable
premise text: s 82–88: 30 Jun 1992 (s (1)) s 83(2)

31 Mar
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
asserts: therapeutic-goods-act-1989-sec-31-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-31
schema version: 2

31 Mar 2000 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: Therapeutic Goods Amendment Act (No. 2) - March 2000
asserts: therapeutic-goods-act-1989-sec-31-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-31-2
schema version: 2

31 May
type: Concept
source: therapeutic-goods-act-1989.pdf, p.403
note: Schedule 1 commencement date
asserts: therapeutic-goods-act-1989-sec-31-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-31-3
schema version: 2

31 May 2011 (s 2(1)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.403
note: Reference to Statute Law Revision Act 2011
asserts: therapeutic-goods-act-1989-sec-31-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-31-4
schema version: 2

31 May
type: Concept
source: therapeutic-goods-act-1989.pdf, p.409
note: Granting permission for therapeutic goods and other legislation amendment
asserts: therapeutic-goods-act-1989-sec-31-5-norm
asserts: therapeutic-goods-act-1989-sec-31-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-31-5
schema version: 2

therapeutic-goods-act-1989-sec-31-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission granted
modality: Deontic
operator: PERM

4 Apr 2002
type: Concept
source: therapeutic-goods-act-1989.pdf, p.399
asserts: therapeutic-goods-act-1989-sec-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-4
schema version: 2

4 Apr 2002 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.399
note: Conditional commencement of the Act
asserts: therapeutic-goods-act-1989-sec-4-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-4-2
schema version: 2

4 Apr 2002
type: Concept
source: therapeutic-goods-act-1989.pdf, p.399
note: Schedule amendments
asserts: therapeutic-goods-act-1989-sec-4-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-4-3
schema version: 2

4 Sept
type: Concept
source: therapeutic-goods-act-1989.pdf, p.409
note: Amendment history for Therapeutic Goods Act 1989
asserts: therapeutic-goods-act-1989-sec-4-4-norm
asserts: therapeutic-goods-act-1989-sec-4-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-4-4
schema version: 2

therapeutic-goods-act-1989-sec-4-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Provision affected
modality: Deontic
operator: affectedBy

therapeutic-goods-act-1989-sec-4-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 4 Sept

41B General
type: Concept
source: therapeutic-goods-act-1989.pdf, p.21
note: Ensures safety and satisfactory performance of medical devices
asserts: therapeutic-goods-act-1989-sec-41b-norm
asserts: therapeutic-goods-act-1989-sec-41b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41b
schema version: 2

therapeutic-goods-act-1989-sec-41b-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Guarantees safety and satisfactory performance
modality: Deontic
operator: ensures

therapeutic-goods-act-1989-sec-41b-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41B General

41BA Requirements for medical devices (Parts 4-2 and 4-3)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.21
note: Requirements for medical devices must conform to safety and performance standards.
asserts: therapeutic-goods-act-1989-sec-41ba-norm
asserts: therapeutic-goods-act-1989-sec-41ba-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ba
schema version: 2

therapeutic-goods-act-1989-sec-41ba-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide requirements for medical devices.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ba-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41BA Requirements for medical devices (Parts 4-2 and 4-3)

41BB Administrative processes (Parts 4-4 to 4-10)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.21
note: List of administrative processes under this Chapter
asserts: therapeutic-goods-act-1989-sec-41bb-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41bb
schema version: 2

41BC Enforcement (Part 4-11)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.22
asserts: therapeutic-goods-act-1989-sec-41bc-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41bc
schema version: 2

41BD What is a medical device
type: Concept
source: therapeutic-goods-act-1989.pdf, p.23
note: Defines what constitutes a medical device.
asserts: therapeutic-goods-act-1989-sec-41bd-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41bd
schema version: 2

41BE Kinds of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.25
curation status: Proposed
has part: 41BE(1) Kinds of medical devices
has part: 41BE(2) Kinds of medical devices
has part: 41BE(3) Kinds of medical devices
proposed by: legis2cml
realized by: sec-41be
schema version: 2

41BE(1) Kinds of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.25
note: Medical devices of the same kind must have the same sponsor, manufacturer, device nomenclature system code, medical device classification, and other characteristics as prescribed by regulations.
asserts: therapeutic-goods-act-1989-sec-41be-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41be-ss-1-logic-alleninterval-1
asserts: therapeutic-goods-act-1989-sec-41be-ss-1-logic-ltl-2
asserts: therapeutic-goods-act-1989-sec-41be-ss-1-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-41be-ss-1
schema version: 2
part of: 41BE Kinds of medical devices

therapeutic-goods-act-1989-sec-41be-ss-1-logic-alleninterval-1
type: LogicApplication
conclusion text: are of the same kind
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Characteristics prescribed by regulations apply during the same period
modality: AllenInterval
operator: during
premise text: either generally or in relation to medical devices of the kind in question

therapeutic-goods-act-1989-sec-41be-ss-1-logic-deontic-3
type: LogicApplication
conclusion text: are of the same kind
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Characteristics prescribed by regulations apply if certain conditions are met
modality: Deontic
operator: if
premise text: (e) are the same in relation to such other characteristics as the regulations prescribe, either generally or in relation to medical devices of the kind in question.

therapeutic-goods-act-1989-sec-41be-ss-1-logic-ltl-2
type: LogicApplication
conclusion text: are of the same kind
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Characteristics prescribed by regulations apply until the end of the period
modality: LTL
operator: until
premise text: either generally or in relation to medical devices of the kind in question

therapeutic-goods-act-1989-sec-41be-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41BE(1) Kinds of medical devices

41BE(2) Kinds of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.25
note: If a medical device is not of the same kind as any other medical device, this Chapter applies in relation to the device.
asserts: therapeutic-goods-act-1989-sec-41be-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41be-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41be-ss-2-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41be-ss-2-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41be-ss-2-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-41be-ss-2-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-41be-ss-2-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41be-ss-2
schema version: 2
part of: 41BE Kinds of medical devices

therapeutic-goods-act-1989-sec-41be-ss-2-logic-alleninterval-3
type: LogicApplication
conclusion text: Delivering the device is temporally related to delivering a reasonable number of samples of the kind of device.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between delivering and delivering
modality: AllenInterval
operator: >=
premise text: References in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device.

therapeutic-goods-act-1989-sec-41be-ss-2-logic-cogai-6
type: LogicApplication
conclusion text: Delivering the device is equivalent to delivering a reasonable number of samples of the kind of device.
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Equivalence between kinds of devices
modality: CogAI
operator: =
premise text: References in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device.

therapeutic-goods-act-1989-sec-41be-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: This Chapter applies in relation to the device.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Conditional obligation
modality: Deontic
operator: if-then
premise text: If a medical device is not of the same kind as any other medical device.

therapeutic-goods-act-1989-sec-41be-ss-2-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Delivering the device is equivalent to delivering a reasonable number of samples of the kind of device.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Equivalence between kinds of devices
modality: DescriptionLogic
operator: =
premise text: References in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device.

therapeutic-goods-act-1989-sec-41be-ss-2-logic-diffusion-5
type: LogicApplication
conclusion text: This Chapter diffuses to the device.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Conditional diffusion
modality: Diffusion
operator: if-then
premise text: If a medical device is not of the same kind as any other medical device, this Chapter applies in relation to the device.

therapeutic-goods-act-1989-sec-41be-ss-2-logic-ltl-4
type: LogicApplication
conclusion text: Delivering the device is temporally related to delivering a reasonable number of samples of the kind of device.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal relation between delivering and delivering
modality: LTL
operator: <=
premise text: References in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device.

therapeutic-goods-act-1989-sec-41be-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41BE(2) Kinds of medical devices

41BE(3) Kinds of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.25
note: Device nomenclature codes for medical devices may be determined by the Minister.
asserts: therapeutic-goods-act-1989-sec-41be-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41be-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41be-ss-3
schema version: 2
part of: 41BE Kinds of medical devices

therapeutic-goods-act-1989-sec-41be-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to determine device nomenclature codes
modality: Deontic
operator: may

41BF System or procedure packs
type: Concept
source: therapeutic-goods-act-1989.pdf, p.26
note: Goods are a system or procedure pack if they are interconnected or combined for use in a medical or surgical procedure.
asserts: therapeutic-goods-act-1989-sec-41bf-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41bf
schema version: 2

41BG Manufacturers of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.26
curation status: Proposed
has part: 41BG(1) Manufacturers of medical devices
has part: 41BG(2) Manufacturers of medical devices
has part: 41BG(3) Manufacturers of medical devices
has part: 41BG(4) Manufacturers of medical devices
proposed by: legis2cml
realized by: sec-41bg
schema version: 2

41BG(1) Manufacturers of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.26
note: Manufacturer is responsible for design, production, packaging and labelling of the device.
asserts: therapeutic-goods-act-1989-sec-41bg-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41bg-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41bg-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41bg-ss-1-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-41bg-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41bg-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41bg-ss-1
schema version: 2
part of: 41BG Manufacturers of medical devices

therapeutic-goods-act-1989-sec-41bg-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: The manufacturer's responsibility for design, production, packaging and labelling begins before the device is supplied.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Manufacturer's responsibility starts before device supply
modality: AllenInterval
operator: during
premise text: Design, production, packaging and labelling occur before the device is supplied under the person’s name.

therapeutic-goods-act-1989-sec-41bg-ss-1-logic-argumentation-3
type: LogicApplication
conclusion text: The manufacturer's responsibility for design, production, packaging and labelling implies that the device must be supplied under their name.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Manufacturer's responsibility implies supply of device
modality: Argumentation
operator: implies
premise text: If the manufacturer is responsible for design, production, packaging and labelling, then the device must be supplied under their name.

therapeutic-goods-act-1989-sec-41bg-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: The manufacturer's responsibility for design, production, packaging and labelling is a cognitive action that implies the supply of the device.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Manufacturer's responsibility is a cognitive action
modality: CogAI
operator: implies
premise text: The manufacturer's responsibility for design, production, packaging and labelling involves making decisions and taking actions.

therapeutic-goods-act-1989-sec-41bg-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The manufacturer is responsible for those operations.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Manufacturer is responsible
modality: Deontic
operator: is
premise text: Design, production, packaging and labelling are operations performed by the manufacturer.

therapeutic-goods-act-1989-sec-41bg-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: The manufacturer's responsibility for design, production, packaging and labelling implies that the device must be supplied under their name or another person acting on their behalf.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Manufacturer's responsibility spreads to supply of device
modality: Diffusion
operator: implies
premise text: The manufacturer's responsibility for design, production, packaging and labelling is not limited to the person themselves but also extends to other persons acting on their behalf.

41BG(2) Manufacturers of medical devices
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.26
note: Manufacturer must provide information about the device's purpose.
asserts: therapeutic-goods-act-1989-sec-41bg-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41bg-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41bg-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41bg-ss-2
schema version: 2
part of: 41BG Manufacturers of medical devices

therapeutic-goods-act-1989-sec-41bg-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide information.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41bg-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Device's purpose is described by the manufacturer.
modality: DescriptionLogic
operator: hasPart

therapeutic-goods-act-1989-sec-41bg-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41BG(2) Manufacturers of medical devices

41BG(3) Manufacturers of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.26
note: Exemptions for individuals assembling or adapting medical devices
asserts: therapeutic-goods-act-1989-sec-41bg-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41bg-ss-3
schema version: 2
part of: 41BG Manufacturers of medical devices

therapeutic-goods-act-1989-sec-41bg-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41BG(3) Manufacturers of medical devices

41BG(4) Manufacturers of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.26
note: Exempts individuals from being considered manufacturers of medical devices if they are part of a prescribed class.
asserts: therapeutic-goods-act-1989-sec-41bg-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41bg-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41bg-ss-4-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41bg-ss-4-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41bg-ss-4-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-41bg-ss-4-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-41bg-ss-4-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41bg-ss-4
schema version: 2
part of: 41BG Manufacturers of medical devices

therapeutic-goods-act-1989-sec-41bg-ss-4-logic-alleninterval-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Exempts individuals from being considered manufacturers of medical devices during the applicable period.
modality: AllenInterval
operator: Temporal exemption
premise text: This section applies in relation to vaping goods that are a medical device.

therapeutic-goods-act-1989-sec-41bg-ss-4-logic-cogai-6
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Applies artificial intelligence to determine exemptions from being considered manufacturers of medical devices.
modality: CogAI
operator: Artificial intelligence application
premise text: This section applies in relation to vaping goods that are a medical device.

therapeutic-goods-act-1989-sec-41bg-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exempts individuals from being considered manufacturers of medical devices.
modality: Deontic
operator: Exemption
premise text: This section applies in relation to vaping goods that are a medical device.

therapeutic-goods-act-1989-sec-41bg-ss-4-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Defines a class of persons prescribed by regulations for the purposes of this subsection.
modality: DescriptionLogic
operator: Class definition
premise text: The person is not the manufacturer of a medical device if the person is included in a class of persons prescribed by the regulations.

therapeutic-goods-act-1989-sec-41bg-ss-4-logic-diffusion-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Disseminates knowledge about exemptions from being considered manufacturers of medical devices.
modality: Diffusion
operator: Knowledge dissemination
premise text: This section applies in relation to vaping goods that are a medical device.

therapeutic-goods-act-1989-sec-41bg-ss-4-logic-ltl-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Exempts individuals from being considered manufacturers of medical devices during the applicable period.
modality: LTL
operator: Temporal exemption
premise text: This section applies in relation to vaping goods that are a medical device.

therapeutic-goods-act-1989-sec-41bg-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41BG(4) Manufacturers of medical devices

41BH Meaning of compliance with essential principles
type: Concept
source: therapeutic-goods-act-1989.pdf, p.27
curation status: Proposed
has part: 41BH(1) Meaning of compliance with essential principles
has part: 41BH(2) Meaning of compliance with essential principles
proposed by: legis2cml
realized by: sec-41bh
schema version: 2

41BH(1) Meaning of compliance with essential principles
type: Concept
source: therapeutic-goods-act-1989.pdf, p.27
note: A medical device complies with the essential principles if it does not contravene any of them.
asserts: therapeutic-goods-act-1989-sec-41bh-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41bh-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41bh-ss-1
schema version: 2
part of: 41BH Meaning of compliance with essential principles

therapeutic-goods-act-1989-sec-41bh-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The device does not contravene any of the essential principles.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Negation of a duty
modality: Deontic
operator: ¬

therapeutic-goods-act-1989-sec-41bh-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41BH(1) Meaning of compliance with essential principles

41BH(2) Meaning of compliance with essential principles
type: Concept
source: therapeutic-goods-act-1989.pdf, p.27
note: Compliance with medical device standards is sufficient for compliance with essential principles.
asserts: therapeutic-goods-act-1989-sec-41bh-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41bh-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41bh-ss-2
schema version: 2
part of: 41BH Meaning of compliance with essential principles

therapeutic-goods-act-1989-sec-41bh-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Medical device compliance with standards implies compliance with essential principles
modality: Deontic
operator: implies

therapeutic-goods-act-1989-sec-41bh-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41BH(2) Meaning of compliance with essential principles

41BI Meaning of non-application of conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.28
curation status: Proposed
has part: 41BI(1) Meaning of non-application of conformity assessment
has part: 41BI(2) Meaning of non-application of conformity assessment
has part: 41BI(3) Meaning of non-application of conformity assessment
proposed by: legis2cml
realized by: sec-41bi
schema version: 2

41BI(1) Meaning of non-application of conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.28
note: Defines overseas regulator A conformity assessment procedure is not applied if there has been a contravention of the procedures. A requirement that is comparable to a conformity assessment procedure is not applied if there has been a contravention of the requirement.
asserts: therapeutic-goods-act-1989-sec-41bi-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41bi-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41bi-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41bi-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41bi-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41bi-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41bi-ss-1
schema version: 2
part of: 41BI Meaning of non-application of conformity assessment

therapeutic-goods-act-1989-sec-41bi-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: ...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between contravention and assessment procedure
modality: AllenInterval
operator: during
premise text: (a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture.

therapeutic-goods-act-1989-sec-41bi-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: ...there is a CogAI from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Conditional relation between contravention and assessment procedure
modality: CogAI
operator: if
premise text: (a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture.

therapeutic-goods-act-1989-sec-41bi-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...if there has been a contravention of the conformity assessment procedures.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Negative obligation
modality: Deontic
operator: not
premise text: (1) A conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied...

therapeutic-goods-act-1989-sec-41bi-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: ...there is a diffusion from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Conditional relation between contravention and assessment procedure
modality: Diffusion
operator: if
premise text: (a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture.

therapeutic-goods-act-1989-sec-41bi-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: ...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal relation between contravention and assessment procedure
modality: LTL
operator: during
premise text: (a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture.

therapeutic-goods-act-1989-sec-41bi-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41BI(1) Meaning of non-application of conformity assessment

41BI(2) Meaning of non-application of conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.28
note: The Secretary may determine a body for the purposes of subsection (1). Exemptions from conformity assessment requirements
asserts: therapeutic-goods-act-1989-sec-41bi-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41bi-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41bi-ss-2
schema version: 2
part of: 41BI Meaning of non-application of conformity assessment

therapeutic-goods-act-1989-sec-41bi-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exemptions from conformity assessment requirements
modality: Deontic
operator: exemption

therapeutic-goods-act-1989-sec-41bi-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41BI(2) Meaning of non-application of conformity assessment

41BI(3) Meaning of non-application of conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.28
note: A conformity assessment standard only applies to specified parts of procedures. The Secretary may determine a body by reference to a designation, recognition, approval or authorization.
asserts: therapeutic-goods-act-1989-sec-41bi-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41bi-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41bi-ss-3-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41bi-ss-3
schema version: 2
part of: 41BI Meaning of non-application of conformity assessment

therapeutic-goods-act-1989-sec-41bi-ss-3-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between intervals
modality: AllenInterval
operator: relates to

therapeutic-goods-act-1989-sec-41bi-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: A conformity assessment standard only applies to specified parts of procedures.
modality: Deontic
operator: Obligate

41BK Application of the Criminal Code
type: Concept
source: therapeutic-goods-act-1989.pdf, p.31
note: Chapter 2 of the Criminal Code applies to all offences against this Chapter.
asserts: therapeutic-goods-act-1989-sec-41bk-norm
asserts: therapeutic-goods-act-1989-sec-41bk-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41bk
schema version: 2

therapeutic-goods-act-1989-sec-41bk-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Chapter 2 of the Criminal Code applies to all offences against this Chapter.
modality: Deontic
operator: applies

therapeutic-goods-act-1989-sec-41bk-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41BK Application of the Criminal Code

41C What this Part is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.32
note: Compliance with medical device standards is not required but can be used to establish compliance with essential principles.
asserts: therapeutic-goods-act-1989-sec-41c-norm
asserts: therapeutic-goods-act-1989-sec-41c-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41c-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41c-logic-diffusion-3
asserts: therapeutic-goods-act-1989-sec-41c-logic-cogai-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-41c
schema version: 2

therapeutic-goods-act-1989-sec-41c-logic-alleninterval-2
type: LogicApplication
conclusion text: The database must be established and maintained.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The regulations may make provision for and in relation to the Secretary causing a database of unique device identifiers of medical devices to be established and maintained.
modality: AllenInterval
operator: >=
premise text: The regulations are applicable.

therapeutic-goods-act-1989-sec-41c-logic-cogai-4
type: LogicApplication
conclusion text: Dealing in medical devices is regulated by the act.
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: The therapeutic goods act regulates dealing in medical devices.
modality: CogAI
operator: IS_A
premise text: The regulations are applicable.

therapeutic-goods-act-1989-sec-41c-logic-deontic-1
type: LogicApplication
conclusion text: Compliance can be used to establish compliance.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must comply with medical device standards.
modality: Deontic
operator: MUST
premise text: Compliance is not required.

therapeutic-goods-act-1989-sec-41c-logic-diffusion-3
type: LogicApplication
conclusion text: Dealing in non-compliant medical devices is prohibited.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Dealing in medical devices that do not comply with the essential principles may be an offence or contravenes a civil penalty provision.
modality: Diffusion
operator: IS_A
premise text: The regulations are applicable.

therapeutic-goods-act-1989-sec-41c-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41C What this Part is about

41CA Essential principles
type: Concept
source: therapeutic-goods-act-1989.pdf, p.33
curation status: Proposed
has part: 41CA(1) Essential principles
has part: 41CA(2) Essential principles
has part: 41CA(3) Essential principles
has part: 41CA(4) Essential principles
has part: 41CA(5) Essential principles
proposed by: legis2cml
realized by: sec-41ca
schema version: 2

41CA(1) Essential principles
type: Concept
source: therapeutic-goods-act-1989.pdf, p.33
note: Requirements for medical devices may be set out by regulations.
asserts: therapeutic-goods-act-1989-sec-41ca-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ca-ss-1
schema version: 2
part of: 41CA Essential principles

therapeutic-goods-act-1989-sec-41ca-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41CA(1) Essential principles

41CA(2) Essential principles
type: Concept
source: therapeutic-goods-act-1989.pdf, p.33
note: These requirements are to be known as the essential principles.
asserts: therapeutic-goods-act-1989-sec-41ca-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ca-ss-2
schema version: 2
part of: 41CA Essential principles

41CA(3) Essential principles
type: Concept
source: therapeutic-goods-act-1989.pdf, p.33
note: Requirements for unique device identifiers and medical devices in the database
asserts: therapeutic-goods-act-1989-sec-41ca-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41ca-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ca-ss-3-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ca-ss-3
schema version: 2
part of: 41CA Essential principles

therapeutic-goods-act-1989-sec-41ca-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires unique device identifiers
modality: Deontic
operator: requires
premise text: (a) unique device identifiers of medical devices;

therapeutic-goods-act-1989-sec-41ca-ss-3-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires information about medical devices
modality: Deontic
operator: requires
premise text: (b) information relating to those unique device identifiers, those medical devices or the import, export, manufacture or supply of those medical devices.

therapeutic-goods-act-1989-sec-41ca-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41CA(3) Essential principles

41CA(4) Essential principles
type: Concept
source: therapeutic-goods-act-1989.pdf, p.33
note: Subsection (3) has effect subject to subsection 41CE(2).
asserts: therapeutic-goods-act-1989-sec-41ca-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ca-ss-4
schema version: 2
part of: 41CA Essential principles

therapeutic-goods-act-1989-sec-41ca-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41CA(4) Essential principles

41CA(5) Essential principles
type: Concept
source: therapeutic-goods-act-1989.pdf, p.33
note: Does not limit subsection (1)
asserts: therapeutic-goods-act-1989-sec-41ca-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ca-ss-5
schema version: 2
part of: 41CA Essential principles

therapeutic-goods-act-1989-sec-41ca-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41CA(5) Essential principles

41CB Medical device standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.34
curation status: Proposed
has part: 41CB(1) Medical device standards
has part: 41CB(2) Medical device standards
has part: 41CB(3) Medical device standards
proposed by: legis2cml
realized by: sec-41cb
schema version: 2

41CB(1) Medical device standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.34
note: The Minister may make an order determining medical device standards.
asserts: therapeutic-goods-act-1989-sec-41cb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41cb-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41cb-ss-1-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41cb-ss-1
schema version: 2
part of: 41CB Medical device standards

therapeutic-goods-act-1989-sec-41cb-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Order may commence at any time
modality: AllenInterval
operator: During
premise text: Note: Section 12 of the Legislation Act 2003 deals with when a legislative instrument commences.

therapeutic-goods-act-1989-sec-41cb-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to make an order
modality: Deontic
operator: May

41CB(2) Medical device standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.34
note: Variation or revocation of orders by Minister
asserts: therapeutic-goods-act-1989-sec-41cb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41cb-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41cb-ss-2
schema version: 2
part of: 41CB Medical device standards

therapeutic-goods-act-1989-sec-41cb-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Granting permission to vary or revoke orders
modality: Deontic
operator: may

41CB(3) Medical device standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.34
note: Allows for incorporation of existing instruments or writings into an order or variation thereof.
asserts: therapeutic-goods-act-1989-sec-41cb-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41cb-ss-3
schema version: 2
part of: 41CB Medical device standards

41CC Content of medical device standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.34
curation status: Proposed
has part: 41CC(1) Content of medical device standards
has part: 41CC(2) Content of medical device standards
proposed by: legis2cml
realized by: sec-41cc
schema version: 2

41CC(1) Content of medical device standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.34
note: Specifies how medical device standards can be established.
asserts: therapeutic-goods-act-1989-sec-41cc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41cc-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41cc-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41cc-ss-1-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-41cc-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41cc-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41cc-ss-1
schema version: 2
part of: 41CC Content of medical device standards

therapeutic-goods-act-1989-sec-41cc-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: ...or (e) a standard published by a standards organisation; or...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Establishes temporal intervals.
modality: AllenInterval
operator: between
premise text: (f) such other matters as the Minister thinks fit.

therapeutic-goods-act-1989-sec-41cc-ss-1-logic-argumentation-3
type: LogicApplication
conclusion text: ...may be specified by reference to...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Establishes implications for medical device standards.
modality: Argumentation
operator: implies
premise text: (1) Without limiting the scope of section 41CB, an order establishing a medical device standard...

therapeutic-goods-act-1989-sec-41cc-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: ...or (e) a standard published by a standards organisation; or...
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Recognizes patterns in medical device standards.
modality: CogAI
operator: recognises
premise text: (f) such other matters as the Minister thinks fit.

therapeutic-goods-act-1989-sec-41cc-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...may be specified by reference to...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Establishes a standard for medical devices.
modality: Deontic
operator: specifies
premise text: (1) Without limiting the scope of section 41CB, an order establishing a medical device standard...

therapeutic-goods-act-1989-sec-41cc-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: ...or (e) a standard published by a standards organisation; or...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Spreads information about medical device standards.
modality: Diffusion
operator: diffuses
premise text: (f) such other matters as the Minister thinks fit.

therapeutic-goods-act-1989-sec-41cc-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41CC(1) Content of medical device standards

41CC(2) Content of medical device standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.34
note: List of organisations that can declare standards
asserts: therapeutic-goods-act-1989-sec-41cc-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41cc-ss-2
schema version: 2
part of: 41CC Content of medical device standards

41CD Inconsistencies between medical device standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.35
curation status: Proposed
has part: 41CD(1) Inconsistencies between medical device standards
has part: 41CD(2) Inconsistencies between medical device standards
proposed by: legis2cml
realized by: sec-41cd
schema version: 2

41CD(1) Inconsistencies between medical device standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.35
note: A medical device standard that is inconsistent with another standard has no effect.
asserts: therapeutic-goods-act-1989-sec-41cd-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41cd-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41cd-ss-1-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41cd-ss-1-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41cd-ss-1-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-41cd-ss-1-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-41cd-ss-1-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41cd-ss-1
schema version: 2
part of: 41CD Inconsistencies between medical device standards

therapeutic-goods-act-1989-sec-41cd-ss-1-logic-alleninterval-3
type: LogicApplication
conclusion text: is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Overlaps inconsistent standards.
modality: AllenInterval
operator: Overlap
premise text: (a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;

therapeutic-goods-act-1989-sec-41cd-ss-1-logic-cogai-6
type: LogicApplication
conclusion text: is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b).
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Classifies inconsistent standards as having no effect.
modality: CogAI
operator: Classify
premise text: (a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;

therapeutic-goods-act-1989-sec-41cd-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the application of inconsistent standards.
modality: Deontic
operator: Prohibit
premise text: (a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;

therapeutic-goods-act-1989-sec-41cd-ss-1-logic-descriptionlogic-2
type: LogicApplication
conclusion text: is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies inconsistent standards as having no effect.
modality: DescriptionLogic
operator: Classify
premise text: (a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;

therapeutic-goods-act-1989-sec-41cd-ss-1-logic-diffusion-5
type: LogicApplication
conclusion text: is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Influences inconsistent standards.
modality: Diffusion
operator: Influence
premise text: (a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;

therapeutic-goods-act-1989-sec-41cd-ss-1-logic-ltl-4
type: LogicApplication
conclusion text: is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Overlaps inconsistent standards.
modality: LTL
operator: Overlap
premise text: (a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;

41CD(2) Inconsistencies between medical device standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.35
note: A medical device standard for a combination of component parts takes precedence over standards for individual parts.
asserts: therapeutic-goods-act-1989-sec-41cd-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41cd-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41cd-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41cd-ss-2
schema version: 2
part of: 41CD Inconsistencies between medical device standards

therapeutic-goods-act-1989-sec-41cd-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...over any medical device standard...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Priority obligation
modality: Deontic
operator: takes precedence
premise text: (2) A medical device standard...

therapeutic-goods-act-1989-sec-41cd-ss-2-logic-descriptionlogic-2
type: LogicApplication
conclusion text: ...applies to the component parts.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Combination of component parts as a subclass of individual parts
modality: DescriptionLogic
operator: subclass hierarchy
premise text: (2) A medical device standard...

therapeutic-goods-act-1989-sec-41cd-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41CD(2) Inconsistencies between medical device standards

41CE Database of unique device identifiers of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.36
curation status: Proposed
has part: 41CE(1) Database of unique device identifiers of medical devices
has part: 41CE(2) Database of unique device identifiers of medical devices
has part: 41CE(3) Database of unique device identifiers of medical devices
has part: 41CE(4) Database of unique device identifiers of medical devices
has part: 41CE(5) Database of unique device identifiers of medical devices
has part: 41CE(6) Database of unique device identifiers of medical devices
has part: 41CE(7) Database of unique device identifiers of medical devices
has part: 41CE(8) Database of unique device identifiers of medical devices
proposed by: legis2cml
realized by: sec-41ce
schema version: 2

41CE(1) Database of unique device identifiers of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.36
note: Establishment of a database for unique device identifiers of medical devices
asserts: therapeutic-goods-act-1989-sec-41ce-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ce-ss-1
schema version: 2
part of: 41CE Database of unique device identifiers of medical devices

41CE(2) Database of unique device identifiers of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.36
note: Personal information must not be included in the database unless certain conditions are met.
asserts: therapeutic-goods-act-1989-sec-41ce-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41ce-ss-2-logic-descriptionlogic-1
asserts: therapeutic-goods-act-1989-sec-41ce-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41ce-ss-2-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-41ce-ss-2-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-41ce-ss-2-logic-cogai-5
asserts: therapeutic-goods-act-1989-sec-41ce-ss-2-logic-shacl-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ce-ss-2
schema version: 2
part of: 41CE Database of unique device identifiers of medical devices

therapeutic-goods-act-1989-sec-41ce-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: Personal Information Collection → Device Registered
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relationship between device registration and personal information collection
modality: AllenInterval
operator: <=
premise text: Device registered → Personal Information Collection

therapeutic-goods-act-1989-sec-41ce-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: Personal Information Collection → Device Registration
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Artificial intelligence application for device registration and personal information collection
modality: CogAI
operator: =
premise text: Device Registration → Personal Information Collection

therapeutic-goods-act-1989-sec-41ce-ss-2-logic-deontic-3
type: LogicApplication
conclusion text: Obligation to Exclude Personal Information → State
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to exclude personal information from the database
modality: Deontic
operator: =
premise text: State → Obligation to Exclude Personal Information

therapeutic-goods-act-1989-sec-41ce-ss-2-logic-descriptionlogic-1
type: LogicApplication
conclusion text: Representative → Device
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Class hierarchy for devices and representatives
modality: DescriptionLogic
operator: =
premise text: Device → Representative

therapeutic-goods-act-1989-sec-41ce-ss-2-logic-ltl-4
type: LogicApplication
conclusion text: Personal Information Collection → Device Registered
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal relationship between device registration and personal information collection
modality: LTL
operator: <=
premise text: Device registered → Personal Information Collection

therapeutic-goods-act-1989-sec-41ce-ss-2-logic-shacl-6
type: LogicApplication
conclusion text: Personal Information Collection → Device Registration
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::shacl
logic summary: Schema-based validation for device registration and personal information collection
modality: SHACL
operator: =
premise text: Device Registration → Personal Information Collection

therapeutic-goods-act-1989-sec-41ce-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41CE(2) Database of unique device identifiers of medical devices

41CE(3) Database of unique device identifiers of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.36
note: Regulations may provide for removal of information from database.
asserts: therapeutic-goods-act-1989-sec-41ce-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ce-ss-3
schema version: 2
part of: 41CE Database of unique device identifiers of medical devices

therapeutic-goods-act-1989-sec-41ce-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41CE(3) Database of unique device identifiers of medical devices

41CE(4) Database of unique device identifiers of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.36
note: Making the database available
asserts: therapeutic-goods-act-1989-sec-41ce-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ce-ss-4
schema version: 2
part of: 41CE Database of unique device identifiers of medical devices

41CE(5) Database of unique device identifiers of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.36
note: Database of unique device identifiers of medical devices may be made available to specified persons, authorities or bodies.
asserts: therapeutic-goods-act-1989-sec-41ce-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ce-ss-5
schema version: 2
part of: 41CE Database of unique device identifiers of medical devices

41CE(6) Database of unique device identifiers of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.36
note: Personal information must not be made publicly available.
asserts: therapeutic-goods-act-1989-sec-41ce-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-41ce-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ce-ss-6
schema version: 2
part of: 41CE Database of unique device identifiers of medical devices

therapeutic-goods-act-1989-sec-41ce-ss-6-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits public disclosure of personal information.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-41ce-ss-6-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41CE(6) Database of unique device identifiers of medical devices

41CE(7) Database of unique device identifiers of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.36
note: Database of unique device identifiers of medical devices is not a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-41ce-ss-7-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ce-ss-7
schema version: 2
part of: 41CE Database of unique device identifiers of medical devices

41CE(8) Database of unique device identifiers of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.36
note: Database of unique device identifiers of medical devices is not a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-41ce-ss-8-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ce-ss-8
schema version: 2
part of: 41CE Database of unique device identifiers of medical devices

41D What this Part is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.38
note: Compliance with applicable conformity assessment standards is not required, but it is one way to establish that one or more parts of the conformity assessment procedures have been applied.
asserts: therapeutic-goods-act-1989-sec-41d-norm
asserts: therapeutic-goods-act-1989-sec-41d-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41d
schema version: 2

therapeutic-goods-act-1989-sec-41d-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must comply with applicable standards
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41d-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41D What this Part is about

41DA Conformity assessment procedures
type: Concept
source: therapeutic-goods-act-1989.pdf, p.39
curation status: Proposed
has part: 41DA(1) Conformity assessment procedures
has part: 41DA(2) Conformity assessment procedures
has part: 41DA(3) Conformity assessment procedures
has part: 41DA(4) Conformity assessment procedures
proposed by: legis2cml
realized by: sec-41da
schema version: 2

41DA(1) Conformity assessment procedures
type: Concept
source: therapeutic-goods-act-1989.pdf, p.39
note: Manufacturers of medical devices must comply with regulations.
asserts: therapeutic-goods-act-1989-sec-41da-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41da-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41da-ss-1
schema version: 2
part of: 41DA Conformity assessment procedures

therapeutic-goods-act-1989-sec-41da-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Expresses a duty
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41da-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41DA(1) Conformity assessment procedures

41DA(2) Conformity assessment procedures
type: Concept
source: therapeutic-goods-act-1989.pdf, p.39
note: Conformity assessment procedures
asserts: therapeutic-goods-act-1989-sec-41da-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41da-ss-2-logic-alleninterval-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41da-ss-2
schema version: 2
part of: 41DA Conformity assessment procedures

therapeutic-goods-act-1989-sec-41da-ss-2-logic-alleninterval-1
type: LogicApplication
conclusion text: Undertaking
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Requires temporal intervals for conformity assessment procedures
modality: AllenInterval
operator: Applicable
premise text: Temporal interval relation

41DA(3) Conformity assessment procedures
type: Concept
source: therapeutic-goods-act-1989.pdf, p.39
note: Conformity assessment procedures may be limited or apply differently to different classifications.
asserts: therapeutic-goods-act-1989-sec-41da-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41da-ss-3-logic-linearlogic-1
asserts: therapeutic-goods-act-1989-sec-41da-ss-3-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41da-ss-3-logic-alleninterval-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-41da-ss-3
schema version: 2
part of: 41DA Conformity assessment procedures

therapeutic-goods-act-1989-sec-41da-ss-3-logic-alleninterval-3
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Procedure may be limited in time
modality: AllenInterval
operator: during

therapeutic-goods-act-1989-sec-41da-ss-3-logic-deontic-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to limit procedure application
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41da-ss-3-logic-linearlogic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::linear
logic summary: Procedure may be limited or apply differently
modality: LinearLogic
operator: or

41DA(4) Conformity assessment procedures
type: Concept
source: therapeutic-goods-act-1989.pdf, p.39
note: Regulations may relate to conformity assessment procedures for medical devices.
asserts: therapeutic-goods-act-1989-sec-41da-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41da-ss-4
schema version: 2
part of: 41DA Conformity assessment procedures

therapeutic-goods-act-1989-sec-41da-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41DA(4) Conformity assessment procedures

41DB Medical device classifications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.40
note: Classifications and matters related to medical device classifications
asserts: therapeutic-goods-act-1989-sec-41db-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41db
schema version: 2

41DC Conformity assessment standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.41
curation status: Proposed
has part: 41DC(1) Conformity assessment standards
has part: 41DC(2) Conformity assessment standards
has part: 41DC(3) Conformity assessment standards
has part: 41DC(4) Conformity assessment standards
proposed by: legis2cml
realized by: sec-41dc
schema version: 2

41DC(1) Conformity assessment standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.41
note: Minister may make an order determining conformity assessment standards.
asserts: therapeutic-goods-act-1989-sec-41dc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41dc-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41dc-ss-1
schema version: 2
part of: 41DC Conformity assessment standards

therapeutic-goods-act-1989-sec-41dc-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Minister has the power to make an order.
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-41dc-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41DC(1) Conformity assessment standards

41DC(2) Conformity assessment standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.41
note: A conformity assessment standard may be limited to particular kinds of medical devices.
asserts: therapeutic-goods-act-1989-sec-41dc-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41dc-ss-2
schema version: 2
part of: 41DC Conformity assessment standards

41DC(3) Conformity assessment standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.41
note: Minister may vary or revoke orders made under subsection (1)
asserts: therapeutic-goods-act-1989-sec-41dc-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41dc-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41dc-ss-3
schema version: 2
part of: 41DC Conformity assessment standards

therapeutic-goods-act-1989-sec-41dc-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Minister may vary or revoke orders
modality: Deontic
operator: May

41DC(4) Conformity assessment standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.41
note: Allows for provision in relation to a matter by applying, adopting or incorporating an existing instrument or writing.
asserts: therapeutic-goods-act-1989-sec-41dc-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41dc-ss-4
schema version: 2
part of: 41DC Conformity assessment standards

41DD Content of conformity assessment standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.41
note: Specifies how an order establishing a conformity assessment standard for a kind of medical device may be specified.
asserts: therapeutic-goods-act-1989-sec-41dd-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41dd
schema version: 2

41DE Inconsistencies between conformity assessment standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.42
note: Inconsistencies between conformity assessment standards are of no effect.
asserts: therapeutic-goods-act-1989-sec-41de-norm
asserts: therapeutic-goods-act-1989-sec-41de-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41de
schema version: 2

therapeutic-goods-act-1989-sec-41de-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits inconsistency between conformity assessment standards.
modality: Deontic
operator: Prohibition

41E What this Part is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.43
note: Secretary can issue conformity assessment certificate for medical devices
asserts: therapeutic-goods-act-1989-sec-41e-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41e
schema version: 2

therapeutic-goods-act-1989-sec-41e-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41E What this Part is about

41EA When conformity assessment certificates are required
type: Concept
source: therapeutic-goods-act-1989.pdf, p.44
note: Regulations may prescribe requirements for manufacturers and medical devices.
asserts: therapeutic-goods-act-1989-sec-41ea-norm
asserts: therapeutic-goods-act-1989-sec-41ea-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ea
schema version: 2

therapeutic-goods-act-1989-sec-41ea-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations must be prescribed.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ea-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EA When conformity assessment certificates are required

41EB Applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.44
curation status: Proposed
has part: 41EB(1) Applications
has part: 41EB(2) Applications
has part: 41EB(3) Applications
has part: 41EB(4) Applications
proposed by: legis2cml
realized by: sec-41eb
schema version: 2

41EB(1) Applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.44
note: Application for conformity assessment certificate must be made in a specific manner.
asserts: therapeutic-goods-act-1989-sec-41eb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41eb-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eb-ss-1
schema version: 2
part of: 41EB Applications

therapeutic-goods-act-1989-sec-41eb-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application must be made in accordance with a form approved by the Secretary.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41eb-ss-1-norm
type: Obligation
scope note: borne by: LegalPerson
curation status: Proposed
modality: Deontic
borne by: LegalPerson
deontic status: HeuristicDerived
part of: 41EB(1) Applications

41EB(2) Applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.44
note: Application is not effective if fee or false information is provided.
asserts: therapeutic-goods-act-1989-sec-41eb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41eb-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eb-ss-2
schema version: 2
part of: 41EB Applications

therapeutic-goods-act-1989-sec-41eb-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application cannot be effective.
modality: Deontic
operator: Prohibit
premise text: Prescribed fee not paid or false information in application.

therapeutic-goods-act-1989-sec-41eb-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EB(2) Applications

41EB(3) Applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.44
note: Application may be given in accordance with specified software requirements.
asserts: therapeutic-goods-act-1989-sec-41eb-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eb-ss-3
schema version: 2
part of: 41EB Applications

therapeutic-goods-act-1989-sec-41eb-ss-3-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EB(3) Applications

41EB(4) Applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.44
note: Inspect premises and equipment for medical devices
asserts: therapeutic-goods-act-1989-sec-41eb-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41eb-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41eb-ss-4-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eb-ss-4
schema version: 2
part of: 41EB Applications

therapeutic-goods-act-1989-sec-41eb-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: ...to inspect at that time.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Specify reasonable time for inspection
modality: AllenInterval
operator: Temporal relation
premise text: ...at any reasonable time specified in the notice...

therapeutic-goods-act-1989-sec-41eb-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: ...require the applicant to allow an authorised person...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Grant permission to inspect
modality: Deontic
operator: Allow
premise text: (4) The Secretary may...

therapeutic-goods-act-1989-sec-41eb-ss-4-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EB(4) Applications

41EC Considering applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.45
curation status: Proposed
has part: 41EC(1) Considering applications
has part: 41EC(2) Considering applications
has part: 41EC(3) Considering applications
proposed by: legis2cml
realized by: sec-41ec
schema version: 2

41EC(1) Considering applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.45
note: Secretary must decide whether to issue conformity assessment certificate.
asserts: therapeutic-goods-act-1989-sec-41ec-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ec-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ec-ss-1
schema version: 2
part of: 41EC Considering applications

therapeutic-goods-act-1989-sec-41ec-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: issue conformity assessment certificate
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must decide
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ec-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EC(1) Considering applications

41EC(2) Considering applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.45
note: Consider conformity assessment procedures when issuing a certificate.
asserts: therapeutic-goods-act-1989-sec-41ec-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41ec-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ec-ss-2
schema version: 2
part of: 41EC Considering applications

therapeutic-goods-act-1989-sec-41ec-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: must consider...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must consider certain aspects
modality: Deontic
operator: MUST
premise text: (2) In deciding...

therapeutic-goods-act-1989-sec-41ec-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EC(2) Considering applications

41EC(3) Considering applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.45
note: Consider applicant's eligibility when issuing certificate
asserts: therapeutic-goods-act-1989-sec-41ec-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41ec-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ec-ss-3
schema version: 2
part of: 41EC Considering applications

therapeutic-goods-act-1989-sec-41ec-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must consider applicant's eligibility
modality: Deontic
operator: MUST
premise text: (3) In deciding whether to issue the certificate, the Secretary must also...

therapeutic-goods-act-1989-sec-41ec-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EC(3) Considering applications

41ED Time for making decisions on applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.49
note: Decision on application must be made within a prescribed period.
asserts: therapeutic-goods-act-1989-sec-41ed-norm
asserts: therapeutic-goods-act-1989-sec-41ed-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ed
schema version: 2

therapeutic-goods-act-1989-sec-41ed-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide decision within prescribed period.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ed-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ED Time for making decisions on applications

41EE Procedure following making a decision whether to issue
type: Concept
source: therapeutic-goods-act-1989.pdf, p.49
curation status: Proposed
has part: 41EE(1) Procedure following making a decision whether to issue
has part: 41EE(2) Procedure following making a decision whether to issue
has part: 41EE(3) Procedure following making a decision whether to issue
proposed by: legis2cml
realized by: sec-41ee
schema version: 2

41EE(1) Procedure following making a decision whether to issue
type: Concept
description: Reasons for decision if not issuing certificate.
source: therapeutic-goods-act-1989.pdf, p.49
note: Secretary must notify applicant of decision within 20 working days.
asserts: therapeutic-goods-act-1989-sec-41ee-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ee-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ee-ss-1
schema version: 2
part of: 41EE Procedure following making a decision whether to issue

therapeutic-goods-act-1989-sec-41ee-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must perform action.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ee-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EE(1) Procedure following making a decision whether to issue

41EE(2) Procedure following making a decision whether to issue
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.49
note: Manufacturer must specify covered medical devices on conformity assessment certificate.
asserts: therapeutic-goods-act-1989-sec-41ee-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41ee-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ee-ss-2
schema version: 2
part of: 41EE Procedure following making a decision whether to issue

therapeutic-goods-act-1989-sec-41ee-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to specify covered medical devices.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ee-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EE(2) Procedure following making a decision whether to issue

41EE(3) Procedure following making a decision whether to issue
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.49
note: Must contain prescribed information
asserts: therapeutic-goods-act-1989-sec-41ee-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41ee-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ee-ss-3
schema version: 2
part of: 41EE Procedure following making a decision whether to issue

therapeutic-goods-act-1989-sec-41ee-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide information
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ee-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EE(3) Procedure following making a decision whether to issue

41EF Duration of certificate
type: Concept
source: therapeutic-goods-act-1989.pdf, p.50
curation status: Proposed
has part: 41EF(1) Duration of certificate
has part: 41EF(2) Duration of certificate
has part: 41EF(3) Duration of certificate
has part: 41EF(4) Duration of certificate
has part: 41EF(5) Duration of certificate
has part: 41EF(6) Duration of certificate
proposed by: legis2cml
realized by: sec-41ef
schema version: 2

41EF(1) Duration of certificate
type: Concept
source: therapeutic-goods-act-1989.pdf, p.50
note: Certificate commences on specified day and must be in force for no longer than 5 years.
asserts: therapeutic-goods-act-1989-sec-41ef-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ef-ss-1-logic-alleninterval-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ef-ss-1
schema version: 2
part of: 41EF Duration of certificate

therapeutic-goods-act-1989-sec-41ef-ss-1-logic-alleninterval-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Specifies temporal interval
modality: AllenInterval
operator: during

41EF(2) Duration of certificate
type: Concept
source: therapeutic-goods-act-1989.pdf, p.50
note: Certificate validity period
asserts: therapeutic-goods-act-1989-sec-41ef-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41ef-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ef-ss-2-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ef-ss-2
schema version: 2
part of: 41EF Duration of certificate

therapeutic-goods-act-1989-sec-41ef-ss-2-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval
modality: AllenInterval
operator: >=

therapeutic-goods-act-1989-sec-41ef-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Certificate validity period
modality: Deontic
operator: Obligate

therapeutic-goods-act-1989-sec-41ef-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EF(2) Duration of certificate

41EF(3) Duration of certificate
type: Concept
source: therapeutic-goods-act-1989.pdf, p.50
note: Secretary may extend certificate period
asserts: therapeutic-goods-act-1989-sec-41ef-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41ef-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ef-ss-3
schema version: 2
part of: 41EF Duration of certificate

therapeutic-goods-act-1989-sec-41ef-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permissive obligation
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41ef-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EF(3) Duration of certificate

41EF(4) Duration of certificate
type: Concept
source: therapeutic-goods-act-1989.pdf, p.50
note: Extension duration limit
asserts: therapeutic-goods-act-1989-sec-41ef-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41ef-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ef-ss-4
schema version: 2
part of: 41EF Duration of certificate

therapeutic-goods-act-1989-sec-41ef-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must be no longer than 12 months
modality: Deontic
operator: =
premise text: (4) An extension must be no longer than 12 months.

therapeutic-goods-act-1989-sec-41ef-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EF(4) Duration of certificate

41EF(5) Duration of certificate
type: Concept
source: therapeutic-goods-act-1989.pdf, p.50
note: Only one extension may be given.
asserts: therapeutic-goods-act-1989-sec-41ef-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-41ef-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ef-ss-5
schema version: 2
part of: 41EF Duration of certificate

therapeutic-goods-act-1989-sec-41ef-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Single extension obligation
modality: Deontic
operator: Single Extension
premise text: (5) Only one extension may be given.

therapeutic-goods-act-1989-sec-41ef-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EF(5) Duration of certificate

41EF(6) Duration of certificate
type: Concept
description: Notice
source: therapeutic-goods-act-1989.pdf, p.50
note: Secretary must give notice of extension to manufacturer and applicant.
asserts: therapeutic-goods-act-1989-sec-41ef-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-41ef-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ef-ss-6
schema version: 2
part of: 41EF Duration of certificate

therapeutic-goods-act-1989-sec-41ef-ss-6-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must give notice.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ef-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EF(6) Duration of certificate

41EG Lapsing of applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.50
note: Failure to comply with certain requirements results in lapse of application.
asserts: therapeutic-goods-act-1989-sec-41eg-norm
asserts: therapeutic-goods-act-1989-sec-41eg-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41eg-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eg
schema version: 2

therapeutic-goods-act-1989-sec-41eg-logic-deontic-1
type: LogicApplication
conclusion text: Lapse of application.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition
modality: Deontic
operator: Prohibit
premise text: Failure to comply with requirements.

therapeutic-goods-act-1989-sec-41eg-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Lapse of application if non-compliant.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of applications based on compliance
modality: DescriptionLogic
operator: Classify
premise text: Applications are classified as compliant or non-compliant.

therapeutic-goods-act-1989-sec-41eg-norm
type: Prohibition
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 41EG Lapsing of applications

41EH Treating applications as having been refused
type: Concept
source: therapeutic-goods-act-1989.pdf, p.51
curation status: Proposed
has part: 41EH(1) Treating applications as having been refused
has part: 41EH(2) Treating applications as having been refused
has part: 41EH(3) Treating applications as having been refused
proposed by: legis2cml
realized by: sec-41eh
schema version: 2

41EH(1) Treating applications as having been refused
type: Concept
source: therapeutic-goods-act-1989.pdf, p.51
note: Applicant may treat application as refused if no decision is made within a period.
asserts: therapeutic-goods-act-1989-sec-41eh-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41eh-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eh-ss-1
schema version: 2
part of: 41EH Treating applications as having been refused

therapeutic-goods-act-1989-sec-41eh-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Applicant has an obligation to treat application as refused if no decision is made within a period.
modality: Deontic
operator: Obligation
premise text: (a) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application; and (b) at the end of the period, the applicant has not been notified of a decision whether to issue the certificate.

therapeutic-goods-act-1989-sec-41eh-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EH(1) Treating applications as having been refused

41EH(2) Treating applications as having been refused
type: Concept
source: therapeutic-goods-act-1989.pdf, p.51
note: The notice may be given at any time before the applicant is notified of the decision.
asserts: therapeutic-goods-act-1989-sec-41eh-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41eh-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41eh-ss-2-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eh-ss-2
schema version: 2
part of: 41EH Treating applications as having been refused

therapeutic-goods-act-1989-sec-41eh-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: May be given at any time
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-41eh-ss-2-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Before applicant is notified of decision
modality: Epistemic
operator: ANYTIME

therapeutic-goods-act-1989-sec-41eh-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EH(2) Treating applications as having been refused

41EH(3) Treating applications as having been refused
type: Concept
source: therapeutic-goods-act-1989.pdf, p.51
note: Act has no effect as if notice was given
asserts: therapeutic-goods-act-1989-sec-41eh-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41eh-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eh-ss-3
schema version: 2
part of: 41EH Treating applications as having been refused

therapeutic-goods-act-1989-sec-41eh-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Act has no effect
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the Act from having effect
modality: Deontic
operator: Prohibition
premise text: Notice has been given

41EI Criminal offences for making a false statement
type: Concept
source: therapeutic-goods-act-1989.pdf, p.52
curation status: Proposed
has part: 41EI(1) Criminal offences for making a false statement
has part: 41EI(4) Criminal offences for making a false statement
has part: 41EI(5) Criminal offences for making a false statement
has part: 41EI(6) Criminal offences for making a false statement
proposed by: legis2cml
realized by: sec-41ei
schema version: 2

41EI(1) Criminal offences for making a false statement
type: Concept
source: therapeutic-goods-act-1989.pdf, p.52
note: Making false statements in an application for a conformity assessment certificate is prohibited.
asserts: therapeutic-goods-act-1989-sec-41ei-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ei-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ei-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ei-ss-1
schema version: 2
part of: 41EI Criminal offences for making a false statement

therapeutic-goods-act-1989-sec-41ei-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making false statements in an application for a conformity assessment certificate.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41ei-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies the statement as false or misleading in a material particular.
modality: DescriptionLogic
operator: Classify

therapeutic-goods-act-1989-sec-41ei-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EI(1) Criminal offences for making a false statement

41EI(4) Criminal offences for making a false statement
type: Concept
source: therapeutic-goods-act-1989.pdf, p.52
note: Making false statements in an application for a conformity assessment certificate is prohibited.
asserts: therapeutic-goods-act-1989-sec-41ei-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41ei-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ei-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41ei-ss-4-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-41ei-ss-4-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41ei-ss-4-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ei-ss-4
schema version: 2
part of: 41EI Criminal offences for making a false statement

therapeutic-goods-act-1989-sec-41ei-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between the making of false statements and the committing of an offence
modality: AllenInterval
operator: Temporal relation
premise text: (c) The person knows that the statement is false or misleading in a material particular.

therapeutic-goods-act-1989-sec-41ei-ss-4-logic-argumentation-3
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Implication of making false statements on committing an offence
modality: Argumentation
operator: Implication
premise text: (a) The person makes a statement (whether orally, in a document or in any other way); and

therapeutic-goods-act-1989-sec-41ei-ss-4-logic-cogai-5
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Recognition of entities involved in the making of false statements
modality: CogAI
operator: Entity recognition
premise text: (a) The person makes a statement (whether orally, in a document or in any other way); and

therapeutic-goods-act-1989-sec-41ei-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of making false statements
modality: Deontic
operator: Prohibit
premise text: The person knows that the statement is false or misleading in a material particular.

therapeutic-goods-act-1989-sec-41ei-ss-4-logic-diffusion-4
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Propagation of the prohibition to related statements
modality: Diffusion
operator: Propagation
premise text: (b) The statement is in or in connection with an application for a conformity assessment certificate; and

therapeutic-goods-act-1989-sec-41ei-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EI(4) Criminal offences for making a false statement

41EI(5) Criminal offences for making a false statement
type: Concept
source: therapeutic-goods-act-1989.pdf, p.52
note: Making false statements in an application for a conformity assessment certificate is prohibited.
asserts: therapeutic-goods-act-1989-sec-41ei-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-41ei-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ei-ss-5
schema version: 2
part of: 41EI Criminal offences for making a false statement

therapeutic-goods-act-1989-sec-41ei-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: (Penalty: 100 penalty units.)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making false statements in an application for a conformity assessment certificate.
modality: Deontic
operator: Prohibit
premise text: (5) A person commits an offence if: (a) the person makes a statement (whether orally, in a document or in any other way); and (b) the statement is in or in connection with an application for a conformity assessment certificate; and (c) the statement is false or misleading in a material particular.

therapeutic-goods-act-1989-sec-41ei-ss-5-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EI(5) Criminal offences for making a false statement

41EI(6) Criminal offences for making a false statement
type: Concept
source: therapeutic-goods-act-1989.pdf, p.52
note: Making a false statement in an application for conformity assessment certificate is prohibited.
asserts: therapeutic-goods-act-1989-sec-41ei-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-41ei-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ei-ss-6
schema version: 2
part of: 41EI Criminal offences for making a false statement

therapeutic-goods-act-1989-sec-41ei-ss-6-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making a false statement in an application for conformity assessment certificate.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41ei-ss-6-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EI(6) Criminal offences for making a false statement

41EJ Automatic conditions on conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.54
curation status: Proposed
has part: 41EJ(1) Automatic conditions on conformity assessment certificates
has part: 41EJ(2) Automatic conditions on conformity assessment certificates
has part: 41EJ(3) Automatic conditions on conformity assessment certificates
has part: 41EJ(4) Automatic conditions on conformity assessment certificates
has part: 41EJ(5) Automatic conditions on conformity assessment certificates
has part: 41EJ(5A) Automatic conditions on conformity assessment certificates
proposed by: legis2cml
realized by: sec-41ej
schema version: 2

41EJ(1) Automatic conditions on conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.54
note: Manufacturer must allow inspection and examination of premises and medical devices.
asserts: therapeutic-goods-act-1989-sec-41ej-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ej-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ej-ss-1
schema version: 2
part of: 41EJ Automatic conditions on conformity assessment certificates

therapeutic-goods-act-1989-sec-41ej-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Manufacturer must allow inspection.
modality: Deontic
operator: Must

therapeutic-goods-act-1989-sec-41ej-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EJ(1) Automatic conditions on conformity assessment certificates

41EJ(2) Automatic conditions on conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.54
note: Manufacturer must cooperate in review of conformity assessment certificate
asserts: therapeutic-goods-act-1989-sec-41ej-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41ej-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ej-ss-2
schema version: 2
part of: 41EJ Automatic conditions on conformity assessment certificates

therapeutic-goods-act-1989-sec-41ej-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to cooperate
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ej-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EJ(2) Automatic conditions on conformity assessment certificates

41EJ(3) Automatic conditions on conformity assessment certificates
type: Concept
description: Notification in writing
source: therapeutic-goods-act-1989.pdf, p.54
note: Notify Secretary of substantial changes to quality management systems, product range, or medical device design.
asserts: therapeutic-goods-act-1989-sec-41ej-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41ej-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ej-ss-3
schema version: 2
part of: 41EJ Automatic conditions on conformity assessment certificates

therapeutic-goods-act-1989-sec-41ej-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to notify
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ej-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EJ(3) Automatic conditions on conformity assessment certificates

41EJ(4) Automatic conditions on conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.54
note: Applicant must pay fee for review of conformity assessment certificate
asserts: therapeutic-goods-act-1989-sec-41ej-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41ej-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ej-ss-4-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ej-ss-4
schema version: 2
part of: 41EJ Automatic conditions on conformity assessment certificates

therapeutic-goods-act-1989-sec-41ej-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: ...when the fee becomes due and payable.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Fee payment occurs during review process
modality: AllenInterval
operator: during
premise text: (4) A conformity assessment certificate is subject to the condition that...

therapeutic-goods-act-1989-sec-41ej-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide payment
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ej-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EJ(4) Automatic conditions on conformity assessment certificates

41EJ(5) Automatic conditions on conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.54
note: Prescribe different levels of fees for manufacturers and medical devices.
asserts: therapeutic-goods-act-1989-sec-41ej-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-41ej-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ej-ss-5
schema version: 2
part of: 41EJ Automatic conditions on conformity assessment certificates

therapeutic-goods-act-1989-sec-41ej-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a duty on the state.
modality: Deontic
operator: shall

therapeutic-goods-act-1989-sec-41ej-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EJ(5) Automatic conditions on conformity assessment certificates

41EJ(5A) Automatic conditions on conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.54
note: Conformity assessment certificates are subject to conditions prescribed by regulations.
asserts: therapeutic-goods-act-1989-sec-41ej-ss-5a-norm
asserts: therapeutic-goods-act-1989-sec-41ej-ss-5a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ej-ss-5a
schema version: 2
part of: 41EJ Automatic conditions on conformity assessment certificates

therapeutic-goods-act-1989-sec-41ej-ss-5a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prescription of conditions
modality: Deontic
operator: SUBJUNCTIVE MODO

therapeutic-goods-act-1989-sec-41ej-ss-5a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EJ(5A) Automatic conditions on conformity assessment certificates

41EK Conditions imposed when conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.56
note: Conditions imposed on conformity assessment certificates
asserts: therapeutic-goods-act-1989-sec-41ek-norm
asserts: therapeutic-goods-act-1989-sec-41ek-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ek
schema version: 2

therapeutic-goods-act-1989-sec-41ek-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: States a duty
modality: Deontic
operator: imposes

therapeutic-goods-act-1989-sec-41ek-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EK Conditions imposed when conformity assessment certificates

41EL Conditions imposed after issuing a conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.56
curation status: Proposed
has part: 41EL(1) Conditions imposed after issuing a conformity assessment
has part: 41EL(2) Conditions imposed after issuing a conformity assessment
has part: 41EL(3) Conditions imposed after issuing a conformity assessment
proposed by: legis2cml
realized by: sec-41el
schema version: 2

41EL(1) Conditions imposed after issuing a conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.56
note: Secretary may impose new conditions on a conformity assessment certificate.
asserts: therapeutic-goods-act-1989-sec-41el-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41el-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41el-ss-1
schema version: 2
part of: 41EL Conditions imposed after issuing a conformity assessment

therapeutic-goods-act-1989-sec-41el-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation on the manufacturer.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41el-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EL(1) Conditions imposed after issuing a conformity assessment

41EL(2) Conditions imposed after issuing a conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.56
note: Conditions imposed after issuing a conformity assessment take effect on the specified day.
asserts: therapeutic-goods-act-1989-sec-41el-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41el-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41el-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41el-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41el-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41el-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41el-ss-2
schema version: 2
part of: 41EL Conditions imposed after issuing a conformity assessment

therapeutic-goods-act-1989-sec-41el-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: The condition occurs during the specified time period.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Conditions occur during the specified time period
modality: AllenInterval
operator: during
premise text: The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or

therapeutic-goods-act-1989-sec-41el-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: The condition occurs during the specified time period.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Conditions occur during the specified time period
modality: CogAI
operator: during
premise text: The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or

therapeutic-goods-act-1989-sec-41el-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: The condition takes effect on the specified day.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Conditions take effect when specified
modality: Deontic
operator: takesEffect
premise text: The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or

therapeutic-goods-act-1989-sec-41el-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: The condition occurs during the specified time period.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Conditions occur during the specified time period
modality: Diffusion
operator: during
premise text: The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or

therapeutic-goods-act-1989-sec-41el-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: The condition occurs during the specified time period.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Conditions occur during the specified time period
modality: LTL
operator: during
premise text: The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or

therapeutic-goods-act-1989-sec-41el-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EL(2) Conditions imposed after issuing a conformity assessment

41EL(3) Conditions imposed after issuing a conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.56
note: The earlier day must not be earlier than the day the notice is given to the person.
asserts: therapeutic-goods-act-1989-sec-41el-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41el-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41el-ss-3
schema version: 2
part of: 41EL Conditions imposed after issuing a conformity assessment

therapeutic-goods-act-1989-sec-41el-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The earlier day must not be earlier than the day the notice is given to the person.
modality: Deontic
operator: MustNot

therapeutic-goods-act-1989-sec-41el-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EL(3) Conditions imposed after issuing a conformity assessment

41EM Suspension of conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.58
curation status: Proposed
has part: 41EM(1) Suspension of conformity assessment certificates
has part: 41EM(2) Suspension of conformity assessment certificates
has part: 41EM(3) Suspension of conformity assessment certificates
proposed by: legis2cml
realized by: sec-41em
schema version: 2

41EM(1) Suspension of conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.58
note: Secretary may suspend conformity assessment certificate
asserts: therapeutic-goods-act-1989-sec-41em-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41em-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41em-ss-1
schema version: 2
part of: 41EM Suspension of conformity assessment certificates

therapeutic-goods-act-1989-sec-41em-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Implies obligation
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41em-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EM(1) Suspension of conformity assessment certificates

41EM(2) Suspension of conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.58
note: Suspension of conformity assessment certificates may be limited to some medical devices.
asserts: therapeutic-goods-act-1989-sec-41em-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41em-ss-2
schema version: 2
part of: 41EM Suspension of conformity assessment certificates

41EM(3) Suspension of conformity assessment certificates
type: Concept
description: Notice specifying period of suspension
source: therapeutic-goods-act-1989.pdf, p.58
note: Specify period of suspension not exceeding 6 months.
asserts: therapeutic-goods-act-1989-sec-41em-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41em-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41em-ss-3
schema version: 2
part of: 41EM Suspension of conformity assessment certificates

therapeutic-goods-act-1989-sec-41em-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Specify period of suspension
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41em-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EM(3) Suspension of conformity assessment certificates

41EN Notice of proposed suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.58
curation status: Proposed
has part: 41EN(1) Notice of proposed suspension
has part: 41EN(2) Notice of proposed suspension
has part: 41EN(3) Notice of proposed suspension
proposed by: legis2cml
realized by: sec-41en
schema version: 2

41EN(1) Notice of proposed suspension
type: Concept
description: Notice, reasons for suspension
source: therapeutic-goods-act-1989.pdf, p.58
note: Secretary must inform person of proposed suspension and give reasonable opportunity to make submissions.
asserts: therapeutic-goods-act-1989-sec-41en-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41en-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41en-ss-1
schema version: 2
part of: 41EN Notice of proposed suspension

therapeutic-goods-act-1989-sec-41en-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must perform action
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41en-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EN(1) Notice of proposed suspension

41EN(2) Notice of proposed suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.58
note: Secretary must consider submissions before making a decision.
asserts: therapeutic-goods-act-1989-sec-41en-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41en-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41en-ss-2
schema version: 2
part of: 41EN Notice of proposed suspension

therapeutic-goods-act-1989-sec-41en-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must consider submissions
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41en-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EN(2) Notice of proposed suspension

41EN(3) Notice of proposed suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.58
note: Exemption from section 41EN(3) if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury.
asserts: therapeutic-goods-act-1989-sec-41en-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41en-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41en-ss-3-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41en-ss-3-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41en-ss-3-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41en-ss-3-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41en-ss-3
schema version: 2
part of: 41EN Notice of proposed suspension

therapeutic-goods-act-1989-sec-41en-ss-3-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Section 41EN(3) does not apply if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury.
modality: AllenInterval
operator: Overlaps

therapeutic-goods-act-1989-sec-41en-ss-3-logic-cogai-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Section 41EN(3) does not apply if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury.
modality: CogAI
operator: Overlaps

therapeutic-goods-act-1989-sec-41en-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits section 41EN(3) application if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-41en-ss-3-logic-diffusion-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Section 41EN(3) does not apply if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury.
modality: Diffusion
operator: Overlaps

therapeutic-goods-act-1989-sec-41en-ss-3-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Section 41EN(3) does not apply if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury.
modality: LTL
operator: Overlaps

41EO Duration of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
curation status: Proposed
has part: 41EO(1) Duration of suspension
has part: 41EO(2) Duration of suspension
has part: 41EO(3) Duration of suspension
proposed by: legis2cml
realized by: sec-41eo
schema version: 2

41EO(1) Duration of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Suspension takes effect on specified day after notice is given.
asserts: therapeutic-goods-act-1989-sec-41eo-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41eo-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41eo-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41eo-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41eo-ss-1-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-41eo-ss-1-logic-paraconsistent-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eo-ss-1
schema version: 2
part of: 41EO Duration of suspension

therapeutic-goods-act-1989-sec-41eo-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: (1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Suspension takes effect on a specified day after notice is given.
modality: AllenInterval
operator: during
premise text: (1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.

therapeutic-goods-act-1989-sec-41eo-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: (1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Suspension takes effect on specified day after notice is given.
modality: Deontic
operator: takesEffect
premise text: (1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.

therapeutic-goods-act-1989-sec-41eo-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: (1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Suspension takes effect if notice states suspension is necessary.
modality: Deontic
operator: ifThen
premise text: (1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.

therapeutic-goods-act-1989-sec-41eo-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: (1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Suspension takes effect on a specified day after notice is given.
modality: LTL
operator: during
premise text: (1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.

therapeutic-goods-act-1989-sec-41eo-ss-1-logic-paraconsistent-5
type: LogicApplication
conclusion text: (1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::paraconsistent
logic summary: Suspension takes effect on specified day after notice is given.
modality: Paraconsistent
operator: or
premise text: (1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.

therapeutic-goods-act-1989-sec-41eo-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EO(1) Duration of suspension

41EO(2) Duration of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Suspension duration
asserts: therapeutic-goods-act-1989-sec-41eo-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eo-ss-2
schema version: 2
part of: 41EO Duration of suspension

41EO(3) Duration of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Extension of period for addressing grounds for revoking medical device certificate
asserts: therapeutic-goods-act-1989-sec-41eo-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eo-ss-3
schema version: 2
part of: 41EO Duration of suspension

therapeutic-goods-act-1989-sec-41eo-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EO(3) Duration of suspension

41EP Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
curation status: Proposed
has part: 41EP(1) Revocation of suspension
has part: 41EP(2) Revocation of suspension
proposed by: legis2cml
realized by: sec-41ep
schema version: 2

41EP(1) Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Must revoke suspension if grounds no longer apply and no other grounds for suspension exist.
asserts: therapeutic-goods-act-1989-sec-41ep-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ep-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ep-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41ep-ss-1-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ep-ss-1
schema version: 2
part of: 41EP Revocation of suspension

therapeutic-goods-act-1989-sec-41ep-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: Revocation obligation applies between specified temporal intervals
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval of revocation obligation
modality: AllenInterval
operator: BETWEEN
premise text: (1) The Secretary must revoke the suspension if the Secretary is satisfied that: (a) the ground on which the conformity assessment certificate was suspended no longer applies; and (b) there are no other grounds for suspending the certificate.

therapeutic-goods-act-1989-sec-41ep-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The Secretary must revoke the suspension.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to revoke suspension
modality: Deontic
operator: MUST
premise text: (a) the ground on which the conformity assessment certificate was suspended no longer applies; and (b) there are no other grounds for suspending the certificate.

therapeutic-goods-act-1989-sec-41ep-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: Revocation obligation applies between specified temporal intervals
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal interval of revocation obligation
modality: LTL
operator: BETWEEN
premise text: (1) The Secretary must revoke the suspension if the Secretary is satisfied that: (a) the ground on which the conformity assessment certificate was suspended no longer applies; and (b) there are no other grounds for suspending the certificate.

41EP(2) Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Exercise of power to revoke suspension
asserts: therapeutic-goods-act-1989-sec-41ep-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ep-ss-2
schema version: 2
part of: 41EP Revocation of suspension

41EQ Powers of revocation of conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.60
curation status: Proposed
has part: 41EQ(1) Powers of revocation of conformity assessment certificates
has part: 41EQ(2) Powers of revocation of conformity assessment certificates
proposed by: legis2cml
realized by: sec-41eq
schema version: 2

41EQ(1) Powers of revocation of conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.60
note: Does not affect Secretary's powers to revoke conformity assessment certificates
asserts: therapeutic-goods-act-1989-sec-41eq-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eq-ss-1
schema version: 2
part of: 41EQ Powers of revocation of conformity assessment certificates

41EQ(2) Powers of revocation of conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.60
note: Suspension ceases to have effect if revocation relates to conformity assessment certificate
asserts: therapeutic-goods-act-1989-sec-41eq-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41eq-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41eq-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41eq-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41eq-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41eq-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eq-ss-2
schema version: 2
part of: 41EQ Powers of revocation of conformity assessment certificates

therapeutic-goods-act-1989-sec-41eq-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: Suspension ceases to have effect during revocation period
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval relation
modality: AllenInterval
operator: during
premise text: (2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates

therapeutic-goods-act-1989-sec-41eq-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: Suspension ceases to have effect if revocation relates to conformity assessment certificate
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Conditional CogAI
modality: CogAI
operator: if
premise text: (2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates

therapeutic-goods-act-1989-sec-41eq-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Suspension ceases to have effect
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation ceases
modality: Deontic
operator: ceases
premise text: (2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates

therapeutic-goods-act-1989-sec-41eq-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: Suspension ceases to have effect if revocation relates to conformity assessment certificate
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Conditional diffusion
modality: Diffusion
operator: if
premise text: (2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates

therapeutic-goods-act-1989-sec-41eq-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: Suspension ceases to have effect during revocation period
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal interval relation
modality: LTL
operator: during
premise text: (2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates

therapeutic-goods-act-1989-sec-41eq-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EQ(2) Powers of revocation of conformity assessment certificates

41ER Automatic revocation of conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.61
note: Revocation of conformity assessment certificates upon expiration of suspension period
asserts: therapeutic-goods-act-1989-sec-41er-norm
asserts: therapeutic-goods-act-1989-sec-41er-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41er
schema version: 2

therapeutic-goods-act-1989-sec-41er-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits revocation without notice
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-41er-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ER Automatic revocation of conformity assessment certificates

41ES Immediate revocation of conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.61
curation status: Proposed
has part: 41ES(1) Immediate revocation of conformity assessment certificates
has part: 41ES(2) Immediate revocation of conformity assessment certificates
has part: 41ES(3) Immediate revocation of conformity assessment certificates
proposed by: legis2cml
realized by: sec-41es
schema version: 2

41ES(1) Immediate revocation of conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.61
note: Manufacturer must request revocation of certificate.
asserts: therapeutic-goods-act-1989-sec-41es-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41es-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41es-ss-1
schema version: 2
part of: 41ES Immediate revocation of conformity assessment certificates

therapeutic-goods-act-1989-sec-41es-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Manufacturer's request is an obligation.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-41es-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ES(1) Immediate revocation of conformity assessment certificates

41ES(2) Immediate revocation of conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.61
note: Secretary may withdraw revocation upon request and payment of fee.
asserts: therapeutic-goods-act-1989-sec-41es-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41es-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41es-ss-2
schema version: 2
part of: 41ES Immediate revocation of conformity assessment certificates

therapeutic-goods-act-1989-sec-41es-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Describes the Secretary's discretion to withdraw revocation.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41es-ss-2-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ES(2) Immediate revocation of conformity assessment certificates

41ES(3) Immediate revocation of conformity assessment certificates
type: Concept
source: therapeutic-goods-act-1989.pdf, p.61
note: Revocation of conformity assessment certificates is taken never to have occurred if withdrawn.
asserts: therapeutic-goods-act-1989-sec-41es-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41es-ss-3
schema version: 2
part of: 41ES Immediate revocation of conformity assessment certificates

41ET Revocation of conformity assessment certificates after notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.62
curation status: Proposed
has part: 41ET(1) Revocation of conformity assessment certificates after notice
has part: 41ET(1A) Revocation of conformity assessment certificates after notice
has part: 41ET(1B) Revocation of conformity assessment certificates after notice
has part: 41ET(2) Revocation of conformity assessment certificates after notice
proposed by: legis2cml
realized by: sec-41et
schema version: 2

41ET(1) Revocation of conformity assessment certificates after notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.62
note: Revocation of conformity assessment certificates after notice
asserts: therapeutic-goods-act-1989-sec-41et-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41et-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41et-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41et-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-41et-ss-1-logic-alleninterval-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-41et-ss-1
schema version: 2
part of: 41ET Revocation of conformity assessment certificates after notice

therapeutic-goods-act-1989-sec-41et-ss-1-logic-alleninterval-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for revocation after notice
modality: AllenInterval
operator: Within
premise text: within a further 10 working days from the day specified in that notice;

therapeutic-goods-act-1989-sec-41et-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41et-ss-1-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Revocation for non-compliance with conditions
modality: Deontic
operator: Prohibit
premise text: (b) the manufacturer in relation to whom the certificate is issued refuses or fails to comply with a condition to which the certificate is subject;

therapeutic-goods-act-1989-sec-41et-ss-1-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Revocation for breach of conformity assessment document conditions
modality: Deontic
operator: Prohibit
premise text: (viii) breached a condition of a conformity assessment document;

therapeutic-goods-act-1989-sec-41et-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ET(1) Revocation of conformity assessment certificates after notice

41ET(1A) Revocation of conformity assessment certificates after notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.62
note: A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence.
asserts: therapeutic-goods-act-1989-sec-41et-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-41et-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41et-ss-1a-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41et-ss-1a-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41et-ss-1a-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-41et-ss-1a-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-41et-ss-1a-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41et-ss-1a
schema version: 2
part of: 41ET Revocation of conformity assessment certificates after notice

therapeutic-goods-act-1989-sec-41et-ss-1a-logic-alleninterval-3
type: LogicApplication
conclusion text: A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The text implies a temporal relationship between convictions and outstanding orders.
modality: AllenInterval
operator: includes
premise text: An order has been made relating to the offence under section 19B of the Crimes Act 1914.

therapeutic-goods-act-1989-sec-41et-ss-1a-logic-cogai-6
type: LogicApplication
conclusion text: A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: The text implies a cognitive process of referencing persons with outstanding orders.
modality: CogAI
operator: includes
premise text: A court that has found a person to have committed an offence can take action without proceeding to record a conviction.

therapeutic-goods-act-1989-sec-41et-ss-1a-logic-deontic-1
type: LogicApplication
conclusion text: A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The text implies a duty on authorities to refer to persons with outstanding orders.
modality: Deontic
operator: includes
premise text: Section 19B of the Crimes Act 1914 empowers courts to take action without proceeding to record a conviction.

therapeutic-goods-act-1989-sec-41et-ss-1a-logic-descriptionlogic-2
type: LogicApplication
conclusion text: A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: The text defines a class hierarchy for persons with outstanding orders.
modality: DescriptionLogic
operator: includes
premise text: A person convicted of an offence is included in this class.

therapeutic-goods-act-1989-sec-41et-ss-1a-logic-diffusion-5
type: LogicApplication
conclusion text: A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: The text implies a diffusion of information between convictions and outstanding orders.
modality: Diffusion
operator: includes
premise text: A court that has found a person to have committed an offence can take action without proceeding to record a conviction.

therapeutic-goods-act-1989-sec-41et-ss-1a-logic-ltl-4
type: LogicApplication
conclusion text: A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The text implies a recurring trace between convictions and outstanding orders.
modality: LTL
operator: includes
premise text: An order has been made relating to the offence under section 19B of the Crimes Act 1914.

therapeutic-goods-act-1989-sec-41et-ss-1a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ET(1A) Revocation of conformity assessment certificates after notice

41ET(1B) Revocation of conformity assessment certificates after notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.62
note: Paragraph (1)(e) does not limit paragraph (1)(f).
asserts: therapeutic-goods-act-1989-sec-41et-ss-1b-norm
asserts: therapeutic-goods-act-1989-sec-41et-ss-1b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41et-ss-1b
schema version: 2
part of: 41ET Revocation of conformity assessment certificates after notice

therapeutic-goods-act-1989-sec-41et-ss-1b-logic-deontic-1
type: LogicApplication
conclusion text: (1)(e)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Paragraph (1)(e) implies paragraph (1)(f)
modality: Deontic
operator: implies
premise text: (1B)

41ET(2) Revocation of conformity assessment certificates after notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.62
note: Secretary must inform and give opportunity to make submissions before revoking conformity assessment certificate.
asserts: therapeutic-goods-act-1989-sec-41et-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41et-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41et-ss-2-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41et-ss-2
schema version: 2
part of: 41ET Revocation of conformity assessment certificates after notice

therapeutic-goods-act-1989-sec-41et-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must inform and give opportunity to make submissions before revoking conformity assessment certificate.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41et-ss-2-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Secretary has obligation to inform and give opportunity to make submissions before revoking conformity assessment certificate.
modality: Epistemic
operator: OBLIGATION

therapeutic-goods-act-1989-sec-41et-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ET(2) Revocation of conformity assessment certificates after notice

41EU Limiting revocation of conformity assessment certificates to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.64
curation status: Proposed
has part: 41EU(1) Limiting revocation of conformity assessment certificates to
has part: 41EU(2) Limiting revocation of conformity assessment certificates to
proposed by: legis2cml
realized by: sec-41eu
schema version: 2

41EU(1) Limiting revocation of conformity assessment certificates to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.64
note: Limiting revocation of conformity assessment certificates to certain medical devices
asserts: therapeutic-goods-act-1989-sec-41eu-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41eu-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41eu-ss-1-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eu-ss-1
schema version: 2
part of: 41EU Limiting revocation of conformity assessment certificates to

therapeutic-goods-act-1989-sec-41eu-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: ...the Secretary must limit...only to those medical devices
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval between revocation and limitation
modality: AllenInterval
operator: between
premise text: (1) If the Secretary is satisfied...

therapeutic-goods-act-1989-sec-41eu-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...the Secretary must limit...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Limiting revocation
modality: Deontic
operator: limitation
premise text: (1) If the Secretary is satisfied...

therapeutic-goods-act-1989-sec-41eu-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EU(1) Limiting revocation of conformity assessment certificates to

41EU(2) Limiting revocation of conformity assessment certificates to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.64
note: Secretary must vary certificate to remove medical devices from scope
asserts: therapeutic-goods-act-1989-sec-41eu-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41eu-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41eu-ss-2
schema version: 2
part of: 41EU Limiting revocation of conformity assessment certificates to

therapeutic-goods-act-1989-sec-41eu-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to vary certificate
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41eu-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EU(2) Limiting revocation of conformity assessment certificates to

41EV Publication of revocation etc. of conformity assessment
type: Concept
description: Notice setting out particulars of the revocation or variation.
source: therapeutic-goods-act-1989.pdf, p.64
note: Publish notice of revocation or variation of conformity assessment certificate.
asserts: therapeutic-goods-act-1989-sec-41ev-norm
asserts: therapeutic-goods-act-1989-sec-41ev-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ev
schema version: 2

therapeutic-goods-act-1989-sec-41ev-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to publish notice.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ev-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41EV Publication of revocation etc. of conformity assessment

41EW Date of effect of revocation etc. of conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.65
note: Date of effect for revocation or variation of conformity assessment certificate
asserts: therapeutic-goods-act-1989-sec-41ew-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ew
schema version: 2

41F What this Part is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.72
note: Medical devices must comply with certain principles and requirements to be included in the Register.
asserts: therapeutic-goods-act-1989-sec-41f-norm
asserts: therapeutic-goods-act-1989-sec-41f-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41f
schema version: 2

therapeutic-goods-act-1989-sec-41f-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must comply with principles and requirements
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41f-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41F What this Part is about

41FA What this Division is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.73
note: Applications for medical devices must pass preliminary assessment.
asserts: therapeutic-goods-act-1989-sec-41fa-norm
asserts: therapeutic-goods-act-1989-sec-41fa-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fa-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fa
schema version: 2

therapeutic-goods-act-1989-sec-41fa-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application must pass preliminary assessment.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41fa-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Kind of medical device is included in the Register if application passes preliminary assessment.
modality: DescriptionLogic
operator: IS_A

therapeutic-goods-act-1989-sec-41fa-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FA What this Division is about

41FC Making an application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.73
curation status: Proposed
has part: 41FC(1) Making an application
has part: 41FC(2) Making an application
proposed by: legis2cml
realized by: sec-41fc
schema version: 2

41FC(1) Making an application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.73
note: A person may make an application to the Secretary for a kind of medical device to be included in the Register.
asserts: therapeutic-goods-act-1989-sec-41fc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41fc-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fc-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fc-ss-1
schema version: 2
part of: 41FC Making an application

therapeutic-goods-act-1989-sec-41fc-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to make an application
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-41fc-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Application for a kind of medical device
modality: DescriptionLogic
operator: ClassInclusion

therapeutic-goods-act-1989-sec-41fc-ss-1-norm
type: Permission
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 41FC(1) Making an application

41FC(2) Making an application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.73
note: Application must not contain false or misleading information.
asserts: therapeutic-goods-act-1989-sec-41fc-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41fc-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fc-ss-2
schema version: 2
part of: 41FC Making an application

therapeutic-goods-act-1989-sec-41fc-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of false or misleading information
modality: Deontic
operator: Prohibit
premise text: Application must not contain false or misleading information.

therapeutic-goods-act-1989-sec-41fc-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FC(2) Making an application

41FD Matters to be certified
type: Concept
source: therapeutic-goods-act-1989.pdf, p.73
note: Applicant must certify that devices are medical devices.
asserts: therapeutic-goods-act-1989-sec-41fd-norm
asserts: therapeutic-goods-act-1989-sec-41fd-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fd
schema version: 2

therapeutic-goods-act-1989-sec-41fd-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide certification
modality: Deontic
operator: MUST
premise text: Applicant must certify that devices are medical devices.

therapeutic-goods-act-1989-sec-41fd-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FD Matters to be certified

41FE Criminal offences for making a false statement
type: Concept
source: therapeutic-goods-act-1989.pdf, p.78
curation status: Proposed
has part: 41FE(1) Criminal offences for making a false statement
has part: 41FE(4) Criminal offences for making a false statement
has part: 41FE(5) Criminal offences for making a false statement
has part: 41FE(6) Criminal offences for making a false statement
proposed by: legis2cml
realized by: sec-41fe
schema version: 2

41FE(1) Criminal offences for making a false statement
type: Concept
source: therapeutic-goods-act-1989.pdf, p.78
note: Making false statements in connection with medical devices is prohibited.
asserts: therapeutic-goods-act-1989-sec-41fe-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41fe-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fe-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fe-ss-1
schema version: 2
part of: 41FE Criminal offences for making a false statement

therapeutic-goods-act-1989-sec-41fe-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Offence committed
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of false statements
modality: Deontic
operator: Prohibit
premise text: Statement is false or misleading

therapeutic-goods-act-1989-sec-41fe-ss-1-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Device type determined
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of medical devices
modality: DescriptionLogic
operator: Classify
premise text: Device included in Register

therapeutic-goods-act-1989-sec-41fe-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FE(1) Criminal offences for making a false statement

41FE(4) Criminal offences for making a false statement
type: Concept
source: therapeutic-goods-act-1989.pdf, p.78
note: Making false statements in connection with medical device applications or certifications is prohibited.
asserts: therapeutic-goods-act-1989-sec-41fe-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41fe-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fe-ss-4-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41fe-ss-4-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41fe-ss-4-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-41fe-ss-4-logic-deontic-5
asserts: therapeutic-goods-act-1989-sec-41fe-ss-4-logic-deontic-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fe-ss-4
schema version: 2
part of: 41FE Criminal offences for making a false statement

therapeutic-goods-act-1989-sec-41fe-ss-4-logic-alleninterval-3
type: LogicApplication
conclusion text: The statement is in or in connection with...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Requires temporal overlap between statements and their context.
modality: AllenInterval
operator: Temporal overlap
premise text: (c) the statement is in or in connection with: (i) an application for including a kind of medical device in the Register under this Chapter; or (ii) a certification or purported certification under section 41FD.

therapeutic-goods-act-1989-sec-41fe-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making false statements in specified contexts.
modality: Deontic
operator: Prohibit
premise text: (a) the person makes a statement (whether orally, in a document or in any other way); and (b) the person knows that the statement is false or misleading in a material particular;

therapeutic-goods-act-1989-sec-41fe-ss-4-logic-deontic-5
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation to avoid making false statements in specified contexts.
modality: Deontic
operator: Obligation
premise text: (a) the person makes a statement (whether orally, in a document or in any other way); and (b) the person knows that the statement is false or misleading in a material particular;

therapeutic-goods-act-1989-sec-41fe-ss-4-logic-deontic-6
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making false statements in specified contexts.
modality: Deontic
operator: Prohibition
premise text: (a) the person makes a statement (whether orally, in a document or in any other way); and (b) the person knows that the statement is false or misleading in a material particular;

therapeutic-goods-act-1989-sec-41fe-ss-4-logic-descriptionlogic-2
type: LogicApplication
conclusion text: The person knows that the statement is false or misleading in a material particular;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies statements as true or false based on knowledge.
modality: DescriptionLogic
operator: Classify
premise text: (b) the person knows that the statement is false or misleading in a material particular;

therapeutic-goods-act-1989-sec-41fe-ss-4-logic-ltl-4
type: LogicApplication
conclusion text: The statement is in or in connection with...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Requires recurring traces of statements and their context.
modality: LTL
operator: Recurring trace
premise text: (c) the statement is in or in connection with: (i) an application for including a kind of medical device in the Register under this Chapter; or (ii) a certification or purported certification under section 41FD.

41FE(5) Criminal offences for making a false statement
type: Concept
source: therapeutic-goods-act-1989.pdf, p.78
note: Making false statements in certain contexts is an offence.
asserts: therapeutic-goods-act-1989-sec-41fe-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-41fe-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fe-ss-5-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fe-ss-5
schema version: 2
part of: 41FE Criminal offences for making a false statement

therapeutic-goods-act-1989-sec-41fe-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: ...Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making false statements in certain contexts.
modality: Deontic
operator: Prohibition
premise text: (5) A person commits an offence if...

therapeutic-goods-act-1989-sec-41fe-ss-5-logic-descriptionlogic-2
type: LogicApplication
conclusion text: ...Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies the provision as a prohibition.
modality: DescriptionLogic
operator: Classify
premise text: A person commits an offence if...

therapeutic-goods-act-1989-sec-41fe-ss-5-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FE(5) Criminal offences for making a false statement

41FE(6) Criminal offences for making a false statement
type: Concept
source: therapeutic-goods-act-1989.pdf, p.78
note: An offence against subsection (5) is an offence of strict liability.
asserts: therapeutic-goods-act-1989-sec-41fe-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-41fe-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fe-ss-6
schema version: 2
part of: 41FE Criminal offences for making a false statement

therapeutic-goods-act-1989-sec-41fe-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: (6)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Strict liability
modality: Deontic
operator: is
premise text: (5)

therapeutic-goods-act-1989-sec-41fe-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FE(6) Criminal offences for making a false statement

41FF Obligation to include kinds of medical devices in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.80
curation status: Proposed
has part: 41FF(1) Obligation to include kinds of medical devices in the Register
has part: 41FF(1A) Obligation to include kinds of medical devices in the Register
has part: 41FF(2) Obligation to include kinds of medical devices in the Register
has part: 41FF(3) Obligation to include kinds of medical devices in the Register
proposed by: legis2cml
realized by: sec-41ff
schema version: 2

41FF(1) Obligation to include kinds of medical devices in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.80
note: Secretary must include kind of medical device in Register if application has passed preliminary assessment and not selected for audit.
asserts: therapeutic-goods-act-1989-sec-41ff-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ff-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ff-ss-1-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41ff-ss-1-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41ff-ss-1-logic-argumentation-4
asserts: therapeutic-goods-act-1989-sec-41ff-ss-1-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-41ff-ss-1-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ff-ss-1
schema version: 2
part of: 41FF Obligation to include kinds of medical devices in the Register

therapeutic-goods-act-1989-sec-41ff-ss-1-logic-alleninterval-3
type: LogicApplication
conclusion text: ...the Secretary must include the kind of device in the Register in relation to the person.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for inclusion in Register
modality: AllenInterval
operator: BETWEEN
premise text: (1) If:...

therapeutic-goods-act-1989-sec-41ff-ss-1-logic-argumentation-4
type: LogicApplication
conclusion text: ...the Secretary must include the kind of device in the Register in relation to the person.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Inference from preliminary assessment and audit selection
modality: Argumentation
operator: IMPLIES
premise text: (a) an application for a kind of medical device...

therapeutic-goods-act-1989-sec-41ff-ss-1-logic-cogai-6
type: LogicApplication
conclusion text: ...the Secretary must include the kind of device in the Register in relation to the person.
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Artificial intelligence application for medical device inclusion
modality: CogAI
operator: REQUIRES
premise text: (1) If:...

therapeutic-goods-act-1989-sec-41ff-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...the Secretary must include the kind of device in the Register in relation to the person.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to include kind of medical device in Register
modality: Deontic
operator: MUST
premise text: (1) If:...

therapeutic-goods-act-1989-sec-41ff-ss-1-logic-descriptionlogic-2
type: LogicApplication
conclusion text: ...the kind of device in the Register in relation to the person.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies medical devices as part of the Register
modality: DescriptionLogic
operator: SUBCLASS OF
premise text: (1) If:...

therapeutic-goods-act-1989-sec-41ff-ss-1-logic-diffusion-5
type: LogicApplication
conclusion text: ...the Secretary must include the kind of device in the Register in relation to the person.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Influence on audit selection and inclusion in Register
modality: Diffusion
operator: SPREADS TO
premise text: (b) the application has not been selected for audit under section 41FH;

therapeutic-goods-act-1989-sec-41ff-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FF(1) Obligation to include kinds of medical devices in the Register

41FF(1A) Obligation to include kinds of medical devices in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.80
note: The Secretary must not include a device in the Register if it is to be used exclusively for purposes specified under section 41BEA.
asserts: therapeutic-goods-act-1989-sec-41ff-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ff-ss-1a
schema version: 2
part of: 41FF Obligation to include kinds of medical devices in the Register

therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-alleninterval-3
type: LogicApplication
conclusion text: ...the kind of device in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Excludes devices from the Register if they are to be used exclusively for specified purposes during a certain time period.
modality: AllenInterval
operator: TemporalExclusion
premise text: The kind of device is to be used exclusively...

therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-cogai-6
type: LogicApplication
conclusion text: ...the kind of device in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Excludes devices from the Register if they are to be used exclusively for specified purposes during a certain time period.
modality: CogAI
operator: TemporalExclusion
premise text: The kind of device is to be used exclusively...

therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-deontic-1
type: LogicApplication
conclusion text: ...the kind of device in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits including a device in the Register if it is to be used exclusively for specified purposes.
modality: Deontic
operator: Prohibition
premise text: The Secretary must not include...

therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-descriptionlogic-2
type: LogicApplication
conclusion text: ...the kind of device in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Includes devices that are not to be included in the Register if used exclusively for specified purposes.
modality: DescriptionLogic
operator: ClassInclusion
premise text: The kind of device is to be used exclusively...

therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-diffusion-5
type: LogicApplication
conclusion text: ...the kind of device in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Excludes devices from the Register if they are to be used exclusively for specified purposes during a certain time period.
modality: Diffusion
operator: TemporalExclusion
premise text: The kind of device is to be used exclusively...

therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-ltl-4
type: LogicApplication
conclusion text: ...the kind of device in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Excludes devices from the Register if they are to be used exclusively for specified purposes during a certain time period.
modality: LTL
operator: TemporalExclusion
premise text: The kind of device is to be used exclusively...

therapeutic-goods-act-1989-sec-41ff-ss-1a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FF(1A) Obligation to include kinds of medical devices in the Register

41FF(2) Obligation to include kinds of medical devices in the Register
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.80
note: The Secretary must provide a certificate of inclusion to the applicant.
asserts: therapeutic-goods-act-1989-sec-41ff-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41ff-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ff-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ff-ss-2
schema version: 2
part of: 41FF Obligation to include kinds of medical devices in the Register

therapeutic-goods-act-1989-sec-41ff-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must provide a certificate.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ff-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: The Register has part of the device included.
modality: DescriptionLogic
operator: hasPartOf

therapeutic-goods-act-1989-sec-41ff-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FF(2) Obligation to include kinds of medical devices in the Register

41FF(3) Obligation to include kinds of medical devices in the Register
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.80
note: Specify commencement day for inclusion of medical devices in the Register
asserts: therapeutic-goods-act-1989-sec-41ff-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41ff-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ff-ss-3-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ff-ss-3
schema version: 2
part of: 41FF Obligation to include kinds of medical devices in the Register

therapeutic-goods-act-1989-sec-41ff-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Specify commencement day
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ff-ss-3-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Specify the day on which the inclusion of the kind of device in the Register commences.
modality: DescriptionLogic
operator: SPECIFY

therapeutic-goods-act-1989-sec-41ff-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FF(3) Obligation to include kinds of medical devices in the Register

41FG Notification of unsuccessful applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.81
curation status: Proposed
has part: 41FG(1) Notification of unsuccessful applications
has part: 41FG(2) Notification of unsuccessful applications
proposed by: legis2cml
realized by: sec-41fg
schema version: 2

41FG(1) Notification of unsuccessful applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.81
note: Notification of unsuccessful applications for medical device inclusion in the Register
asserts: therapeutic-goods-act-1989-sec-41fg-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fg-ss-1
schema version: 2
part of: 41FG Notification of unsuccessful applications

therapeutic-goods-act-1989-sec-41fg-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FG(1) Notification of unsuccessful applications

41FG(2) Notification of unsuccessful applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.81
note: Secretary must notify applicant in writing within 20 working days after application is received and fee is paid.
asserts: therapeutic-goods-act-1989-sec-41fg-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41fg-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fg-ss-2
schema version: 2
part of: 41FG Notification of unsuccessful applications

therapeutic-goods-act-1989-sec-41fg-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must notify applicant
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41fg-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FG(2) Notification of unsuccessful applications

41FH Selecting applications for auditing
type: Concept
source: therapeutic-goods-act-1989.pdf, p.81
curation status: Proposed
has part: 41FH(1A) Selecting applications for auditing
has part: 41FH(1) Selecting applications for auditing
has part: 41FH(2) Selecting applications for auditing
proposed by: legis2cml
realized by: sec-41fh
schema version: 2

41FH(1) Selecting applications for auditing
type: Concept
source: therapeutic-goods-act-1989.pdf, p.81
note: Secretary must select applications for auditing.
asserts: therapeutic-goods-act-1989-sec-41fh-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41fh-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fh-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fh-ss-1
schema version: 2
part of: 41FH Selecting applications for auditing

therapeutic-goods-act-1989-sec-41fh-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must select applications.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41fh-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Selects applications of a kind prescribed by regulations.
modality: DescriptionLogic
operator: IS_A

therapeutic-goods-act-1989-sec-41fh-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FH(1) Selecting applications for auditing

41FH(1A) Selecting applications for auditing
type: Concept
source: therapeutic-goods-act-1989.pdf, p.81
note: This section applies to applications that have passed preliminary assessment.
asserts: therapeutic-goods-act-1989-sec-41fh-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-41fh-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fh-ss-1a
schema version: 2
part of: 41FH Selecting applications for auditing

therapeutic-goods-act-1989-sec-41fh-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Section applies to specified applications.
modality: Deontic
operator: applies
premise text: (1A) This section applies to applications that have passed preliminary assessment.

therapeutic-goods-act-1989-sec-41fh-ss-1a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FH(1A) Selecting applications for auditing

41FH(2) Selecting applications for auditing
type: Concept
description: written notice
source: therapeutic-goods-act-1989.pdf, p.81
note: Secretary must give applicant a written notice upon selection for auditing.
asserts: therapeutic-goods-act-1989-sec-41fh-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41fh-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fh-ss-2
schema version: 2
part of: 41FH Selecting applications for auditing

therapeutic-goods-act-1989-sec-41fh-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must give applicant a written notice.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41fh-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FH(2) Selecting applications for auditing

41FI Auditing of applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.82
curation status: Proposed
has part: 41FI(1) Auditing of applications
has part: 41FI(1A) Auditing of applications
has part: 41FI(2) Auditing of applications
has part: 41FI(3) Auditing of applications
proposed by: legis2cml
realized by: sec-41fi
schema version: 2

41FI(1) Auditing of applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.82
note: The Secretary may consider certain aspects of an application during auditing. Secretary may have regard to certificate in auditing application
asserts: therapeutic-goods-act-1989-sec-41fi-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41fi-ss-1-logic-descriptionlogic-3
asserts: therapeutic-goods-act-1989-sec-41fi-ss-1-logic-alleninterval-4
asserts: therapeutic-goods-act-1989-sec-41fi-ss-1-logic-ltl-5
asserts: therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-6
asserts: therapeutic-goods-act-1989-sec-41fi-ss-1-logic-descriptionlogic-7
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fi-ss-1
schema version: 2
part of: 41FI Auditing of applications

therapeutic-goods-act-1989-sec-41fi-ss-1-logic-alleninterval-4
type: LogicApplication
conclusion text: The certificate was issued within a specified timeframe.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Certificate must be given to Secretary within a specified timeframe
modality: AllenInterval
operator: Within a specified time frame
premise text: (d) the certificate has been given to the Secretary;

therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: May consider certain aspects
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: The Secretary may have regard to the certificate in auditing the application.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits Secretary to consider certificate
modality: Deontic
operator: May
premise text: (a) a section 41FC application is made for a kind of medical device...

therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-6
type: LogicApplication
conclusion text: The Secretary must consider the certificate in auditing the application.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must consider certificate in auditing application
modality: Deontic
operator: Must consider
premise text: (1) If...

therapeutic-goods-act-1989-sec-41fi-ss-1-logic-descriptionlogic-3
type: LogicApplication
conclusion text: The Secretary is satisfied that the certificate has been issued consistently with the determination.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Certificate must be consistent with conformity assessment body determination
modality: DescriptionLogic
operator: Has been issued consistently with
premise text: (e) if the conformity assessment body determination that relates to the body is limited as mentioned in paragraph 41EWA(4)(b)—the Secretary is satisfied that the certificate has been issued...

therapeutic-goods-act-1989-sec-41fi-ss-1-logic-descriptionlogic-7
type: LogicApplication
conclusion text: The certificate is a requirement for the audit.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Certificate is a requirement for audit of section 41FC application
modality: DescriptionLogic
operator: Is a requirement for audit
premise text: (1) If...

therapeutic-goods-act-1989-sec-41fi-ss-1-logic-ltl-5
type: LogicApplication
conclusion text: The certificate is part of a recurring audit process.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Certificate must be audited as part of recurring audit process
modality: LTL
operator: Recurring trace
premise text: (b) the application has been selected for audit;

therapeutic-goods-act-1989-sec-41fi-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FI(1) Auditing of applications

41FI(1A) Auditing of applications
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.82
note: The applicant must deliver a reasonable number of samples within 14 days after receiving the notice.
asserts: therapeutic-goods-act-1989-sec-41fi-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-41fi-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fi-ss-1a-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fi-ss-1a
schema version: 2
part of: 41FI Auditing of applications

therapeutic-goods-act-1989-sec-41fi-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The applicant must deliver samples
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41fi-ss-1a-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: The application has a part that requires delivery of samples
modality: DescriptionLogic
operator: hasPart

therapeutic-goods-act-1989-sec-41fi-ss-1a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FI(1A) Auditing of applications

41FI(2) Auditing of applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.82
note: The Secretary must decide to include a device in the Register. The Secretary may have regard for matters beyond the scope of this section.
asserts: therapeutic-goods-act-1989-sec-41fi-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41fi-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fi-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fi-ss-2
schema version: 2
part of: 41FI Auditing of applications

therapeutic-goods-act-1989-sec-41fi-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must decide.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41fi-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: The device is included in the Register.
modality: DescriptionLogic
operator: IS_A

therapeutic-goods-act-1989-sec-41fi-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FI(2) Auditing of applications

41FI(3) Auditing of applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.82
note: Secretary must decide not to include device in Register if not satisfied.
asserts: therapeutic-goods-act-1989-sec-41fi-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41fi-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fi-ss-3-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fi-ss-3
schema version: 2
part of: 41FI Auditing of applications

therapeutic-goods-act-1989-sec-41fi-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must decide
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41fi-ss-3-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Device type is a kind of device
modality: DescriptionLogic
operator: IS_A

therapeutic-goods-act-1989-sec-41fi-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FI(3) Auditing of applications

41FJ Procedure following audits
type: Concept
description: Decision notice with reasons
source: therapeutic-goods-act-1989.pdf, p.83
note: Notify applicant of decision within 20 working days and state reasons for non-inclusion in Register if applicable.
asserts: therapeutic-goods-act-1989-sec-41fj-norm
asserts: therapeutic-goods-act-1989-sec-41fj-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fj-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fj
schema version: 2

therapeutic-goods-act-1989-sec-41fj-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to notify applicant
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41fj-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Definition of decision notice
modality: DescriptionLogic
operator: IS_A

41FK Lapsing of applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.84
curation status: Proposed
has part: 41FK(1) Lapsing of applications
has part: 41FK(2) Lapsing of applications
has part: 41FK(3) Lapsing of applications
has part: 41FK(4) Lapsing of applications
has part: 41FK(5) Lapsing of applications
proposed by: legis2cml
realized by: sec-41fk
schema version: 2

41FK(1) Lapsing of applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.84
note: Regulations may empower Secretary to make medical devices priority applicant determinations.
asserts: therapeutic-goods-act-1989-sec-41fk-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fk-ss-1
schema version: 2
part of: 41FK Lapsing of applications

41FK(2) Lapsing of applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.84
note: A medical devices (priority applicant) determination is a specified person's priority applicant in relation to any section 41FC application.
asserts: therapeutic-goods-act-1989-sec-41fk-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41fk-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fk-ss-2
schema version: 2
part of: 41FK Lapsing of applications

therapeutic-goods-act-1989-sec-41fk-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Has priority applicant
modality: Deontic
operator: hasPriorityApplicant

therapeutic-goods-act-1989-sec-41fk-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FK(2) Lapsing of applications

41FK(3) Lapsing of applications
type: Concept
description: specified information or documents within a specified period
source: therapeutic-goods-act-1989.pdf, p.84
note: Regulations may make provision for and in relation to applications for medical devices.
asserts: therapeutic-goods-act-1989-sec-41fk-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41fk-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fk-ss-3
schema version: 2
part of: 41FK Lapsing of applications

therapeutic-goods-act-1989-sec-41fk-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide specified information or documents
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41fk-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FK(3) Lapsing of applications

41FK(4) Lapsing of applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.84
note: Regulations may revoke medical devices priority applicant determination
asserts: therapeutic-goods-act-1989-sec-41fk-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fk-ss-4
schema version: 2
part of: 41FK Lapsing of applications

therapeutic-goods-act-1989-sec-41fk-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FK(4) Lapsing of applications

41FK(5) Lapsing of applications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.84
note: Subsections (3) and (4) do not limit subsection (1).
asserts: therapeutic-goods-act-1989-sec-41fk-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fk-ss-5
schema version: 2
part of: 41FK Lapsing of applications

therapeutic-goods-act-1989-sec-41fk-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FK(5) Lapsing of applications

41FL Device number
type: Concept
source: therapeutic-goods-act-1989.pdf, p.86
note: Secretary must assign unique device number to included medical devices.
asserts: therapeutic-goods-act-1989-sec-41fl-norm
asserts: therapeutic-goods-act-1989-sec-41fl-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fl-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fl
schema version: 2

therapeutic-goods-act-1989-sec-41fl-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide a unique device number.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41fl-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of medical devices in the Register.
modality: DescriptionLogic
operator: CLASSIFICATION

therapeutic-goods-act-1989-sec-41fl-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FL Device number

41FM Duration of inclusion in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.87
curation status: Proposed
has part: 41FM(1) Duration of inclusion in the Register
has part: 41FM(2) Duration of inclusion in the Register
proposed by: legis2cml
realized by: sec-41fm
schema version: 2

41FM(1) Duration of inclusion in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.87
note: Commences on a specified day
asserts: therapeutic-goods-act-1989-sec-41fm-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fm-ss-1
schema version: 2
part of: 41FM Duration of inclusion in the Register

41FM(2) Duration of inclusion in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.87
note: Device must be included in Register until cancellation or suspension.
asserts: therapeutic-goods-act-1989-sec-41fm-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41fm-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fm-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fm-ss-2
schema version: 2
part of: 41FM Duration of inclusion in the Register

therapeutic-goods-act-1989-sec-41fm-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Device must be included in Register.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-41fm-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Device is included in Register.
modality: DescriptionLogic
operator: ClassInclusion

therapeutic-goods-act-1989-sec-41fm-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FM(2) Duration of inclusion in the Register

41FN Conditions applying automatically
type: Concept
source: therapeutic-goods-act-1989.pdf, p.88
curation status: Proposed
has part: 41FN(1) Conditions applying automatically
has part: 41FN(2) Conditions applying automatically
has part: 41FN(3) Conditions applying automatically
proposed by: legis2cml
realized by: sec-41fn
schema version: 2

41FN(1) Conditions applying automatically
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.88
note: Allow authorised person to inspect premises and devices
asserts: therapeutic-goods-act-1989-sec-41fn-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41fn-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fn-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fn-ss-1
schema version: 2
part of: 41FN Conditions applying automatically

therapeutic-goods-act-1989-sec-41fn-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Grant permission to inspect premises and devices
modality: Deontic
operator: Allow

therapeutic-goods-act-1989-sec-41fn-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classify devices into categories
modality: DescriptionLogic
operator: Classify

therapeutic-goods-act-1989-sec-41fn-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FN(1) Conditions applying automatically

41FN(2) Conditions applying automatically
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.88
note: Deliver a reasonable number of samples if requested by the Secretary.
asserts: therapeutic-goods-act-1989-sec-41fn-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41fn-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fn-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fn-ss-2
schema version: 2
part of: 41FN Conditions applying automatically

therapeutic-goods-act-1989-sec-41fn-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Deliver a reasonable number of samples
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must deliver samples
modality: Deontic
operator: MUST
premise text: The Secretary requests samples

therapeutic-goods-act-1989-sec-41fn-ss-2-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Subject to a condition
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Condition for inclusion in the Register
modality: DescriptionLogic
operator: IS_A
premise text: The kind of device is included in the Register

therapeutic-goods-act-1989-sec-41fn-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FN(2) Conditions applying automatically

41FN(3) Conditions applying automatically
type: Concept
description: sufficient information to substantiate compliance with essential principles and conformity assessment procedures
source: therapeutic-goods-act-1989.pdf, p.88
note: Conditions for inclusion of medical devices in the Register
asserts: therapeutic-goods-act-1989-sec-41fn-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41fn-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fn-ss-3-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41fn-ss-3-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41fn-ss-3-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-41fn-ss-3-logic-deontic-5
asserts: therapeutic-goods-act-1989-sec-41fn-ss-3-logic-descriptionlogic-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fn-ss-3
schema version: 2
part of: 41FN Conditions applying automatically

therapeutic-goods-act-1989-sec-41fn-ss-3-logic-alleninterval-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for obtaining information from the manufacturer
modality: AllenInterval
operator: within
premise text: (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;

therapeutic-goods-act-1989-sec-41fn-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide sufficient information
modality: Deontic
operator: must

therapeutic-goods-act-1989-sec-41fn-ss-3-logic-deontic-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide sufficient information for conformity assessment procedures
modality: Deontic
operator: must
premise text: (i) has available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device or that requirements, comparable to those procedures, have been applied to the kind of medical device to the satisfaction of an overseas regulator; or (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;

therapeutic-goods-act-1989-sec-41fn-ss-3-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Description of conditions for inclusion in the Register
modality: DescriptionLogic
operator: has
premise text: (i) has available sufficient information to substantiate compliance with the essential principles; or (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;

therapeutic-goods-act-1989-sec-41fn-ss-3-logic-descriptionlogic-6
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Description of conditions for inclusion in the Register
modality: DescriptionLogic
operator: has
premise text: (i) has available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device or that requirements, comparable to those procedures, have been applied to the kind of medical device to the satisfaction of an overseas regulator; or (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;

therapeutic-goods-act-1989-sec-41fn-ss-3-logic-ltl-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal interval for obtaining information from the manufacturer
modality: LTL
operator: until
premise text: (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;

therapeutic-goods-act-1989-sec-41fn-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FN(3) Conditions applying automatically

41FO Conditions imposed when kinds of medical devices are
type: Concept
source: therapeutic-goods-act-1989.pdf, p.91
curation status: Proposed
has part: 41FO(1) Conditions imposed when kinds of medical devices are
has part: 41FO(2) Conditions imposed when kinds of medical devices are
proposed by: legis2cml
realized by: sec-41fo
schema version: 2

41FO(1) Conditions imposed when kinds of medical devices are
type: Concept
source: therapeutic-goods-act-1989.pdf, p.91
note: Secretary may impose conditions on medical device inclusion in Register
asserts: therapeutic-goods-act-1989-sec-41fo-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41fo-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fo-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fo-ss-1
schema version: 2
part of: 41FO Conditions imposed when kinds of medical devices are

therapeutic-goods-act-1989-sec-41fo-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits Secretary to impose conditions
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-41fo-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies medical devices by type
modality: DescriptionLogic
operator: Classifies

41FO(2) Conditions imposed when kinds of medical devices are
type: Concept
source: therapeutic-goods-act-1989.pdf, p.91
note: Conditions for medical devices
asserts: therapeutic-goods-act-1989-sec-41fo-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41fo-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fo-ss-2-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fo-ss-2
schema version: 2
part of: 41FO Conditions imposed when kinds of medical devices are

therapeutic-goods-act-1989-sec-41fo-ss-2-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for tracking and location of devices
modality: AllenInterval
operator: >=

therapeutic-goods-act-1989-sec-41fo-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Conditions for medical devices
modality: Deontic
operator: Obligate

therapeutic-goods-act-1989-sec-41fo-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FO(2) Conditions imposed when kinds of medical devices are

41FP Conditions imposed after kinds of medical devices are
type: Concept
source: therapeutic-goods-act-1989.pdf, p.92
curation status: Proposed
has part: 41FP(1) Conditions imposed after kinds of medical devices are
has part: 41FP(2) Conditions imposed after kinds of medical devices are
has part: 41FP(3) Conditions imposed after kinds of medical devices are
proposed by: legis2cml
realized by: sec-41fp
schema version: 2

41FP(1) Conditions imposed after kinds of medical devices are
type: Concept
source: therapeutic-goods-act-1989.pdf, p.92
note: Secretary may impose new conditions on medical devices
asserts: therapeutic-goods-act-1989-sec-41fp-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41fp-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41fp-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fp-ss-1
schema version: 2
part of: 41FP Conditions imposed after kinds of medical devices are

therapeutic-goods-act-1989-sec-41fp-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41fp-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies medical devices
modality: DescriptionLogic
operator: includes

therapeutic-goods-act-1989-sec-41fp-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FP(1) Conditions imposed after kinds of medical devices are

41FP(2) Conditions imposed after kinds of medical devices are
type: Concept
source: therapeutic-goods-act-1989.pdf, p.92
note: Conditions for imposition, variation or removal of conditions under this section
asserts: therapeutic-goods-act-1989-sec-41fp-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fp-ss-2
schema version: 2
part of: 41FP Conditions imposed after kinds of medical devices are

41FP(3) Conditions imposed after kinds of medical devices are
type: Concept
source: therapeutic-goods-act-1989.pdf, p.92
note: The earlier day must not be earlier than the day the notice is given to the person.
asserts: therapeutic-goods-act-1989-sec-41fp-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41fp-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41fp-ss-3
schema version: 2
part of: 41FP Conditions imposed after kinds of medical devices are

therapeutic-goods-act-1989-sec-41fp-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The earlier day must not be earlier than the given day.
modality: Deontic
operator: MustNot

therapeutic-goods-act-1989-sec-41fp-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41FP(3) Conditions imposed after kinds of medical devices are

41G What this Part is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.93
note: Inclusions in the Register may be suspended or cancelled under certain circumstances.
asserts: therapeutic-goods-act-1989-sec-41g-norm
asserts: therapeutic-goods-act-1989-sec-41g-logic-descriptionlogic-1
asserts: therapeutic-goods-act-1989-sec-41g-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41g
schema version: 2

therapeutic-goods-act-1989-sec-41g-logic-alleninterval-2
type: LogicApplication
conclusion text: Temporal intervals are defined
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines temporal intervals for suspension and cancellation
modality: AllenInterval
operator: Applicable
premise text: Suspension and cancellation occur under certain circumstances.

therapeutic-goods-act-1989-sec-41g-logic-descriptionlogic-1
type: LogicApplication
conclusion text: Classification of inclusions is possible
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies inclusions in the Register
modality: DescriptionLogic
operator: Applicable
premise text: Inclusions in the Register may be suspended or cancelled.

41GA Suspension of kinds of medical devices from the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.93
note: Suspension of medical devices from the Register
asserts: therapeutic-goods-act-1989-sec-41ga-norm
asserts: therapeutic-goods-act-1989-sec-41ga-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ga-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ga
schema version: 2

therapeutic-goods-act-1989-sec-41ga-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits suspension of medical devices
modality: Deontic
operator: Prohibit
premise text: (1) The Secretary may, by written notice...

therapeutic-goods-act-1989-sec-41ga-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies medical devices into the Register
modality: DescriptionLogic
operator: Classify
premise text: (a) the Secretary is satisfied that...

therapeutic-goods-act-1989-sec-41ga-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GA Suspension of kinds of medical devices from the Register

41GB Notice of proposed suspension must be given in certain cases
type: Concept
source: therapeutic-goods-act-1989.pdf, p.94
curation status: Proposed
has part: 41GB(1) Notice of proposed suspension must be given in certain cases
has part: 41GB(2) Notice of proposed suspension must be given in certain cases
proposed by: legis2cml
realized by: sec-41gb
schema version: 2

41GB(1) Notice of proposed suspension must be given in certain cases
type: Concept
description: Notice, reasons for suspension
source: therapeutic-goods-act-1989.pdf, p.94
note: Secretary must inform person of proposed suspension and give reasonable opportunity to make submissions.
asserts: therapeutic-goods-act-1989-sec-41gb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41gb-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gb-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gb-ss-1
schema version: 2
part of: 41GB Notice of proposed suspension must be given in certain cases

therapeutic-goods-act-1989-sec-41gb-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to inform and provide reasons
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41gb-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies as obligation under section 41GB(1)
modality: DescriptionLogic
operator: SUBCLASS OF

therapeutic-goods-act-1989-sec-41gb-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GB(1) Notice of proposed suspension must be given in certain cases

41GB(2) Notice of proposed suspension must be given in certain cases
type: Concept
source: therapeutic-goods-act-1989.pdf, p.94
note: Secretary must consider submissions before making a decision on proposed suspension.
asserts: therapeutic-goods-act-1989-sec-41gb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41gb-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gb-ss-2
schema version: 2
part of: 41GB Notice of proposed suspension must be given in certain cases

therapeutic-goods-act-1989-sec-41gb-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...until the Secretary has had regard...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must consider submissions
modality: Deontic
operator: MUST
premise text: Secretary is not to make a decision...

therapeutic-goods-act-1989-sec-41gb-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GB(2) Notice of proposed suspension must be given in certain cases

41GC Duration of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.94
curation status: Proposed
has part: 41GC(1) Duration of suspension
has part: 41GC(2) Duration of suspension
has part: 41GC(3) Duration of suspension
has part: 41GC(4) Duration of suspension
proposed by: legis2cml
realized by: sec-41gc
schema version: 2

41GC(1) Duration of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.94
note: Suspension takes effect on specified day after notice is given to person.
asserts: therapeutic-goods-act-1989-sec-41gc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41gc-ss-1-logic-alleninterval-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gc-ss-1
schema version: 2
part of: 41GC Duration of suspension

therapeutic-goods-act-1989-sec-41gc-ss-1-logic-alleninterval-1
type: LogicApplication
conclusion text: period
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Suspension occurs during specified period
modality: AllenInterval
operator: during

therapeutic-goods-act-1989-sec-41gc-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GC(1) Duration of suspension

41GC(2) Duration of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.94
note: Suspension duration
asserts: therapeutic-goods-act-1989-sec-41gc-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gc-ss-2
schema version: 2
part of: 41GC Duration of suspension

41GC(3) Duration of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.94
note: Extend period of suspension for medical device removal
asserts: therapeutic-goods-act-1989-sec-41gc-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41gc-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gc-ss-3-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gc-ss-3
schema version: 2
part of: 41GC Duration of suspension

therapeutic-goods-act-1989-sec-41gc-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to extend period of suspension
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-41gc-ss-3-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies medical devices by type
modality: DescriptionLogic
operator: class

therapeutic-goods-act-1989-sec-41gc-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GC(3) Duration of suspension

41GC(4) Duration of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.94
note: Notice of extension publication
asserts: therapeutic-goods-act-1989-sec-41gc-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gc-ss-4
schema version: 2
part of: 41GC Duration of suspension

41GD Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.95
curation status: Proposed
has part: 41GD(1) Revocation of suspension
has part: 41GD(2) Revocation of suspension
proposed by: legis2cml
realized by: sec-41gd
schema version: 2

41GD(1) Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.95
note: Revocation of suspension under specified conditions.
asserts: therapeutic-goods-act-1989-sec-41gd-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41gd-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gd-ss-1-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41gd-ss-1-logic-alleninterval-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gd-ss-1
schema version: 2
part of: 41GD Revocation of suspension

therapeutic-goods-act-1989-sec-41gd-ss-1-logic-alleninterval-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for revocation
modality: AllenInterval
operator: BETWEEN
premise text: (1) The Secretary must revoke the suspension...

therapeutic-goods-act-1989-sec-41gd-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must revoke suspension
modality: Deontic
operator: MUST
premise text: (1) The Secretary must revoke the suspension...

therapeutic-goods-act-1989-sec-41gd-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Device type is a medical device
modality: DescriptionLogic
operator: IS_A
premise text: (a) the ground on which the kind of medical device concerned was suspended from the Register no longer applies;

41GD(2) Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.95
note: Exercise of power to revoke suspension
asserts: therapeutic-goods-act-1989-sec-41gd-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gd-ss-2
schema version: 2
part of: 41GD Revocation of suspension

41GE Treating applications for revocation as having been refused
type: Concept
source: therapeutic-goods-act-1989.pdf, p.96
curation status: Proposed
has part: 41GE(1) Treating applications for revocation as having been refused
has part: 41GE(2) Treating applications for revocation as having been refused
has part: 41GE(3) Treating applications for revocation as having been refused
proposed by: legis2cml
realized by: sec-41ge
schema version: 2

41GE(1) Treating applications for revocation as having been refused
type: Concept
source: therapeutic-goods-act-1989.pdf, p.96
note: Applicant can treat application as refused if Secretary fails to decide within prescribed time.
asserts: therapeutic-goods-act-1989-sec-41ge-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ge-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ge-ss-1
schema version: 2
part of: 41GE Treating applications for revocation as having been refused

therapeutic-goods-act-1989-sec-41ge-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Duty to provide decision within time
modality: Deontic
operator: imposes

therapeutic-goods-act-1989-sec-41ge-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 41GE(1) Treating applications for revocation as having been refused

41GE(2) Treating applications for revocation as having been refused
type: Concept
source: therapeutic-goods-act-1989.pdf, p.96
note: Notice may be given at any time before decision on application.
asserts: therapeutic-goods-act-1989-sec-41ge-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ge-ss-2
schema version: 2
part of: 41GE Treating applications for revocation as having been refused

therapeutic-goods-act-1989-sec-41ge-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GE(2) Treating applications for revocation as having been refused

41GE(3) Treating applications for revocation as having been refused
type: Concept
source: therapeutic-goods-act-1989.pdf, p.96
note: If a notice has been given, the Act has no effect as if the Secretary had decided not to revoke the suspension.
asserts: therapeutic-goods-act-1989-sec-41ge-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41ge-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ge-ss-3-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41ge-ss-3-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41ge-ss-3-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ge-ss-3
schema version: 2
part of: 41GE Treating applications for revocation as having been refused

therapeutic-goods-act-1989-sec-41ge-ss-3-logic-alleninterval-2
type: LogicApplication
conclusion text: The Minister's decision had been made on the day on which notice was given to the Secretary.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The text describes a temporal interval where the notice being given overlaps with the day on which the Minister's decision was made.
modality: AllenInterval
operator: Overlaps
premise text: Notice has been given.

therapeutic-goods-act-1989-sec-41ge-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: The Act has no effect as if the Secretary had decided not to revoke the suspension.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: If a notice has been given, then the Act has no effect as if the Secretary had decided not to revoke the suspension.
modality: Deontic
operator: Implies
premise text: Notice has been given.

therapeutic-goods-act-1989-sec-41ge-ss-3-logic-deontic-4
type: LogicApplication
conclusion text: The Minister's decision had been made on the day on which notice was given to the Secretary.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: If a notice has been given, then the Minister's decision is confirmed by the Secretary.
modality: Deontic
operator: Implies
premise text: Notice has been given.

therapeutic-goods-act-1989-sec-41ge-ss-3-logic-ltl-3
type: LogicApplication
conclusion text: The Act has no effect as if the Secretary had decided not to revoke the suspension.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The text describes a repeating pattern where the notice being given repeats indefinitely.
modality: LTL
operator: Repeats
premise text: Notice has been given.

therapeutic-goods-act-1989-sec-41ge-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GE(3) Treating applications for revocation as having been refused

41GF Suspension where conformity assessment certificate
type: Concept
source: therapeutic-goods-act-1989.pdf, p.97
curation status: Proposed
has part: 41GF(1) Suspension where conformity assessment certificate
has part: 41GF(2) Suspension where conformity assessment certificate
has part: 41GF(3) Suspension where conformity assessment certificate
proposed by: legis2cml
realized by: sec-41gf
schema version: 2

41GF(1) Suspension where conformity assessment certificate
type: Concept
source: therapeutic-goods-act-1989.pdf, p.97
note: Suspension of medical device from Register upon suspension of Australian conformity assessment body certificate or overseas regulator conformity assessment document. Secretary may suspend medical device from Register if conformity assessment certificate is suspended.
asserts: therapeutic-goods-act-1989-sec-41gf-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41gf-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gf-ss-1-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41gf-ss-1-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41gf-ss-1-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-41gf-ss-1-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-41gf-ss-1-logic-cogai-6
asserts: therapeutic-goods-act-1989-sec-41gf-ss-1-logic-deontic-7
asserts: therapeutic-goods-act-1989-sec-41gf-ss-1-logic-descriptionlogic-8
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gf-ss-1
schema version: 2
part of: 41GF Suspension where conformity assessment certificate

therapeutic-goods-act-1989-sec-41gf-ss-1-logic-alleninterval-3
type: LogicApplication
conclusion text: (1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Suspension occurs during suspension of relevant certificates.
modality: AllenInterval
operator: During
premise text: (1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.

therapeutic-goods-act-1989-sec-41gf-ss-1-logic-cogai-6
type: LogicApplication
conclusion text: (1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Classification of medical devices based on suspension of relevant certificates.
modality: CogAI
operator: Classify
premise text: (1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.

therapeutic-goods-act-1989-sec-41gf-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: (1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of medical device from Register upon suspension of relevant certificates.
modality: Deontic
operator: Prohibit
premise text: (1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.

therapeutic-goods-act-1989-sec-41gf-ss-1-logic-deontic-7
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Implies obligation
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41gf-ss-1-logic-descriptionlogic-2
type: LogicApplication
conclusion text: (1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of medical devices based on suspension of relevant certificates.
modality: DescriptionLogic
operator: Classify
premise text: (1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.

therapeutic-goods-act-1989-sec-41gf-ss-1-logic-descriptionlogic-8
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies device as part of a set
modality: DescriptionLogic
operator: is included in the Register

therapeutic-goods-act-1989-sec-41gf-ss-1-logic-diffusion-5
type: LogicApplication
conclusion text: (1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Suspension occurs if relevant certificates are suspended.
modality: Diffusion
operator: If
premise text: (1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.

therapeutic-goods-act-1989-sec-41gf-ss-1-logic-ltl-4
type: LogicApplication
conclusion text: (1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Suspension continues until relevant certificates are reinstated.
modality: LTL
operator: Until
premise text: (1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.

therapeutic-goods-act-1989-sec-41gf-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GF(1) Suspension where conformity assessment certificate

41GF(2) Suspension where conformity assessment certificate
type: Concept
source: therapeutic-goods-act-1989.pdf, p.97
note: Suspension under this section is limited to the same extent as suspension under Division 3 of Part 4-4. Secretary must take action before suspending a device from the Register
asserts: therapeutic-goods-act-1989-sec-41gf-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41gf-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gf-ss-2
schema version: 2
part of: 41GF Suspension where conformity assessment certificate

therapeutic-goods-act-1989-sec-41gf-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Suspension under this section is limited to the same extent as suspension under Division 3 of Part 4-4.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: If suspension under Division 3 of Part 4-4 is limited to some medical devices, then suspension under this section is also limited.
modality: Deontic
operator: implies
premise text: Suspension under Division 3 of Part 4-4 is limited to some medical devices.

therapeutic-goods-act-1989-sec-41gf-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GF(2) Suspension where conformity assessment certificate

41GF(3) Suspension where conformity assessment certificate
type: Concept
description: Notice setting out particulars of the suspension.
source: therapeutic-goods-act-1989.pdf, p.97
note: Secretary must publish notice of suspension particulars.
asserts: therapeutic-goods-act-1989-sec-41gf-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41gf-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gf-ss-3
schema version: 2
part of: 41GF Suspension where conformity assessment certificate

therapeutic-goods-act-1989-sec-41gf-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must publish notice.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41gf-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GF(3) Suspension where conformity assessment certificate

41GG Duration of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.98
curation status: Proposed
has part: 41GG(1) Duration of suspension
has part: 41GG(2) Duration of suspension
proposed by: legis2cml
realized by: sec-41gg
schema version: 2

41GG(1) Duration of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.98
note: Commencement of suspension
asserts: therapeutic-goods-act-1989-sec-41gg-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gg-ss-1
schema version: 2
part of: 41GG Duration of suspension

41GG(2) Duration of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.98
note: Duration of suspension
asserts: therapeutic-goods-act-1989-sec-41gg-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gg-ss-2
schema version: 2
part of: 41GG Duration of suspension

41GH Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.98
curation status: Proposed
has part: 41GH(1) Revocation of suspension
has part: 41GH(1A) Revocation of suspension
has part: 41GH(2) Revocation of suspension
proposed by: legis2cml
realized by: sec-41gh
schema version: 2

41GH(1) Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.98
note: Secretary must revoke suspension under certain conditions.
asserts: therapeutic-goods-act-1989-sec-41gh-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41gh-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gh-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gh-ss-1
schema version: 2
part of: 41GH Revocation of suspension

therapeutic-goods-act-1989-sec-41gh-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Suspension must be revoked
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to revoke suspension
modality: Deontic
operator: MUST
premise text: Secretary has power to revoke suspension

therapeutic-goods-act-1989-sec-41gh-ss-1-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Cessation of effect is revocation
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Definition of revocation
modality: DescriptionLogic
operator: IS_A
premise text: Revocation is defined as cessation of effect

therapeutic-goods-act-1989-sec-41gh-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GH(1) Revocation of suspension

41GH(1A) Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.98
note: The Secretary may revoke a suspension under section 41GFA if certain conditions are met.
asserts: therapeutic-goods-act-1989-sec-41gh-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-41gh-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gh-ss-1a-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gh-ss-1a
schema version: 2
part of: 41GH Revocation of suspension

therapeutic-goods-act-1989-sec-41gh-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary may revoke a suspension under section 41GFA.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41gh-ss-1a-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: The kind of medical device is included in the Register.
modality: DescriptionLogic
operator: includes

therapeutic-goods-act-1989-sec-41gh-ss-1a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GH(1A) Revocation of suspension

41GH(2) Revocation of suspension
type: Concept
description: Notice of revocation, publication in Gazette or website
source: therapeutic-goods-act-1989.pdf, p.98
note: Secretary must provide written notice and publish revocation notice within specified timeframe.
asserts: therapeutic-goods-act-1989-sec-41gh-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41gh-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gh-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gh-ss-2
schema version: 2
part of: 41GH Revocation of suspension

therapeutic-goods-act-1989-sec-41gh-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide notice and publish revocation
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41gh-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of revocation as a subclass of suspension
modality: DescriptionLogic
operator: SUBCLASS OF

therapeutic-goods-act-1989-sec-41gh-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GH(2) Revocation of suspension

41GI Effect of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.99
note: Medical devices of a particular kind are not included in the Register while suspension has effect.
asserts: therapeutic-goods-act-1989-sec-41gi-norm
asserts: therapeutic-goods-act-1989-sec-41gi-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gi
schema version: 2

therapeutic-goods-act-1989-sec-41gi-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits dealing in medical devices not included in the Register.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41gi-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GI Effect of suspension

41GJ Powers of cancellation from Register unaffected
type: Concept
source: therapeutic-goods-act-1989.pdf, p.99
note: Does not affect Secretary's powers to cancel medical device entries from Register
asserts: therapeutic-goods-act-1989-sec-41gj-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gj
schema version: 2

41GK Automatic cancellation of entries of kinds of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.100
curation status: Proposed
has part: 41GK(1) Automatic cancellation of entries of kinds of medical devices
has part: 41GK(2) Automatic cancellation of entries of kinds of medical devices
proposed by: legis2cml
realized by: sec-41gk
schema version: 2

41GK(1) Automatic cancellation of entries of kinds of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.100
note: Secretary must cancel entry of medical device from Register under certain conditions.
asserts: therapeutic-goods-act-1989-sec-41gk-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41gk-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gk-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gk-ss-1
schema version: 2
part of: 41GK Automatic cancellation of entries of kinds of medical devices

therapeutic-goods-act-1989-sec-41gk-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must cancel entry
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41gk-ss-1-logic-descriptionlogic-2
type: LogicApplication
conclusion text: kind of medical device
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Relation to Register
modality: DescriptionLogic
operator: hasPartOf
premise text: Register

therapeutic-goods-act-1989-sec-41gk-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GK(1) Automatic cancellation of entries of kinds of medical devices

41GK(2) Automatic cancellation of entries of kinds of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.100
note: Automatic cancellation of entries of kinds of medical devices if they contravene absolute prohibitions or conditions.
asserts: therapeutic-goods-act-1989-sec-41gk-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41gk-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gk-ss-2-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41gk-ss-2-logic-descriptionlogic-3
asserts: therapeutic-goods-act-1989-sec-41gk-ss-2-logic-alleninterval-4
asserts: therapeutic-goods-act-1989-sec-41gk-ss-2-logic-ltl-5
asserts: therapeutic-goods-act-1989-sec-41gk-ss-2-logic-diffusion-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gk-ss-2
schema version: 2
part of: 41GK Automatic cancellation of entries of kinds of medical devices

therapeutic-goods-act-1989-sec-41gk-ss-2-logic-alleninterval-4
type: LogicApplication
conclusion text: The device manufacture/supplies would contravene one or more of those prohibitions.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap between prohibitions and device manufacture/supplies.
modality: AllenInterval
operator: Overlap
premise text: If there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3).

therapeutic-goods-act-1989-sec-41gk-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Imports, exports, manufacture, and supplies would contravene one or more of those prohibitions.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Absolute prohibition on imports, exports, manufacture, and supplies.
modality: Deontic
operator: Prohibit
premise text: There are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3).

therapeutic-goods-act-1989-sec-41gk-ss-2-logic-deontic-2
type: LogicApplication
conclusion text: Imports, exports, manufacture, and supplies would contravene one or more of those conditions.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Conditioned prohibition on imports, exports, manufacture, and supplies.
modality: Deontic
operator: Prohibit
premise text: There are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions.

therapeutic-goods-act-1989-sec-41gk-ss-2-logic-descriptionlogic-3
type: LogicApplication
conclusion text: The device is classified as prohibited or subject to conditions.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of medical devices based on prohibitions and conditions.
modality: DescriptionLogic
operator: Classify
premise text: The Secretary must cancel the entry of the kind of device from the Register if...

therapeutic-goods-act-1989-sec-41gk-ss-2-logic-diffusion-6
type: LogicApplication
conclusion text: The device would spread to other areas.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Spread of prohibited devices through imports, exports, manufacture, and supplies.
modality: Diffusion
operator: Spread
premise text: If there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3).

therapeutic-goods-act-1989-sec-41gk-ss-2-logic-ltl-5
type: LogicApplication
conclusion text: The device would be subject to recurring prohibition.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of prohibited devices.
modality: LTL
operator: Recurring
premise text: There are one or more prohibitions in force for the purposes of subsection 9K(1) or (3).

therapeutic-goods-act-1989-sec-41gk-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GK(2) Automatic cancellation of entries of kinds of medical devices

41GL Immediate cancellation of entries of kinds of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.101
note: Cancellation of medical device entries from the Register
asserts: therapeutic-goods-act-1989-sec-41gl-norm
asserts: therapeutic-goods-act-1989-sec-41gl-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gl-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gl
schema version: 2

therapeutic-goods-act-1989-sec-41gl-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on continued inclusion of medical devices in the Register
modality: Deontic
operator: Prohibit
premise text: The Secretary may cancel the entry of a kind of device from the Register if...

therapeutic-goods-act-1989-sec-41gl-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of medical devices into therapeutic goods and medical devices
modality: DescriptionLogic
operator: Classify
premise text: devices of that kind are no longer therapeutic goods; or

therapeutic-goods-act-1989-sec-41gl-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GL Immediate cancellation of entries of kinds of medical devices

41GM Cancellation of entries of kinds of medical devices from the
type: Concept
source: therapeutic-goods-act-1989.pdf, p.103
note: Cancellation of entries from medical device register upon non-compliance with notice.
asserts: therapeutic-goods-act-1989-sec-41gm-norm
asserts: therapeutic-goods-act-1989-sec-41gm-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gm-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41gm-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gm
schema version: 2

therapeutic-goods-act-1989-sec-41gm-logic-deontic-1
type: LogicApplication
conclusion text: Cancellation not permitted.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits cancellation of entries without compliance.
modality: Deontic
operator: Prohibit
premise text: Notice given under section 41JA.

therapeutic-goods-act-1989-sec-41gm-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Device entry cancelled.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies medical devices based on non-compliance with notice.
modality: DescriptionLogic
operator: Classify
premise text: Person fails to comply with notice under section 41JA.

therapeutic-goods-act-1989-sec-41gm-logic-ltl-3
type: LogicApplication
conclusion text: Cancellation upon repeated non-compliance.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of non-compliance leads to cancellation.
modality: LTL
operator: Recurring
premise text: Notice given for ascertainment purposes.

therapeutic-goods-act-1989-sec-41gm-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GM Cancellation of entries of kinds of medical devices from the

41GN Cancellation of entries of kinds of medical devices from the
type: Concept
source: therapeutic-goods-act-1989.pdf, p.104
note: The Secretary may cancel an entry of a kind of medical device from the Register under certain conditions.
asserts: therapeutic-goods-act-1989-sec-41gn-norm
asserts: therapeutic-goods-act-1989-sec-41gn-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gn-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41gn-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41gn-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-41gn-logic-deontic-5
asserts: therapeutic-goods-act-1989-sec-41gn-logic-argumentation-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gn
schema version: 2

therapeutic-goods-act-1989-sec-41gn-logic-alleninterval-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The cancellation must occur within a certain timeframe after notice is given.
modality: AllenInterval
operator: >=

therapeutic-goods-act-1989-sec-41gn-logic-argumentation-6
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: The cancellation implies that the person has failed to comply with a condition or direction.
modality: Argumentation
operator: implies

therapeutic-goods-act-1989-sec-41gn-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary can cancel an entry of a kind of medical device from the Register.
modality: Deontic
operator: can

therapeutic-goods-act-1989-sec-41gn-logic-deontic-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The person in relation to whom the kind of medical device is included in the Register must comply with certain conditions.
modality: Deontic
operator: must

therapeutic-goods-act-1989-sec-41gn-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: The cancellation is related to changes in the safety or performance of the device.
modality: DescriptionLogic
operator: is-a

therapeutic-goods-act-1989-sec-41gn-logic-ltl-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The cancellation must occur before the device's conformity assessment document expires.
modality: LTL
operator: <

therapeutic-goods-act-1989-sec-41gn-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GN Cancellation of entries of kinds of medical devices from the

41GO Limiting cancellation of entries from Register to some
type: Concept
source: therapeutic-goods-act-1989.pdf, p.106
curation status: Proposed
has part: 41GO(1) Limiting cancellation of entries from Register to some
has part: 41GO(2) Limiting cancellation of entries from Register to some
proposed by: legis2cml
realized by: sec-41go
schema version: 2

41GO(1) Limiting cancellation of entries from Register to some
type: Concept
source: therapeutic-goods-act-1989.pdf, p.106
note: Secretary must limit cancellation of entries from Register to some medical devices.
asserts: therapeutic-goods-act-1989-sec-41go-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41go-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41go-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41go-ss-1
schema version: 2
part of: 41GO Limiting cancellation of entries from Register to some

therapeutic-goods-act-1989-sec-41go-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide limit on cancellation.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41go-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classify medical devices into categories.
modality: DescriptionLogic
operator: CLASSIFICATION

therapeutic-goods-act-1989-sec-41go-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GO(1) Limiting cancellation of entries from Register to some

41GO(2) Limiting cancellation of entries from Register to some
type: Concept
source: therapeutic-goods-act-1989.pdf, p.106
note: Must vary entry in Register upon cancellation of medical device
asserts: therapeutic-goods-act-1989-sec-41go-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41go-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41go-ss-2-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41go-ss-2-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41go-ss-2-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-41go-ss-2-logic-deontic-5
asserts: therapeutic-goods-act-1989-sec-41go-ss-2-logic-descriptionlogic-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41go-ss-2
schema version: 2
part of: 41GO Limiting cancellation of entries from Register to some

therapeutic-goods-act-1989-sec-41go-ss-2-logic-alleninterval-3
type: LogicApplication
conclusion text: ...the Secretary: (a) must vary the entry in the Register accordingly;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Varying entry in Register occurs within cancellation of medical device
modality: AllenInterval
operator: CONTAINS
premise text: (2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind...

therapeutic-goods-act-1989-sec-41go-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...the Secretary: (a) must vary the entry in the Register accordingly;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to vary entry in Register
modality: Deontic
operator: MUST
premise text: (2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind...

therapeutic-goods-act-1989-sec-41go-ss-2-logic-deontic-5
type: LogicApplication
conclusion text: ...the Secretary: (b) must not delete the entry from the Register because of the cancellation.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must not delete entry from Register upon cancellation of medical device
modality: Deontic
operator: MUST NOT
premise text: (2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind...

therapeutic-goods-act-1989-sec-41go-ss-2-logic-descriptionlogic-2
type: LogicApplication
conclusion text: ...the Secretary: (a) must vary the entry in the Register accordingly;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Varying entry in Register is a subclass of obligation to update
modality: DescriptionLogic
operator: SUBCLASS OF
premise text: (2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind...

therapeutic-goods-act-1989-sec-41go-ss-2-logic-descriptionlogic-6
type: LogicApplication
conclusion text: ...the Secretary: (b) must not delete the entry from the Register because of the cancellation.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Not deleting entry from Register is a subclass of obligation to preserve
modality: DescriptionLogic
operator: SUBCLASS OF
premise text: (2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind...

therapeutic-goods-act-1989-sec-41go-ss-2-logic-ltl-4
type: LogicApplication
conclusion text: ...the Secretary: (a) must vary the entry in the Register accordingly;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Varying entry in Register occurs within cancellation of medical device
modality: LTL
operator: CONTAINS
premise text: (2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind...

41GP Publication of cancellation of entry from Register
type: Concept
description: Notice setting out particulars of cancellation.
source: therapeutic-goods-act-1989.pdf, p.106
note: Publish notice of cancellation from Register after cancelling medical device entry.
asserts: therapeutic-goods-act-1989-sec-41gp-norm
asserts: therapeutic-goods-act-1989-sec-41gp-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gp-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gp
schema version: 2

therapeutic-goods-act-1989-sec-41gp-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to publish notice.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41gp-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Publication of cancellation from Register is a subclass of obligation.
modality: DescriptionLogic
operator: SUBCLASS_OF

therapeutic-goods-act-1989-sec-41gp-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GP Publication of cancellation of entry from Register

41GQ Date of effect of cancellation of entries from Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.107
note: Cancellation of medical device entries has a specified effective date.
asserts: therapeutic-goods-act-1989-sec-41gq-norm
asserts: therapeutic-goods-act-1989-sec-41gq-logic-descriptionlogic-1
asserts: therapeutic-goods-act-1989-sec-41gq-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gq
schema version: 2

therapeutic-goods-act-1989-sec-41gq-logic-alleninterval-2
type: LogicApplication
conclusion text: later day
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Specifies a later day
modality: AllenInterval
operator: >=
premise text: 20 working days after notice is given

therapeutic-goods-act-1989-sec-41gq-logic-descriptionlogic-1
type: LogicApplication
conclusion text: key
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Identifies the key
modality: DescriptionLogic
operator: =

therapeutic-goods-act-1989-sec-41gq-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GQ Date of effect of cancellation of entries from Register

41GR What this Part is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.108
note: Exemption of medical devices from certain provisions
asserts: therapeutic-goods-act-1989-sec-41gr-norm
asserts: therapeutic-goods-act-1989-sec-41gr-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gr-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41gr-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41gr-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-41gr-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gr
schema version: 2

therapeutic-goods-act-1989-sec-41gr-logic-alleninterval-2
type: LogicApplication
conclusion text: Note 1:
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Conditional commencement of exemptions
modality: AllenInterval
operator: Temporal Interval
premise text: The Minister may exempt certain medical devices from various provisions of this Chapter so that the devices may be stockpiled to deal with possible future emergencies or made available urgently to deal with actual emergencies.

therapeutic-goods-act-1989-sec-41gr-logic-deontic-1
type: LogicApplication
conclusion text: from various provisions of this Chapter
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Granting permission to exempt medical devices
modality: Deontic
operator: Permit
premise text: The Minister may exempt certain medical devices

therapeutic-goods-act-1989-sec-41gr-logic-deontic-4
type: LogicApplication
conclusion text: (a) section 41JCA (providing information to the Secretary); and (b) section 41KA (public notification and recall of medical devices);
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide information about exemptions under Part 41GR
modality: Deontic
operator: Obligation
premise text: Some of the other provisions of this Act about medical devices exempt under this Part are:

therapeutic-goods-act-1989-sec-41gr-logic-deontic-5
type: LogicApplication
conclusion text: (c) section 46A (search of premises).
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide information about exemptions under Part 41GR
modality: Deontic
operator: Obligation
premise text: Some of the other provisions of this Act about medical devices exempt under this Part are:

therapeutic-goods-act-1989-sec-41gr-logic-ltl-3
type: LogicApplication
conclusion text: Note 2:
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of exemptions under Part 41GR
modality: LTL
operator: Recurring Trace
premise text: The Minister may exempt certain medical devices from various provisions of this Chapter so that the devices may be stockpiled to deal with possible future emergencies or made available urgently to deal with actual emergencies.

41GS Minister may make exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.108
curation status: Proposed
has part: 41GS(1) Minister may make exemptions
has part: 41GS(1A) Minister may make exemptions
has part: 41GS(2) Minister may make exemptions
has part: 41GS(2A) Minister may make exemptions
has part: 41GS(3) Minister may make exemptions
has part: 41GS(4) Minister may make exemptions
has part: 41GS(5) Minister may make exemptions
proposed by: legis2cml
realized by: sec-41gs
schema version: 2

41GS(1) Minister may make exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.108
note: Minister may exempt specified kinds of medical devices from certain regulations.
asserts: therapeutic-goods-act-1989-sec-41gs-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41gs-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gs-ss-1
schema version: 2
part of: 41GS Minister may make exemptions

therapeutic-goods-act-1989-sec-41gs-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to exempt
modality: Deontic
operator: may

41GS(1A) Minister may make exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.108
note: Minister may grant exemptions under certain conditions.
asserts: therapeutic-goods-act-1989-sec-41gs-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-41gs-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gs-ss-1a
schema version: 2
part of: 41GS Minister may make exemptions

therapeutic-goods-act-1989-sec-41gs-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to exempt devices
modality: Deontic
operator: May

41GS(2) Minister may make exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.108
note: Minister may make exemptions in the national interest to stockpile medical devices quickly and provide them urgently in case of an emergency.
asserts: therapeutic-goods-act-1989-sec-41gs-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41gs-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gs-ss-2
schema version: 2
part of: 41GS Minister may make exemptions

therapeutic-goods-act-1989-sec-41gs-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Minister has the obligation to make exemptions in the national interest.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-41gs-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GS(2) Minister may make exemptions

41GS(2A) Minister may make exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.108
note: Exemption from certain requirements under national emergency declaration
asserts: therapeutic-goods-act-1989-sec-41gs-ss-2a-norm
asserts: therapeutic-goods-act-1989-sec-41gs-ss-2a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gs-ss-2a
schema version: 2
part of: 41GS Minister may make exemptions

therapeutic-goods-act-1989-sec-41gs-ss-2a-logic-deontic-1
type: LogicApplication
conclusion text: Exemption is permitted
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Granting permission
modality: Deontic
operator: Permit
premise text: Minister has discretion to make exemptions

41GS(3) Minister may make exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.108
note: Exemptions come into force on specified day or later
asserts: therapeutic-goods-act-1989-sec-41gs-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gs-ss-3
schema version: 2
part of: 41GS Minister may make exemptions

41GS(4) Minister may make exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.108
note: Exemptions remain in force for the specified period unless revoked earlier.
asserts: therapeutic-goods-act-1989-sec-41gs-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41gs-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gs-ss-4-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gs-ss-4
schema version: 2
part of: 41GS Minister may make exemptions

therapeutic-goods-act-1989-sec-41gs-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Holds true
modality: Deontic
operator: holds

therapeutic-goods-act-1989-sec-41gs-ss-4-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Subclass of exemptions
modality: DescriptionLogic
operator: subClassOf

therapeutic-goods-act-1989-sec-41gs-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GS(4) Minister may make exemptions

41GS(5) Minister may make exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.108
note: Exemption ceases to have effect when device is included in the Register.
asserts: therapeutic-goods-act-1989-sec-41gs-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-41gs-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gs-ss-5-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gs-ss-5
schema version: 2
part of: 41GS Minister may make exemptions

therapeutic-goods-act-1989-sec-41gs-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: ceases to have effect in relation to a particular kind of medical device
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation ceases
modality: Deontic
operator: ceases
premise text: (5) An exemption under subsection (1)

therapeutic-goods-act-1989-sec-41gs-ss-5-logic-descriptionlogic-2
type: LogicApplication
conclusion text: exemption ceases when device is included in the Register
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Device inclusion implies exclusion
modality: DescriptionLogic
operator: includes
premise text: (5) An exemption under subsection (1)

therapeutic-goods-act-1989-sec-41gs-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GS(5) Minister may make exemptions

41GT Conditions of exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.110
note: Conditions for exemptions under section 41GS
asserts: therapeutic-goods-act-1989-sec-41gt-norm
asserts: therapeutic-goods-act-1989-sec-41gt-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gt-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gt
schema version: 2

therapeutic-goods-act-1989-sec-41gt-logic-deontic-1
type: LogicApplication
conclusion text: Those conditions must be met
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Conditions must be met for exemptions
modality: Deontic
operator: must
premise text: An exemption under section 41GS is subject to conditions

therapeutic-goods-act-1989-sec-41gt-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Exemptions have conditions
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Conditions are related to exemptions
modality: DescriptionLogic
operator: is-a
premise text: The conditions specified in the exemption about any of the following:

therapeutic-goods-act-1989-sec-41gt-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GT Conditions of exemptions

41GU Variation or revocation of exemption
type: Concept
source: therapeutic-goods-act-1989.pdf, p.111
curation status: Proposed
has part: 41GU(1) Variation or revocation of exemption
has part: 41GU(2) Variation or revocation of exemption
has part: 41GU(3) Variation or revocation of exemption
has part: 41GU(4) Variation or revocation of exemption
proposed by: legis2cml
realized by: sec-41gu
schema version: 2

41GU(1) Variation or revocation of exemption
type: Concept
source: therapeutic-goods-act-1989.pdf, p.111
note: Variation of exemption by Minister
asserts: therapeutic-goods-act-1989-sec-41gu-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41gu-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gu-ss-1
schema version: 2
part of: 41GU Variation or revocation of exemption

therapeutic-goods-act-1989-sec-41gu-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Granting permission to vary exemptions
modality: Deontic
operator: may

41GU(2) Variation or revocation of exemption
type: Concept
source: therapeutic-goods-act-1989.pdf, p.111
note: Revocation of exemption by Minister
asserts: therapeutic-goods-act-1989-sec-41gu-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41gu-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gu-ss-2
schema version: 2
part of: 41GU Variation or revocation of exemption

therapeutic-goods-act-1989-sec-41gu-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: The exemption is revoked.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Granting permission
modality: Deontic
operator: Permit
premise text: (2) The Minister may, by writing...

41GU(3) Variation or revocation of exemption
type: Concept
source: therapeutic-goods-act-1989.pdf, p.111
note: Variation or revocation of exemption conditions
asserts: therapeutic-goods-act-1989-sec-41gu-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41gu-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gu-ss-3
schema version: 2
part of: 41GU Variation or revocation of exemption

therapeutic-goods-act-1989-sec-41gu-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to vary or revoke exemptions
modality: Deontic
operator: may

41GU(4) Variation or revocation of exemption
type: Concept
source: therapeutic-goods-act-1989.pdf, p.111
note: Variation or revocation of exemption takes effect under specified conditions.
asserts: therapeutic-goods-act-1989-sec-41gu-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41gu-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gu-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41gu-ss-4-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41gu-ss-4-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41gu-ss-4-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gu-ss-4
schema version: 2
part of: 41GU Variation or revocation of exemption

therapeutic-goods-act-1989-sec-41gu-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: Effect of variation or revocation occurs within 28 days after it is made
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval between variation or revocation and its effect
modality: AllenInterval
operator: between
premise text: Variation or revocation is made on a specific day

therapeutic-goods-act-1989-sec-41gu-ss-4-logic-cogai-5
type: LogicApplication
conclusion text: Exemption has subclasses Variation and Revocation recognized by CogAI
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: CogAI recognizes variation or revocation as a subclass of exemption
modality: CogAI
operator: recognizes
premise text: Variation/Revocation is recognized as a subclass of Exemption by CogAI

therapeutic-goods-act-1989-sec-41gu-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: Variation or revocation takes effect under specified conditions
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to specify conditions for variation or revocation
modality: Deontic
operator: obligation
premise text: Minister must state imminent risk

therapeutic-goods-act-1989-sec-41gu-ss-4-logic-diffusion-4
type: LogicApplication
conclusion text: Information about imminent risk diffuses to relevant parties
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusion of information about variation or revocation
modality: Diffusion
operator: diffuses
premise text: Minister states imminent risk in variation or revocation

therapeutic-goods-act-1989-sec-41gu-ss-4-logic-ltl-3
type: LogicApplication
conclusion text: Effect of variation or revocation occurs after specified day
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal interval until effect of variation or revocation
modality: LTL
operator: until
premise text: Variation or revocation takes effect on a later day specified in the variation or revocation

therapeutic-goods-act-1989-sec-41gu-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GU(4) Variation or revocation of exemption

41GV Informing persons of exemption etc.
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.111
note: Must provide Chapter 4 Medical devices to persons covered by paragraph 41GT(c)
asserts: therapeutic-goods-act-1989-sec-41gv-norm
asserts: therapeutic-goods-act-1989-sec-41gv-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gv-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gv
schema version: 2

therapeutic-goods-act-1989-sec-41gv-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The Minister must provide Chapter 4 Medical devices within a reasonable timeframe
modality: AllenInterval
operator: CONTAINS

therapeutic-goods-act-1989-sec-41gv-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide Chapter 4 Medical devices
modality: Deontic
operator: MUST PROVIDE

41GW Notification and tabling
type: Concept
source: therapeutic-goods-act-1989.pdf, p.112
curation status: Proposed
has part: 41GW(1) Notification and tabling
has part: 41GW(2) Notification and tabling
proposed by: legis2cml
realized by: sec-41gw
schema version: 2

41GW(1) Notification and tabling
type: Concept
description: Notice setting out particulars of exemption, variation or revocation
source: therapeutic-goods-act-1989.pdf, p.112
note: Publish notice in Gazette within 5 working days after exemption, variation or revocation is made.
asserts: therapeutic-goods-act-1989-sec-41gw-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41gw-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gw-ss-1
schema version: 2
part of: 41GW Notification and tabling

therapeutic-goods-act-1989-sec-41gw-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must publish notice in Gazette
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41gw-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GW(1) Notification and tabling

41GW(2) Notification and tabling
type: Concept
source: therapeutic-goods-act-1989.pdf, p.112
note: Minister must table document within 5 sitting days of exemption, variation or revocation made.
asserts: therapeutic-goods-act-1989-sec-41gw-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41gw-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gw-ss-2
schema version: 2
part of: 41GW Notification and tabling

therapeutic-goods-act-1989-sec-41gw-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Minister must table document
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41gw-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GW(2) Notification and tabling

41GY Disposal of unused medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.113
curation status: Proposed
has part: 41GY(1) Disposal of unused medical devices
has part: 41GY(2) Disposal of unused medical devices
has part: 41GY(3) Disposal of unused medical devices
has part: 41GY(4) Disposal of unused medical devices
proposed by: legis2cml
realized by: sec-41gy
schema version: 2

41GY(1) Disposal of unused medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.113
note: Medical device must be disposed of if exemption ceases to have effect
asserts: therapeutic-goods-act-1989-sec-41gy-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41gy-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gy-ss-1-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41gy-ss-1-logic-alleninterval-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gy-ss-1
schema version: 2
part of: 41GY Disposal of unused medical devices

therapeutic-goods-act-1989-sec-41gy-ss-1-logic-alleninterval-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Cease to have effect before use
modality: AllenInterval
operator: >=
premise text: (b) the medical device has not been used before the exemption so ceases to have effect.

therapeutic-goods-act-1989-sec-41gy-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must be disposed of
modality: Deontic
operator: MUST
premise text: (1) This section applies to a medical device...

therapeutic-goods-act-1989-sec-41gy-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Related to disposal of medical devices
modality: DescriptionLogic
operator: IS_A
premise text: (a) an exemption under section 41GS in relation to that kind of medical device ceases to have effect...

therapeutic-goods-act-1989-sec-41gy-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GY(1) Disposal of unused medical devices

41GY(2) Disposal of unused medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.113
note: The Secretary may arrange for disposal of medical devices.
asserts: therapeutic-goods-act-1989-sec-41gy-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41gy-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gy-ss-2
schema version: 2
part of: 41GY Disposal of unused medical devices

therapeutic-goods-act-1989-sec-41gy-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Implies obligation
modality: Deontic
operator: may

41GY(3) Disposal of unused medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.113
note: Methods for disposal of medical devices
asserts: therapeutic-goods-act-1989-sec-41gy-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gy-ss-3
schema version: 2
part of: 41GY Disposal of unused medical devices

41GY(4) Disposal of unused medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.113
note: Prohibits benefit conferred on person other than owner of medical device
asserts: therapeutic-goods-act-1989-sec-41gy-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41gy-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41gy-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41gy-ss-4-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41gy-ss-4-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41gy-ss-4-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41gy-ss-4
schema version: 2
part of: 41GY Disposal of unused medical devices

therapeutic-goods-act-1989-sec-41gy-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal scope of regulation
modality: AllenInterval
operator: during
premise text: (4) A method set out in the regulations under subsection (3)

therapeutic-goods-act-1989-sec-41gy-ss-4-logic-cogai-5
type: LogicApplication
conclusion text: must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Temporal scope of regulation
modality: CogAI
operator: during
premise text: (4) A method set out in the regulations under subsection (3)

therapeutic-goods-act-1989-sec-41gy-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits benefit
modality: Deontic
operator: forbid
premise text: (4) A method set out in the regulations under subsection (3)

therapeutic-goods-act-1989-sec-41gy-ss-4-logic-diffusion-4
type: LogicApplication
conclusion text: must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Temporal scope of regulation
modality: Diffusion
operator: during
premise text: (4) A method set out in the regulations under subsection (3)

therapeutic-goods-act-1989-sec-41gy-ss-4-logic-ltl-3
type: LogicApplication
conclusion text: must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal scope of regulation
modality: LTL
operator: during
premise text: (4) A method set out in the regulations under subsection (3)

therapeutic-goods-act-1989-sec-41gy-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41GY(4) Disposal of unused medical devices

41H What this Part is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.114
note: Exemptions from prohibitions on dealing in medical devices
asserts: therapeutic-goods-act-1989-sec-41h-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41h
schema version: 2

therapeutic-goods-act-1989-sec-41h-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41H What this Part is about

41HA Devices exempted from inclusion in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.114
note: Exemptions from Division 3 regulation
asserts: therapeutic-goods-act-1989-sec-41ha-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ha
schema version: 2

41HB Approvals for special and experimental uses
type: Concept
source: therapeutic-goods-act-1989.pdf, p.115
curation status: Proposed
has part: 41HB(1) Approvals for special and experimental uses
has part: 41HB(1A) Approvals for special and experimental uses
has part: 41HB(2) Approvals for special and experimental uses
has part: 41HB(3) Approvals for special and experimental uses
proposed by: legis2cml
realized by: sec-41hb
schema version: 2

41HB(1) Approvals for special and experimental uses
type: Concept
source: therapeutic-goods-act-1989.pdf, p.115
note: Grant of written approval for specified medical device use
asserts: therapeutic-goods-act-1989-sec-41hb-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hb-ss-1
schema version: 2
part of: 41HB Approvals for special and experimental uses

therapeutic-goods-act-1989-sec-41hb-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41HB(1) Approvals for special and experimental uses

41HB(1A) Approvals for special and experimental uses
type: Concept
source: therapeutic-goods-act-1989.pdf, p.115
note: Approval for special and experimental uses must be granted only to health practitioners.
asserts: therapeutic-goods-act-1989-sec-41hb-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hb-ss-1a
schema version: 2
part of: 41HB Approvals for special and experimental uses

therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-alleninterval-2
type: LogicApplication
conclusion text: Approval of special and experimental uses has a specific temporal interval.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines temporal interval for approval of special and experimental uses.
modality: AllenInterval
operator: Temporal Interval
premise text: (1A) An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner.

therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-cogai-5
type: LogicApplication
conclusion text: Approval for special and experimental uses requires health practitioner eligibility.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Classifies approval for special and experimental uses as requiring health practitioner eligibility.
modality: CogAI
operator: Classify
premise text: (1A) An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner.

therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-deontic-1
type: LogicApplication
conclusion text: Approval must be granted only to health practitioners.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits granting approval to non-health practitioners.
modality: Deontic
operator: Prohibit
premise text: (1A) An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner.

therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-diffusion-4
type: LogicApplication
conclusion text: Approval eligibility for special and experimental uses is diffused through the system.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses information about approval eligibility for special and experimental uses.
modality: Diffusion
operator: Diffuse
premise text: (1A) An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner.

therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-ltl-3
type: LogicApplication
conclusion text: Approval of special and experimental uses has a specific temporal interval.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines temporal interval for approval of special and experimental uses.
modality: LTL
operator: Temporal Interval
premise text: (1A) An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner.

therapeutic-goods-act-1989-sec-41hb-ss-1a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41HB(1A) Approvals for special and experimental uses

41HB(2) Approvals for special and experimental uses
type: Concept
source: therapeutic-goods-act-1989.pdf, p.115
note: Breach of conditions may be an offence
asserts: therapeutic-goods-act-1989-sec-41hb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41hb-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hb-ss-2
schema version: 2
part of: 41HB Approvals for special and experimental uses

therapeutic-goods-act-1989-sec-41hb-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of breach
modality: Deontic
operator: Prohibition
premise text: Breach of conditions may be an offence

41HB(3) Approvals for special and experimental uses
type: Concept
source: therapeutic-goods-act-1989.pdf, p.115
note: Conditions for approval of medical devices for experimental use in humans.
asserts: therapeutic-goods-act-1989-sec-41hb-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41hb-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41hb-ss-3-logic-ltl-2
asserts: therapeutic-goods-act-1989-sec-41hb-ss-3-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-41hb-ss-3-logic-alleninterval-4
asserts: therapeutic-goods-act-1989-sec-41hb-ss-3-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hb-ss-3
schema version: 2
part of: 41HB Approvals for special and experimental uses

therapeutic-goods-act-1989-sec-41hb-ss-3-logic-alleninterval-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: During experimental use
modality: AllenInterval
operator: during
premise text: The conditions may relate to one or more of the following:

therapeutic-goods-act-1989-sec-41hb-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires preconditions
modality: Deontic
operator: requires
premise text: (a) the preconditions on another person’s use of devices of those kinds for those purposes;

therapeutic-goods-act-1989-sec-41hb-ss-3-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires principles of device use
modality: Deontic
operator: requires
premise text: (b) the principles to be followed in another person’s use of devices of those kinds for those purposes;

therapeutic-goods-act-1989-sec-41hb-ss-3-logic-deontic-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires relation to device types
modality: Deontic
operator: requires
premise text: The conditions may relate to one or more of the following:

therapeutic-goods-act-1989-sec-41hb-ss-3-logic-ltl-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: For all persons using medical devices
modality: LTL
operator: for all
premise text: (a) the preconditions on another person’s use of devices of those kinds for those purposes;

therapeutic-goods-act-1989-sec-41hb-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41HB(3) Approvals for special and experimental uses

41HC Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.118
curation status: Proposed
has part: 41HC(1) Authorities for health practitioners
has part: 41HC(1A) Authorities for health practitioners
has part: 41HC(2) Authorities for health practitioners
has part: 41HC(3) Authorities for health practitioners
has part: 41HC(4) Authorities for health practitioners
has part: 41HC(5) Authorities for health practitioners
has part: 41HC(6) Authorities for health practitioners
has part: 41HC(6A) Authorities for health practitioners
has part: 41HC(6B) Authorities for health practitioners
has part: 41HC(6C) Authorities for health practitioners
has part: 41HC(6D) Authorities for health practitioners
has part: 41HC(6E) Authorities for health practitioners
proposed by: legis2cml
realized by: sec-41hc
schema version: 2

41HC(1) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.118
note: Secretary may authorise medical practitioner to supply medical devices.
asserts: therapeutic-goods-act-1989-sec-41hc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41hc-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41hc-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hc-ss-1
schema version: 2
part of: 41HC Authorities for health practitioners

therapeutic-goods-act-1989-sec-41hc-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission granted by the Secretary.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41hc-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Class of recipients specified in the authorisation.
modality: DescriptionLogic
operator: hasPart

therapeutic-goods-act-1989-sec-41hc-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41HC(1) Authorities for health practitioners

41HC(1A) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.118
note: Application for authority must be in approved form
asserts: therapeutic-goods-act-1989-sec-41hc-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-41hc-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hc-ss-1a
schema version: 2
part of: 41HC Authorities for health practitioners

therapeutic-goods-act-1989-sec-41hc-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide approved application form
modality: Deontic
operator: MUST

41HC(2) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.118
note: Authority may be given subject to conditions.
asserts: therapeutic-goods-act-1989-sec-41hc-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hc-ss-2
schema version: 2
part of: 41HC Authorities for health practitioners

41HC(3) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.118
note: Secretary may impose conditions on health practitioners
asserts: therapeutic-goods-act-1989-sec-41hc-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41hc-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hc-ss-3
schema version: 2
part of: 41HC Authorities for health practitioners

therapeutic-goods-act-1989-sec-41hc-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41hc-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41HC(3) Authorities for health practitioners

41HC(4) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.118
note: Authority for health practitioners may only be given under certain conditions.
asserts: therapeutic-goods-act-1989-sec-41hc-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41hc-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41hc-ss-4-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hc-ss-4
schema version: 2
part of: 41HC Authorities for health practitioners

therapeutic-goods-act-1989-sec-41hc-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: (c)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authority is conditional on meeting specific requirements.
modality: Deontic
operator: onlyIf
premise text: (a) and (b)

therapeutic-goods-act-1989-sec-41hc-ss-4-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Authority applies to classes of medical practitioners.
modality: DescriptionLogic
operator: classOf
premise text: (a) and (c)

therapeutic-goods-act-1989-sec-41hc-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41HC(4) Authorities for health practitioners

41HC(5) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.118
note: Authority to prescribe circumstances for medical device supply
asserts: therapeutic-goods-act-1989-sec-41hc-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hc-ss-5
schema version: 2
part of: 41HC Authorities for health practitioners

41HC(6) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.118
note: The Minister may make rules authorising health practitioners to supply medical devices.
asserts: therapeutic-goods-act-1989-sec-41hc-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-41hc-ss-6-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41hc-ss-6-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hc-ss-6
schema version: 2
part of: 41HC Authorities for health practitioners

therapeutic-goods-act-1989-sec-41hc-ss-6-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to supply medical devices
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-41hc-ss-6-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Rules specify class of health practitioners
modality: DescriptionLogic
operator: Class inclusion
premise text: Health practitioner included in a specified Medical device Chapter 4

therapeutic-goods-act-1989-sec-41hc-ss-6-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41HC(6) Authorities for health practitioners

41HC(6A) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.118
note: Comply with regulations' requirements, restrictions, and limitations.
asserts: therapeutic-goods-act-1989-sec-41hc-ss-6a-norm
asserts: therapeutic-goods-act-1989-sec-41hc-ss-6a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41hc-ss-6a-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hc-ss-6a
schema version: 2
part of: 41HC Authorities for health practitioners

therapeutic-goods-act-1989-sec-41hc-ss-6a-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Requirements, restrictions, and limitations are within regulations.
modality: AllenInterval
operator: Within
premise text: (b) such restrictions (if any) as are prescribed by the regulations;

therapeutic-goods-act-1989-sec-41hc-ss-6a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Minister must comply with regulations.
modality: Deontic
operator: Must
premise text: (6A) In making rules under subsection (6), the Minister...

41HC(6B) Authorities for health practitioners
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.118
note: Notify supply within 28 days after supplying medical device.
asserts: therapeutic-goods-act-1989-sec-41hc-ss-6b-norm
asserts: therapeutic-goods-act-1989-sec-41hc-ss-6b-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41hc-ss-6b-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hc-ss-6b
schema version: 2
part of: 41HC Authorities for health practitioners

therapeutic-goods-act-1989-sec-41hc-ss-6b-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide notification.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41hc-ss-6b-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Notification must be made within 28 days.
modality: DescriptionLogic
operator: hasValue

therapeutic-goods-act-1989-sec-41hc-ss-6b-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41HC(6B) Authorities for health practitioners

41HC(6C) Authorities for health practitioners
type: Concept
description: Information as prescribed by regulations
source: therapeutic-goods-act-1989.pdf, p.118
note: Notification requirements for health practitioners
asserts: therapeutic-goods-act-1989-sec-41hc-ss-6c-norm
asserts: therapeutic-goods-act-1989-sec-41hc-ss-6c-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hc-ss-6c
schema version: 2
part of: 41HC Authorities for health practitioners

therapeutic-goods-act-1989-sec-41hc-ss-6c-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Notification requirement
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41hc-ss-6c-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41HC(6C) Authorities for health practitioners

41HC(6D) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.118
note: Approval of form may require or permit information to be given in accordance with specified software requirements.
asserts: therapeutic-goods-act-1989-sec-41hc-ss-6d-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hc-ss-6d
schema version: 2
part of: 41HC Authorities for health practitioners

41HC(6E) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.118
note: Offence for subject to requirement under subsection (6B)
asserts: therapeutic-goods-act-1989-sec-41hc-ss-6e-norm
asserts: therapeutic-goods-act-1989-sec-41hc-ss-6e-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hc-ss-6e
schema version: 2
part of: 41HC Authorities for health practitioners

therapeutic-goods-act-1989-sec-41hc-ss-6e-logic-deontic-1
type: LogicApplication
conclusion text: (6E)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Subject is required
modality: Deontic
operator: has
premise text: (6B)

therapeutic-goods-act-1989-sec-41hc-ss-6e-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41HC(6E) Authorities for health practitioners

41HD Approvals if substitutes for medical devices are unavailable
type: Concept
source: therapeutic-goods-act-1989.pdf, p.120
curation status: Proposed
has part: 41HD(1) Approvals if substitutes for medical devices are unavailable
has part: 41HD(1A) Approvals if substitutes for medical devices are unavailable
proposed by: legis2cml
realized by: sec-41hd
schema version: 2

41HD(1) Approvals if substitutes for medical devices are unavailable
type: Concept
source: therapeutic-goods-act-1989.pdf, p.120
note: Secretary may grant approval for importation and supply of medical device under certain conditions.
asserts: therapeutic-goods-act-1989-sec-41hd-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41hd-ss-1-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41hd-ss-1-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-5
asserts: therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hd-ss-1
schema version: 2
part of: 41HD Approvals if substitutes for medical devices are unavailable

therapeutic-goods-act-1989-sec-41hd-ss-1-logic-alleninterval-3
type: LogicApplication
conclusion text: ...the medical device is specified in a determination under subsection (6);
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Medical device may become unavailable or be in short supply.
modality: AllenInterval
operator: Temporal Interval
premise text: (ii) may, in the reasonably foreseeable future, become unavailable or be in short supply;

therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...the Secretary is satisfied that...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary grants approval.
modality: Deontic
operator: Grant
premise text: (1) The Secretary may, by notice in writing...

therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: ...the Secretary is satisfied that...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must satisfy certain conditions before granting approval.
modality: Deontic
operator: Obligation
premise text: (c) the kinds of medical devices included in the Register that...

therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-5
type: LogicApplication
conclusion text: ...the Secretary may, by notice in writing...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Approval is necessary in the interests of public health.
modality: Deontic
operator: Permission
premise text: (f) the approval is necessary in the interests of public health.

therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-6
type: LogicApplication
conclusion text: ...the Secretary may, by notice in writing...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Medical device must be registered or approved for general marketing in at least one foreign country.
modality: Deontic
operator: Permission
premise text: (i) the medical device is registered or approved for general marketing in at least one foreign country specified in a determination under subsection (5);

therapeutic-goods-act-1989-sec-41hd-ss-1-logic-descriptionlogic-2
type: LogicApplication
conclusion text: ...the kinds of medical devices included in the Register...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Medical devices included in the Register are classified as substitutes.
modality: DescriptionLogic
operator: Classify
premise text: (i) are unavailable or are in short supply;

therapeutic-goods-act-1989-sec-41hd-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41HD(1) Approvals if substitutes for medical devices are unavailable

41HD(1A) Approvals if substitutes for medical devices are unavailable
type: Concept
source: therapeutic-goods-act-1989.pdf, p.120
note: Secretary may grant approval for importation of medical device under certain conditions.
asserts: therapeutic-goods-act-1989-sec-41hd-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-41hd-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41hd-ss-1a
schema version: 2
part of: 41HD Approvals if substitutes for medical devices are unavailable

therapeutic-goods-act-1989-sec-41hd-ss-1a-logic-deontic-1
type: LogicApplication
conclusion text: Approval granted
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary grants approval
modality: Deontic
operator: Grant
premise text: Secretary has discretion to grant approval

therapeutic-goods-act-1989-sec-41hd-ss-1a-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41HD(1A) Approvals if substitutes for medical devices are unavailable

41J What this Part is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.125
note: The Secretary may seek information or documents relating to certain matters.
asserts: therapeutic-goods-act-1989-sec-41j-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41j
schema version: 2

therapeutic-goods-act-1989-sec-41j-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41J What this Part is about

41JA Secretary may require information or documents
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.126
note: The Secretary may require information or documents from a person related to medical devices.
asserts: therapeutic-goods-act-1989-sec-41ja-norm
asserts: therapeutic-goods-act-1989-sec-41ja-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ja-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ja
schema version: 2

therapeutic-goods-act-1989-sec-41ja-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must require information or documents.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41ja-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: The provision is part of the Therapeutic Goods Act 1989.
modality: DescriptionLogic
operator: SUBCLASS_OF

therapeutic-goods-act-1989-sec-41ja-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JA Secretary may require information or documents

41JB Complying with the Secretary’s requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.129
curation status: Proposed
has part: 41JB(1) Complying with the Secretary’s requirements
has part: 41JB(2) Complying with the Secretary’s requirements
has part: 41JB(3) Complying with the Secretary’s requirements
has part: 41JB(3A) Complying with the Secretary’s requirements
proposed by: legis2cml
realized by: sec-41jb
schema version: 2

41JB(1) Complying with the Secretary’s requirements
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.129
note: Provide information or documents to the Secretary within a specified time and form.
asserts: therapeutic-goods-act-1989-sec-41jb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41jb-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jb-ss-1
schema version: 2
part of: 41JB Complying with the Secretary’s requirements

therapeutic-goods-act-1989-sec-41jb-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide information or documents
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41jb-ss-1-norm
type: Obligation
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 41JB(1) Complying with the Secretary’s requirements

41JB(2) Complying with the Secretary’s requirements
type: Concept
description: Offence for failing to comply with a notice
source: therapeutic-goods-act-1989.pdf, p.129
note: Comply with specified software requirements for data processing device or electronic transmission.
asserts: therapeutic-goods-act-1989-sec-41jb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41jb-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41jb-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jb-ss-2
schema version: 2
part of: 41JB Complying with the Secretary’s requirements

therapeutic-goods-act-1989-sec-41jb-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must comply
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41jb-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Complying with requirements is a form of compliance
modality: DescriptionLogic
operator: IS-A

therapeutic-goods-act-1989-sec-41jb-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JB(2) Complying with the Secretary’s requirements

41JB(3) Complying with the Secretary’s requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.129
note: Failure to comply with notice leads to penalty and potential suspension/cancellation of certificates.
asserts: therapeutic-goods-act-1989-sec-41jb-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41jb-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41jb-ss-3-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41jb-ss-3-logic-descriptionlogic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jb-ss-3
schema version: 2
part of: 41JB Complying with the Secretary’s requirements

therapeutic-goods-act-1989-sec-41jb-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Penalty of 500 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits failure to comply with notice.
modality: Deontic
operator: Prohibition
premise text: Given notice under section 41JA

therapeutic-goods-act-1989-sec-41jb-ss-3-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Suspension or revocation of conformity assessment certificate.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Includes conditions for suspension/cancellation of certificates.
modality: DescriptionLogic
operator: ClassInclusion
premise text: Divisions 3 and 4 of Part 4-4

therapeutic-goods-act-1989-sec-41jb-ss-3-logic-descriptionlogic-3
type: LogicApplication
conclusion text: Suspension or cancellation of entry in Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Includes conditions for suspension/cancellation of medical device entries.
modality: DescriptionLogic
operator: ClassInclusion
premise text: Part 4-6

therapeutic-goods-act-1989-sec-41jb-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JB(3) Complying with the Secretary’s requirements

41JB(3A) Complying with the Secretary’s requirements
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.129
note: Must provide a reasonable excuse to avoid liability.
asserts: therapeutic-goods-act-1989-sec-41jb-ss-3a-norm
asserts: therapeutic-goods-act-1989-sec-41jb-ss-3a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41jb-ss-3a-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jb-ss-3a
schema version: 2
part of: 41JB Complying with the Secretary’s requirements

therapeutic-goods-act-1989-sec-41jb-ss-3a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Mandatory duty
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-41jb-ss-3a-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Defendant bears evidential burden
modality: Epistemic
operator: Belief

therapeutic-goods-act-1989-sec-41jb-ss-3a-norm
type: Obligation
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 41JB(3A) Complying with the Secretary’s requirements

41JC Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.132
curation status: Proposed
has part: 41JC(1) Self-incrimination
has part: 41JC(2) Self-incrimination
proposed by: legis2cml
realized by: sec-41jc
schema version: 2

41JC(1) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.132
note: No excuse for providing information under section 41JB
asserts: therapeutic-goods-act-1989-sec-41jc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41jc-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jc-ss-1
schema version: 2
part of: 41JC Self-incrimination

therapeutic-goods-act-1989-sec-41jc-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: No excuse for providing information under section 41JB
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-41jc-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JC(1) Self-incrimination

41JC(2) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.132
note: Protection from self-incrimination in certain cases
asserts: therapeutic-goods-act-1989-sec-41jc-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41jc-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jc-ss-2
schema version: 2
part of: 41JC Self-incrimination

therapeutic-goods-act-1989-sec-41jc-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits admissibility of information in certain cases
modality: Deontic
operator: Prohibition
premise text: (2) However, in the case of an individual:

therapeutic-goods-act-1989-sec-41jc-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JC(2) Self-incrimination

41JD Secretary may require information etc. about devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.133
note: Secretary may give sponsor permission to exclude from Division 3 of Part 4-11
asserts: therapeutic-goods-act-1989-sec-41jd-norm
asserts: therapeutic-goods-act-1989-sec-41jd-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jd
schema version: 2

therapeutic-goods-act-1989-sec-41jd-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to exclude from Division 3 of Part 4-11
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41jd-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JD Secretary may require information etc. about devices

41JE Secretary may require information relating to approvals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.135
curation status: Proposed
has part: 41JE(1) Secretary may require information relating to approvals
has part: 41JE(2) Secretary may require information relating to approvals
has part: 41JE(3) Secretary may require information relating to approvals
proposed by: legis2cml
realized by: sec-41je
schema version: 2

41JE(1) Secretary may require information relating to approvals
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.135
note: The Secretary may require a person granted an approval to provide specified information or documents.
asserts: therapeutic-goods-act-1989-sec-41je-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41je-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41je-ss-1
schema version: 2
part of: 41JE Secretary may require information relating to approvals

therapeutic-goods-act-1989-sec-41je-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary may require the person to provide information.
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-41je-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JE(1) Secretary may require information relating to approvals

41JE(2) Secretary may require information relating to approvals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.135
note: Secretary may require information from a person using specified medical devices.
asserts: therapeutic-goods-act-1989-sec-41je-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41je-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41je-ss-2
schema version: 2
part of: 41JE Secretary may require information relating to approvals

therapeutic-goods-act-1989-sec-41je-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide information
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41je-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JE(2) Secretary may require information relating to approvals

41JE(3) Secretary may require information relating to approvals
type: Concept
description: Notice period
source: therapeutic-goods-act-1989.pdf, p.135
note: Secretary must specify a reasonable period for compliance with notice.
asserts: therapeutic-goods-act-1989-sec-41je-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41je-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41je-ss-3
schema version: 2
part of: 41JE Secretary may require information relating to approvals

therapeutic-goods-act-1989-sec-41je-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide a reasonable notice period
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41je-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JE(3) Secretary may require information relating to approvals

41JF Secretary may require information relating to health
type: Concept
source: therapeutic-goods-act-1989.pdf, p.136
curation status: Proposed
has part: 41JF(1) Secretary may require information relating to health
has part: 41JF(1A) Secretary may require information relating to health
has part: 41JF(2) Secretary may require information relating to health
has part: 41JF(3) Secretary may require information relating to health
proposed by: legis2cml
realized by: sec-41jf
schema version: 2

41JF(1) Secretary may require information relating to health
type: Concept
description: specified information or documents
source: therapeutic-goods-act-1989.pdf, p.136
note: Secretary may require specified information or documents from a person granted an approval. The Secretary may require information from a person granted an authority under subsection 41HC(1)
asserts: therapeutic-goods-act-1989-sec-41jf-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41jf-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41jf-ss-1-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41jf-ss-1-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jf-ss-1
schema version: 2
part of: 41JF Secretary may require information relating to health

therapeutic-goods-act-1989-sec-41jf-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide specified information or documents.
modality: Deontic
operator: MUST PROVIDE

therapeutic-goods-act-1989-sec-41jf-ss-1-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary may require information
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-41jf-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of medical devices.
modality: DescriptionLogic
operator: CLASSIFICATION

therapeutic-goods-act-1989-sec-41jf-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JF(1) Secretary may require information relating to health

41JF(1A) Secretary may require information relating to health
type: Concept
source: therapeutic-goods-act-1989.pdf, p.136
note: The Secretary may require a person to provide specified information or documents.
asserts: therapeutic-goods-act-1989-sec-41jf-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-41jf-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41jf-ss-1a-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jf-ss-1a
schema version: 2
part of: 41JF Secretary may require information relating to health

therapeutic-goods-act-1989-sec-41jf-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary may require the person to provide information.
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-41jf-ss-1a-logic-descriptionlogic-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: The provision is part of a class hierarchy for medical device regulations.
modality: DescriptionLogic
operator: IS_A

therapeutic-goods-act-1989-sec-41jf-ss-1a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JF(1A) Secretary may require information relating to health

41JF(2) Secretary may require information relating to health
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.136
note: Secretary must require information within a specified period. Secretary must specify a reasonable period for compliance with notice.
asserts: therapeutic-goods-act-1989-sec-41jf-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41jf-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jf-ss-2
schema version: 2
part of: 41JF Secretary may require information relating to health

therapeutic-goods-act-1989-sec-41jf-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide information
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41jf-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JF(2) Secretary may require information relating to health

41JF(3) Secretary may require information relating to health
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.136
note: Secretary may require information to be given in a specified way. Secretary may require information relating to health
asserts: therapeutic-goods-act-1989-sec-41jf-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41jf-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41jf-ss-3-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41jf-ss-3-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-41jf-ss-3-logic-descriptionlogic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jf-ss-3
schema version: 2
part of: 41JF Secretary may require information relating to health

therapeutic-goods-act-1989-sec-41jf-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires information to be provided.
modality: Deontic
operator: requires

therapeutic-goods-act-1989-sec-41jf-ss-3-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide information
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41jf-ss-3-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Has specified software requirements.
modality: DescriptionLogic
operator: has specified software requirements

therapeutic-goods-act-1989-sec-41jf-ss-3-logic-descriptionlogic-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of data processing devices and electronic transmissions
modality: DescriptionLogic
operator: CLASSIFICATION

therapeutic-goods-act-1989-sec-41jf-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JF(3) Secretary may require information relating to health

41JG Criminal offences for failing to give information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
curation status: Proposed
has part: 41JG(1) Criminal offences for failing to give information or documents
has part: 41JG(2) Criminal offences for failing to give information or documents
has part: 41JG(3) Criminal offences for failing to give information or documents
proposed by: legis2cml
realized by: sec-41jg
schema version: 2

41JG(1) Criminal offences for failing to give information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Failure to comply with notice results in penalty.
asserts: therapeutic-goods-act-1989-sec-41jg-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41jg-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41jg-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41jg-ss-1-logic-alleninterval-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jg-ss-1
schema version: 2
part of: 41JG Criminal offences for failing to give information or documents

therapeutic-goods-act-1989-sec-41jg-ss-1-logic-alleninterval-3
type: LogicApplication
conclusion text: Penalty applies when person fails to comply.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Describes temporal interval for penalty application.
modality: AllenInterval
operator: Applicable
premise text: (b) the person fails to comply with the notice.

therapeutic-goods-act-1989-sec-41jg-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Penalty: 400 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits failure to comply with notice.
modality: Deontic
operator: Prohibition
premise text: (a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;

therapeutic-goods-act-1989-sec-41jg-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: Penalty: 400 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation to comply with notice.
modality: Deontic
operator: Obligation
premise text: (b) the person fails to comply with the notice.

therapeutic-goods-act-1989-sec-41jg-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JG(1) Criminal offences for failing to give information or documents

41JG(2) Criminal offences for failing to give information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Failure to comply with notice results in criminal offence.
asserts: therapeutic-goods-act-1989-sec-41jg-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41jg-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41jg-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41jg-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41jg-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41jg-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jg-ss-2
schema version: 2
part of: 41JG Criminal offences for failing to give information or documents

therapeutic-goods-act-1989-sec-41jg-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: ...and (b) the person fails to comply with the notice.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap between notice and failure to comply.
modality: AllenInterval
operator: Overlaps
premise text: (2) A person commits an offence if: (a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;

therapeutic-goods-act-1989-sec-41jg-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: ...and (b) the person fails to comply with the notice.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Artificial agent enforces obligation to comply with notice.
modality: CogAI
operator: Enforces
premise text: (2) A person commits an offence if: (a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;

therapeutic-goods-act-1989-sec-41jg-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits failure to comply with notice.
modality: Deontic
operator: Prohibition
premise text: (2) A person commits an offence if...

therapeutic-goods-act-1989-sec-41jg-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: ...and (b) the person fails to comply with the notice.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusion of obligation from notice to failure to comply.
modality: Diffusion
operator: Diffuses
premise text: (2) A person commits an offence if: (a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;

therapeutic-goods-act-1989-sec-41jg-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: ...and (b) the person fails to comply with the notice.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal relationship between notice and failure to comply.
modality: LTL
operator: Until
premise text: (2) A person commits an offence if: (a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;

therapeutic-goods-act-1989-sec-41jg-ss-2-norm
type: Prohibition
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 41JG(2) Criminal offences for failing to give information or documents

41JG(3) Criminal offences for failing to give information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Offence of strict liability for failing to give information or documents
asserts: therapeutic-goods-act-1989-sec-41jg-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41jg-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jg-ss-3
schema version: 2
part of: 41JG Criminal offences for failing to give information or documents

therapeutic-goods-act-1989-sec-41jg-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a duty on the state to prosecute
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-41jg-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JG(3) Criminal offences for failing to give information or documents

41JH False or misleading information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
curation status: Proposed
has part: 41JH(1) False or misleading information
has part: 41JH(2) False or misleading information
has part: 41JH(3) False or misleading information
has part: 41JH(4) False or misleading information
has part: 41JH(5) False or misleading information
proposed by: legis2cml
realized by: sec-41jh
schema version: 2

41JH(1) False or misleading information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Giving false or misleading information in compliance with a notice is an offence.
asserts: therapeutic-goods-act-1989-sec-41jh-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41jh-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41jh-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41jh-ss-1-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jh-ss-1
schema version: 2
part of: 41JH False or misleading information

therapeutic-goods-act-1989-sec-41jh-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The person commits an offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with a notice.
modality: Deontic
operator: Obligation
premise text: The person gives information to the Secretary.

therapeutic-goods-act-1989-sec-41jh-ss-1-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Giving false or misleading information is prohibited.
modality: Deontic
operator: Prohibition
premise text: (a) the person gives information to the Secretary; and (b) the person knows that the information: (i) is false or misleading; or (ii) omits any matter or thing without which the information is misleading;

therapeutic-goods-act-1989-sec-41jh-ss-1-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The person must provide accurate information.
modality: Deontic
operator: Obligation
premise text: (c) the information is given in compliance or purported compliance with the notice.

therapeutic-goods-act-1989-sec-41jh-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JH(1) False or misleading information

41JH(2) False or misleading information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Committing an offence for providing false or misleading information in compliance with a notice.
asserts: therapeutic-goods-act-1989-sec-41jh-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jh-ss-2
schema version: 2
part of: 41JH False or misleading information

therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: The person commits an offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits providing false or misleading information.
modality: Deontic
operator: Prohibit
premise text: The person gives information to the Secretary.

therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-2
type: LogicApplication
conclusion text: The person commits an offence if they provide false or misleading information in compliance with the notice.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits providing false or misleading information in compliance with a notice.
modality: Deontic
operator: Prohibit
premise text: The information is given in compliance or purported compliance with the notice.

therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-3
type: LogicApplication
conclusion text: The person commits an offence if they provide false or misleading information to the Secretary.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits providing false or misleading information to the Secretary.
modality: Deontic
operator: Prohibit
premise text: The person gives information to the Secretary.

therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-4
type: LogicApplication
conclusion text: The person commits an offence if they provide false or misleading information without which it is misleading.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits providing false or misleading information without which it is misleading.
modality: Deontic
operator: Prohibit
premise text: The information omits any matter or thing without which the information is misleading.

therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-5
type: LogicApplication
conclusion text: The person commits an offence if they provide false or misleading information in any form.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits providing false or misleading information in any form.
modality: Deontic
operator: Prohibit
premise text: The information is false or misleading; or omits any matter or thing without which the information is misleading.

therapeutic-goods-act-1989-sec-41jh-ss-2-norm
type: Prohibition
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 41JH(2) False or misleading information

41JH(3) False or misleading information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: An offence against subsection (2) is an obligation.
asserts: therapeutic-goods-act-1989-sec-41jh-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41jh-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jh-ss-3
schema version: 2
part of: 41JH False or misleading information

therapeutic-goods-act-1989-sec-41jh-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: An offence against subsection (2) is an obligation.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: An obligation exists.
modality: Deontic
operator: Obligation
premise text: (3) An offence against subsection (2) is an offence of strict liability.

therapeutic-goods-act-1989-sec-41jh-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JH(3) False or misleading information

41JH(4) False or misleading information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Exemption from subsection (1) or (2) if information is not false or misleading in a material particular.
asserts: therapeutic-goods-act-1989-sec-41jh-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jh-ss-4
schema version: 2
part of: 41JH False or misleading information

therapeutic-goods-act-1989-sec-41jh-ss-4-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 41JH(4) False or misleading information

41JH(5) False or misleading information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Defendant bears evidential burden for information not omitting material particulars.
asserts: therapeutic-goods-act-1989-sec-41jh-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-41jh-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jh-ss-5
schema version: 2
part of: 41JH False or misleading information

therapeutic-goods-act-1989-sec-41jh-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Defendant bears evidential burden
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-41jh-ss-5-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 41JH(5) False or misleading information

41JI False or misleading documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.139
note: Producing false or misleading documents is an offence.
asserts: therapeutic-goods-act-1989-sec-41ji-norm
asserts: therapeutic-goods-act-1989-sec-41ji-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ji
schema version: 2

therapeutic-goods-act-1989-sec-41ji-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits producing false or misleading documents.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-41ji-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JI False or misleading documents

41JJ Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.140
curation status: Proposed
has part: 41JJ(1) Self-incrimination
has part: 41JJ(2) Self-incrimination
proposed by: legis2cml
realized by: sec-41jj
schema version: 2

41JJ(1) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.140
note: Must provide information or document under notice without claiming self-incrimination
asserts: therapeutic-goods-act-1989-sec-41jj-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41jj-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41jj-ss-1-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jj-ss-1
schema version: 2
part of: 41JJ Self-incrimination

therapeutic-goods-act-1989-sec-41jj-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Contains information relating to medical devices covered by exemptions
modality: AllenInterval
operator: CONTAINS

therapeutic-goods-act-1989-sec-41jj-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide information or document
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41jj-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JJ(1) Self-incrimination

41JJ(2) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.140
note: Protection from self-incrimination in certain cases
asserts: therapeutic-goods-act-1989-sec-41jj-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41jj-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jj-ss-2
schema version: 2
part of: 41JJ Self-incrimination

therapeutic-goods-act-1989-sec-41jj-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: None
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits admissibility of self-incrimination evidence in certain cases
modality: Deontic
operator: Prohibition
premise text: None

therapeutic-goods-act-1989-sec-41jj-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JJ(2) Self-incrimination

41JK Simplified outline of this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.142
note: Chief executive officer of a healthcare facility must report adverse events involving reportable medical devices.
asserts: therapeutic-goods-act-1989-sec-41jk-norm
asserts: therapeutic-goods-act-1989-sec-41jk-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jk
schema version: 2

therapeutic-goods-act-1989-sec-41jk-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide a report
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41jk-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JK Simplified outline of this Part

41JL Purposes of this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.142
note: Facilitate monitoring and enforcing compliance with Chapter requirements.
asserts: therapeutic-goods-act-1989-sec-41jl-norm
asserts: therapeutic-goods-act-1989-sec-41jl-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jl
schema version: 2

therapeutic-goods-act-1989-sec-41jl-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Facilitate monitoring and enforcing compliance.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-41jl-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JL Purposes of this Part

41JM Requirement to report adverse events involving reportable
type: Concept
source: therapeutic-goods-act-1989.pdf, p.143
curation status: Proposed
has part: 41JM(1) Requirement to report adverse events involving reportable
has part: 41JM(4) Requirement to report adverse events involving reportable
has part: 41JM(2) Requirement to report adverse events involving reportable
has part: 41JM(3) Requirement to report adverse events involving reportable
has part: 41JM(5) Requirement to report adverse events involving reportable
proposed by: legis2cml
realized by: sec-41jm
schema version: 2

41JM(1) Requirement to report adverse events involving reportable
type: Concept
source: therapeutic-goods-act-1989.pdf, p.143
note: Healthcare facility must report adverse events to the Secretary.
asserts: therapeutic-goods-act-1989-sec-41jm-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41jm-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jm-ss-1
schema version: 2
part of: 41JM Requirement to report adverse events involving reportable

therapeutic-goods-act-1989-sec-41jm-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Duty obligation
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41jm-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 41JM(1) Requirement to report adverse events involving reportable

41JM(2) Requirement to report adverse events involving reportable
type: Concept
source: therapeutic-goods-act-1989.pdf, p.143
note: Healthcare facility must report adverse events involving reportable medical devices.
asserts: therapeutic-goods-act-1989-sec-41jm-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41jm-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jm-ss-2
schema version: 2
part of: 41JM Requirement to report adverse events involving reportable

therapeutic-goods-act-1989-sec-41jm-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide information
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41jm-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JM(2) Requirement to report adverse events involving reportable

41JM(3) Requirement to report adverse events involving reportable
type: Concept
source: therapeutic-goods-act-1989.pdf, p.143
note: Healthcare facility must report adverse events involving reportable medical devices.
asserts: therapeutic-goods-act-1989-sec-41jm-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41jm-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jm-ss-3
schema version: 2
part of: 41JM Requirement to report adverse events involving reportable

therapeutic-goods-act-1989-sec-41jm-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Mandatory reporting obligation.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41jm-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JM(3) Requirement to report adverse events involving reportable

41JM(4) Requirement to report adverse events involving reportable
type: Concept
description: Report requirements
source: therapeutic-goods-act-1989.pdf, p.143
note: Healthcare facility must report adverse events involving reportable medical devices. Healthcare facility must report adverse events involving reportable medical devices and persons.
asserts: therapeutic-goods-act-1989-sec-41jm-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41jm-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jm-ss-4
schema version: 2
part of: 41JM Requirement to report adverse events involving reportable

therapeutic-goods-act-1989-sec-41jm-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Duty to report
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41jm-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JM(4) Requirement to report adverse events involving reportable

41JM(5) Requirement to report adverse events involving reportable
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.143
note: Report must include information about reportable medical device and person.
asserts: therapeutic-goods-act-1989-sec-41jm-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-41jm-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41jm-ss-5
schema version: 2
part of: 41JM Requirement to report adverse events involving reportable

therapeutic-goods-act-1989-sec-41jm-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to report
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41jm-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41JM(5) Requirement to report adverse events involving reportable

41K What this Part is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.145
note: The Secretary can require action to recall medical devices, or to inform the public about medical devices that do not comply with requirements or cannot lawfully be supplied.
asserts: therapeutic-goods-act-1989-sec-41k-norm
asserts: therapeutic-goods-act-1989-sec-41k-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41k
schema version: 2

therapeutic-goods-act-1989-sec-41k-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Expresses ability to perform an action
modality: Deontic
operator: can

therapeutic-goods-act-1989-sec-41k-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41K What this Part is about

41KA Public notification, and recall, of medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.145
note: The Secretary may impose requirements on a person if certain circumstances occur.
asserts: therapeutic-goods-act-1989-sec-41ka-norm
asserts: therapeutic-goods-act-1989-sec-41ka-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ka-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ka
schema version: 2

therapeutic-goods-act-1989-sec-41ka-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposition of requirements is permitted.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41ka-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Requirements apply to medical devices of a certain kind.
modality: DescriptionLogic
operator: hasKindOf

therapeutic-goods-act-1989-sec-41ka-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41KA Public notification, and recall, of medical devices

41KB Publication of requirements
type: Concept
description: Notice setting out particulars of the requirement
source: therapeutic-goods-act-1989.pdf, p.149
note: Secretary must publish notice after imposing requirement.
asserts: therapeutic-goods-act-1989-sec-41kb-norm
asserts: therapeutic-goods-act-1989-sec-41kb-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41kb
schema version: 2

therapeutic-goods-act-1989-sec-41kb-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to publish notice
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41kb-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41KB Publication of requirements

41KC Criminal offences for failing to comply with requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.149
curation status: Proposed
has part: 41KC(1) Criminal offences for failing to comply with requirements
has part: 41KC(4) Criminal offences for failing to comply with requirements
proposed by: legis2cml
realized by: sec-41kc
schema version: 2

41KC(1) Criminal offences for failing to comply with requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.149
note: Offence for failing to comply with requirements
asserts: therapeutic-goods-act-1989-sec-41kc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41kc-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41kc-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41kc-ss-1-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41kc-ss-1-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-41kc-ss-1
schema version: 2
part of: 41KC Criminal offences for failing to comply with requirements

therapeutic-goods-act-1989-sec-41kc-ss-1-logic-alleninterval-3
type: LogicApplication
conclusion text: ...will result in, or is likely to result in, harm or injury to any person.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: States that act resulted in harm or injury to any person
modality: AllenInterval
operator: ResultedIn
premise text: (c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.

therapeutic-goods-act-1989-sec-41kc-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...breaches a requirement imposed on the person under section 41KA;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits failure to comply with requirements
modality: Deontic
operator: Prohibition
premise text: (1) A person commits an offence...

therapeutic-goods-act-1989-sec-41kc-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: ...breaches a requirement imposed on the person under section 41KA;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation to comply with requirements
modality: Deontic
operator: Obligation
premise text: (b) the act or omission breaches a requirement imposed on the person under section 41KA;

therapeutic-goods-act-1989-sec-41kc-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: ...may convict the person of an offence against subsection (4) instead:
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits conviction of offence against subsection (4)
modality: Deontic
operator: Prohibition
premise text: Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead:

therapeutic-goods-act-1989-sec-41kc-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41KC(1) Criminal offences for failing to comply with requirements

41KC(4) Criminal offences for failing to comply with requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.149
note: Failure to comply with requirements is a criminal offence.
asserts: therapeutic-goods-act-1989-sec-41kc-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41kc-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41kc-ss-4
schema version: 2
part of: 41KC Criminal offences for failing to comply with requirements

therapeutic-goods-act-1989-sec-41kc-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation on the state.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-41kc-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41KC(4) Criminal offences for failing to comply with requirements

41KD Powers of suspension and cancellation unaffected
type: Concept
source: therapeutic-goods-act-1989.pdf, p.150
note: Imposition of requirement under section 41KA does not affect suspension powers.
asserts: therapeutic-goods-act-1989-sec-41kd-norm
asserts: therapeutic-goods-act-1989-sec-41kd-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41kd-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41kd-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-41kd-logic-linearlogic-4
asserts: therapeutic-goods-act-1989-sec-41kd-logic-alleninterval-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41kd
schema version: 2

therapeutic-goods-act-1989-sec-41kd-logic-alleninterval-5
type: LogicApplication
conclusion text: Powers of suspension and cancellation unaffected.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relationship between requirement imposition and suspension power.
modality: AllenInterval
operator: during
premise text: Imposition of a requirement under section 41KA does not affect the Secretary’s powers to:

therapeutic-goods-act-1989-sec-41kd-logic-deontic-1
type: LogicApplication
conclusion text: Does not affect the Secretary's powers to suspend entry.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exclusion of suspension power from requirement imposition.
modality: Deontic
operator: excludes
premise text: Imposition of a requirement under section 41KA.

therapeutic-goods-act-1989-sec-41kd-logic-deontic-3
type: LogicApplication
conclusion text: Imposition of a requirement under section 41KA does not affect the Secretary’s powers to suspend entry.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Inclusion of suspension power within Secretary's powers.
modality: Deontic
operator: includes
premise text: The Secretary’s powers to:

therapeutic-goods-act-1989-sec-41kd-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Powers of suspension and cancellation unaffected.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Subclass relationship between suspension power and requirement imposition.
modality: DescriptionLogic
operator: subClassOf
premise text: Imposition of a requirement under section 41KA does not affect the Secretary’s powers to:

therapeutic-goods-act-1989-sec-41kd-logic-linearlogic-4
type: LogicApplication
conclusion text: Powers of suspension and cancellation unaffected.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::linear
logic summary: Conjunction of suspension power and requirement imposition.
modality: LinearLogic
operator: and
premise text: Imposition of a requirement under section 41KA does not affect the Secretary’s powers to:

therapeutic-goods-act-1989-sec-41kd-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41KD Powers of suspension and cancellation unaffected

41KE Saving of other laws
type: Concept
source: therapeutic-goods-act-1989.pdf, p.150
note: No exclusion or limitation of other laws
asserts: therapeutic-goods-act-1989-sec-41ke-norm
asserts: therapeutic-goods-act-1989-sec-41ke-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ke
schema version: 2

therapeutic-goods-act-1989-sec-41ke-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: No exclusion or limitation of other laws
modality: Deontic
operator: Obligate

41L What this Part is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.151
note: Fees must be paid for consideration of applications and auditing.
asserts: therapeutic-goods-act-1989-sec-41l-norm
asserts: therapeutic-goods-act-1989-sec-41l-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41l
schema version: 2

therapeutic-goods-act-1989-sec-41l-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to pay fees
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41l-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41L What this Part is about

41LA Assessment fees
type: Concept
source: therapeutic-goods-act-1989.pdf, p.151
curation status: Proposed
has part: 41LA(1) Assessment fees
has part: 41LA(2) Assessment fees
has part: 41LA(3) Assessment fees
has part: 41LA(4) Assessment fees
proposed by: legis2cml
realized by: sec-41la
schema version: 2

41LA(1) Assessment fees
type: Concept
source: therapeutic-goods-act-1989.pdf, p.151
note: Payable assessment fee for application of conformity assessment certificate
asserts: therapeutic-goods-act-1989-sec-41la-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41la-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41la-ss-1
schema version: 2
part of: 41LA Assessment fees

therapeutic-goods-act-1989-sec-41la-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Payable assessment fee
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-41la-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41LA(1) Assessment fees

41LA(2) Assessment fees
type: Concept
source: therapeutic-goods-act-1989.pdf, p.151
note: Prescribe different levels of conformity assessment fees
asserts: therapeutic-goods-act-1989-sec-41la-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41la-ss-2
schema version: 2
part of: 41LA Assessment fees

41LA(3) Assessment fees
type: Concept
source: therapeutic-goods-act-1989.pdf, p.151
note: Pay assessment fee for auditing medical device application
asserts: therapeutic-goods-act-1989-sec-41la-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41la-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41la-ss-3-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41la-ss-3
schema version: 2
part of: 41LA Assessment fees

therapeutic-goods-act-1989-sec-41la-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must pay assessment fee
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41la-ss-3-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Assessment fee is a type of payment
modality: DescriptionLogic
operator: IS_A

therapeutic-goods-act-1989-sec-41la-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41LA(3) Assessment fees

41LA(4) Assessment fees
type: Concept
source: therapeutic-goods-act-1989.pdf, p.151
note: Prescribes different levels of application audit assessment fees
asserts: therapeutic-goods-act-1989-sec-41la-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41la-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41la-ss-4
schema version: 2
part of: 41LA Assessment fees

therapeutic-goods-act-1989-sec-41la-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation on the state
modality: Deontic
operator: prescribes

therapeutic-goods-act-1989-sec-41la-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41LA(4) Assessment fees

41LB When assessment fee due for payment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.152
note: Assessment fee due on specified day and manner
asserts: therapeutic-goods-act-1989-sec-41lb-norm
asserts: therapeutic-goods-act-1989-sec-41lb-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41lb
schema version: 2

therapeutic-goods-act-1989-sec-41lb-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to pay assessment fee
modality: Deontic
operator: due

therapeutic-goods-act-1989-sec-41lb-norm
type: Obligation
scope note: borne by: LegalPerson
curation status: Proposed
modality: Deontic
borne by: LegalPerson
deontic status: HeuristicDerived
part of: 41LB When assessment fee due for payment

41LC Payment of assessment fee by instalments
type: Concept
source: therapeutic-goods-act-1989.pdf, p.152
curation status: Proposed
has part: 41LC(1) Payment of assessment fee by instalments
has part: 41LC(2) Payment of assessment fee by instalments
has part: 41LC(3) Payment of assessment fee by instalments
proposed by: legis2cml
realized by: sec-41lc
schema version: 2

41LC(1) Payment of assessment fee by instalments
type: Concept
source: therapeutic-goods-act-1989.pdf, p.152
note: Payment of assessment fee by instalments is obligatory.
asserts: therapeutic-goods-act-1989-sec-41lc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41lc-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41lc-ss-1
schema version: 2
part of: 41LC Payment of assessment fee by instalments

therapeutic-goods-act-1989-sec-41lc-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Payment of assessment fee by instalments is obligatory.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-41lc-ss-1-norm
type: Obligation
scope note: borne by: LegalPerson
curation status: Proposed
modality: Deontic
borne by: LegalPerson
deontic status: HeuristicDerived
part of: 41LC(1) Payment of assessment fee by instalments

41LC(2) Payment of assessment fee by instalments
type: Concept
source: therapeutic-goods-act-1989.pdf, p.152
note: Payment of assessment fee by instalments is not allowed if any part of an instalment is unpaid immediately after it became due.
asserts: therapeutic-goods-act-1989-sec-41lc-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41lc-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41lc-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41lc-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41lc-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41lc-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41lc-ss-2
schema version: 2
part of: 41LC Payment of assessment fee by instalments

therapeutic-goods-act-1989-sec-41lc-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: was unpaid immediately after the time when it became due for payment.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap between payment and evaluation fees
modality: AllenInterval
operator: Overlap
premise text: (a) that or any other assessment fee payable by the person; or (b) any evaluation fee under section 24 payable by the person;

therapeutic-goods-act-1989-sec-41lc-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: if any part of an instalment is unpaid immediately after it became due.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Recognition of prohibition in AI systems
modality: CogAI
operator: Recognize
premise text: (2) Regulations may provide that a person is not allowed to pay an assessment fee by instalments

therapeutic-goods-act-1989-sec-41lc-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: if any part of an instalment is unpaid immediately after it became due.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of payment by instalments
modality: Deontic
operator: Prohibit
premise text: (2) Regulations may provide that a person is not allowed to pay an assessment fee by instalments

therapeutic-goods-act-1989-sec-41lc-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: was unpaid immediately after the time when it became due for payment.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusion of prohibition to related fees
modality: Diffusion
operator: Diffuse
premise text: (a) that or any other assessment fee payable by the person; or (b) any evaluation fee under section 24 payable by the person;

therapeutic-goods-act-1989-sec-41lc-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: was unpaid immediately after the time when it became due for payment.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of unpaid instalments
modality: LTL
operator: Recurring
premise text: (a) that or any other assessment fee payable by the person; or (b) any evaluation fee under section 24 payable by the person;

therapeutic-goods-act-1989-sec-41lc-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41LC(2) Payment of assessment fee by instalments

41LC(3) Payment of assessment fee by instalments
type: Concept
source: therapeutic-goods-act-1989.pdf, p.152
note: Payment of assessment fee by instalments is not limited by subsection (2).
asserts: therapeutic-goods-act-1989-sec-41lc-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41lc-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41lc-ss-3-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41lc-ss-3-logic-linearlogic-3
asserts: therapeutic-goods-act-1989-sec-41lc-ss-3-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-41lc-ss-3
schema version: 2
part of: 41LC Payment of assessment fee by instalments

therapeutic-goods-act-1989-sec-41lc-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Payment of assessment fee by instalments is obligatory.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Payment of assessment fee is obligatory.
modality: Deontic
operator: Implies
premise text: Subsection (2) does not limit subsection (1).

therapeutic-goods-act-1989-sec-41lc-ss-3-logic-deontic-2
type: LogicApplication
conclusion text: Payment of assessment fee by instalments is obligatory if it is due.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Payment of assessment fee is obligatory if it is due.
modality: Deontic
operator: Implies
premise text: Subsection (2) does not limit subsection (1).

therapeutic-goods-act-1989-sec-41lc-ss-3-logic-deontic-4
type: LogicApplication
conclusion text: Payment of assessment fee by instalments is obligatory if it is due and paid.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Payment of assessment fee is obligatory if it is due and paid.
modality: Deontic
operator: Implies
premise text: Subsection (2) does not limit subsection (1).

therapeutic-goods-act-1989-sec-41lc-ss-3-logic-linearlogic-3
type: LogicApplication
conclusion text: Payment of assessment fee by instalments implies obligation to pay.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::linear
logic summary: Payment of assessment fee implies obligation to pay.
modality: LinearLogic
operator: Implication
premise text: Subsection (2) does not limit subsection (1).

41LD Recovery of assessment fee
type: Concept
source: therapeutic-goods-act-1989.pdf, p.152
note: Recovery of assessment fee
asserts: therapeutic-goods-act-1989-sec-41ld-norm
asserts: therapeutic-goods-act-1989-sec-41ld-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ld
schema version: 2

therapeutic-goods-act-1989-sec-41ld-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Can recover assessment fee
modality: Deontic
operator: can

41LE Reduction of conformity assessment fee where decision not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.153
curation status: Proposed
has part: 41LE(1) Reduction of conformity assessment fee where decision not
has part: 41LE(2) Reduction of conformity assessment fee where decision not
has part: 41LE(3) Reduction of conformity assessment fee where decision not
has part: 41LE(4) Reduction of conformity assessment fee where decision not
proposed by: legis2cml
realized by: sec-41le
schema version: 2

41LE(1) Reduction of conformity assessment fee where decision not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.153
note: Reduction of conformity assessment fee under certain conditions.
asserts: therapeutic-goods-act-1989-sec-41le-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41le-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41le-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41le-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41le-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41le-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41le-ss-1
schema version: 2
part of: 41LE Reduction of conformity assessment fee where decision not

therapeutic-goods-act-1989-sec-41le-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for reduction of conformity assessment fee.
modality: AllenInterval
operator: Temporal Interval
premise text: (a) the application is for the issuing of a conformity assessment certificate under Part 4-4; and (b) consideration of the application will involve an examination of the design of medical devices; and (c) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application.

therapeutic-goods-act-1989-sec-41le-ss-1-logic-cogai-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Classification of reduction of conformity assessment fee using CogAI.
modality: CogAI
operator: Classification
premise text: (a) the application is for the issuing of a conformity assessment certificate under Part 4-4; and (b) consideration of the application will involve an examination of the design of medical devices; and (c) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application.

therapeutic-goods-act-1989-sec-41le-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to reduce conformity assessment fee.
modality: Deontic
operator: Obligation
premise text: (1) Nothing in section 41LA, 41LB or 41LC requires the applicant to pay more than 3/4 of the conformity assessment fee before the making of the decision if:...

therapeutic-goods-act-1989-sec-41le-ss-1-logic-diffusion-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusion of reduction of conformity assessment fee.
modality: Diffusion
operator: Diffusion
premise text: (a) the application is for the issuing of a conformity assessment certificate under Part 4-4; and (b) consideration of the application will involve an examination of the design of medical devices; and (c) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application.

therapeutic-goods-act-1989-sec-41le-ss-1-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of reduction of conformity assessment fee.
modality: LTL
operator: Recurring Trace
premise text: (a) the application is for the issuing of a conformity assessment certificate under Part 4-4; and (b) consideration of the application will involve an examination of the design of medical devices; and (c) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application.

therapeutic-goods-act-1989-sec-41le-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41LE(1) Reduction of conformity assessment fee where decision not

41LE(2) Reduction of conformity assessment fee where decision not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.153
note: Conformity assessment fee reduction upon non-decision within period
asserts: therapeutic-goods-act-1989-sec-41le-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41le-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41le-ss-2
schema version: 2
part of: 41LE Reduction of conformity assessment fee where decision not

therapeutic-goods-act-1989-sec-41le-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to pay reduced fee upon non-decision
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-41le-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41LE(2) Reduction of conformity assessment fee where decision not

41LE(3) Reduction of conformity assessment fee where decision not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.153
note: Payment of part of conformity assessment fee becomes due upon decision making.
asserts: therapeutic-goods-act-1989-sec-41le-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41le-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41le-ss-3-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41le-ss-3-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41le-ss-3-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41le-ss-3-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41le-ss-3
schema version: 2
part of: 41LE Reduction of conformity assessment fee where decision not

therapeutic-goods-act-1989-sec-41le-ss-3-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Describes a temporal relationship between payment and decision making.
modality: AllenInterval
operator: Overlaps
premise text: (3) If: (a) the decision is made within that period; and (b) part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;

therapeutic-goods-act-1989-sec-41le-ss-3-logic-cogai-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Describes a relationship between payment and decision making.
modality: CogAI
operator: Recognizes
premise text: (3) If: (a) the decision is made within that period; and (b) part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;

therapeutic-goods-act-1989-sec-41le-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: The state must pay the fee.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a duty on the state.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-41le-ss-3-logic-diffusion-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Describes a relationship between payment and decision making.
modality: Diffusion
operator: Diffuses
premise text: (3) If: (a) the decision is made within that period; and (b) part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;

therapeutic-goods-act-1989-sec-41le-ss-3-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Describes a temporal relationship between payment and decision making.
modality: LTL
operator: Until
premise text: (3) If: (a) the decision is made within that period; and (b) part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;

therapeutic-goods-act-1989-sec-41le-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41LE(3) Reduction of conformity assessment fee where decision not

41LE(4) Reduction of conformity assessment fee where decision not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.153
note: Decision is taken when applicant notified of Secretary's decision on application.
asserts: therapeutic-goods-act-1989-sec-41le-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41le-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41le-ss-4
schema version: 2
part of: 41LE Reduction of conformity assessment fee where decision not

therapeutic-goods-act-1989-sec-41le-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: Decision is made
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Decision is taken
modality: Deontic
operator: TAKE
premise text: Applicant notified of Secretary's decision on application.

therapeutic-goods-act-1989-sec-41le-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41LE(4) Reduction of conformity assessment fee where decision not

41M What this Part is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.154
note: Ensure conformity with essential principles and administrative processes.
asserts: therapeutic-goods-act-1989-sec-41m-norm
asserts: therapeutic-goods-act-1989-sec-41m-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41m
schema version: 2

therapeutic-goods-act-1989-sec-41m-logic-deontic-1
type: LogicApplication
conclusion text: There is an obligation to comply with the essential principles.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Ensure compliance
modality: Deontic
operator: MUST
premise text: The essential principles must be complied with.

therapeutic-goods-act-1989-sec-41m-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41M What this Part is about

41MA Criminal offences for importing, supplying or exporting a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.155
curation status: Proposed
has part: 41MA(1) Criminal offences for importing, supplying or exporting a
has part: 41MA(4) Criminal offences for importing, supplying or exporting a
proposed by: legis2cml
realized by: sec-41ma
schema version: 2

41MA(1) Criminal offences for importing, supplying or exporting a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.155
note: Importing a non-compliant medical device is prohibited.
asserts: therapeutic-goods-act-1989-sec-41ma-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ma-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ma-ss-1
schema version: 2
part of: 41MA Criminal offences for importing, supplying or exporting a

therapeutic-goods-act-1989-sec-41ma-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the importation of non-compliant medical devices.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41ma-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MA(1) Criminal offences for importing, supplying or exporting a

41MA(4) Criminal offences for importing, supplying or exporting a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.155
note: Committing an offence for importing a medical device into Australia
asserts: therapeutic-goods-act-1989-sec-41ma-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41ma-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ma-ss-4
schema version: 2
part of: 41MA Criminal offences for importing, supplying or exporting a

therapeutic-goods-act-1989-sec-41ma-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: A person commits an offence if they import a medical device into Australia.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with import regulations
modality: Deontic
operator: Obligation
premise text: Importing a medical device into Australia without permission is prohibited.

therapeutic-goods-act-1989-sec-41ma-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MA(4) Criminal offences for importing, supplying or exporting a

41MB Exceptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.160
curation status: Proposed
has part: 41MB(1) Exceptions
has part: 41MB(2) Exceptions
proposed by: legis2cml
realized by: sec-41mb
schema version: 2

41MB(1) Exceptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.160
note: Exceptions for medical devices that comply with standards and fail to comply only in respect of specific principles.
asserts: therapeutic-goods-act-1989-sec-41mb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41mb-ss-1-logic-alleninterval-1
asserts: therapeutic-goods-act-1989-sec-41mb-ss-1-logic-ltl-2
asserts: therapeutic-goods-act-1989-sec-41mb-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-41mb-ss-1-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mb-ss-1
schema version: 2
part of: 41MB Exceptions

therapeutic-goods-act-1989-sec-41mb-ss-1-logic-alleninterval-1
type: LogicApplication
conclusion text: The exemption is valid only if the medical device meets the specified standard.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines the temporal interval for which the exemption applies.
modality: AllenInterval
operator: <
premise text: (a) the medical device complies with one or more medical device standards that apply to it;

therapeutic-goods-act-1989-sec-41mb-ss-1-logic-deontic-3
type: LogicApplication
conclusion text: The exemption is a permission for the medical device to comply with specific standards.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Classifies the type of duty or obligation.
modality: Deontic
operator: =
premise text: (a) the medical device complies with one or more medical device standards that apply to it;

therapeutic-goods-act-1989-sec-41mb-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: The exemption is a permission for the medical device to fail to comply with specific principles.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Classifies the type of duty or obligation.
modality: Deontic
operator: =
premise text: (b) the medical device fails to comply with the essential principles only in respect of a part or parts of the essential principles.

therapeutic-goods-act-1989-sec-41mb-ss-1-logic-ltl-2
type: LogicApplication
conclusion text: The exemption is valid only if the non-compliance occurs within the specified interval.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Specifies the temporal relationship between the exemption and the non-compliance.
modality: LTL
operator: <
premise text: (b) the medical device fails to comply with the essential principles only in respect of a part or parts of the essential principles.

41MB(2) Exceptions
type: Concept
description: Evidence of matters in section 13.3(3) of Criminal Code.
source: therapeutic-goods-act-1989.pdf, p.160
note: Defendant bears evidential burden in prosecution for offence.
asserts: therapeutic-goods-act-1989-sec-41mb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41mb-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41mb-ss-2-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mb-ss-2
schema version: 2
part of: 41MB Exceptions

therapeutic-goods-act-1989-sec-41mb-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Defendant bears evidential burden.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-41mb-ss-2-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Defendant must prove matters in section.
modality: Epistemic
operator: Burden of Proof

therapeutic-goods-act-1989-sec-41mb-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MB(2) Exceptions

41MC Criminal offences relating to breaching a condition of a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.161
curation status: Proposed
has part: 41MC(1) Criminal offences relating to breaching a condition of a
has part: 41MC(2) Criminal offences relating to breaching a condition of a
proposed by: legis2cml
realized by: sec-41mc
schema version: 2

41MC(1) Criminal offences relating to breaching a condition of a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.161
note: Secretary's consent may be given unconditionally or subject to conditions for certain medical devices.
asserts: therapeutic-goods-act-1989-sec-41mc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41mc-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mc-ss-1
schema version: 2
part of: 41MC Criminal offences relating to breaching a condition of a

therapeutic-goods-act-1989-sec-41mc-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission granted by the Secretary.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41mc-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MC(1) Criminal offences relating to breaching a condition of a

41MC(2) Criminal offences relating to breaching a condition of a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.161
note: Breach of consent results in harm or injury to a person.
asserts: therapeutic-goods-act-1989-sec-41mc-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41mc-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mc-ss-2
schema version: 2
part of: 41MC Criminal offences relating to breaching a condition of a

therapeutic-goods-act-1989-sec-41mc-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: (Penalty: 2,000 penalty units.)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits breach of consent.
modality: Deontic
operator: Prohibition
premise text: (2) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent; and (c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.

therapeutic-goods-act-1989-sec-41mc-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MC(2) Criminal offences relating to breaching a condition of a

41MD Treating medical devices as prohibited imports or exports
type: Concept
source: therapeutic-goods-act-1989.pdf, p.162
note: Importation or exportation of medical devices is prohibited if notified to Customs Act 1901.
asserts: therapeutic-goods-act-1989-sec-41md-norm
asserts: therapeutic-goods-act-1989-sec-41md-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41md
schema version: 2

therapeutic-goods-act-1989-sec-41md-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of importation or exportation.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-41md-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MD Treating medical devices as prohibited imports or exports

41ME Criminal offences for failing to apply conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.164
curation status: Proposed
has part: 41ME(1) Criminal offences for failing to apply conformity assessment
has part: 41ME(4) Criminal offences for failing to apply conformity assessment
has part: 41ME(4A) Criminal offences for failing to apply conformity assessment
has part: 41ME(4B) Criminal offences for failing to apply conformity assessment
has part: 41ME(5) Criminal offences for failing to apply conformity assessment
proposed by: legis2cml
realized by: sec-41me
schema version: 2

41ME(1) Criminal offences for failing to apply conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.164
note: Manufacturing, supplying or using a non-exempt medical device without conformity assessment
asserts: therapeutic-goods-act-1989-sec-41me-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41me-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41me-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41me-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41me-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41me-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41me-ss-1
schema version: 2
part of: 41ME Criminal offences for failing to apply conformity assessment

therapeutic-goods-act-1989-sec-41me-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: (1) A person commits an offence...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Establishes a temporal relationship between the manufacture/supply/use of medical devices and conformity assessment
modality: AllenInterval
operator: Temporal relation
premise text: (c) the conformity assessment procedures have not been applied to the device; and (d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;

therapeutic-goods-act-1989-sec-41me-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: (1) A person commits an offence...
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Applies artificial intelligence to reason about the obligations and consequences of conformity assessment
modality: CogAI
operator: Reasoning
premise text: (d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;

therapeutic-goods-act-1989-sec-41me-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: (1) A person commits an offence...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the manufacture, supply or use of non-exempt medical devices without conformity assessment
modality: Deontic
operator: Prohibit
premise text: (ca) the device is not of a kind covered by an exemption in force under section 41GS; and (d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;

therapeutic-goods-act-1989-sec-41me-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: (1) A person commits an offence...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses the obligation to comply with conformity assessment across all parties involved
modality: Diffusion
operator: Diffuse
premise text: (d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;

therapeutic-goods-act-1989-sec-41me-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: (1) A person commits an offence...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Establishes a recurring trace of the use of medical devices and conformity assessment
modality: LTL
operator: Recurring trace
premise text: (d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;

therapeutic-goods-act-1989-sec-41me-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ME(1) Criminal offences for failing to apply conformity assessment

41ME(4) Criminal offences for failing to apply conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.164
note: Failure to apply conformity assessment procedures for medical devices is prohibited.
asserts: therapeutic-goods-act-1989-sec-41me-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41me-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41me-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41me-ss-4-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41me-ss-4-logic-cogai-4
asserts: therapeutic-goods-act-1989-sec-41me-ss-4-logic-shacl-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41me-ss-4
schema version: 2
part of: 41ME Criminal offences for failing to apply conformity assessment

therapeutic-goods-act-1989-sec-41me-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: ...the device is not of a kind covered by an exemption in force under section 41GS.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between conformity assessment procedures and medical devices.
modality: AllenInterval
operator: Temporal relation
premise text: (4) A person commits an offence if...

therapeutic-goods-act-1989-sec-41me-ss-4-logic-cogai-4
type: LogicApplication
conclusion text: ...the device is not of a kind covered by an exemption in force under section 41GS.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Knowledge representation of medical devices and conformity assessment procedures.
modality: CogAI
operator: Knowledge representation
premise text: (4) A person commits an offence if...

therapeutic-goods-act-1989-sec-41me-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: ...the device is not of a kind covered by an exemption in force under section 41GS.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of failing to apply conformity assessment procedures.
modality: Deontic
operator: Prohibit
premise text: (4) A person commits an offence if...

therapeutic-goods-act-1989-sec-41me-ss-4-logic-ltl-3
type: LogicApplication
conclusion text: ...the device is not of a kind covered by an exemption in force under section 41GS.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of conformity assessment procedures for medical devices.
modality: LTL
operator: Recurring trace
premise text: (4) A person commits an offence if...

therapeutic-goods-act-1989-sec-41me-ss-4-logic-shacl-5
type: LogicApplication
conclusion text: ...the device is not of a kind covered by an exemption in force under section 41GS.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::shacl
logic summary: Schema validation of medical devices and conformity assessment procedures.
modality: SHACL
operator: Schema validation
premise text: (4) A person commits an offence if...

therapeutic-goods-act-1989-sec-41me-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ME(4) Criminal offences for failing to apply conformity assessment

41ME(4A) Criminal offences for failing to apply conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.164
note: Manufacturing or supplying a medical device without conformity assessment
asserts: therapeutic-goods-act-1989-sec-41me-ss-4a-norm
asserts: therapeutic-goods-act-1989-sec-41me-ss-4a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41me-ss-4a-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41me-ss-4a-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41me-ss-4a-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41me-ss-4a-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41me-ss-4a
schema version: 2
part of: 41ME Criminal offences for failing to apply conformity assessment

therapeutic-goods-act-1989-sec-41me-ss-4a-logic-alleninterval-2
type: LogicApplication
conclusion text: ...Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines the temporal interval during which the action of manufacturing or supplying a medical device without conformity assessment is prohibited
modality: AllenInterval
operator: Temporal Interval
premise text: (4A) A person commits an offence...

therapeutic-goods-act-1989-sec-41me-ss-4a-logic-cogai-5
type: LogicApplication
conclusion text: ...Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Recognizes the need for conformity assessment in medical device manufacturing and supply
modality: CogAI
operator: Recognize
premise text: (4A) A person commits an offence...

therapeutic-goods-act-1989-sec-41me-ss-4a-logic-deontic-1
type: LogicApplication
conclusion text: ...Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits manufacturing or supplying a medical device without conformity assessment
modality: Deontic
operator: Prohibit
premise text: (4A) A person commits an offence...

therapeutic-goods-act-1989-sec-41me-ss-4a-logic-diffusion-4
type: LogicApplication
conclusion text: ...Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses the prohibition to all relevant parties and entities
modality: Diffusion
operator: Diffuse
premise text: (4A) A person commits an offence...

therapeutic-goods-act-1989-sec-41me-ss-4a-logic-ltl-3
type: LogicApplication
conclusion text: ...Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines the recurring trace of actions that must be prevented or prohibited
modality: LTL
operator: Recurring Trace
premise text: (4A) A person commits an offence...

therapeutic-goods-act-1989-sec-41me-ss-4a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ME(4A) Criminal offences for failing to apply conformity assessment

41ME(4B) Criminal offences for failing to apply conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.164
note: Offences relating to exporting a medical device are prohibited.
asserts: therapeutic-goods-act-1989-sec-41me-ss-4b-norm
asserts: therapeutic-goods-act-1989-sec-41me-ss-4b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41me-ss-4b
schema version: 2
part of: 41ME Criminal offences for failing to apply conformity assessment

therapeutic-goods-act-1989-sec-41me-ss-4b-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits exporting a medical device.
modality: Deontic
operator: Prohibit
premise text: (4B) An offence against subsection (4A) is an offence of strict liability.

therapeutic-goods-act-1989-sec-41me-ss-4b-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ME(4B) Criminal offences for failing to apply conformity assessment

41ME(5) Criminal offences for failing to apply conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.164
note: Manufacturing, exporting, or using a medical device without conformity assessment is prohibited.
asserts: therapeutic-goods-act-1989-sec-41me-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-41me-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41me-ss-5
schema version: 2
part of: 41ME Criminal offences for failing to apply conformity assessment

therapeutic-goods-act-1989-sec-41me-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition
modality: Deontic
operator: Prohibit
premise text: (5) A person commits an offence...

therapeutic-goods-act-1989-sec-41me-ss-5-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ME(5) Criminal offences for failing to apply conformity assessment

41MF Criminal offences for failing to apply conformity assessment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.167
note: Offences relating to supplying a medical device
asserts: therapeutic-goods-act-1989-sec-41mf-norm
asserts: therapeutic-goods-act-1989-sec-41mf-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mf
schema version: 2

therapeutic-goods-act-1989-sec-41mf-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying a medical device
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41mf-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MF Criminal offences for failing to apply conformity assessment

41MG Exceptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.170
note: Exceptions for certain conformity assessment standards
asserts: therapeutic-goods-act-1989-sec-41mg-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mg
schema version: 2

41MH Criminal offence for making false statements in declarations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.170
note: Making false statements in declarations is a criminal offence.
asserts: therapeutic-goods-act-1989-sec-41mh-norm
asserts: therapeutic-goods-act-1989-sec-41mh-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mh
schema version: 2

therapeutic-goods-act-1989-sec-41mh-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making false statements in declarations.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41mh-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MH Criminal offence for making false statements in declarations

41MI Criminal offences for importing, exporting, supplying or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.172
curation status: Proposed
has part: 41MI(1) Criminal offences for importing, exporting, supplying or
has part: 41MI(4) Criminal offences for importing, exporting, supplying or
has part: 41MI(5) Criminal offences for importing, exporting, supplying or
proposed by: legis2cml
realized by: sec-41mi
schema version: 2

41MI(1) Criminal offences for importing, exporting, supplying or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.172
note: Importing, exporting, supplying or manufacturing a medical device without proper authorization is prohibited.
asserts: therapeutic-goods-act-1989-sec-41mi-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41mi-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mi-ss-1
schema version: 2
part of: 41MI Criminal offences for importing, exporting, supplying or

therapeutic-goods-act-1989-sec-41mi-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of actions
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41mi-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MI(1) Criminal offences for importing, exporting, supplying or

41MI(4) Criminal offences for importing, exporting, supplying or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.172
note: Importing, exporting, supplying or manufacturing a medical device without proper approval is prohibited.
asserts: therapeutic-goods-act-1989-sec-41mi-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41mi-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41mi-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41mi-ss-4-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41mi-ss-4-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-41mi-ss-4-logic-argumentation-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mi-ss-4
schema version: 2
part of: 41MI Criminal offences for importing, exporting, supplying or

therapeutic-goods-act-1989-sec-41mi-ss-4-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for approval requirements
modality: AllenInterval
operator: Temporal Interval
premise text: (4) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;

therapeutic-goods-act-1989-sec-41mi-ss-4-logic-argumentation-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Implication of non-compliance with approval requirements
modality: Argumentation
operator: Implication
premise text: (4) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;

therapeutic-goods-act-1989-sec-41mi-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41mi-ss-4-logic-deontic-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to obtain approval
modality: Deontic
operator: Obligation
premise text: (4) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;

therapeutic-goods-act-1989-sec-41mi-ss-4-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace for approval requirements
modality: LTL
operator: Recurring Trace
premise text: (4) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;

41MI(5) Criminal offences for importing, exporting, supplying or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.172
note: Importing, exporting, supplying or manufacturing a medical device without permission is prohibited.
asserts: therapeutic-goods-act-1989-sec-41mi-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-41mi-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41mi-ss-5-logic-ltl-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mi-ss-5
schema version: 2
part of: 41MI Criminal offences for importing, exporting, supplying or

therapeutic-goods-act-1989-sec-41mi-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the action of importing, exporting, supplying or manufacturing a medical device.
modality: Deontic
operator: Prohibit
premise text: (5) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;

therapeutic-goods-act-1989-sec-41mi-ss-5-logic-ltl-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Prohibits the action of importing, exporting, supplying or manufacturing a medical device.
modality: LTL
operator: Prohibit
premise text: (5) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;

therapeutic-goods-act-1989-sec-41mi-ss-5-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MI(5) Criminal offences for importing, exporting, supplying or

41MJ Treating medical devices as prohibited imports or exports
type: Concept
source: therapeutic-goods-act-1989.pdf, p.177
note: Medical devices are prohibited imports or exports.
asserts: therapeutic-goods-act-1989-sec-41mj-norm
asserts: therapeutic-goods-act-1989-sec-41mj-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mj
schema version: 2

therapeutic-goods-act-1989-sec-41mj-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits medical devices as imports or exports.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41mj-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MJ Treating medical devices as prohibited imports or exports

41MK Wholesale supply of medical devices not included in the
type: Concept
source: therapeutic-goods-act-1989.pdf, p.178
note: Supplying medical devices not included in the Register is an offence.
asserts: therapeutic-goods-act-1989-sec-41mk-norm
asserts: therapeutic-goods-act-1989-sec-41mk-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mk
schema version: 2

therapeutic-goods-act-1989-sec-41mk-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying medical devices not included in the Register.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41mk-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MK Wholesale supply of medical devices not included in the

41ML False advertising about medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.179
curation status: Proposed
has part: 41ML(1) False advertising about medical devices
has part: 41ML(2) False advertising about medical devices
has part: 41ML(3) False advertising about medical devices
proposed by: legis2cml
realized by: sec-41ml
schema version: 2

41ML(1) False advertising about medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.179
note: False advertising about medical devices is prohibited.
asserts: therapeutic-goods-act-1989-sec-41ml-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ml-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ml-ss-1-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41ml-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-41ml-ss-1-logic-linearlogic-4
asserts: therapeutic-goods-act-1989-sec-41ml-ss-1-logic-descriptionlogic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ml-ss-1
schema version: 2
part of: 41ML False advertising about medical devices

therapeutic-goods-act-1989-sec-41ml-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: False advertising about medical devices is prohibited.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits false advertising about medical devices.
modality: Deontic
operator: Prohibit
premise text: (a) the person, by any means, advertises a medical device as being for a purpose;

therapeutic-goods-act-1989-sec-41ml-ss-1-logic-deontic-3
type: LogicApplication
conclusion text: The use of the medical device for the advertised purpose must not result in harm or injury.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits harm or injury resulting from false advertising.
modality: Deontic
operator: Prohibit
premise text: (d) either: (i) the use of the medical device for the advertised purpose has resulted in, will result in, or is likely to result in, harm or injury to any person;

therapeutic-goods-act-1989-sec-41ml-ss-1-logic-descriptionlogic-2
type: LogicApplication
conclusion text: The device must be classified as being for a purpose accepted in relation to its inclusion in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies medical devices in the Register.
modality: DescriptionLogic
operator: Classify
premise text: (b) the device is of a kind included in the Register;

therapeutic-goods-act-1989-sec-41ml-ss-1-logic-descriptionlogic-5
type: LogicApplication
conclusion text: The device must be classified as being for a purpose accepted in relation to its inclusion in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies the device as being for a purpose accepted in relation to its inclusion in the Register.
modality: DescriptionLogic
operator: Classify
premise text: (c) the purpose is not a purpose accepted in relation to that inclusion;

therapeutic-goods-act-1989-sec-41ml-ss-1-logic-linearlogic-4
type: LogicApplication
conclusion text: False advertising about medical devices is prohibited if it results in harm or injury.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Implies that false advertising is prohibited if it results in harm or injury.
modality: LinearLogic
operator: Imply
premise text: (d) either: (i) the use of the medical device for the advertised purpose has resulted in, will result in, or is likely to result in, harm or injury to any person;

therapeutic-goods-act-1989-sec-41ml-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ML(1) False advertising about medical devices

41ML(2) False advertising about medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.179
note: False advertising about medical devices is prohibited.
asserts: therapeutic-goods-act-1989-sec-41ml-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41ml-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ml-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ml-ss-2
schema version: 2
part of: 41ML False advertising about medical devices

therapeutic-goods-act-1989-sec-41ml-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: (Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits false advertising about medical devices.
modality: Deontic
operator: Prohibit
premise text: (2) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-41ml-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies medical devices as those included in the Register.
modality: DescriptionLogic
operator: Classify
premise text: (b) the device is of a kind included in the Register;

therapeutic-goods-act-1989-sec-41ml-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ML(2) False advertising about medical devices

41ML(3) False advertising about medical devices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.179
note: False advertising about medical devices is prohibited.
asserts: therapeutic-goods-act-1989-sec-41ml-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41ml-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ml-ss-3-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41ml-ss-3-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41ml-ss-3-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-41ml-ss-3-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-41ml-ss-3-logic-argumentation-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ml-ss-3
schema version: 2
part of: 41ML False advertising about medical devices

therapeutic-goods-act-1989-sec-41ml-ss-3-logic-alleninterval-3
type: LogicApplication
conclusion text: (The advertising must occur after registration.)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Requires temporal overlap between advertising and medical device registration.
modality: AllenInterval
operator: Temporal overlap
premise text: (3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-41ml-ss-3-logic-argumentation-6
type: LogicApplication
conclusion text: (The advertising must be rebutted.)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Requires rebuttal of false advertising claims.
modality: Argumentation
operator: Rebuttal
premise text: (3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-41ml-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: (Penalty: 100 penalty units.)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits false advertising about medical devices.
modality: Deontic
operator: Prohibit
premise text: (3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-41ml-ss-3-logic-descriptionlogic-2
type: LogicApplication
conclusion text: (The device is of a kind included in the Register.)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies medical devices into categories based on their purposes.
modality: DescriptionLogic
operator: Classify
premise text: (3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-41ml-ss-3-logic-diffusion-5
type: LogicApplication
conclusion text: (The information must be diffused widely.)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Requires diffusion of information about medical device registration.
modality: Diffusion
operator: Diffusion
premise text: (3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-41ml-ss-3-logic-ltl-4
type: LogicApplication
conclusion text: (The advertising must recur over time.)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Requires recurring traces of false advertising and medical device registration.
modality: LTL
operator: Recurring trace
premise text: (3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-41ml-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41ML(3) False advertising about medical devices

41MN Criminal offences relating to breaches of conditions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.181
curation status: Proposed
has part: 41MN(1) Criminal offences relating to breaches of conditions
has part: 41MN(4) Criminal offences relating to breaches of conditions
has part: 41MN(4A) Criminal offences relating to breaches of conditions
proposed by: legis2cml
realized by: sec-41mn
schema version: 2

41MN(1) Criminal offences relating to breaches of conditions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.181
note: A person commits an offence if they include a kind of medical device in the Register and breach a condition related to it.
asserts: therapeutic-goods-act-1989-sec-41mn-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41mn-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41mn-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41mn-ss-1-logic-descriptionlogic-3
asserts: therapeutic-goods-act-1989-sec-41mn-ss-1-logic-alleninterval-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mn-ss-1
schema version: 2
part of: 41MN Criminal offences relating to breaches of conditions

therapeutic-goods-act-1989-sec-41mn-ss-1-logic-alleninterval-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Resulted in harm or injury to any person.
modality: AllenInterval
operator: resulted-in

therapeutic-goods-act-1989-sec-41mn-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Includes a kind of medical device in the Register.
modality: Deontic
operator: includes

therapeutic-goods-act-1989-sec-41mn-ss-1-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Breach a condition related to the inclusion of the kind of device.
modality: Deontic
operator: breaches

therapeutic-goods-act-1989-sec-41mn-ss-1-logic-descriptionlogic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Includes a kind of medical device in the Register.
modality: DescriptionLogic
operator: includes

therapeutic-goods-act-1989-sec-41mn-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MN(1) Criminal offences relating to breaches of conditions

41MN(4) Criminal offences relating to breaches of conditions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.181
note: Committing an offence if a medical device is included in the Register and an act or omission breaches a condition of its inclusion.
asserts: therapeutic-goods-act-1989-sec-41mn-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41mn-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41mn-ss-4-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41mn-ss-4-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41mn-ss-4-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-41mn-ss-4-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-41mn-ss-4-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mn-ss-4
schema version: 2
part of: 41MN Criminal offences relating to breaches of conditions

therapeutic-goods-act-1989-sec-41mn-ss-4-logic-alleninterval-3
type: LogicApplication
conclusion text: The act or omission breaches a condition of the inclusion of the kind of device in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Act or omission occurs during the period of device inclusion.
modality: AllenInterval
operator: During
premise text: (b) the person does an act or omits to do an act;

therapeutic-goods-act-1989-sec-41mn-ss-4-logic-cogai-6
type: LogicApplication
conclusion text: The condition of inclusion is related to the person.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Device inclusion is classified as a condition.
modality: CogAI
operator: Classification
premise text: (a) a kind of medical device is included in the Register in relation to the person;

therapeutic-goods-act-1989-sec-41mn-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: A person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with conditions related to medical devices.
modality: Deontic
operator: Obligation
premise text: (a) a kind of medical device is included in the Register in relation to the person;

therapeutic-goods-act-1989-sec-41mn-ss-4-logic-descriptionlogic-2
type: LogicApplication
conclusion text: The condition of inclusion is related to the person.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Device inclusion in the Register is a descriptive class.
modality: DescriptionLogic
operator: ClassInclusion
premise text: (a) a kind of medical device is included in the Register in relation to the person;

therapeutic-goods-act-1989-sec-41mn-ss-4-logic-diffusion-5
type: LogicApplication
conclusion text: A person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Device inclusion is related to the person if certain conditions are met.
modality: Diffusion
operator: If
premise text: (a) a kind of medical device is included in the Register in relation to the person;

therapeutic-goods-act-1989-sec-41mn-ss-4-logic-ltl-4
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Condition of inclusion is breached until the period ends.
modality: LTL
operator: Until
premise text: (c) the act or omission breaches a condition of the inclusion of the kind of device in the Register;

therapeutic-goods-act-1989-sec-41mn-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MN(4) Criminal offences relating to breaches of conditions

41MN(4A) Criminal offences relating to breaches of conditions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.181
note: A person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act that breaches a condition of the inclusion.
asserts: therapeutic-goods-act-1989-sec-41mn-ss-4a-norm
asserts: therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-deontic-5
asserts: therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-deontic-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mn-ss-4a
schema version: 2
part of: 41MN Criminal offences relating to breaches of conditions

therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-alleninterval-3
type: LogicApplication
conclusion text: The act or omission must occur during the time the medical device is included in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The act or omission must occur during the time the medical device is included in the Register.
modality: AllenInterval
operator: during
premise text: The person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act.

therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-deontic-1
type: LogicApplication
conclusion text: The state has an obligation to ensure the medical device is included in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The state has an obligation to ensure the medical device is included in the Register.
modality: Deontic
operator: hasObligation
premise text: The person commits an offence if a kind of medical device is included in the Register.

therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-deontic-5
type: LogicApplication
conclusion text: The state has permission to include a kind of medical device in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The state has permission to include a kind of medical device in the Register.
modality: Deontic
operator: hasPermission
premise text: A person commits an offence if a kind of medical device is included in the Register.

therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-deontic-6
type: LogicApplication
conclusion text: The person has a right to be included in the Register if a kind of medical device is included.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The person has a right to be included in the Register if a kind of medical device is included.
modality: Deontic
operator: hasRight
premise text: A person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act.

therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Medical devices are sub classes of devices that can be included in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Medical devices are sub classes of devices that can be included in the Register.
modality: DescriptionLogic
operator: isSubClassOf
premise text: The person commits an offence if a kind of medical device is included in the Register.

therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-ltl-4
type: LogicApplication
conclusion text: The condition of the inclusion of the medical device in the Register must be breached until the person commits an offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The condition of the inclusion of the medical device in the Register must be breached until the person commits an offence.
modality: LTL
operator: until
premise text: The person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act.

therapeutic-goods-act-1989-sec-41mn-ss-4a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MN(4A) Criminal offences relating to breaches of conditions

41MO Criminal offences for misusing medical devices exempted for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.190
curation status: Proposed
has part: 41MO(1) Criminal offences for misusing medical devices exempted for
has part: 41MO(4) Criminal offences for misusing medical devices exempted for
has part: 41MO(4A) Criminal offences for misusing medical devices exempted for
proposed by: legis2cml
realized by: sec-41mo
schema version: 2

41MO(1) Criminal offences for misusing medical devices exempted for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.190
note: Supplying a medical device without proper authority is prohibited.
asserts: therapeutic-goods-act-1989-sec-41mo-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41mo-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41mo-ss-1-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41mo-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-41mo-ss-1-logic-descriptionlogic-4
asserts: therapeutic-goods-act-1989-sec-41mo-ss-1-logic-deontic-5
asserts: therapeutic-goods-act-1989-sec-41mo-ss-1-logic-descriptionlogic-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mo-ss-1
schema version: 2
part of: 41MO Criminal offences for misusing medical devices exempted for

therapeutic-goods-act-1989-sec-41mo-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying a medical device without proper authority.
modality: Deontic
operator: Prohibit
premise text: (a) the person has been granted an authority under subsection 41HC(1) relating to a specified kind of medical device; and (b) the person supplies a medical device of that kind: ...

therapeutic-goods-act-1989-sec-41mo-ss-1-logic-deontic-3
type: LogicApplication
conclusion text: ...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits using a medical device without proper authority.
modality: Deontic
operator: Prohibit
premise text: (c) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person.

therapeutic-goods-act-1989-sec-41mo-ss-1-logic-deontic-5
type: LogicApplication
conclusion text: ...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying a medical device without proper conditions.
modality: Deontic
operator: Prohibit
premise text: (b) the person supplies a medical device of that kind: ... (ii) otherwise than in accordance with any conditions to which the authority is subject; or (iii) otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5).

therapeutic-goods-act-1989-sec-41mo-ss-1-logic-descriptionlogic-2
type: LogicApplication
conclusion text: ...the person supplies a medical device of that kind: ...
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies medical devices into categories based on their specifications.
modality: DescriptionLogic
operator: Classify
premise text: (subsection 41HC(1) relating to a specified kind of medical device)

therapeutic-goods-act-1989-sec-41mo-ss-1-logic-descriptionlogic-4
type: LogicApplication
conclusion text: ...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5).
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies harm or injury into categories based on their severity.
modality: DescriptionLogic
operator: Classify
premise text: (the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person.)

therapeutic-goods-act-1989-sec-41mo-ss-1-logic-descriptionlogic-6
type: LogicApplication
conclusion text: ...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5).
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies conditions into categories based on their specifications.
modality: DescriptionLogic
operator: Classify
premise text: (any conditions to which the authority is subject)

therapeutic-goods-act-1989-sec-41mo-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MO(1) Criminal offences for misusing medical devices exempted for

41MO(4) Criminal offences for misusing medical devices exempted for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.190
note: Supplying a medical device without authority is prohibited.
asserts: therapeutic-goods-act-1989-sec-41mo-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41mo-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41mo-ss-4-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41mo-ss-4-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-41mo-ss-4-logic-linearlogic-4
asserts: therapeutic-goods-act-1989-sec-41mo-ss-4-logic-descriptionlogic-5
asserts: therapeutic-goods-act-1989-sec-41mo-ss-4-logic-deontic-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mo-ss-4
schema version: 2
part of: 41MO Criminal offences for misusing medical devices exempted for

therapeutic-goods-act-1989-sec-41mo-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: ...the person supplies a medical device of that kind: ...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of supplying a medical device without authority.
modality: Deontic
operator: Prohibit
premise text: (4) A person commits an offence if...

therapeutic-goods-act-1989-sec-41mo-ss-4-logic-deontic-3
type: LogicApplication
conclusion text: ...the person supplies a medical device of that kind: ...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of supplying a medical device without authority.
modality: Deontic
operator: Prohibit
premise text: (4AA) A person commits an offence if...

therapeutic-goods-act-1989-sec-41mo-ss-4-logic-deontic-6
type: LogicApplication
conclusion text: ...the person supplies a medical device of that kind: ...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of supplying a medical device without authority.
modality: Deontic
operator: Prohibit
premise text: (4AB) An offence against subsection (4AA) is an offence of strict liability.

therapeutic-goods-act-1989-sec-41mo-ss-4-logic-descriptionlogic-2
type: LogicApplication
conclusion text: ...the person supplies a medical device of that kind: ...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of supplying a medical device without authority as prohibited.
modality: DescriptionLogic
operator: Classify
premise text: (4) A person commits an offence if...

therapeutic-goods-act-1989-sec-41mo-ss-4-logic-descriptionlogic-5
type: LogicApplication
conclusion text: ...the person supplies a medical device of that kind: ...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of supplying a medical device without authority as prohibited.
modality: DescriptionLogic
operator: Classify
premise text: (4AA) A person commits an offence if...

therapeutic-goods-act-1989-sec-41mo-ss-4-logic-linearlogic-4
type: LogicApplication
conclusion text: ...the person supplies a medical device of that kind: ...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Supplying a medical device without authority implies prohibition.
modality: LinearLogic
operator: Implication
premise text: (4) A person commits an offence if...

therapeutic-goods-act-1989-sec-41mo-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MO(4) Criminal offences for misusing medical devices exempted for

41MO(4A) Criminal offences for misusing medical devices exempted for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.190
note: Misusing medical devices is prohibited for specified health practitioners.
asserts: therapeutic-goods-act-1989-sec-41mo-ss-4a-norm
asserts: therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-argumentation-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mo-ss-4a
schema version: 2
part of: 41MO Criminal offences for misusing medical devices exempted for

therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-alleninterval-3
type: LogicApplication
conclusion text: ...the supply is not in accordance with those rules;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between supply and rule
modality: AllenInterval
operator: Temporal relation
premise text: (c) the person supplies a medical device of a kind specified in...

therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-argumentation-4
type: LogicApplication
conclusion text: ...the person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Implication of rule violation on offence
modality: Argumentation
operator: Implication
premise text: (d) any of the following applies:

therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-deontic-1
type: LogicApplication
conclusion text: ...the supply is not in accordance with those rules;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of misuse
modality: Deontic
operator: Prohibit
premise text: (4A) A person commits an offence...

therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-descriptionlogic-2
type: LogicApplication
conclusion text: ...specified in subsection 41HC(6) rules;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of health practitioners
modality: DescriptionLogic
operator: Classify
premise text: (b) the person is included in a class of health practitioners...

therapeutic-goods-act-1989-sec-41mo-ss-4a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MO(4A) Criminal offences for misusing medical devices exempted for

41MP Criminal offence for failing to notify adverse events etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.194
curation status: Proposed
has part: 41MP(1) Criminal offence for failing to notify adverse events etc.
has part: 41MP(2) Criminal offence for failing to notify adverse events etc.
proposed by: legis2cml
realized by: sec-41mp
schema version: 2

41MP(1) Criminal offence for failing to notify adverse events etc.
type: Concept
description: Information of a kind mentioned in subsection (2)
source: therapeutic-goods-act-1989.pdf, p.194
note: Failing to notify adverse events is a criminal offence. Notify adverse events etc. within specified period.
asserts: therapeutic-goods-act-1989-sec-41mp-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41mp-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41mp-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41mp-ss-1-logic-descriptionlogic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mp-ss-1
schema version: 2
part of: 41MP Criminal offence for failing to notify adverse events etc.

therapeutic-goods-act-1989-sec-41mp-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits failing to notify adverse events.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-41mp-ss-1-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide information
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41mp-ss-1-logic-descriptionlogic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Information of a kind mentioned in subsection (2)
modality: DescriptionLogic
operator: IS_A

therapeutic-goods-act-1989-sec-41mp-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 41MP(1) Criminal offence for failing to notify adverse events etc.

41MP(2) Criminal offence for failing to notify adverse events etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.194
note: Notify adverse events etc.
asserts: therapeutic-goods-act-1989-sec-41mp-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41mp-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41mp-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mp-ss-2
schema version: 2
part of: 41MP Criminal offence for failing to notify adverse events etc.

therapeutic-goods-act-1989-sec-41mp-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must notify adverse events etc.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41mp-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Device malfunction or deterioration
modality: DescriptionLogic
operator: IS_A
premise text: (a) information relating to any malfunction or deterioration in the characteristics or performance of the kind of device;

therapeutic-goods-act-1989-sec-41mp-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MP(2) Criminal offence for failing to notify adverse events etc.

41MQ Notification of adverse events etc. where application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.198
curation status: Proposed
has part: 41MQ(1) Notification of adverse events etc. where application
has part: 41MQ(2) Notification of adverse events etc. where application
has part: 41MQ(3) Notification of adverse events etc. where application
has part: 41MQ(4) Notification of adverse events etc. where application
proposed by: legis2cml
realized by: sec-41mq
schema version: 2

41MQ(1) Notification of adverse events etc. where application
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.198
note: Notify applicant of information about withdrawn application.
asserts: therapeutic-goods-act-1989-sec-41mq-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41mq-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41mq-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mq-ss-1
schema version: 2
part of: 41MQ Notification of adverse events etc. where application

therapeutic-goods-act-1989-sec-41mq-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must notify applicant.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41mq-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Notification is a subclass of obligation.
modality: DescriptionLogic
operator: SUBCLASS OF

therapeutic-goods-act-1989-sec-41mq-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MQ(1) Notification of adverse events etc. where application

41MQ(2) Notification of adverse events etc. where application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.198
note: Notice under subsection (1) must be given within 10 working days after an application is withdrawn or lapses.
asserts: therapeutic-goods-act-1989-sec-41mq-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41mq-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mq-ss-2
schema version: 2
part of: 41MQ Notification of adverse events etc. where application

therapeutic-goods-act-1989-sec-41mq-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: may only be given within 10 working days after an application is withdrawn or lapses.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must be given within 10 working days
modality: Deontic
operator: MUST
premise text: (2) Notice under subsection (1)

therapeutic-goods-act-1989-sec-41mq-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MQ(2) Notification of adverse events etc. where application

41MQ(3) Notification of adverse events etc. where application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.198
note: Failure to comply with notice within 20 working days is an offence.
asserts: therapeutic-goods-act-1989-sec-41mq-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41mq-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mq-ss-3
schema version: 2
part of: 41MQ Notification of adverse events etc. where application

therapeutic-goods-act-1989-sec-41mq-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Failure to comply is an offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with notice.
modality: Deontic
operator: Obligation
premise text: Notice given

therapeutic-goods-act-1989-sec-41mq-ss-3-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 41MQ(3) Notification of adverse events etc. where application

41MQ(4) Notification of adverse events etc. where application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.198
note: Giving false information in response to a notice is an offence.
asserts: therapeutic-goods-act-1989-sec-41mq-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41mq-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mq-ss-4
schema version: 2
part of: 41MQ Notification of adverse events etc. where application

therapeutic-goods-act-1989-sec-41mq-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: The person commits an offence if the information is false or misleading in a material particular.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of false information
modality: Deontic
operator: Prohibition
premise text: The person gives information in purported compliance with a notice.

therapeutic-goods-act-1989-sec-41mq-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MQ(4) Notification of adverse events etc. where application

41MR Civil penalties for failing to notify adverse effects etc. where
type: Concept
source: therapeutic-goods-act-1989.pdf, p.199
curation status: Proposed
has part: 41MR(1) Civil penalties for failing to notify adverse effects etc. where
has part: 41MR(2) Civil penalties for failing to notify adverse effects etc. where
proposed by: legis2cml
realized by: sec-41mr
schema version: 2

41MR(1) Civil penalties for failing to notify adverse effects etc. where
type: Concept
source: therapeutic-goods-act-1989.pdf, p.199
note: Failure to comply with notice requirements within 20 working days
asserts: therapeutic-goods-act-1989-sec-41mr-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41mr-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mr-ss-1
schema version: 2
part of: 41MR Civil penalties for failing to notify adverse effects etc. where

therapeutic-goods-act-1989-sec-41mr-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with notice requirements
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-41mr-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MR(1) Civil penalties for failing to notify adverse effects etc. where

41MR(2) Civil penalties for failing to notify adverse effects etc. where
type: Concept
source: therapeutic-goods-act-1989.pdf, p.199
note: False or misleading information in a notice
asserts: therapeutic-goods-act-1989-sec-41mr-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41mr-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41mr-ss-2
schema version: 2
part of: 41MR Civil penalties for failing to notify adverse effects etc. where

therapeutic-goods-act-1989-sec-41mr-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: The person contravenes this subsection
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of false or misleading information
modality: Deontic
operator: Prohibit
premise text: The person gives information in purported compliance with a notice

therapeutic-goods-act-1989-sec-41mr-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41MR(2) Civil penalties for failing to notify adverse effects etc. where

41N Simplified outline of this Chapter
type: Concept
source: therapeutic-goods-act-1989.pdf, p.200
note: Importation of vaping goods and manufacture, supply or possession are prohibited in Australia.
asserts: therapeutic-goods-act-1989-sec-41n-norm
asserts: therapeutic-goods-act-1989-sec-41n-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41n-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41n
schema version: 2

therapeutic-goods-act-1989-sec-41n-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of vaping goods importation and manufacture, supply or possession.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41n-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of vaping goods as prohibited.
modality: DescriptionLogic
operator: Classify

therapeutic-goods-act-1989-sec-41n-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41N Simplified outline of this Chapter

41NA Relationship with other Chapters of this Act
type: Concept
source: therapeutic-goods-act-1989.pdf, p.201
note: No limitation on generality of offence provisions or civil penalty provisions between Chapters.
asserts: therapeutic-goods-act-1989-sec-41na-norm
asserts: therapeutic-goods-act-1989-sec-41na-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41na
schema version: 2

therapeutic-goods-act-1989-sec-41na-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: No limitation on generality.
modality: Deontic
operator: !

therapeutic-goods-act-1989-sec-41na-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41NA Relationship with other Chapters of this Act

41P Meaning of vaping goods and related terms
type: Concept
source: therapeutic-goods-act-1989.pdf, p.202
curation status: Proposed
has part: 41P(1) Meaning of vaping goods and related terms
has part: 41P(2) Meaning of vaping goods and related terms
has part: 41P(3) Meaning of vaping goods and related terms
proposed by: legis2cml
realized by: sec-41p
schema version: 2

41P(1) Meaning of vaping goods and related terms
type: Concept
source: therapeutic-goods-act-1989.pdf, p.202
note: Defines vaping goods and related terms.
asserts: therapeutic-goods-act-1989-sec-41p-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41p-ss-1
schema version: 2
part of: 41P Meaning of vaping goods and related terms

41P(2) Meaning of vaping goods and related terms
type: Concept
source: therapeutic-goods-act-1989.pdf, p.202
note: Goods must be presented in a certain way to be considered vaping goods.
asserts: therapeutic-goods-act-1989-sec-41p-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41p-ss-2-logic-descriptionlogic-1
asserts: therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-5
asserts: therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41p-ss-2
schema version: 2
part of: 41P Meaning of vaping goods and related terms

therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-2
type: LogicApplication
conclusion text: Goods must meet specific presentation requirements to be considered vaping goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Presentation requirements for vaping goods
modality: Deontic
operator: =
premise text: (a) the presentation of goods includes matters in relation to...

therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-3
type: LogicApplication
conclusion text: Goods cannot be presented in a way that is misleading or confusing.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Misleading or confusing presentation is prohibited
modality: Deontic
operator: =
premise text: (i) is capable of being misleading or confusing as to the content or proper use or identification of the goods;

therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-4
type: LogicApplication
conclusion text: The Minister has the authority to determine whether goods are vaping goods or not.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Minister's discretion for determining vaping goods
modality: Deontic
operator: =
premise text: Minister may determine that goods are or are not vaping goods etc.

therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-5
type: LogicApplication
conclusion text: Goods cannot be presented as having ingredients or characteristics they do not actually have.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on presenting false information
modality: Deontic
operator: =
premise text: (ii) suggests that the goods have ingredients, components or characteristics that they do not have.

therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-6
type: LogicApplication
conclusion text: The Minister has the right to determine whether goods are vaping goods or not.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Right to determine vaping goods
modality: Deontic
operator: =
premise text: (b) goods are taken to be presented as being a particular kind of goods even if...

therapeutic-goods-act-1989-sec-41p-ss-2-logic-descriptionlogic-1
type: LogicApplication
conclusion text: Goods must be presented in a certain way to be considered vaping goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Definition of vaping goods
modality: DescriptionLogic
operator: =
premise text: Goods are taken to be presented as being a particular kind of goods

41P(3) Meaning of vaping goods and related terms
type: Concept
source: therapeutic-goods-act-1989.pdf, p.202
note: Authority to determine vaping goods classification
asserts: therapeutic-goods-act-1989-sec-41p-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41p-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41p-ss-3
schema version: 2
part of: 41P Meaning of vaping goods and related terms

therapeutic-goods-act-1989-sec-41p-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Granting permission
modality: Deontic
operator: May

41Q Offences and civil penalty provision—importing vaping goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.204
curation status: Proposed
has part: 41Q(1) Offences and civil penalty provision—importing vaping goods
has part: 41Q(2) Offences and civil penalty provision—importing vaping goods
has part: 41Q(3) Offences and civil penalty provision—importing vaping goods
has part: 41Q(4) Offences and civil penalty provision—importing vaping goods
has part: 41Q(5) Offences and civil penalty provision—importing vaping goods
proposed by: legis2cml
realized by: sec-41q
schema version: 2

41Q(1) Offences and civil penalty provision—importing vaping goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.204
note: Importing vaping goods into Australia is an offence.
asserts: therapeutic-goods-act-1989-sec-41q-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41q-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41q-ss-1
schema version: 2
part of: 41Q Offences and civil penalty provision—importing vaping goods

therapeutic-goods-act-1989-sec-41q-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits importing vaping goods into Australia.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41q-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41Q(1) Offences and civil penalty provision—importing vaping goods

41Q(2) Offences and civil penalty provision—importing vaping goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.204
note: Importing vaping goods into Australia is an offence of strict liability.
asserts: therapeutic-goods-act-1989-sec-41q-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41q-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41q-ss-2
schema version: 2
part of: 41Q Offences and civil penalty provision—importing vaping goods

therapeutic-goods-act-1989-sec-41q-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits importing vaping goods into Australia.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41q-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41Q(2) Offences and civil penalty provision—importing vaping goods

41Q(3) Offences and civil penalty provision—importing vaping goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.204
note: Importing vaping goods into Australia is prohibited.
asserts: therapeutic-goods-act-1989-sec-41q-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41q-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41q-ss-3
schema version: 2
part of: 41Q Offences and civil penalty provision—importing vaping goods

therapeutic-goods-act-1989-sec-41q-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits importing vaping goods.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41q-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41Q(3) Offences and civil penalty provision—importing vaping goods

41Q(4) Offences and civil penalty provision—importing vaping goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.204
note: Importing vaping goods without compliance with subsection (3) is prohibited.
asserts: therapeutic-goods-act-1989-sec-41q-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41q-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41q-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41q-ss-4-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41q-ss-4-logic-cogai-4
asserts: therapeutic-goods-act-1989-sec-41q-ss-4-logic-shacl-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41q-ss-4
schema version: 2
part of: 41Q Offences and civil penalty provision—importing vaping goods

therapeutic-goods-act-1989-sec-41q-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: Importation of vaping goods must comply with subsection (3).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap between subsection (3) and importation.
modality: AllenInterval
operator: Overlap
premise text: Subsection (3) sets conditions for importation.

therapeutic-goods-act-1989-sec-41q-ss-4-logic-cogai-4
type: LogicApplication
conclusion text: Compliance with subsection (3) must be analyzed.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Analyzing compliance with subsection (3).
modality: CogAI
operator: Analyze
premise text: Subsection (3) sets conditions for importation.

therapeutic-goods-act-1989-sec-41q-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: Importing vaping goods without compliance is prohibited.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of importing vaping goods without compliance.
modality: Deontic
operator: Prohibit
premise text: Subsection (3) sets conditions for importing vaping goods.

therapeutic-goods-act-1989-sec-41q-ss-4-logic-ltl-3
type: LogicApplication
conclusion text: Compliance with subsection (3) must be recurring.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of compliance with subsection (3).
modality: LTL
operator: Recurring
premise text: Subsection (3) sets conditions for importation.

therapeutic-goods-act-1989-sec-41q-ss-4-logic-shacl-5
type: LogicApplication
conclusion text: Compliance with subsection (3) must be validated.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::shacl
logic summary: Validation of compliance with subsection (3).
modality: SHACL
operator: Validate
premise text: Subsection (3) sets conditions for importation.

therapeutic-goods-act-1989-sec-41q-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41Q(4) Offences and civil penalty provision—importing vaping goods

41Q(5) Offences and civil penalty provision—importing vaping goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.204
note: Exemptions from subsections (1) to (4)
asserts: therapeutic-goods-act-1989-sec-41q-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41q-ss-5
schema version: 2
part of: 41Q Offences and civil penalty provision—importing vaping goods

41QA Offences and civil penalty provision—manufacturing vaping
type: Concept
source: therapeutic-goods-act-1989.pdf, p.205
curation status: Proposed
has part: 41QA(1) Offences and civil penalty provision—manufacturing vaping
has part: 41QA(2) Offences and civil penalty provision—manufacturing vaping
has part: 41QA(3) Offences and civil penalty provision—manufacturing vaping
has part: 41QA(4) Offences and civil penalty provision—manufacturing vaping
proposed by: legis2cml
realized by: sec-41qa
schema version: 2

41QA(1) Offences and civil penalty provision—manufacturing vaping
type: Concept
source: therapeutic-goods-act-1989.pdf, p.205
note: Manufacturing vaping goods in Australia is prohibited.
asserts: therapeutic-goods-act-1989-sec-41qa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41qa-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qa-ss-1
schema version: 2
part of: 41QA Offences and civil penalty provision—manufacturing vaping

therapeutic-goods-act-1989-sec-41qa-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits manufacturing vaping goods.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41qa-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41QA(1) Offences and civil penalty provision—manufacturing vaping

41QA(2) Offences and civil penalty provision—manufacturing vaping
type: Concept
source: therapeutic-goods-act-1989.pdf, p.205
note: Manufacturing vaping goods is prohibited.
asserts: therapeutic-goods-act-1989-sec-41qa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41qa-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qa-ss-2
schema version: 2
part of: 41QA Offences and civil penalty provision—manufacturing vaping

therapeutic-goods-act-1989-sec-41qa-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits manufacturing vaping goods.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41qa-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41QA(2) Offences and civil penalty provision—manufacturing vaping

41QA(3) Offences and civil penalty provision—manufacturing vaping
type: Concept
source: therapeutic-goods-act-1989.pdf, p.205
note: Manufacturing vaping goods in Australia is prohibited.
asserts: therapeutic-goods-act-1989-sec-41qa-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41qa-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qa-ss-3
schema version: 2
part of: 41QA Offences and civil penalty provision—manufacturing vaping

therapeutic-goods-act-1989-sec-41qa-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits manufacturing vaping goods.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41qa-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41QA(3) Offences and civil penalty provision—manufacturing vaping

41QA(4) Offences and civil penalty provision—manufacturing vaping
type: Concept
source: therapeutic-goods-act-1989.pdf, p.205
note: Manufacturing vaping goods without compliance with subsection (3) is prohibited.
asserts: therapeutic-goods-act-1989-sec-41qa-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41qa-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41qa-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41qa-ss-4-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41qa-ss-4-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41qa-ss-4-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qa-ss-4
schema version: 2
part of: 41QA Offences and civil penalty provision—manufacturing vaping

therapeutic-goods-act-1989-sec-41qa-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: Manufacture overlaps with subsection (3) conditions.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap between manufacture and subsection (3) conditions.
modality: AllenInterval
operator: Overlap
premise text: Manufacture occurs before or concurrently with subsection (3) conditions.

therapeutic-goods-act-1989-sec-41qa-ss-4-logic-cogai-5
type: LogicApplication
conclusion text: Manufacturing vaping goods must be analyzed for compliance.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Analyzing manufacturing vaping goods for compliance with subsection (3).
modality: CogAI
operator: Analyze
premise text: Manufacturing vaping goods requires analysis for compliance.

therapeutic-goods-act-1989-sec-41qa-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: Manufacturing without compliance is prohibited.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of manufacturing vaping goods without compliance.
modality: Deontic
operator: Prohibit
premise text: Subsection (3) sets conditions for manufacture.

therapeutic-goods-act-1989-sec-41qa-ss-4-logic-diffusion-4
type: LogicApplication
conclusion text: Non-compliance in manufacturing vaping goods spreads to other units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusion of non-compliance in manufacturing vaping goods.
modality: Diffusion
operator: Spread
premise text: Non-compliance in manufacture spreads to other units of vaping goods.

therapeutic-goods-act-1989-sec-41qa-ss-4-logic-ltl-3
type: LogicApplication
conclusion text: Manufacturing vaping goods without compliance has a recurring trace.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of manufacturing vaping goods without compliance.
modality: LTL
operator: Recurring
premise text: Manufacturing vaping goods without compliance is a recurring action.

therapeutic-goods-act-1989-sec-41qa-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41QA(4) Offences and civil penalty provision—manufacturing vaping

41QB Offences and civil penalty provision—supplying vaping goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.206
curation status: Proposed
has part: 41QB(1) Offences and civil penalty provision—supplying vaping goods
has part: 41QB(2) Offences and civil penalty provision—supplying vaping goods
has part: 41QB(3) Offences and civil penalty provision—supplying vaping goods
has part: 41QB(4) Offences and civil penalty provision—supplying vaping goods
has part: 41QB(5) Offences and civil penalty provision—supplying vaping goods
has part: 41QB(6) Offences and civil penalty provision—supplying vaping goods
proposed by: legis2cml
realized by: sec-41qb
schema version: 2

41QB(1) Offences and civil penalty provision—supplying vaping goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.206
note: Supplying vaping goods in Australia is an offence.
asserts: therapeutic-goods-act-1989-sec-41qb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41qb-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qb-ss-1
schema version: 2
part of: 41QB Offences and civil penalty provision—supplying vaping goods

therapeutic-goods-act-1989-sec-41qb-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying vaping goods in Australia.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41qb-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41QB(1) Offences and civil penalty provision—supplying vaping goods

41QB(2) Offences and civil penalty provision—supplying vaping goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.206
note: Supplying vaping goods is an offence of strict liability.
asserts: therapeutic-goods-act-1989-sec-41qb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41qb-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qb-ss-2
schema version: 2
part of: 41QB Offences and civil penalty provision—supplying vaping goods

therapeutic-goods-act-1989-sec-41qb-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying vaping goods.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41qb-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41QB(2) Offences and civil penalty provision—supplying vaping goods

41QB(3) Offences and civil penalty provision—supplying vaping goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.206
note: Supplying vaping goods in Australia is prohibited.
asserts: therapeutic-goods-act-1989-sec-41qb-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41qb-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qb-ss-3
schema version: 2
part of: 41QB Offences and civil penalty provision—supplying vaping goods

therapeutic-goods-act-1989-sec-41qb-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying vaping goods.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41qb-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41QB(3) Offences and civil penalty provision—supplying vaping goods

41QB(4) Offences and civil penalty provision—supplying vaping goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.206
note: Supplying vaping goods without compliance with subsection (3) is prohibited.
asserts: therapeutic-goods-act-1989-sec-41qb-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41qb-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41qb-ss-4-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qb-ss-4
schema version: 2
part of: 41QB Offences and civil penalty provision—supplying vaping goods

therapeutic-goods-act-1989-sec-41qb-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: Prohibition overlaps with supply.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap between supply and prohibition.
modality: AllenInterval
operator: Overlap
premise text: Supplying vaping goods is prohibited after subsection (3) applies.

therapeutic-goods-act-1989-sec-41qb-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: No supply is allowed.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of supplying vaping goods without compliance.
modality: Deontic
operator: Prohibit
premise text: Subsection (3) sets conditions for supply.

therapeutic-goods-act-1989-sec-41qb-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41QB(4) Offences and civil penalty provision—supplying vaping goods

41QB(5) Offences and civil penalty provision—supplying vaping goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.206
note: Exemptions from subsections (1) to (4)
asserts: therapeutic-goods-act-1989-sec-41qb-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qb-ss-5
schema version: 2
part of: 41QB Offences and civil penalty provision—supplying vaping goods

41QB(6) Offences and civil penalty provision—supplying vaping goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.206
note: Supply of vaping goods without proper exemption is prohibited.
asserts: therapeutic-goods-act-1989-sec-41qb-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-41qb-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qb-ss-6
schema version: 2
part of: 41QB Offences and civil penalty provision—supplying vaping goods

therapeutic-goods-act-1989-sec-41qb-ss-6-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition
modality: Deontic
operator: Prohibit

41QC Offences and civil penalty provision—possessing at least
type: Concept
source: therapeutic-goods-act-1989.pdf, p.211
curation status: Proposed
has part: 41QC(1) Offences and civil penalty provision—possessing at least
has part: 41QC(2) Offences and civil penalty provision—possessing at least
has part: 41QC(3) Offences and civil penalty provision—possessing at least
proposed by: legis2cml
realized by: sec-41qc
schema version: 2

41QC(1) Offences and civil penalty provision—possessing at least
type: Concept
source: therapeutic-goods-act-1989.pdf, p.211
note: Possessing vaping goods in Australia without permission
asserts: therapeutic-goods-act-1989-sec-41qc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41qc-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41qc-ss-1-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-41qc-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41qc-ss-1-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-41qc-ss-1-logic-descriptionlogic-5
asserts: therapeutic-goods-act-1989-sec-41qc-ss-1-logic-alleninterval-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qc-ss-1
schema version: 2
part of: 41QC Offences and civil penalty provision—possessing at least

therapeutic-goods-act-1989-sec-41qc-ss-1-logic-alleninterval-6
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Establishes a temporal interval for imprisonment for possession of vaping goods in Australia
modality: AllenInterval
operator: Temporal Interval
premise text: Penalty: Imprisonment for 2 years or 1,000 penalty units, or both.

therapeutic-goods-act-1989-sec-41qc-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits possession of vaping goods in Australia
modality: Deontic
operator: Prohibit
premise text: (a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity of that kind of vaping goods.

therapeutic-goods-act-1989-sec-41qc-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imprisonment for 2 years or 1,000 penalty units for possession of vaping goods in Australia
modality: Deontic
operator: Prohibit
premise text: Penalty: Imprisonment for 2 years or 1,000 penalty units, or both.

therapeutic-goods-act-1989-sec-41qc-ss-1-logic-descriptionlogic-2
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies possession of vaping goods in Australia as an offence
modality: DescriptionLogic
operator: Classify
premise text: (a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity of that kind of vaping goods.

therapeutic-goods-act-1989-sec-41qc-ss-1-logic-descriptionlogic-5
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies imprisonment for 2 years or 1,000 penalty units as a penalty for possession of vaping goods in Australia
modality: DescriptionLogic
operator: Classify
premise text: Penalty: Imprisonment for 2 years or 1,000 penalty units, or both.

therapeutic-goods-act-1989-sec-41qc-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Establishes a recurring trace for possession of vaping goods in Australia
modality: LTL
operator: Recurring Trace
premise text: (a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity of that kind of vaping goods.

therapeutic-goods-act-1989-sec-41qc-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41QC(1) Offences and civil penalty provision—possessing at least

41QC(2) Offences and civil penalty provision—possessing at least
type: Concept
source: therapeutic-goods-act-1989.pdf, p.211
note: Absolute liability applies for possessing at least
asserts: therapeutic-goods-act-1989-sec-41qc-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qc-ss-2
schema version: 2
part of: 41QC Offences and civil penalty provision—possessing at least

therapeutic-goods-act-1989-sec-41qc-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41QC(2) Offences and civil penalty provision—possessing at least

41QC(3) Offences and civil penalty provision—possessing at least
type: Concept
source: therapeutic-goods-act-1989.pdf, p.211
note: Possessing a quantity of vaping goods without exceeding the commercial quantity is an offence.
asserts: therapeutic-goods-act-1989-sec-41qc-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41qc-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41qc-ss-3-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qc-ss-3
schema version: 2
part of: 41QC Offences and civil penalty provision—possessing at least

therapeutic-goods-act-1989-sec-41qc-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: A person commits an offence of strict liability if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits possessing vaping goods
modality: Deontic
operator: Prohibition
premise text: (a) the person possesses a quantity of a kind of vaping goods in Australia;

therapeutic-goods-act-1989-sec-41qc-ss-3-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Penalty: 120 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies vaping goods as prohibited
modality: DescriptionLogic
operator: Classify
premise text: (3) A person commits an offence of strict liability if:

therapeutic-goods-act-1989-sec-41qc-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41QC(3) Offences and civil penalty provision—possessing at least

41QD Offences and civil penalty provision—possessing less than
type: Concept
source: therapeutic-goods-act-1989.pdf, p.215
note: Possessing less than a commercial quantity of vaping goods is an offence.
asserts: therapeutic-goods-act-1989-sec-41qd-norm
asserts: therapeutic-goods-act-1989-sec-41qd-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41qd-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41qd-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41qd-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41qd-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qd
schema version: 2

therapeutic-goods-act-1989-sec-41qd-logic-alleninterval-2
type: LogicApplication
conclusion text: Possessing less than a commercial quantity of vaping goods is an offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Overlaps with the definition of a commercial quantity.
modality: AllenInterval
operator: Overlap
premise text: commercial quantity of vaping goods

therapeutic-goods-act-1989-sec-41qd-logic-cogai-5
type: LogicApplication
conclusion text: Offences (1) A person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Recognizes the legal concept of possessing less than a commercial quantity of vaping goods as an offence.
modality: CogAI
operator: Recognize
premise text: Chapter 4A Vaping goods

therapeutic-goods-act-1989-sec-41qd-logic-deontic-1
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits possessing less than a commercial quantity of vaping goods.
modality: Deontic
operator: Prohibit
premise text: The person is a retailer in relation to retail premises in Australia.

therapeutic-goods-act-1989-sec-41qd-logic-diffusion-4
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses the definition of a commercial quantity to include retail premises in Australia.
modality: Diffusion
operator: Diffuse
premise text: the person is a retailer in relation to retail premises in Australia.

therapeutic-goods-act-1989-sec-41qd-logic-ltl-3
type: LogicApplication
conclusion text: Possessing less than a commercial quantity of vaping goods is an offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace for the definition of a commercial quantity.
modality: LTL
operator: Recurring
premise text: commercial quantity of vaping goods

therapeutic-goods-act-1989-sec-41qd-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41QD Offences and civil penalty provision—possessing less than

41QE Exceptions etc. to civil penalty provisions—burden of proof
type: Concept
source: therapeutic-goods-act-1989.pdf, p.220
note: Burden of proof for exceptions to civil penalty provisions
asserts: therapeutic-goods-act-1989-sec-41qe-norm
asserts: therapeutic-goods-act-1989-sec-41qe-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41qe
schema version: 2

therapeutic-goods-act-1989-sec-41qe-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation on the person to bear evidential burden
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-41qe-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41QE Exceptions etc. to civil penalty provisions—burden of proof

41R Minister may determine that specified vaping goods may be
type: Concept
source: therapeutic-goods-act-1989.pdf, p.221
note: The Minister may determine that specified vaping goods may be supplied or possessed in Australia under certain circumstances.
asserts: therapeutic-goods-act-1989-sec-41r-norm
asserts: therapeutic-goods-act-1989-sec-41r-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41r-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41r
schema version: 2

therapeutic-goods-act-1989-sec-41r-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission granted by the Minister.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-41r-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Specific goods subject to permission.
modality: DescriptionLogic
operator: specified vaping goods

therapeutic-goods-act-1989-sec-41r-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41R Minister may determine that specified vaping goods may be

41RA Minister may determine other indications for which vaping
type: Concept
source: therapeutic-goods-act-1989.pdf, p.221
note: Minister may determine indications for vaping goods use
asserts: therapeutic-goods-act-1989-sec-41ra-norm
asserts: therapeutic-goods-act-1989-sec-41ra-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ra
schema version: 2

therapeutic-goods-act-1989-sec-41ra-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to vape goods
modality: Deontic
operator: May

41RB Application to Secretary for consent to manufacture, supply
type: Concept
source: therapeutic-goods-act-1989.pdf, p.222
curation status: Proposed
has part: 41RB(1) Application to Secretary for consent to manufacture, supply
has part: 41RB(2) Application to Secretary for consent to manufacture, supply
has part: 41RB(3) Application to Secretary for consent to manufacture, supply
has part: 41RB(4) Application to Secretary for consent to manufacture, supply
proposed by: legis2cml
realized by: sec-41rb
schema version: 2

41RB(1) Application to Secretary for consent to manufacture, supply
type: Concept
source: therapeutic-goods-act-1989.pdf, p.222
note: Consent required for manufacture, supply or possession of vaping goods.
asserts: therapeutic-goods-act-1989-sec-41rb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41rb-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41rb-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41rb-ss-1-logic-argumentation-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-41rb-ss-1
schema version: 2
part of: 41RB Application to Secretary for consent to manufacture, supply

therapeutic-goods-act-1989-sec-41rb-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: to manufacture, supply or possess vaping goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal scope of application
modality: AllenInterval
operator: during
premise text: The key applies to a person who may apply to the Secretary for consent during the relevant period

therapeutic-goods-act-1989-sec-41rb-ss-1-logic-argumentation-3
type: LogicApplication
conclusion text: then they may manufacture, supply or possess vaping goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Implication of application
modality: Argumentation
operator: implies
premise text: If a person applies to the Secretary for consent

therapeutic-goods-act-1989-sec-41rb-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: to manufacture, supply or possess vaping goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Granting permission
modality: Deontic
operator: hasPermission
premise text: A person may apply to the Secretary for consent

therapeutic-goods-act-1989-sec-41rb-ss-1-norm
type: Permission
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 41RB(1) Application to Secretary for consent to manufacture, supply

41RB(2) Application to Secretary for consent to manufacture, supply
type: Concept
description: Form, Fee
source: therapeutic-goods-act-1989.pdf, p.222
note: Application must be in accordance with a form approved by the Secretary and accompanied by fee (if any)
asserts: therapeutic-goods-act-1989-sec-41rb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41rb-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41rb-ss-2
schema version: 2
part of: 41RB Application to Secretary for consent to manufacture, supply

therapeutic-goods-act-1989-sec-41rb-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application must be in accordance with a form approved by the Secretary
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41rb-ss-2-norm
type: Obligation
scope note: borne by: LegalPerson
curation status: Proposed
modality: Deontic
borne by: LegalPerson
deontic status: HeuristicDerived
part of: 41RB(2) Application to Secretary for consent to manufacture, supply

41RB(3) Application to Secretary for consent to manufacture, supply
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.222
note: Secretary may require applicant to provide further information within a reasonable time.
asserts: therapeutic-goods-act-1989-sec-41rb-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41rb-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41rb-ss-3
schema version: 2
part of: 41RB Application to Secretary for consent to manufacture, supply

therapeutic-goods-act-1989-sec-41rb-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary may require applicant to provide further information.
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-41rb-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41RB(3) Application to Secretary for consent to manufacture, supply

41RB(4) Application to Secretary for consent to manufacture, supply
type: Concept
description: Information in accordance with specified software requirements
source: therapeutic-goods-act-1989.pdf, p.222
note: Application for consent may be required or permitted
asserts: therapeutic-goods-act-1989-sec-41rb-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41rb-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41rb-ss-4-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41rb-ss-4
schema version: 2
part of: 41RB Application to Secretary for consent to manufacture, supply

therapeutic-goods-act-1989-sec-41rb-ss-4-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to apply for consent
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-41rb-ss-4-logic-descriptionlogic-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Requirements for application
modality: DescriptionLogic
operator: Has specified software requirements

therapeutic-goods-act-1989-sec-41rb-ss-4-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41RB(4) Application to Secretary for consent to manufacture, supply

41RC Secretary may give consent
type: Concept
source: therapeutic-goods-act-1989.pdf, p.222
curation status: Proposed
has part: 41RC(1) Secretary may give consent
has part: 41RC(2) Secretary may give consent
has part: 41RC(2A) Secretary may give consent
has part: 41RC(2B) Secretary may give consent
has part: 41RC(2C) Secretary may give consent
has part: 41RC(3) Secretary may give consent
proposed by: legis2cml
realized by: sec-41rc
schema version: 2

41RC(1) Secretary may give consent
type: Concept
source: therapeutic-goods-act-1989.pdf, p.222
note: Secretary may give consent for manufacture, supply or possession of vaping goods.
asserts: therapeutic-goods-act-1989-sec-41rc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41rc-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41rc-ss-1
schema version: 2
part of: 41RC Secretary may give consent

therapeutic-goods-act-1989-sec-41rc-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary can give consent.
modality: Deontic
operator: can

therapeutic-goods-act-1989-sec-41rc-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41RC(1) Secretary may give consent

41RC(2) Secretary may give consent
type: Concept
source: therapeutic-goods-act-1989.pdf, p.222
note: Secretary may give consent for vaping goods
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41rc-ss-2
schema version: 2
part of: 41RC Secretary may give consent

therapeutic-goods-act-1989-sec-41rc-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to vape goods
modality: Deontic
operator: may

41RC(2A) Secretary may give consent
type: Concept
source: therapeutic-goods-act-1989.pdf, p.222
note: Secretary must comply with decision-making principles
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2a-norm
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-41rc-ss-2a
schema version: 2
part of: 41RC Secretary may give consent

therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-alleninterval-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Decision-making principle is a prerequisite for decision making
modality: AllenInterval
operator: MEETS
premise text: (2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B).

therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must comply
modality: Deontic
operator: MUST
premise text: (2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B).

therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-deontic-4
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Decision making is a subclass of general action
modality: Deontic
operator: IS_A
premise text: (2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B).

therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-ltl-3
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Decision making is contingent on compliance with principle
modality: LTL
operator: MEETS
premise text: (2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B).

41RC(2B) Secretary may give consent
type: Concept
source: therapeutic-goods-act-1989.pdf, p.222
note: Secretary must comply with decision-making principles
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2b-norm
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41rc-ss-2b
schema version: 2
part of: 41RC Secretary may give consent

therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-alleninterval-2
type: LogicApplication
conclusion text: The decision-making principles apply to decisions made within the interval of the Minister's power.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Decision-making principles apply to decisions made within this interval
modality: AllenInterval
operator: CONTAINS
premise text: (2B) The Minister may, by legislative instrument...

therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-argumentation-3
type: LogicApplication
conclusion text: The decision-making principles imply that the Secretary must take certain actions.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Decision-making principles imply certain actions
modality: Argumentation
operator: IMPLIES
premise text: (2B) The Minister may, by legislative instrument...

therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-cogai-5
type: LogicApplication
conclusion text: The decision-making principles are a type of AI algorithm that the Secretary must use.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Decision-making principles are a type of AI algorithm
modality: CogAI
operator: IS_A
premise text: (2B) The Minister may, by legislative instrument...

therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-deontic-1
type: LogicApplication
conclusion text: The Secretary must comply with the decision-making principles.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must comply
modality: Deontic
operator: MUST
premise text: (2B) The Minister may, by legislative instrument...

therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-diffusion-4
type: LogicApplication
conclusion text: The decision-making principles spread to other agents who must comply with the Secretary's decisions.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Decision-making principles spread to other agents
modality: Diffusion
operator: SPREADS_TO
premise text: (2B) The Minister may, by legislative instrument...

therapeutic-goods-act-1989-sec-41rc-ss-2b-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41RC(2B) Secretary may give consent

41RC(2C) Secretary may give consent
type: Concept
source: therapeutic-goods-act-1989.pdf, p.222
note: Secretary may give consent under certain circumstances.
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2c-norm
asserts: therapeutic-goods-act-1989-sec-41rc-ss-2c-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41rc-ss-2c
schema version: 2
part of: 41RC Secretary may give consent

therapeutic-goods-act-1989-sec-41rc-ss-2c-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to give consent
modality: Deontic
operator: may
premise text: (2C) Without limiting subsection (2B)

therapeutic-goods-act-1989-sec-41rc-ss-2c-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41RC(2C) Secretary may give consent

41RC(3) Secretary may give consent
type: Concept
source: therapeutic-goods-act-1989.pdf, p.222
note: Secretary must publish decision particulars on website after giving consent
asserts: therapeutic-goods-act-1989-sec-41rc-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41rc-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41rc-ss-3
schema version: 2
part of: 41RC Secretary may give consent

therapeutic-goods-act-1989-sec-41rc-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide information
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-41rc-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41RC(3) Secretary may give consent

41RD Offences and civil penalty provision—breaching condition of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.224
curation status: Proposed
has part: 41RD(1) Offences and civil penalty provision—breaching condition of
has part: 41RD(2) Offences and civil penalty provision—breaching condition of
has part: 41RD(3) Offences and civil penalty provision—breaching condition of
has part: 41RD(4) Offences and civil penalty provision—breaching condition of
proposed by: legis2cml
realized by: sec-41rd
schema version: 2

41RD(1) Offences and civil penalty provision—breaching condition of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.224
note: Offence for breaching condition of consent
asserts: therapeutic-goods-act-1989-sec-41rd-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41rd-ss-1-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41rd-ss-1
schema version: 2
part of: 41RD Offences and civil penalty provision—breaching condition of

therapeutic-goods-act-1989-sec-41rd-ss-1-logic-alleninterval-3
type: LogicApplication
conclusion text: ...will result in, or is likely to result in, harm or injury to any person.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines temporal interval for penalty application
modality: AllenInterval
operator: Between
premise text: (c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.

therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...breaches a condition of a consent imposed under subsection 41RC(2); and
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits certain actions
modality: Deontic
operator: Prohibition
premise text: (1) A person commits an offence if...

therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: ...breaches a condition of a consent imposed under subsection 41RC(2); and
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation to comply with consent conditions
modality: Deontic
operator: Obligation
premise text: (a) the person does an act or omits to do an act; and

therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: ...harm or injury to any person.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits certain actions resulting in harm or injury
modality: Deontic
operator: Prohibition
premise text: (c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.

therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-5
type: LogicApplication
conclusion text: ...breaches a condition of a consent imposed under subsection 41RC(2); and
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation to prevent harm or injury
modality: Deontic
operator: Obligation
premise text: (b) the act or omission breaches a condition of a consent imposed under subsection 41RC(2); and

therapeutic-goods-act-1989-sec-41rd-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41RD(1) Offences and civil penalty provision—breaching condition of

41RD(2) Offences and civil penalty provision—breaching condition of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.224
note: Breach of condition results in an offence and a penalty.
asserts: therapeutic-goods-act-1989-sec-41rd-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41rd-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41rd-ss-2
schema version: 2
part of: 41RD Offences and civil penalty provision—breaching condition of

therapeutic-goods-act-1989-sec-41rd-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Penalty: 500 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Breach of obligation
modality: Deontic
operator: breach
premise text: (2) A person commits an offence if...

therapeutic-goods-act-1989-sec-41rd-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41RD(2) Offences and civil penalty provision—breaching condition of

41RD(3) Offences and civil penalty provision—breaching condition of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.224
note: Offence of strict liability for breaching condition of consent
asserts: therapeutic-goods-act-1989-sec-41rd-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41rd-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41rd-ss-3-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41rd-ss-3-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-41rd-ss-3
schema version: 2
part of: 41RD Offences and civil penalty provision—breaching condition of

therapeutic-goods-act-1989-sec-41rd-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: ...Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits strict liability for breaching condition of consent
modality: Deontic
operator: Prohibition
premise text: (3) A person commits an offence of strict liability if...

therapeutic-goods-act-1989-sec-41rd-ss-3-logic-deontic-2
type: LogicApplication
conclusion text: ...Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation to comply with condition of consent
modality: Deontic
operator: Obligation
premise text: (3) A person commits an offence of strict liability if...

therapeutic-goods-act-1989-sec-41rd-ss-3-logic-ltl-3
type: LogicApplication
conclusion text: ...Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Traces breach of condition to strict liability
modality: LTL
operator: Trace
premise text: (3) A person commits an offence of strict liability if...

therapeutic-goods-act-1989-sec-41rd-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41RD(3) Offences and civil penalty provision—breaching condition of

41RD(4) Offences and civil penalty provision—breaching condition of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.224
note: Breaching a condition of consent imposed under subsection 41RC(2) is prohibited.
asserts: therapeutic-goods-act-1989-sec-41rd-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-41rd-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41rd-ss-4
schema version: 2
part of: 41RD Offences and civil penalty provision—breaching condition of

therapeutic-goods-act-1989-sec-41rd-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of breaching a condition of consent.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-41rd-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41RD(4) Offences and civil penalty provision—breaching condition of

42AA This Part not to apply to advertisements directed at health
type: Concept
source: therapeutic-goods-act-1989.pdf, p.226
curation status: Proposed
has part: 42AA(1) This Part not to apply to advertisements directed at health
has part: 42AA(1A) This Part not to apply to advertisements directed at health
has part: 42AA(2) This Part not to apply to advertisements directed at health
has part: 42AA(3) This Part not to apply to advertisements directed at health
has part: 42AA(4) This Part not to apply to advertisements directed at health
proposed by: legis2cml
realized by: sec-42aa
schema version: 2

42AA(1) This Part not to apply to advertisements directed at health
type: Concept
source: therapeutic-goods-act-1989.pdf, p.226
note: Exemptions from advertising restrictions
asserts: therapeutic-goods-act-1989-sec-42aa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42aa-ss-1-logic-descriptionlogic-1
asserts: therapeutic-goods-act-1989-sec-42aa-ss-1-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-42aa-ss-1
schema version: 2
part of: 42AA This Part not to apply to advertisements directed at health

therapeutic-goods-act-1989-sec-42aa-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: No exemption after this date
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for exemptions
modality: AllenInterval
operator: <
premise text: Exemptions apply until a certain date

therapeutic-goods-act-1989-sec-42aa-ss-1-logic-descriptionlogic-1
type: LogicApplication
conclusion text: Member of the specified class
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Class hierarchy for health professions
modality: DescriptionLogic
operator: =
premise text: Registered or licensed to practice in a specific health profession

42AA(1A) This Part not to apply to advertisements directed at health
type: Concept
source: therapeutic-goods-act-1989.pdf, p.226
note: Minister may specify class of persons for purposes of paragraph (1)(d)
asserts: therapeutic-goods-act-1989-sec-42aa-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-42aa-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42aa-ss-1a-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-42aa-ss-1a
schema version: 2
part of: 42AA This Part not to apply to advertisements directed at health

therapeutic-goods-act-1989-sec-42aa-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to specify class of persons
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-42aa-ss-1a-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Specify a class of persons for purposes of paragraph (1)(d)
modality: DescriptionLogic
operator: Class specification

therapeutic-goods-act-1989-sec-42aa-ss-1a-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42AA(1A) This Part not to apply to advertisements directed at health

42AA(2) This Part not to apply to advertisements directed at health
type: Concept
source: therapeutic-goods-act-1989.pdf, p.226
note: This Part does not apply to advertisements directed exclusively to members of an Australian branch of one of the bodies prescribed for the purposes of this subsection.
asserts: therapeutic-goods-act-1989-sec-42aa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42aa-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42aa-ss-2
schema version: 2
part of: 42AA This Part not to apply to advertisements directed at health

therapeutic-goods-act-1989-sec-42aa-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exclusion from application
modality: Deontic
operator: Exclusion

therapeutic-goods-act-1989-sec-42aa-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42AA(2) This Part not to apply to advertisements directed at health

42AA(3) This Part not to apply to advertisements directed at health
type: Concept
source: therapeutic-goods-act-1989.pdf, p.226
note: Person must have qualifications and training for membership of relevant body.
asserts: therapeutic-goods-act-1989-sec-42aa-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42aa-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42aa-ss-3
schema version: 2
part of: 42AA This Part not to apply to advertisements directed at health

therapeutic-goods-act-1989-sec-42aa-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Person is a member of the relevant body.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Mandatory qualification requirement.
modality: Deontic
operator: Must
premise text: Person has qualifications and training.

therapeutic-goods-act-1989-sec-42aa-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42AA(3) This Part not to apply to advertisements directed at health

42AA(4) This Part not to apply to advertisements directed at health
type: Concept
source: therapeutic-goods-act-1989.pdf, p.226
note: Exemption from Part for certain patient advice
asserts: therapeutic-goods-act-1989-sec-42aa-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-42aa-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42aa-ss-4
schema version: 2
part of: 42AA This Part not to apply to advertisements directed at health

therapeutic-goods-act-1989-sec-42aa-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exempts from Part
modality: Deontic
operator: exemption

therapeutic-goods-act-1989-sec-42aa-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42AA(4) This Part not to apply to advertisements directed at health

42AB This Part not to apply to advertisements for goods not for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.227
note: This Part does not apply to advertisements in respect of goods that are not for use in humans.
asserts: therapeutic-goods-act-1989-sec-42ab-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ab
schema version: 2

42AC This Part not to apply to advertisements for exported goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.227
curation status: Proposed
has part: 42AC(1) This Part not to apply to advertisements for exported goods
has part: 42AC(2) This Part not to apply to advertisements for exported goods
proposed by: legis2cml
realized by: sec-42ac
schema version: 2

42AC(1) This Part not to apply to advertisements for exported goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.227
note: This Part applies to advertisements for goods other than therapeutic goods intended exclusively for export.
asserts: therapeutic-goods-act-1989-sec-42ac-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42ac-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42ac-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42ac-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-42ac-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-42ac-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ac-ss-1
schema version: 2
part of: 42AC This Part not to apply to advertisements for exported goods

therapeutic-goods-act-1989-sec-42ac-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: The advertisement does not comply with this Part.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The advertisement's applicability to this Part overlaps with the time period during which the exported goods are intended to be used.
modality: AllenInterval
operator: Overlaps
premise text: The advertisement is for therapeutic goods intended exclusively for export.

therapeutic-goods-act-1989-sec-42ac-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: The advertisement does not comply with this Part.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: The advertisement's applicability to this Part is recognized by the AI system.
modality: CogAI
operator: Recognizes
premise text: The advertisement is for therapeutic goods intended exclusively for export.

therapeutic-goods-act-1989-sec-42ac-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The advertisement does not comply with this Part.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: If the advertisement is not solely for therapeutic goods intended exclusively for export, then it must comply with this Part.
modality: Deontic
operator: Implies
premise text: Exported goods are subject to this Part.

therapeutic-goods-act-1989-sec-42ac-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: The advertisement does not comply with this Part.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: The advertisement's applicability to this Part diffuses through the time period during which the exported goods are intended to be used.
modality: Diffusion
operator: Diffuses
premise text: The advertisement is for therapeutic goods intended exclusively for export.

therapeutic-goods-act-1989-sec-42ac-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: The advertisement does not comply with this Part.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The advertisement's applicability to this Part repeats every time the exported goods are intended to be used.
modality: LTL
operator: Repeats
premise text: The advertisement is for therapeutic goods intended exclusively for export.

therapeutic-goods-act-1989-sec-42ac-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42AC(1) This Part not to apply to advertisements for exported goods

42AC(2) This Part not to apply to advertisements for exported goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.227
note: Sections 42DKB, 42DLA and 42DLC apply to advertisements of that kind.
asserts: therapeutic-goods-act-1989-sec-42ac-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42ac-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ac-ss-2
schema version: 2
part of: 42AC This Part not to apply to advertisements for exported goods

therapeutic-goods-act-1989-sec-42ac-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation on the state.
modality: Deontic
operator: apply

therapeutic-goods-act-1989-sec-42ac-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42AC(2) This Part not to apply to advertisements for exported goods

42AD This Part not to apply to advertisements or generic
type: Concept
source: therapeutic-goods-act-1989.pdf, p.228
note: Exemption from Part for advertisements about vaping goods
asserts: therapeutic-goods-act-1989-sec-42ad-norm
asserts: therapeutic-goods-act-1989-sec-42ad-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ad
schema version: 2

therapeutic-goods-act-1989-sec-42ad-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits application of Part to advertisements about vaping goods
modality: Deontic
operator: forbid

42B Definitions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.228
curation status: Proposed
has part: 42B(1) Definitions
has part: 42B(2) Definitions
proposed by: legis2cml
realized by: sec-42b
schema version: 2

42B(1) Definitions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.228
note: The Minister may make a code relating to advertisements about therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-42b-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-42b-ss-1
schema version: 2
part of: 42B Definitions

42B(2) Definitions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.228
note: Allows modification of existing instruments or writings in legislative instruments.
asserts: therapeutic-goods-act-1989-sec-42b-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-42b-ss-2
schema version: 2
part of: 42B Definitions

42DA Simplified outline of this Division
type: Concept
source: therapeutic-goods-act-1989.pdf, p.230
note: Representations in advertisements about therapeutic goods may be restricted, required or prohibited.
asserts: therapeutic-goods-act-1989-sec-42da-norm
asserts: therapeutic-goods-act-1989-sec-42da-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42da
schema version: 2

therapeutic-goods-act-1989-sec-42da-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits representations in advertisements about therapeutic goods.
modality: Deontic
operator: Prohibit

42DB Definitions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.230
note: Definition of applicant and approval holder.
asserts: therapeutic-goods-act-1989-sec-42db-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-42db
schema version: 2

therapeutic-goods-act-1989-sec-42db-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DB Definitions

42DD Restricted representations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.230
note: Restricted representations in therapeutic goods advertising
asserts: therapeutic-goods-act-1989-sec-42dd-norm
asserts: therapeutic-goods-act-1989-sec-42dd-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dd
schema version: 2

therapeutic-goods-act-1989-sec-42dd-logic-deontic-1
type: LogicApplication
conclusion text: None
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits restricted representations
modality: Deontic
operator: Prohibit
premise text: None

42DE Applications for approval of use of restricted representation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.231
curation status: Proposed
has part: 42DE(1) Applications for approval of use of restricted representation
has part: 42DE(2) Applications for approval of use of restricted representation
proposed by: legis2cml
realized by: sec-42de
schema version: 2

42DE(1) Applications for approval of use of restricted representation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.231
note: Application for approval of use of restricted representation must be made to the Secretary.
asserts: therapeutic-goods-act-1989-sec-42de-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42de-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42de-ss-1
schema version: 2
part of: 42DE Applications for approval of use of restricted representation

therapeutic-goods-act-1989-sec-42de-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application is required.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42de-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 42DE(1) Applications for approval of use of restricted representation

42DE(2) Applications for approval of use of restricted representation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.231
note: Application for approval of use of restricted representation may be required or permitted
asserts: therapeutic-goods-act-1989-sec-42de-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42de-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42de-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-42de-ss-2
schema version: 2
part of: 42DE Applications for approval of use of restricted representation

therapeutic-goods-act-1989-sec-42de-ss-2-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to apply for approval
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-42de-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of applications based on software requirements
modality: DescriptionLogic
operator: Classifies

therapeutic-goods-act-1989-sec-42de-ss-2-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DE(2) Applications for approval of use of restricted representation

42DF Approval of use of restricted representation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.231
curation status: Proposed
has part: 42DF(1) Approval of use of restricted representation
has part: 42DF(2) Approval of use of restricted representation
has part: 42DF(3) Approval of use of restricted representation
has part: 42DF(4) Approval of use of restricted representation
proposed by: legis2cml
realized by: sec-42df
schema version: 2

42DF(1) Approval of use of restricted representation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.231
note: Secretary must approve use of restricted representation if it is accurate and balanced.
asserts: therapeutic-goods-act-1989-sec-42df-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42df-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42df-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-42df-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-42df-ss-1-logic-alleninterval-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-42df-ss-1
schema version: 2
part of: 42DF Approval of use of restricted representation

therapeutic-goods-act-1989-sec-42df-ss-1-logic-alleninterval-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Time period for approval of use of restricted representation.
modality: AllenInterval
operator: BETWEEN
premise text: (1)

therapeutic-goods-act-1989-sec-42df-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must approve use of restricted representation.
modality: Deontic
operator: MUST
premise text: (1) If an application for approval of the use of a restricted representation is made, the Secretary must approve the use of the restricted representation if the Secretary is satisfied that:

therapeutic-goods-act-1989-sec-42df-ss-1-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must be satisfied that the representation is accurate and balanced.
modality: Deontic
operator: MUST
premise text: (a) the representation is accurate and balanced;

therapeutic-goods-act-1989-sec-42df-ss-1-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must be satisfied that the representation is not misleading or likely to be misleading.
modality: Deontic
operator: MUST
premise text: (b) the representation is not misleading or likely to be misleading.

therapeutic-goods-act-1989-sec-42df-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DF(1) Approval of use of restricted representation

42DF(2) Approval of use of restricted representation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.231
note: Must approve restricted representation use
asserts: therapeutic-goods-act-1989-sec-42df-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42df-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42df-ss-2
schema version: 2
part of: 42DF Approval of use of restricted representation

therapeutic-goods-act-1989-sec-42df-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to approve
modality: Deontic
operator: MUST

42DF(3) Approval of use of restricted representation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.231
note: Approval may be subject to conditions imposed by the Secretary.
asserts: therapeutic-goods-act-1989-sec-42df-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42df-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42df-ss-3
schema version: 2
part of: 42DF Approval of use of restricted representation

therapeutic-goods-act-1989-sec-42df-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: May impose conditions on approval
modality: Deontic
operator: may

42DF(4) Approval of use of restricted representation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.231
note: Secretary must consider certain factors when deciding to approve or refuse the use of a restricted representation.
asserts: therapeutic-goods-act-1989-sec-42df-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-42df-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42df-ss-4
schema version: 2
part of: 42DF Approval of use of restricted representation

therapeutic-goods-act-1989-sec-42df-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary has an obligation to consider certain factors.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42df-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DF(4) Approval of use of restricted representation

42DG Notice of approval or refusal
type: Concept
source: therapeutic-goods-act-1989.pdf, p.232
curation status: Proposed
has part: 42DG(1) Notice of approval or refusal
has part: 42DG(2) Notice of approval or refusal
has part: 42DG(3) Notice of approval or refusal
has part: 42DG(4) Notice of approval or refusal
proposed by: legis2cml
realized by: sec-42dg
schema version: 2

42DG(1) Notice of approval or refusal
type: Concept
source: therapeutic-goods-act-1989.pdf, p.232
note: Secretary must give written notice to applicant of approval or refusal.
asserts: therapeutic-goods-act-1989-sec-42dg-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42dg-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dg-ss-1
schema version: 2
part of: 42DG Notice of approval or refusal

therapeutic-goods-act-1989-sec-42dg-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must give written notice.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42dg-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 42DG(1) Notice of approval or refusal

42DG(2) Notice of approval or refusal
type: Concept
description: Written notice
source: therapeutic-goods-act-1989.pdf, p.232
note: Failure to provide written notice within 60 days results in approval of use.
asserts: therapeutic-goods-act-1989-sec-42dg-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42dg-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dg-ss-2
schema version: 2
part of: 42DG Notice of approval or refusal

therapeutic-goods-act-1989-sec-42dg-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide written notice
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-42dg-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DG(2) Notice of approval or refusal

42DG(3) Notice of approval or refusal
type: Concept
source: therapeutic-goods-act-1989.pdf, p.232
note: Conditions for approval must be set out in the notice.
asserts: therapeutic-goods-act-1989-sec-42dg-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42dg-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dg-ss-3
schema version: 2
part of: 42DG Notice of approval or refusal

therapeutic-goods-act-1989-sec-42dg-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide conditions for approval
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42dg-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DG(3) Notice of approval or refusal

42DG(4) Notice of approval or refusal
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.232
note: Must provide reasons for refusal and inform applicant of right to review decision.
asserts: therapeutic-goods-act-1989-sec-42dg-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-42dg-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dg-ss-4
schema version: 2
part of: 42DG Notice of approval or refusal

therapeutic-goods-act-1989-sec-42dg-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide reasons for refusal and inform applicant of right to review decision.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42dg-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DG(4) Notice of approval or refusal

42DH Variation of conditions of approval
type: Concept
source: therapeutic-goods-act-1989.pdf, p.232
curation status: Proposed
has part: 42DH(1) Variation of conditions of approval
has part: 42DH(2) Variation of conditions of approval
proposed by: legis2cml
realized by: sec-42dh
schema version: 2

42DH(1) Variation of conditions of approval
type: Concept
source: therapeutic-goods-act-1989.pdf, p.232
note: Variation of conditions of approval
asserts: therapeutic-goods-act-1989-sec-42dh-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42dh-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dh-ss-1
schema version: 2
part of: 42DH Variation of conditions of approval

therapeutic-goods-act-1989-sec-42dh-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to vary conditions
modality: Deontic
operator: may

42DH(2) Variation of conditions of approval
type: Concept
description: yes
source: therapeutic-goods-act-1989.pdf, p.232
note: Secretary must provide reasons and inform approval holder of right to review decision.
asserts: therapeutic-goods-act-1989-sec-42dh-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42dh-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dh-ss-2
schema version: 2
part of: 42DH Variation of conditions of approval

therapeutic-goods-act-1989-sec-42dh-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must provide reasons and inform approval holder of right to review decision.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42dh-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DH(2) Variation of conditions of approval

42DI Withdrawal of approval
type: Concept
source: therapeutic-goods-act-1989.pdf, p.232
curation status: Proposed
has part: 42DI(1) Withdrawal of approval
has part: 42DI(2) Withdrawal of approval
proposed by: legis2cml
realized by: sec-42di
schema version: 2

42DI(1) Withdrawal of approval
type: Concept
source: therapeutic-goods-act-1989.pdf, p.232
note: Withdrawal of approval for restricted representation
asserts: therapeutic-goods-act-1989-sec-42di-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42di-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42di-ss-1
schema version: 2
part of: 42DI Withdrawal of approval

therapeutic-goods-act-1989-sec-42di-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits withdrawal of approval
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-42di-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DI(1) Withdrawal of approval

42DI(2) Withdrawal of approval
type: Concept
description: yes
source: therapeutic-goods-act-1989.pdf, p.232
note: Secretary must provide reasons and inform approval holder of right to review decision.
asserts: therapeutic-goods-act-1989-sec-42di-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42di-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42di-ss-2
schema version: 2
part of: 42DI Withdrawal of approval

therapeutic-goods-act-1989-sec-42di-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must provide reasons and inform approval holder of right to review decision.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42di-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DI(2) Withdrawal of approval

42DJ Prohibited and required representations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.233
curation status: Proposed
has part: 42DJ(1) Prohibited and required representations
has part: 42DJ(2) Prohibited and required representations
proposed by: legis2cml
realized by: sec-42dj
schema version: 2

42DJ(1) Prohibited and required representations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.233
note: Prohibited representations about therapeutic goods
asserts: therapeutic-goods-act-1989-sec-42dj-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42dj-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dj-ss-1
schema version: 2
part of: 42DJ Prohibited and required representations

therapeutic-goods-act-1989-sec-42dj-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...are prohibited representations about therapeutic goods...
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits specified representations
modality: Deontic
operator: forbid
premise text: (1) For the purposes of this Part, representations...

42DJ(2) Prohibited and required representations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.233
note: Representations about therapeutic goods are required.
asserts: therapeutic-goods-act-1989-sec-42dj-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42dj-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dj-ss-2
schema version: 2
part of: 42DJ Prohibited and required representations

therapeutic-goods-act-1989-sec-42dj-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires representations.
modality: Deontic
operator: requires

therapeutic-goods-act-1989-sec-42dj-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DJ(2) Prohibited and required representations

42DK Permitted use of restricted or prohibited representations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.234
curation status: Proposed
has part: 42DK(1) Permitted use of restricted or prohibited representations
has part: 42DK(2) Permitted use of restricted or prohibited representations
has part: 42DK(3) Permitted use of restricted or prohibited representations
has part: 42DK(4) Permitted use of restricted or prohibited representations
has part: 42DK(5) Permitted use of restricted or prohibited representations
has part: 42DK(6) Permitted use of restricted or prohibited representations
proposed by: legis2cml
realized by: sec-42dk
schema version: 2

42DK(1) Permitted use of restricted or prohibited representations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.234
note: Permits use of restricted representations in advertisements
asserts: therapeutic-goods-act-1989-sec-42dk-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42dk-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dk-ss-1
schema version: 2
part of: 42DK Permitted use of restricted or prohibited representations

therapeutic-goods-act-1989-sec-42dk-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Grants permission
modality: Deontic
operator: permit

42DK(2) Permitted use of restricted or prohibited representations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.234
note: Permits use of specified prohibited representations under certain conditions.
asserts: therapeutic-goods-act-1989-sec-42dk-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42dk-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dk-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42dk-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-42dk-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-42dk-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dk-ss-2
schema version: 2
part of: 42DK Permitted use of restricted or prohibited representations

therapeutic-goods-act-1989-sec-42dk-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: ...the representations are necessary for the appropriate use of the goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines a temporal interval for the permitted use of prohibited representations.
modality: AllenInterval
operator: Temporal Interval
premise text: (2) The Secretary may, by writing...

therapeutic-goods-act-1989-sec-42dk-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: ...the representations are necessary for the appropriate use of the goods.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Represents knowledge about permitted use of restricted or prohibited representations.
modality: CogAI
operator: Knowledge Representation
premise text: (2) The Secretary may, by writing...

therapeutic-goods-act-1989-sec-42dk-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...the representations are necessary for the appropriate use of the goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Allows the Secretary to permit use of prohibited representations.
modality: Deontic
operator: Allow
premise text: (2) The Secretary may, by writing...

therapeutic-goods-act-1989-sec-42dk-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: ...the representations are necessary for the appropriate use of the goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses the permitted use of restricted or prohibited representations.
modality: Diffusion
operator: Diffusion
premise text: (2) The Secretary may, by writing...

therapeutic-goods-act-1989-sec-42dk-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: ...the representations are necessary for the appropriate use of the goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines a recurring trace for the permitted use of prohibited representations.
modality: LTL
operator: Recurring Trace
premise text: (2) The Secretary may, by writing...

therapeutic-goods-act-1989-sec-42dk-ss-2-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DK(2) Permitted use of restricted or prohibited representations

42DK(3) Permitted use of restricted or prohibited representations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.234
note: Permits use of prohibited representations in advertisements under certain conditions.
asserts: therapeutic-goods-act-1989-sec-42dk-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42dk-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dk-ss-3
schema version: 2
part of: 42DK Permitted use of restricted or prohibited representations

therapeutic-goods-act-1989-sec-42dk-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Allows the use of prohibited representations in advertisements.
modality: Deontic
operator: Allow

42DK(4) Permitted use of restricted or prohibited representations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.234
note: Permitted use of restricted or prohibited representations
asserts: therapeutic-goods-act-1989-sec-42dk-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dk-ss-4
schema version: 2
part of: 42DK Permitted use of restricted or prohibited representations

42DK(5) Permitted use of restricted or prohibited representations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.234
note: Permission under this section is not a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-42dk-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dk-ss-5
schema version: 2
part of: 42DK Permitted use of restricted or prohibited representations

42DK(6) Permitted use of restricted or prohibited representations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.234
note: Publishing permission on Department's website after giving a permission under this section.
asserts: therapeutic-goods-act-1989-sec-42dk-ss-6-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dk-ss-6
schema version: 2
part of: 42DK Permitted use of restricted or prohibited representations

therapeutic-goods-act-1989-sec-42dk-ss-6-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DK(6) Permitted use of restricted or prohibited representations

42DL Advertising offences—general
type: Concept
source: therapeutic-goods-act-1989.pdf, p.235
note: Advertising therapeutic goods without permission is prohibited.
asserts: therapeutic-goods-act-1989-sec-42dl-norm
asserts: therapeutic-goods-act-1989-sec-42dl-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dl-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-42dl-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-42dl-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-42dl-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-42dl-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dl
schema version: 2

therapeutic-goods-act-1989-sec-42dl-logic-alleninterval-3
type: LogicApplication
conclusion text: ...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines a temporal interval for the offence.
modality: AllenInterval
operator: Temporal Interval
premise text: (1) A person commits an offence if: (a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;

therapeutic-goods-act-1989-sec-42dl-logic-cogai-6
type: LogicApplication
conclusion text: ...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Classifies the advertising as a cognitive task.
modality: CogAI
operator: Classify
premise text: (a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;

therapeutic-goods-act-1989-sec-42dl-logic-deontic-1
type: LogicApplication
conclusion text: ...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits advertising therapeutic goods.
modality: Deontic
operator: Prohibit
premise text: (1) A person commits an offence...

therapeutic-goods-act-1989-sec-42dl-logic-descriptionlogic-2
type: LogicApplication
conclusion text: ...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies advertising as an offence.
modality: DescriptionLogic
operator: Classify
premise text: (a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;

therapeutic-goods-act-1989-sec-42dl-logic-diffusion-5
type: LogicApplication
conclusion text: ...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses the prohibition.
modality: Diffusion
operator: Diffuse
premise text: (a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;

therapeutic-goods-act-1989-sec-42dl-logic-ltl-4
type: LogicApplication
conclusion text: ...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines a recurring trace for the offence.
modality: LTL
operator: Recurring Trace
premise text: (a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;

therapeutic-goods-act-1989-sec-42dl-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DL Advertising offences—general

42DM Offences—non-compliance with the Therapeutic Goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.243
curation status: Proposed
has part: 42DM(1) Offences—non-compliance with the Therapeutic Goods
has part: 42DM(2) Offences—non-compliance with the Therapeutic Goods
has part: 42DM(3) Offences—non-compliance with the Therapeutic Goods
proposed by: legis2cml
realized by: sec-42dm
schema version: 2

42DM(1) Offences—non-compliance with the Therapeutic Goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.243
note: Advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code is prohibited.
asserts: therapeutic-goods-act-1989-sec-42dm-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42dm-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dm-ss-1-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-42dm-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-42dm-ss-1-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-42dm-ss-1-logic-descriptionlogic-5
asserts: therapeutic-goods-act-1989-sec-42dm-ss-1-logic-linearlogic-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dm-ss-1
schema version: 2
part of: 42DM Offences—non-compliance with the Therapeutic Goods

therapeutic-goods-act-1989-sec-42dm-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code.
modality: Deontic
operator: Prohibit
premise text: (1) A person commits an offence if: (a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods; and

therapeutic-goods-act-1989-sec-42dm-ss-1-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code.
modality: Deontic
operator: Prohibit
premise text: (c) either: (i) the use of the goods in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person; or

therapeutic-goods-act-1989-sec-42dm-ss-1-logic-deontic-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code.
modality: Deontic
operator: Prohibit
premise text: (c) either: (ii) the use of the goods in reliance on the advertisement, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person.

therapeutic-goods-act-1989-sec-42dm-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of advertising as therapeutic goods without compliance with the Therapeutic Goods Advertising Code.
modality: DescriptionLogic
operator: Classify
premise text: (b) the advertisement does not comply with the Therapeutic Goods Advertising Code; and

therapeutic-goods-act-1989-sec-42dm-ss-1-logic-descriptionlogic-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of advertising as therapeutic goods without compliance with the Therapeutic Goods Advertising Code.
modality: DescriptionLogic
operator: Classify
premise text: Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

therapeutic-goods-act-1989-sec-42dm-ss-1-logic-linearlogic-6
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Implication of advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code on imprisonment.
modality: LinearLogic
operator: Imply
premise text: (c) either: (i) the use of the goods in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person; or

therapeutic-goods-act-1989-sec-42dm-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DM(1) Offences—non-compliance with the Therapeutic Goods

42DM(2) Offences—non-compliance with the Therapeutic Goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.243
note: Non-compliance with Therapeutic Goods Advertising Code is an offence.
asserts: therapeutic-goods-act-1989-sec-42dm-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42dm-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dm-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dm-ss-2
schema version: 2
part of: 42DM Offences—non-compliance with the Therapeutic Goods

therapeutic-goods-act-1989-sec-42dm-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits non-compliance with the Therapeutic Goods Advertising Code.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-42dm-ss-2-logic-descriptionlogic-2
type: LogicApplication
conclusion text: NaturalPerson
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Defines a class of persons who are subject to this prohibition.
modality: DescriptionLogic
operator: ClassInclusion
premise text: State

therapeutic-goods-act-1989-sec-42dm-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DM(2) Offences—non-compliance with the Therapeutic Goods

42DM(3) Offences—non-compliance with the Therapeutic Goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.243
note: Non-compliance with therapeutic goods advertising
asserts: therapeutic-goods-act-1989-sec-42dm-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42dm-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dm-ss-3-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-42dm-ss-3-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-42dm-ss-3-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-42dm-ss-3-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-42dm-ss-3-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dm-ss-3
schema version: 2
part of: 42DM Offences—non-compliance with the Therapeutic Goods

therapeutic-goods-act-1989-sec-42dm-ss-3-logic-alleninterval-3
type: LogicApplication
conclusion text: ...if the person advertises, by any means, therapeutic goods;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines a temporal interval for non-compliance
modality: AllenInterval
operator: Temporal Interval
premise text: (3) A person commits an offence...

therapeutic-goods-act-1989-sec-42dm-ss-3-logic-cogai-6
type: LogicApplication
conclusion text: ...if the person advertises, by any means, therapeutic goods;
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Recognizes the prohibition as a rule
modality: CogAI
operator: Recognize
premise text: (3) A person commits an offence...

therapeutic-goods-act-1989-sec-42dm-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: ...if the person advertises, by any means, therapeutic goods;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits advertising therapeutic goods
modality: Deontic
operator: Prohibit
premise text: (3) A person commits an offence...

therapeutic-goods-act-1989-sec-42dm-ss-3-logic-descriptionlogic-2
type: LogicApplication
conclusion text: ...if the person advertises, by any means, therapeutic goods;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies non-compliance as an offence
modality: DescriptionLogic
operator: Classify
premise text: (3) A person commits an offence...

therapeutic-goods-act-1989-sec-42dm-ss-3-logic-diffusion-5
type: LogicApplication
conclusion text: ...if the person advertises, by any means, therapeutic goods;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses the prohibition to all agents
modality: Diffusion
operator: Diffuse
premise text: (3) A person commits an offence...

therapeutic-goods-act-1989-sec-42dm-ss-3-logic-ltl-4
type: LogicApplication
conclusion text: ...if the person advertises, by any means, therapeutic goods;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines a recurring trace for non-compliance
modality: LTL
operator: Recurring Trace
premise text: (3) A person commits an offence...

therapeutic-goods-act-1989-sec-42dm-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DM(3) Offences—non-compliance with the Therapeutic Goods

42DN Application of Division
type: Concept
source: therapeutic-goods-act-1989.pdf, p.246
note: Division applies to generic information about goods used in therapeutic goods manufacture or representation.
asserts: therapeutic-goods-act-1989-sec-42dn-norm
asserts: therapeutic-goods-act-1989-sec-42dn-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dn
schema version: 2

therapeutic-goods-act-1989-sec-42dn-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Division applies to generic information about goods.
modality: Deontic
operator: applies

therapeutic-goods-act-1989-sec-42dn-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DN Application of Division

42DO Compliance with the Code
type: Concept
source: therapeutic-goods-act-1989.pdf, p.246
note: Generic information must comply with the Therapeutic Goods Advertising Code.
asserts: therapeutic-goods-act-1989-sec-42do-norm
asserts: therapeutic-goods-act-1989-sec-42do-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42do
schema version: 2

therapeutic-goods-act-1989-sec-42do-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Generic information must comply with the Therapeutic Goods Advertising Code.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42do-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DO Compliance with the Code

42DP Offences—dissemination of generic information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.246
curation status: Proposed
has part: 42DP(1) Offences—dissemination of generic information
has part: 42DP(2) Offences—dissemination of generic information
has part: 42DP(3) Offences—dissemination of generic information
proposed by: legis2cml
realized by: sec-42dp
schema version: 2

42DP(1) Offences—dissemination of generic information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.246
note: Dissemination of generic information about therapeutic goods to the public or a section of the public is prohibited.
asserts: therapeutic-goods-act-1989-sec-42dp-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42dp-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dp-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dp-ss-1
schema version: 2
part of: 42DP Offences—dissemination of generic information

therapeutic-goods-act-1989-sec-42dp-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-42dp-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of generic information as prohibited
modality: DescriptionLogic
operator: Classify

therapeutic-goods-act-1989-sec-42dp-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DP(1) Offences—dissemination of generic information

42DP(2) Offences—dissemination of generic information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.246
note: Dissemination of generic information about therapeutic goods is prohibited.
asserts: therapeutic-goods-act-1989-sec-42dp-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42dp-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dp-ss-2-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-42dp-ss-2-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dp-ss-2
schema version: 2
part of: 42DP Offences—dissemination of generic information

therapeutic-goods-act-1989-sec-42dp-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the dissemination of generic information.
modality: Deontic
operator: Prohibit
premise text: (2) A person commits an offence if: (a) the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and (b) the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO.

therapeutic-goods-act-1989-sec-42dp-ss-2-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the dissemination of generic information.
modality: Deontic
operator: Prohibit
premise text: (2) A person commits an offence if: (a) the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and (b) the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO.

therapeutic-goods-act-1989-sec-42dp-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies dissemination as an offence.
modality: DescriptionLogic
operator: Classify
premise text: (2) A person commits an offence if: (a) the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and (b) the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO.

therapeutic-goods-act-1989-sec-42dp-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DP(2) Offences—dissemination of generic information

42DP(3) Offences—dissemination of generic information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.246
note: An offence against subsection (2) is an offence of strict liability.
asserts: therapeutic-goods-act-1989-sec-42dp-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42dp-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dp-ss-3-logic-linearlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dp-ss-3
schema version: 2
part of: 42DP Offences—dissemination of generic information

therapeutic-goods-act-1989-sec-42dp-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: The state must punish offenders.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a duty on the state.
modality: Deontic
operator: Obligation
premise text: (3) An offence against subsection (2) is an offence of strict liability.

therapeutic-goods-act-1989-sec-42dp-ss-3-logic-linearlogic-2
type: LogicApplication
conclusion text: If there is a strict liability offence, then punishment must follow.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: States that punishment follows from the existence of a strict liability offence.
modality: LinearLogic
operator: Implication
premise text: (3) An offence against subsection (2) is an offence of strict liability.

therapeutic-goods-act-1989-sec-42dp-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DP(3) Offences—dissemination of generic information

42DQ Civil penalty for dissemination of generic information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.247
note: Dissemination of generic information about therapeutic goods is prohibited.
asserts: therapeutic-goods-act-1989-sec-42dq-norm
asserts: therapeutic-goods-act-1989-sec-42dq-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dq-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dq
schema version: 2

therapeutic-goods-act-1989-sec-42dq-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the dissemination of generic information.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-42dq-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies as a prohibition.
modality: DescriptionLogic
operator: Classify

therapeutic-goods-act-1989-sec-42dq-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DQ Civil penalty for dissemination of generic information

42DR Secretary may require information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.248
curation status: Proposed
has part: 42DR(1) Secretary may require information or documents
has part: 42DR(2) Secretary may require information or documents
has part: 42DR(3) Secretary may require information or documents
has part: 42DR(4) Secretary may require information or documents
has part: 42DR(5) Secretary may require information or documents
proposed by: legis2cml
realized by: sec-42dr
schema version: 2

42DR(1) Secretary may require information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.248
note: Secretary may require information or documents from a person responsible for advertising therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-42dr-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42dr-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dr-ss-1
schema version: 2
part of: 42DR Secretary may require information or documents

therapeutic-goods-act-1989-sec-42dr-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Implies an obligation.
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-42dr-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DR(1) Secretary may require information or documents

42DR(2) Secretary may require information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.248
note: Secretary may require information or documents from a person responsible for disseminating generic information.
asserts: therapeutic-goods-act-1989-sec-42dr-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42dr-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dr-ss-2
schema version: 2
part of: 42DR Secretary may require information or documents

therapeutic-goods-act-1989-sec-42dr-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary may require information or documents.
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-42dr-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DR(2) Secretary may require information or documents

42DR(3) Secretary may require information or documents
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.248
note: Must provide information or documents within a specified period and in the form specified by the notice.
asserts: therapeutic-goods-act-1989-sec-42dr-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42dr-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dr-ss-3-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42dr-ss-3-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dr-ss-3
schema version: 2
part of: 42DR Secretary may require information or documents

therapeutic-goods-act-1989-sec-42dr-ss-3-logic-alleninterval-2
type: LogicApplication
conclusion text: The person must provide the information or documents within that period.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The period within which the person must provide the information or documents is not less than 14 days after the day the notice is given.
modality: AllenInterval
operator: within
premise text: The notice specifies a period.

therapeutic-goods-act-1989-sec-42dr-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide information or documents within a specified period and in the form specified by the notice.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42dr-ss-3-logic-ltl-3
type: LogicApplication
conclusion text: The person must provide the information or documents within that period.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The period within which the person must provide the information or documents is not less than 14 days after the day the notice is given.
modality: LTL
operator: within
premise text: The notice specifies a period.

therapeutic-goods-act-1989-sec-42dr-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DR(3) Secretary may require information or documents

42DR(4) Secretary may require information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.248
note: The Secretary may require information or documents in a specified way.
asserts: therapeutic-goods-act-1989-sec-42dr-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dr-ss-4
schema version: 2
part of: 42DR Secretary may require information or documents

42DR(5) Secretary may require information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.248
note: Secretary may require information or documents
asserts: therapeutic-goods-act-1989-sec-42dr-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-42dr-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dr-ss-5-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-42dr-ss-5-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dr-ss-5
schema version: 2
part of: 42DR Secretary may require information or documents

therapeutic-goods-act-1989-sec-42dr-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires information or documents from the recipient
modality: Deontic
operator: requires

therapeutic-goods-act-1989-sec-42dr-ss-5-logic-deontic-2
type: LogicApplication
conclusion text: is a legislative instrument
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Legislative instruments are excluded from the notice
modality: Deontic
operator: is not
premise text: (5) A notice under subsection (1) or (2)

therapeutic-goods-act-1989-sec-42dr-ss-5-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary may require information or documents
modality: Deontic
operator: may

42DS Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.249
curation status: Proposed
has part: 42DS(1) Criminal offences for failing to comply with a notice etc.
has part: 42DS(2) Criminal offences for failing to comply with a notice etc.
has part: 42DS(3) Criminal offences for failing to comply with a notice etc.
has part: 42DS(4) Criminal offences for failing to comply with a notice etc.
has part: 42DS(5) Criminal offences for failing to comply with a notice etc.
proposed by: legis2cml
realized by: sec-42ds
schema version: 2

42DS(1) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.249
note: Failure to comply with a notice results in an offence.
asserts: therapeutic-goods-act-1989-sec-42ds-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42ds-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ds-ss-1
schema version: 2
part of: 42DS Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-42ds-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with a notice.
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-42ds-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DS(1) Criminal offences for failing to comply with a notice etc.

42DS(2) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.249
note: Failure to comply with a notice results in an offence.
asserts: therapeutic-goods-act-1989-sec-42ds-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42ds-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ds-ss-2
schema version: 2
part of: 42DS Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-42ds-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with a notice.
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-42ds-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DS(2) Criminal offences for failing to comply with a notice etc.

42DS(3) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.249
note: Offence of strict liability for failing to comply with a notice
asserts: therapeutic-goods-act-1989-sec-42ds-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42ds-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ds-ss-3
schema version: 2
part of: 42DS Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-42ds-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation on the state
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-42ds-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DS(3) Criminal offences for failing to comply with a notice etc.

42DS(4) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.249
note: Failure to comply with a notice results in an offence.
asserts: therapeutic-goods-act-1989-sec-42ds-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-42ds-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ds-ss-4
schema version: 2
part of: 42DS Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-42ds-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits failing to comply with a notice.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-42ds-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DS(4) Criminal offences for failing to comply with a notice etc.

42DS(5) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.249
note: Failure to comply with a notice results in an offence.
asserts: therapeutic-goods-act-1989-sec-42ds-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-42ds-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ds-ss-5
schema version: 2
part of: 42DS Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-42ds-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits failing to comply with a notice.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-42ds-ss-5-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DS(5) Criminal offences for failing to comply with a notice etc.

42DT Civil penalty for giving false or misleading information or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.250
note: Giving false or misleading information in compliance with a notice is prohibited.
asserts: therapeutic-goods-act-1989-sec-42dt-norm
asserts: therapeutic-goods-act-1989-sec-42dt-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dt
schema version: 2

therapeutic-goods-act-1989-sec-42dt-logic-deontic-1
type: LogicApplication
conclusion text: The person contravenes this section if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of giving false or misleading information.
modality: Deontic
operator: Prohibit
premise text: The person is given a notice under section 42DR.

therapeutic-goods-act-1989-sec-42dt-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DT Civil penalty for giving false or misleading information or

42DU Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.250
curation status: Proposed
has part: 42DU(1) Self-incrimination
has part: 42DU(2) Self-incrimination
proposed by: legis2cml
realized by: sec-42du
schema version: 2

42DU(1) Self-incrimination
type: Concept
description: True
source: therapeutic-goods-act-1989.pdf, p.250
note: No excuse for refusing to provide information or produce a document under section 42DR.
asserts: therapeutic-goods-act-1989-sec-42du-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42du-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42du-ss-1
schema version: 2
part of: 42DU Self-incrimination

therapeutic-goods-act-1989-sec-42du-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide information or produce a document.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42du-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DU(1) Self-incrimination

42DU(2) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.250
note: Protection from self-incrimination in certain cases
asserts: therapeutic-goods-act-1989-sec-42du-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-5
asserts: therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-42du-ss-2
schema version: 2
part of: 42DU Self-incrimination

therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...the information or producing the document; ... are not admissible in evidence against the individual:
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits admissibility of self-incrimination in certain cases
modality: Deontic
operator: Prohibition
premise text: (2) However, in the case of an individual...

therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-2
type: LogicApplication
conclusion text: ...in criminal proceedings, except proceedings for an offence against subsection 42DS(4) or (5); ...
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits admissibility in certain cases
modality: Deontic
operator: Permission
premise text: (2) However, in the case of an individual...

therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-3
type: LogicApplication
conclusion text: ...the information or producing the document; ... are not admissible in evidence against the individual:
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Establishes a right to protection from self-incrimination in certain cases
modality: Deontic
operator: Right
premise text: (2) However, in the case of an individual...

therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-4
type: LogicApplication
conclusion text: ...the information or producing the document; ... are not admissible in evidence against the individual:
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation on the state to protect self-incrimination in certain cases
modality: Deontic
operator: Obligation
premise text: (2) However, in the case of an individual...

therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-5
type: LogicApplication
conclusion text: ...in civil proceedings, except proceedings under section 42Y for a contravention of section 42DT.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits admissibility in certain cases under specific circumstances
modality: Deontic
operator: Permission
premise text: (2) However, in the case of an individual...

therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-6
type: LogicApplication
conclusion text: ...in civil proceedings, except proceedings under section 42Y for a contravention of section 42DT.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation on the state to protect self-incrimination in certain cases under specific circumstances
modality: Deontic
operator: Obligation
premise text: (2) However, in the case of an individual...

therapeutic-goods-act-1989-sec-42du-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DU(2) Self-incrimination

42DV Directions about advertisements or generic information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.251
curation status: Proposed
has part: 42DV(1) Directions about advertisements or generic information
has part: 42DV(2) Directions about advertisements or generic information
proposed by: legis2cml
realized by: sec-42dv
schema version: 2

42DV(1) Directions about advertisements or generic information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.251
note: Directs a person to cease advertising or take corrective action.
asserts: therapeutic-goods-act-1989-sec-42dv-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42dv-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dv-ss-1
schema version: 2
part of: 42DV Directions about advertisements or generic information

therapeutic-goods-act-1989-sec-42dv-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Directs a person to cease advertising.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-42dv-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DV(1) Directions about advertisements or generic information

42DV(2) Directions about advertisements or generic information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.251
note: Directs a person responsible for disseminating generic information to take corrective action.
asserts: therapeutic-goods-act-1989-sec-42dv-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42dv-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dv-ss-2-logic-diffusion-2
asserts: therapeutic-goods-act-1989-sec-42dv-ss-2-logic-cogai-3
asserts: therapeutic-goods-act-1989-sec-42dv-ss-2-logic-shacl-4
asserts: therapeutic-goods-act-1989-sec-42dv-ss-2-logic-n3logic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dv-ss-2
schema version: 2
part of: 42DV Directions about advertisements or generic information

therapeutic-goods-act-1989-sec-42dv-ss-2-logic-cogai-3
type: LogicApplication
conclusion text: ...the Secretary may, in writing, direct a person...
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Analyzes the impact of generic information on public health.
modality: CogAI
operator: Analyze
premise text: (2) If, in relation to the dissemination of generic information...

therapeutic-goods-act-1989-sec-42dv-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...the Secretary may, in writing, direct a person...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Directs a person to withdraw or correct generic information.
modality: Deontic
operator: Prohibit
premise text: (2) If, in relation to the dissemination of generic information...

therapeutic-goods-act-1989-sec-42dv-ss-2-logic-diffusion-2
type: LogicApplication
conclusion text: ...the Secretary may, in writing, direct a person...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Affects the dissemination of generic information.
modality: Diffusion
operator: Influence
premise text: (2) If, in relation to the dissemination of generic information...

therapeutic-goods-act-1989-sec-42dv-ss-2-logic-n3logic-5
type: LogicApplication
conclusion text: ...the Secretary may, in writing, direct a person...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::n3_compiler
logic summary: Defines the scope of prohibited generic information.
modality: N3Logic
operator: Define
premise text: (2) If, in relation to the dissemination of generic information...

therapeutic-goods-act-1989-sec-42dv-ss-2-logic-shacl-4
type: LogicApplication
conclusion text: ...the Secretary may, in writing, direct a person...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::shacl
logic summary: Validates the accuracy of generic information.
modality: SHACL
operator: Validate
premise text: (2) If, in relation to the dissemination of generic information...

therapeutic-goods-act-1989-sec-42dv-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DV(2) Directions about advertisements or generic information

42DW Offences—contravening direction under section 42DV
type: Concept
source: therapeutic-goods-act-1989.pdf, p.252
curation status: Proposed
has part: 42DW(1) Offences—contravening direction under section 42DV
has part: 42DW(2) Offences—contravening direction under section 42DV
has part: 42DW(3) Offences—contravening direction under section 42DV
has part: 42DW(4) Offences—contravening direction under section 42DV
proposed by: legis2cml
realized by: sec-42dw
schema version: 2

42DW(1) Offences—contravening direction under section 42DV
type: Concept
source: therapeutic-goods-act-1989.pdf, p.252
note: Offence for contravening direction under section 42DV
asserts: therapeutic-goods-act-1989-sec-42dw-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42dw-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dw-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42dw-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-42dw-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-42dw-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dw-ss-1
schema version: 2
part of: 42DW Offences—contravening direction under section 42DV

therapeutic-goods-act-1989-sec-42dw-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: ...the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between contravention and harm
modality: AllenInterval
operator: Temporal relation
premise text: (d) either: (i) the use of the goods has resulted in, will result in, or is likely to result in, harm or injury...

therapeutic-goods-act-1989-sec-42dw-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: ...the use of the goods has resulted in, will result in, or is likely to result in, harm or injury...
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Classification of therapeutic goods
modality: CogAI
operator: Classification
premise text: (c) the act or omission contravenes the direction or a condition...

therapeutic-goods-act-1989-sec-42dw-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...the act or omission contravenes the direction...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of contravening direction
modality: Deontic
operator: Prohibit
premise text: (1) A person commits an offence...

therapeutic-goods-act-1989-sec-42dw-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: ...the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusion of contravention and harm
modality: Diffusion
operator: Diffusion
premise text: (d) either: (i) the use of the goods has resulted in, will result in, or is likely to result in, harm or injury...

therapeutic-goods-act-1989-sec-42dw-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: ...the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of contravention and harm
modality: LTL
operator: Recurring trace
premise text: (d) either: (i) the use of the goods has resulted in, will result in, or is likely to result in, harm or injury...

therapeutic-goods-act-1989-sec-42dw-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DW(1) Offences—contravening direction under section 42DV

42DW(2) Offences—contravening direction under section 42DV
type: Concept
source: therapeutic-goods-act-1989.pdf, p.252
note: Offence for contravening direction under section 42DV
asserts: therapeutic-goods-act-1989-sec-42dw-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42dw-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dw-ss-2-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-42dw-ss-2-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-42dw-ss-2-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-42dw-ss-2-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dw-ss-2
schema version: 2
part of: 42DW Offences—contravening direction under section 42DV

therapeutic-goods-act-1989-sec-42dw-ss-2-logic-alleninterval-3
type: LogicApplication
conclusion text: ...the act or omission contravenes the direction or a condition of the direction.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Establishes temporal relation between direction under section 42DV and acts/omissions
modality: AllenInterval
operator: Temporal relation
premise text: (2) A person commits an offence if...

therapeutic-goods-act-1989-sec-42dw-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...the act or omission contravenes the direction or a condition of the direction.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits contravening direction under section 42DV
modality: Deontic
operator: Prohibition
premise text: (2) A person commits an offence if...

therapeutic-goods-act-1989-sec-42dw-ss-2-logic-deontic-2
type: LogicApplication
conclusion text: ...the act or omission contravenes the direction or a condition of the direction.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation to comply with direction under section 42DV
modality: Deontic
operator: Obligation
premise text: (2) A person commits an offence if...

therapeutic-goods-act-1989-sec-42dw-ss-2-logic-deontic-5
type: LogicApplication
conclusion text: ...the act or omission contravenes the direction or a condition of the direction.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits acts/omissions that contravene direction under section 42DV
modality: Deontic
operator: Prohibition
premise text: (b) the person does an act or omits to do an act;

therapeutic-goods-act-1989-sec-42dw-ss-2-logic-ltl-4
type: LogicApplication
conclusion text: ...the act or omission contravenes the direction or a condition of the direction.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Establishes recurring trace between direction under section 42DV and acts/omissions
modality: LTL
operator: Recurring trace
premise text: (2) A person commits an offence if...

therapeutic-goods-act-1989-sec-42dw-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DW(2) Offences—contravening direction under section 42DV

42DW(3) Offences—contravening direction under section 42DV
type: Concept
source: therapeutic-goods-act-1989.pdf, p.252
note: Offence for contravening direction under section 42DV
asserts: therapeutic-goods-act-1989-sec-42dw-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dw-ss-3
schema version: 2
part of: 42DW Offences—contravening direction under section 42DV

therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: ...the act or omission contravenes the direction or a condition of the direction.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits contravening direction under section 42DV
modality: Deontic
operator: Prohibition
premise text: (3) A person commits an offence if...

therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-2
type: LogicApplication
conclusion text: ...the person does an act or omits to do an act.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation to comply with direction under section 42DV
modality: Deontic
operator: Obligation
premise text: (a) the Secretary has given a direction to the person under subsection 42DV(1) or (2); and...

therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-3
type: LogicApplication
conclusion text: ...the act or omission contravenes the direction or a condition of the direction.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits omission of act under direction under section 42DV
modality: Deontic
operator: Prohibition
premise text: (b) the person does an act or omits to do an act; and...

therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-4
type: LogicApplication
conclusion text: ...the person does an act or omits to do an act.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation to comply with conditions of direction under section 42DV
modality: Deontic
operator: Obligation
premise text: (c) the act or omission contravenes the direction or a condition of the direction.

therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-5
type: LogicApplication
conclusion text: ...the person does an act or omits to do an act.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits failure to comply with conditions of direction under section 42DV
modality: Deontic
operator: Prohibition
premise text: (c) the act or omission contravenes the direction or a condition of the direction.

therapeutic-goods-act-1989-sec-42dw-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DW(3) Offences—contravening direction under section 42DV

42DW(4) Offences—contravening direction under section 42DV
type: Concept
source: therapeutic-goods-act-1989.pdf, p.252
note: An offence against subsection (3) is an offence of strict liability.
asserts: therapeutic-goods-act-1989-sec-42dw-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-42dw-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dw-ss-4
schema version: 2
part of: 42DW Offences—contravening direction under section 42DV

therapeutic-goods-act-1989-sec-42dw-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a duty on the state.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-42dw-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DW(4) Offences—contravening direction under section 42DV

42DX Civil penalty for contravening direction under section 42DV
type: Concept
source: therapeutic-goods-act-1989.pdf, p.253
note: Contravening direction under section 42DV is prohibited.
asserts: therapeutic-goods-act-1989-sec-42dx-norm
asserts: therapeutic-goods-act-1989-sec-42dx-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dx
schema version: 2

therapeutic-goods-act-1989-sec-42dx-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of contravening direction
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-42dx-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DX Civil penalty for contravening direction under section 42DV

42DY Secretary may issue a public warning notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.255
curation status: Proposed
has part: 42DY(1) Secretary may issue a public warning notice
has part: 42DY(2) Secretary may issue a public warning notice
has part: 42DY(3) Secretary may issue a public warning notice
has part: 42DY(4) Secretary may issue a public warning notice
proposed by: legis2cml
realized by: sec-42dy
schema version: 2

42DY(1) Secretary may issue a public warning notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.255
note: Secretary may issue a public warning notice about therapeutic goods under certain conditions.
asserts: therapeutic-goods-act-1989-sec-42dy-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42dy-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dy-ss-1
schema version: 2
part of: 42DY Secretary may issue a public warning notice

therapeutic-goods-act-1989-sec-42dy-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary may issue a public warning notice.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-42dy-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DY(1) Secretary may issue a public warning notice

42DY(2) Secretary may issue a public warning notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.255
note: Secretary may issue a public warning notice if person fails to comply with substantiation notice.
asserts: therapeutic-goods-act-1989-sec-42dy-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42dy-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42dy-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42dy-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-42dy-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-42dy-ss-2-logic-argumentation-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dy-ss-2
schema version: 2
part of: 42DY Secretary may issue a public warning notice

therapeutic-goods-act-1989-sec-42dy-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: the warning notice is issued during the period of non-compliance
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Warning notice issued during period of non-compliance.
modality: AllenInterval
operator: During
premise text: (c) the Secretary is satisfied that it is in the public interest to issue a notice under this subsection;

therapeutic-goods-act-1989-sec-42dy-ss-2-logic-argumentation-5
type: LogicApplication
conclusion text: the warning notice implies that the person has failed to comply
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Warning notice implies that person has failed to comply.
modality: Argumentation
operator: Imply
premise text: (2) If: (a) the Secretary gives a person a notice (the substantiation notice) under subsection 42DR(1) or (2); and (b) the person fails to comply with the substantiation notice;

therapeutic-goods-act-1989-sec-42dy-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: the Secretary may issue to the public a written notice containing a warning that the person has failed to comply with the substantiation notice, and specifying the matter to which the substantiation notice related.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits person from failing to comply with substantiation notice.
modality: Deontic
operator: Prohibit
premise text: (a) the Secretary gives a person a notice (the substantiation notice) under subsection 42DR(1) or (2); and (b) the person fails to comply with the substantiation notice;

therapeutic-goods-act-1989-sec-42dy-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: the warning notice spreads to the public
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Warning notice spreads to public.
modality: Diffusion
operator: Spread
premise text: (2) If: (a) the Secretary gives a person a notice (the substantiation notice) under subsection 42DR(1) or (2); and (b) the person fails to comply with the substantiation notice;

therapeutic-goods-act-1989-sec-42dy-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: the warning notice remains in effect until the person complies
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Warning notice remains in effect until person complies.
modality: LTL
operator: Until
premise text: (c) the Secretary is satisfied that it is in the public interest to issue a notice under this subsection;

therapeutic-goods-act-1989-sec-42dy-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DY(2) Secretary may issue a public warning notice

42DY(3) Secretary may issue a public warning notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.255
note: Secretary must issue a public warning notice
asserts: therapeutic-goods-act-1989-sec-42dy-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42dy-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dy-ss-3
schema version: 2
part of: 42DY Secretary may issue a public warning notice

therapeutic-goods-act-1989-sec-42dy-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide a public warning notice
modality: Deontic
operator: MUST

42DY(4) Secretary may issue a public warning notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.255
note: Secretary must issue a public warning notice.
asserts: therapeutic-goods-act-1989-sec-42dy-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-42dy-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42dy-ss-4
schema version: 2
part of: 42DY Secretary may issue a public warning notice

therapeutic-goods-act-1989-sec-42dy-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide a public warning notice.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42dy-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42DY(4) Secretary may issue a public warning notice

42E Offence of dealing with counterfeit therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.270
curation status: Proposed
has part: 42E(1) Offence of dealing with counterfeit therapeutic goods
has part: 42E(2) Offence of dealing with counterfeit therapeutic goods
has part: 42E(3) Offence of dealing with counterfeit therapeutic goods
has part: 42E(5) Offence of dealing with counterfeit therapeutic goods
proposed by: legis2cml
realized by: sec-42e
schema version: 2

42E(1) Offence of dealing with counterfeit therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.270
note: Dealing with counterfeit therapeutic goods is an offence.
asserts: therapeutic-goods-act-1989-sec-42e-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42e-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42e-ss-1
schema version: 2
part of: 42E Offence of dealing with counterfeit therapeutic goods

therapeutic-goods-act-1989-sec-42e-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits dealing with counterfeit therapeutic goods.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-42e-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42E(1) Offence of dealing with counterfeit therapeutic goods

42E(2) Offence of dealing with counterfeit therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.270
note: Dealing with counterfeit therapeutic goods is an offence.
asserts: therapeutic-goods-act-1989-sec-42e-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42e-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42e-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42e-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-42e-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-42e-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42e-ss-2
schema version: 2
part of: 42E Offence of dealing with counterfeit therapeutic goods

therapeutic-goods-act-1989-sec-42e-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: This provision overlaps with other provisions related to therapeutic goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Overlaps with other provisions related to therapeutic goods.
modality: AllenInterval
operator: Overlap
premise text: (2) Goods are counterfeit if any of the following contain a false representation...

therapeutic-goods-act-1989-sec-42e-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: This provision recognizes counterfeit therapeutic goods based on representations.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Recognizes counterfeit therapeutic goods based on representations.
modality: CogAI
operator: Recognize
premise text: (2) Goods are counterfeit if any of the following contain a false representation...

therapeutic-goods-act-1989-sec-42e-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Dealing with counterfeit therapeutic goods is an offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits dealing with counterfeit therapeutic goods.
modality: Deontic
operator: Prohibit
premise text: (2) Goods are counterfeit if any of the following contain a false representation...

therapeutic-goods-act-1989-sec-42e-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: This provision diffuses to other provisions related to therapeutic goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses to other provisions related to therapeutic goods.
modality: Diffusion
operator: Diffuse
premise text: (2) Goods are counterfeit if any of the following contain a false representation...

therapeutic-goods-act-1989-sec-42e-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: Dealing with counterfeit therapeutic goods is a recurring trace.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace for dealing with counterfeit therapeutic goods.
modality: LTL
operator: Recurring
premise text: (2) Goods are counterfeit if any of the following contain a false representation...

therapeutic-goods-act-1989-sec-42e-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42E(2) Offence of dealing with counterfeit therapeutic goods

42E(3) Offence of dealing with counterfeit therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.270
note: Offence of dealing with counterfeit therapeutic goods
asserts: therapeutic-goods-act-1989-sec-42e-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42e-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42e-ss-3
schema version: 2
part of: 42E Offence of dealing with counterfeit therapeutic goods

therapeutic-goods-act-1989-sec-42e-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits dealing with counterfeit therapeutic goods
modality: Deontic
operator: Prohibit
premise text: (3) The matters are as follows:

therapeutic-goods-act-1989-sec-42e-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42E(3) Offence of dealing with counterfeit therapeutic goods

42E(5) Offence of dealing with counterfeit therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.270
note: Defines term for therapeutic goods in section
asserts: therapeutic-goods-act-1989-sec-42e-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-42e-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42e-ss-5
schema version: 2
part of: 42E Offence of dealing with counterfeit therapeutic goods

therapeutic-goods-act-1989-sec-42e-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Defines term
modality: Deontic
operator: defines

therapeutic-goods-act-1989-sec-42e-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42E(5) Offence of dealing with counterfeit therapeutic goods

42EA Civil penalty relating to dealing with counterfeit therapeutic
type: Concept
source: therapeutic-goods-act-1989.pdf, p.271
note: Dealing with counterfeit therapeutic goods is prohibited.
asserts: therapeutic-goods-act-1989-sec-42ea-norm
asserts: therapeutic-goods-act-1989-sec-42ea-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ea
schema version: 2

therapeutic-goods-act-1989-sec-42ea-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits dealing with counterfeit therapeutic goods.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-42ea-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42EA Civil penalty relating to dealing with counterfeit therapeutic

42EB Relief from liability for certain contraventions relating to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.271
note: Excuse from liability for certain contraventions relating to counterfeit therapeutic goods
asserts: therapeutic-goods-act-1989-sec-42eb-norm
asserts: therapeutic-goods-act-1989-sec-42eb-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42eb-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42eb-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-42eb
schema version: 2

therapeutic-goods-act-1989-sec-42eb-logic-alleninterval-2
type: LogicApplication
conclusion text: The person ought fairly be excused for the contravention
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Excuse from liability overlaps with other excuses
modality: AllenInterval
operator: Overlaps
premise text: The person has a reasonable excuse

therapeutic-goods-act-1989-sec-42eb-logic-deontic-1
type: LogicApplication
conclusion text: The person ought fairly be excused for the contravention
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to excuse liability for certain contraventions
modality: Deontic
operator: Obligation
premise text: The person has a reasonable excuse

therapeutic-goods-act-1989-sec-42eb-logic-ltl-3
type: LogicApplication
conclusion text: The person ought fairly be excused for the contravention
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Excuse from liability is recurrent
modality: LTL
operator: Recurrent
premise text: The person has a reasonable excuse

therapeutic-goods-act-1989-sec-42eb-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42EB Relief from liability for certain contraventions relating to

42F Customs treatment of counterfeit therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.272
curation status: Proposed
has part: 42F(1) Customs treatment of counterfeit therapeutic goods
has part: 42F(2) Customs treatment of counterfeit therapeutic goods
proposed by: legis2cml
realized by: sec-42f
schema version: 2

42F(1) Customs treatment of counterfeit therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.272
note: Customs treatment of counterfeit therapeutic goods
asserts: therapeutic-goods-act-1989-sec-42f-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42f-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42f-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42f-ss-1-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-42f-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-42f-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42f-ss-1
schema version: 2
part of: 42F Customs treatment of counterfeit therapeutic goods

therapeutic-goods-act-1989-sec-42f-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: Customs treatment applies until commencement
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Customs treatment applies during the period from notification to commencement
modality: AllenInterval
operator: during
premise text: Secretary notifies Comptroller-General of Customs in writing

therapeutic-goods-act-1989-sec-42f-ss-1-logic-argumentation-3
type: LogicApplication
conclusion text: Customs Act 1901 applies
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Notification implies application of the Customs Act 1901
modality: Argumentation
operator: implies
premise text: Secretary notifies Comptroller-General of Customs in writing

therapeutic-goods-act-1989-sec-42f-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: Comptroller-General of Customs acknowledges receipt of notification
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Comptroller-General of Customs recognizes the notification as a directive from Secretary
modality: CogAI
operator: recognizes
premise text: Secretary notifies Comptroller-General of Customs in writing

therapeutic-goods-act-1989-sec-42f-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Act has effect as if goods were forfeited to the Crown
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes duty on Secretary to notify Comptroller-General of Customs
modality: Deontic
operator: hasEffectAsIf
premise text: Secretary wishes the Customs Act 1901 to apply

therapeutic-goods-act-1989-sec-42f-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: Comptroller-General of Customs receives notification
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Notification diffuses to Comptroller-General of Customs
modality: Diffusion
operator: diffuses
premise text: Secretary notifies Comptroller-General of Customs in writing

therapeutic-goods-act-1989-sec-42f-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42F(1) Customs treatment of counterfeit therapeutic goods

42F(2) Customs treatment of counterfeit therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.272
note: Customs treatment of counterfeit therapeutic goods
asserts: therapeutic-goods-act-1989-sec-42f-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42f-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42f-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42f-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-42f-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-42f-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42f-ss-2
schema version: 2
part of: 42F Customs treatment of counterfeit therapeutic goods

therapeutic-goods-act-1989-sec-42f-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: Sections overlap in time
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Overlaps with section 229 of the Customs Act 1901
modality: AllenInterval
operator: Overlap
premise text: Section 42F(2) of the Customs Act 1901

therapeutic-goods-act-1989-sec-42f-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: Prohibition is recognized
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Recognizes prohibition as a rule
modality: CogAI
operator: Recognize
premise text: Section 42F(2) of the Customs Act 1901

therapeutic-goods-act-1989-sec-42f-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Customs Act 1901 applies to export
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits export of counterfeit therapeutic goods
modality: Deontic
operator: Prohibit
premise text: Section 229 of the Customs Act 1901

therapeutic-goods-act-1989-sec-42f-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: Prohibition is diffuse
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses prohibition to export of counterfeit therapeutic goods
modality: Diffusion
operator: Diffuse
premise text: Section 42F(2) of the Customs Act 1901

therapeutic-goods-act-1989-sec-42f-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: Trace is recurring
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace with section 229 of the Customs Act 1901
modality: LTL
operator: Recurring
premise text: Section 42F(2) of the Customs Act 1901

therapeutic-goods-act-1989-sec-42f-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42F(2) Customs treatment of counterfeit therapeutic goods

42T Notifying of actual or potential tampering
type: Concept
source: therapeutic-goods-act-1989.pdf, p.274
curation status: Proposed
has part: 42T(1) Notifying of actual or potential tampering
has part: 42T(2) Notifying of actual or potential tampering
has part: 42T(3) Notifying of actual or potential tampering
has part: 42T(4) Notifying of actual or potential tampering
proposed by: legis2cml
realized by: sec-42t
schema version: 2

42T(1) Notifying of actual or potential tampering
type: Concept
description: Notification to Secretary
source: therapeutic-goods-act-1989.pdf, p.274
note: Notify Secretary of actual or potential tampering within 24 hours.
asserts: therapeutic-goods-act-1989-sec-42t-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42t-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42t-ss-1-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-42t-ss-1
schema version: 2
part of: 42T Notifying of actual or potential tampering

therapeutic-goods-act-1989-sec-42t-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The person must notify the Secretary.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide notification
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42t-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: The person has a duty to notify the Secretary.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Notification is an obligation
modality: Deontic
operator: OBLIGATION

therapeutic-goods-act-1989-sec-42t-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42T(1) Notifying of actual or potential tampering

42T(2) Notifying of actual or potential tampering
type: Concept
source: therapeutic-goods-act-1989.pdf, p.274
note: Failure to notify of actual or potential tampering with therapeutic goods within 24 hours.
asserts: therapeutic-goods-act-1989-sec-42t-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42t-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42t-ss-2
schema version: 2
part of: 42T Notifying of actual or potential tampering

therapeutic-goods-act-1989-sec-42t-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Failure to comply results in penalty
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of failure to notify
modality: Deontic
operator: Prohibition
premise text: Notification is required within 24 hours

therapeutic-goods-act-1989-sec-42t-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42T(2) Notifying of actual or potential tampering

42T(3) Notifying of actual or potential tampering
type: Concept
source: therapeutic-goods-act-1989.pdf, p.274
note: Negligence standard for notification of tampering
asserts: therapeutic-goods-act-1989-sec-42t-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42t-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42t-ss-3-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42t-ss-3-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-42t-ss-3-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-42t-ss-3-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42t-ss-3
schema version: 2
part of: 42T Notifying of actual or potential tampering

therapeutic-goods-act-1989-sec-42t-ss-3-logic-alleninterval-2
type: LogicApplication
conclusion text: ...of the standard of care that a reasonable person would exercise in the circumstances;
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between notification and standard of care
modality: AllenInterval
operator: Temporal relation
premise text: (a) the person’s acts or omissions involve such a great falling short...

therapeutic-goods-act-1989-sec-42t-ss-3-logic-cogai-5
type: LogicApplication
conclusion text: ...of the standard of care that a reasonable person would exercise in the circumstances;
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Knowledge representation of negligence standard
modality: CogAI
operator: Knowledge representation
premise text: (a) the person’s acts or omissions involve such a great falling short...

therapeutic-goods-act-1989-sec-42t-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: the person is only taken to be negligent...
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Notification obligation
modality: Deontic
operator: Obligation
premise text: (3) For the purposes of subparagraph (2)(c)(ii)

therapeutic-goods-act-1989-sec-42t-ss-3-logic-diffusion-4
type: LogicApplication
conclusion text: ...that the acts or omissions merit criminal punishment.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Risk assessment for tampering notification
modality: Diffusion
operator: Risk assessment
premise text: (b) there is such a high risk...

therapeutic-goods-act-1989-sec-42t-ss-3-logic-ltl-3
type: LogicApplication
conclusion text: ...that the acts or omissions merit criminal punishment.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of notification and risk assessment
modality: LTL
operator: Recurring trace
premise text: (b) there is such a high risk...

therapeutic-goods-act-1989-sec-42t-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42T(3) Notifying of actual or potential tampering

42T(4) Notifying of actual or potential tampering
type: Concept
source: therapeutic-goods-act-1989.pdf, p.274
note: No possession or control required for notification
asserts: therapeutic-goods-act-1989-sec-42t-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-42t-ss-4
schema version: 2
part of: 42T Notifying of actual or potential tampering

therapeutic-goods-act-1989-sec-42t-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42T(4) Notifying of actual or potential tampering

42U Meaning of actual or potential tampering etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.275
note: Tampering with therapeutic goods is prohibited.
asserts: therapeutic-goods-act-1989-sec-42u-norm
asserts: therapeutic-goods-act-1989-sec-42u-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42u-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-42u-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-42u-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-42u-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-42u-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-42u
schema version: 2

therapeutic-goods-act-1989-sec-42u-logic-alleninterval-3
type: LogicApplication
conclusion text: Tampering occurs during these times.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Tampering occurs during the manufacturing or distribution of therapeutic goods.
modality: AllenInterval
operator: During
premise text: Therapeutic goods are manufactured or distributed at specific times.

therapeutic-goods-act-1989-sec-42u-logic-cogai-6
type: LogicApplication
conclusion text: The entity or action responsible for tampering is specified.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Tampering with therapeutic goods is done by a specific entity or action.
modality: CogAI
operator: By
premise text: Therapeutic goods have a specific purpose and are subject to regulation.

therapeutic-goods-act-1989-sec-42u-logic-deontic-1
type: LogicApplication
conclusion text: Tampering is prohibited.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits tampering with therapeutic goods.
modality: Deontic
operator: Prohibit
premise text: Therapeutic goods are protected by law.

therapeutic-goods-act-1989-sec-42u-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Tampering is prohibited for these goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies therapeutic goods as subject to tampering prohibition.
modality: DescriptionLogic
operator: Classify
premise text: Therapeutic goods have a specific meaning in this context.

therapeutic-goods-act-1989-sec-42u-logic-diffusion-5
type: LogicApplication
conclusion text: The risk of harm is diffused through tampering.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Tampering with therapeutic goods diffuses the risk of harm to others.
modality: Diffusion
operator: Through
premise text: Therapeutic goods can cause harm if tampered with.

therapeutic-goods-act-1989-sec-42u-logic-ltl-4
type: LogicApplication
conclusion text: Tampering occurs until this safety condition is met.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Tampering is prohibited until the therapeutic goods reach a safe state.
modality: LTL
operator: Until
premise text: Therapeutic goods must be in a safe state before they can be used.

therapeutic-goods-act-1989-sec-42u-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42U Meaning of actual or potential tampering etc.

42V Recall of therapeutic goods because of actual or potential
type: Concept
source: therapeutic-goods-act-1989.pdf, p.276
curation status: Proposed
has part: 42V(1) Recall of therapeutic goods because of actual or potential
has part: 42V(2) Recall of therapeutic goods because of actual or potential
has part: 42V(3) Recall of therapeutic goods because of actual or potential
has part: 42V(4) Recall of therapeutic goods because of actual or potential
has part: 42V(5) Recall of therapeutic goods because of actual or potential
has part: 42V(6) Recall of therapeutic goods because of actual or potential
has part: 42V(6C) Recall of therapeutic goods because of actual or potential
has part: 42V(6D) Recall of therapeutic goods because of actual or potential
has part: 42V(6E) Recall of therapeutic goods because of actual or potential
proposed by: legis2cml
realized by: sec-42v
schema version: 2

42V(1) Recall of therapeutic goods because of actual or potential
type: Concept
source: therapeutic-goods-act-1989.pdf, p.276
note: Secretary may impose requirements on a person supplying therapeutic goods
asserts: therapeutic-goods-act-1989-sec-42v-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42v-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42v-ss-1
schema version: 2
part of: 42V Recall of therapeutic goods because of actual or potential

therapeutic-goods-act-1989-sec-42v-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-42v-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42V(1) Recall of therapeutic goods because of actual or potential

42V(2) Recall of therapeutic goods because of actual or potential
type: Concept
description: specified steps, in the specified manner and within a reasonable period
source: therapeutic-goods-act-1989.pdf, p.276
note: Recall of therapeutic goods because of actual or potential tampering
asserts: therapeutic-goods-act-1989-sec-42v-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42v-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42v-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-42v-ss-2
schema version: 2
part of: 42V Recall of therapeutic goods because of actual or potential

therapeutic-goods-act-1989-sec-42v-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Duty to recall therapeutic goods
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42v-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of therapeutic goods based on tampering risk
modality: DescriptionLogic
operator: CLASSIFICATION

therapeutic-goods-act-1989-sec-42v-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42V(2) Recall of therapeutic goods because of actual or potential

42V(3) Recall of therapeutic goods because of actual or potential
type: Concept
source: therapeutic-goods-act-1989.pdf, p.276
note: Therapeutic goods that have been administered to a person cannot be recalled.
asserts: therapeutic-goods-act-1989-sec-42v-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42v-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42v-ss-3-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-42v-ss-3
schema version: 2
part of: 42V Recall of therapeutic goods because of actual or potential

therapeutic-goods-act-1989-sec-42v-ss-3-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The recall requirement overlaps with the administration of therapeutic goods.
modality: AllenInterval
operator: Overlaps
premise text: (3) Requirements referred to in paragraph (2)(a) do not apply...

therapeutic-goods-act-1989-sec-42v-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits recall of therapeutic goods administered to a person.
modality: Deontic
operator: Prohibition
premise text: (3) Requirements referred to in paragraph (2)(a) do not apply...

therapeutic-goods-act-1989-sec-42v-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42V(3) Recall of therapeutic goods because of actual or potential

42V(4) Recall of therapeutic goods because of actual or potential
type: Concept
source: therapeutic-goods-act-1989.pdf, p.276
note: Secretary must publish notice setting out requirements after imposing them.
asserts: therapeutic-goods-act-1989-sec-42v-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-42v-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42v-ss-4
schema version: 2
part of: 42V Recall of therapeutic goods because of actual or potential

therapeutic-goods-act-1989-sec-42v-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: The Secretary must publish a notice.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes duty on the Secretary.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42v-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42V(4) Recall of therapeutic goods because of actual or potential

42V(5) Recall of therapeutic goods because of actual or potential
type: Concept
source: therapeutic-goods-act-1989.pdf, p.276
note: Secretary may impose requirements under this section
asserts: therapeutic-goods-act-1989-sec-42v-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-42v-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42v-ss-5
schema version: 2
part of: 42V Recall of therapeutic goods because of actual or potential

therapeutic-goods-act-1989-sec-42v-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation on the Secretary
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-42v-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42V(5) Recall of therapeutic goods because of actual or potential

42V(6) Recall of therapeutic goods because of actual or potential
type: Concept
source: therapeutic-goods-act-1989.pdf, p.276
note: Failure to comply with a requirement under subsection (1) in relation to a supply of therapeutic goods is an offence.
asserts: therapeutic-goods-act-1989-sec-42v-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-42v-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42v-ss-6
schema version: 2
part of: 42V Recall of therapeutic goods because of actual or potential

therapeutic-goods-act-1989-sec-42v-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: An offence is committed.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of non-compliance with a requirement.
modality: Deontic
operator: Prohibition
premise text: The person fails to comply with a requirement under subsection (1).

therapeutic-goods-act-1989-sec-42v-ss-6-norm
type: Prohibition
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 42V(6) Recall of therapeutic goods because of actual or potential

42V(6C) Recall of therapeutic goods because of actual or potential
type: Concept
source: therapeutic-goods-act-1989.pdf, p.276
note: Failure to comply with a requirement in relation to a supply of therapeutic goods is an offence.
asserts: therapeutic-goods-act-1989-sec-42v-ss-6c-norm
asserts: therapeutic-goods-act-1989-sec-42v-ss-6c-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42v-ss-6c
schema version: 2
part of: 42V Recall of therapeutic goods because of actual or potential

therapeutic-goods-act-1989-sec-42v-ss-6c-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with a requirement
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-42v-ss-6c-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42V(6C) Recall of therapeutic goods because of actual or potential

42V(6D) Recall of therapeutic goods because of actual or potential
type: Concept
source: therapeutic-goods-act-1989.pdf, p.276
note: Failure to comply with a requirement under subsection (1) in relation to a supply of therapeutic goods is an offence.
asserts: therapeutic-goods-act-1989-sec-42v-ss-6d-norm
asserts: therapeutic-goods-act-1989-sec-42v-ss-6d-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42v-ss-6d
schema version: 2
part of: 42V Recall of therapeutic goods because of actual or potential

therapeutic-goods-act-1989-sec-42v-ss-6d-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with a requirement.
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-42v-ss-6d-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42V(6D) Recall of therapeutic goods because of actual or potential

42V(6E) Recall of therapeutic goods because of actual or potential
type: Concept
source: therapeutic-goods-act-1989.pdf, p.276
note: Offence of strict liability for recall of therapeutic goods
asserts: therapeutic-goods-act-1989-sec-42v-ss-6e-norm
asserts: therapeutic-goods-act-1989-sec-42v-ss-6e-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42v-ss-6e
schema version: 2
part of: 42V Recall of therapeutic goods because of actual or potential

therapeutic-goods-act-1989-sec-42v-ss-6e-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits recall of therapeutic goods
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-42v-ss-6e-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42V(6E) Recall of therapeutic goods because of actual or potential

42VA Civil penalty relating to the recall of therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.278
note: Failure to comply with a requirement under subsection 42V(1) in relation to a supply of therapeutic goods is prohibited.
asserts: therapeutic-goods-act-1989-sec-42va-norm
asserts: therapeutic-goods-act-1989-sec-42va-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42va
schema version: 2

therapeutic-goods-act-1989-sec-42va-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-42va-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42VA Civil penalty relating to the recall of therapeutic goods

42VB Relief from liability for contraventions relating to the recall of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.278
curation status: Proposed
has part: 42VB(1) Relief from liability for contraventions relating to the recall of
has part: 42VB(2) Relief from liability for contraventions relating to the recall of
has part: 42VB(3) Relief from liability for contraventions relating to the recall of
has part: 42VB(4) Relief from liability for contraventions relating to the recall of
proposed by: legis2cml
realized by: sec-42vb
schema version: 2

42VB(1) Relief from liability for contraventions relating to the recall of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.278
note: Relief from liability for contraventions relating to the recall of
asserts: therapeutic-goods-act-1989-sec-42vb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42vb-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42vb-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42vb-ss-1-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-42vb-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-42vb-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42vb-ss-1
schema version: 2
part of: 42VB Relief from liability for contraventions relating to the recall of

therapeutic-goods-act-1989-sec-42vb-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: Relief from liability is granted during a specific temporal interval.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval during which relief from liability applies
modality: AllenInterval
operator: during
premise text: The relief from liability applies if the proceedings are brought within a certain timeframe.

therapeutic-goods-act-1989-sec-42vb-ss-1-logic-argumentation-3
type: LogicApplication
conclusion text: The person's actions are justified by their honesty and circumstances.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Justification for exemption from liability
modality: Argumentation
operator: justification
premise text: The person's honesty and circumstances of the case justify relief from liability.

therapeutic-goods-act-1989-sec-42vb-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: The Court recognizes the person's exemption from liability.
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Recognition of exemption from liability
modality: CogAI
operator: recognition
premise text: The Court recognizes the person's honesty and circumstances as justification for relief from liability.

therapeutic-goods-act-1989-sec-42vb-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Relief from liability is granted.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exemptions from liability
modality: Deontic
operator: exemption
premise text: The person has acted honestly and ought fairly to be excused for the contravention.

therapeutic-goods-act-1989-sec-42vb-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: The exemption from liability propagates to the person.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Propagation of exemption from liability
modality: Diffusion
operator: propagation
premise text: Relief from liability is granted to the person if they have acted honestly.

therapeutic-goods-act-1989-sec-42vb-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42VB(1) Relief from liability for contraventions relating to the recall of

42VB(2) Relief from liability for contraventions relating to the recall of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.278
note: Right to apply for relief from liability
asserts: therapeutic-goods-act-1989-sec-42vb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42vb-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42vb-ss-2
schema version: 2
part of: 42VB Relief from liability for contraventions relating to the recall of

therapeutic-goods-act-1989-sec-42vb-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Right to apply
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-42vb-ss-2-norm
type: Obligation
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 42VB(2) Relief from liability for contraventions relating to the recall of

42VB(3) Relief from liability for contraventions relating to the recall of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.278
note: Granting relief from liability for contraventions relating to the recall of therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-42vb-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42vb-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42vb-ss-3
schema version: 2
part of: 42VB Relief from liability for contraventions relating to the recall of

therapeutic-goods-act-1989-sec-42vb-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Granting obligation
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-42vb-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42VB(3) Relief from liability for contraventions relating to the recall of

42VB(4) Relief from liability for contraventions relating to the recall of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.278
note: Relief from liability for contraventions relating to the recall of
asserts: therapeutic-goods-act-1989-sec-42vb-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-42vb-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42vb-ss-4-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-42vb-ss-4
schema version: 2
part of: 42VB Relief from liability for contraventions relating to the recall of

therapeutic-goods-act-1989-sec-42vb-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a duty on the State
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-42vb-ss-4-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Defines a subclass of 'contraventions'
modality: DescriptionLogic
operator: ClassInclusion

therapeutic-goods-act-1989-sec-42vb-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42VB(4) Relief from liability for contraventions relating to the recall of

42W Supply etc. of therapeutic goods that are subject to recall
type: Concept
source: therapeutic-goods-act-1989.pdf, p.279
curation status: Proposed
has part: 42W(1) Supply etc. of therapeutic goods that are subject to recall
has part: 42W(2) Supply etc. of therapeutic goods that are subject to recall
proposed by: legis2cml
realized by: sec-42w
schema version: 2

42W(1) Supply etc. of therapeutic goods that are subject to recall
type: Concept
source: therapeutic-goods-act-1989.pdf, p.279
note: Supply of therapeutic goods subject to recall is prohibited.
asserts: therapeutic-goods-act-1989-sec-42w-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42w-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42w-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-42w-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-42w-ss-1-logic-alleninterval-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-42w-ss-1
schema version: 2
part of: 42W Supply etc. of therapeutic goods that are subject to recall

therapeutic-goods-act-1989-sec-42w-ss-1-logic-alleninterval-4
type: LogicApplication
conclusion text: ...requirements have been imposed under section 42V, on that person or another person, to recall therapeutic goods;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines temporal interval for recall requirements.
modality: AllenInterval
operator: Temporal Interval
premise text: (i) the person knows that the therapeutic goods are of a kind, or are included in a batch, in respect of which requirements have been imposed...

therapeutic-goods-act-1989-sec-42w-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...the person supplies therapeutic goods in Australia;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supply of therapeutic goods subject to recall.
modality: Deontic
operator: Prohibit
premise text: (1) A person commits an offence...

therapeutic-goods-act-1989-sec-42w-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: ...the person supplies therapeutic goods in Australia;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supply of therapeutic goods without consent.
modality: Deontic
operator: Prohibit
premise text: (c) the Secretary has not consented in writing to the supply.

therapeutic-goods-act-1989-sec-42w-ss-1-logic-deontic-3
type: LogicApplication
conclusion text: ...the person supplies therapeutic goods in Australia;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits reckless supply of therapeutic goods subject to recall.
modality: Deontic
operator: Prohibit
premise text: (ii) the therapeutic goods are of such a kind, or are included in such a batch, and the person is reckless as to that fact;

therapeutic-goods-act-1989-sec-42w-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42W(1) Supply etc. of therapeutic goods that are subject to recall

42W(2) Supply etc. of therapeutic goods that are subject to recall
type: Concept
source: therapeutic-goods-act-1989.pdf, p.279
note: Exporting therapeutic goods from Australia is prohibited.
asserts: therapeutic-goods-act-1989-sec-42w-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42w-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42w-ss-2
schema version: 2
part of: 42W Supply etc. of therapeutic goods that are subject to recall

therapeutic-goods-act-1989-sec-42w-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits exportation of therapeutic goods.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-42w-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42W(2) Supply etc. of therapeutic goods that are subject to recall

42X Saving of other laws
type: Concept
source: therapeutic-goods-act-1989.pdf, p.280
note: No exclusion or limitation of other laws
asserts: therapeutic-goods-act-1989-sec-42x-norm
asserts: therapeutic-goods-act-1989-sec-42x-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42x
schema version: 2

therapeutic-goods-act-1989-sec-42x-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exclusion clause
modality: Deontic
operator: excludes
premise text: No exclusion or limitation

42Y Federal Court may order person to pay pecuniary penalty for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.281
curation status: Proposed
has part: 42Y(1) Federal Court may order person to pay pecuniary penalty for
has part: 42Y(2) Federal Court may order person to pay pecuniary penalty for
has part: 42Y(3) Federal Court may order person to pay pecuniary penalty for
proposed by: legis2cml
realized by: sec-42y
schema version: 2

42Y(1) Federal Court may order person to pay pecuniary penalty for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.281
note: Order to pay pecuniary penalty for contravening a civil penalty provision.
asserts: therapeutic-goods-act-1989-sec-42y-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42y-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42y-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42y-ss-1-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-42y-ss-1-logic-diffusion-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-42y-ss-1
schema version: 2
part of: 42Y Federal Court may order person to pay pecuniary penalty for

therapeutic-goods-act-1989-sec-42y-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: Secretary may apply for an order within this time frame
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Within 6 years of the wrongdoer's contravention
modality: AllenInterval
operator: within-6-years
premise text: Time period

therapeutic-goods-act-1989-sec-42y-ss-1-logic-argumentation-3
type: LogicApplication
conclusion text: Secretary has authority to act on behalf of the Commonwealth
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Secretary may apply on behalf of the Commonwealth
modality: Argumentation
operator: may-apply-on-behalf-of
premise text: Commonwealth's interest

therapeutic-goods-act-1989-sec-42y-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Pay the Commonwealth a pecuniary penalty
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to pay pecuniary penalty
modality: Deontic
operator: obligation
premise text: Contravening a civil penalty provision

therapeutic-goods-act-1989-sec-42y-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: Wrongdoer is subject to the court's order
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: May order wrongdoer to pay pecuniary penalty
modality: Diffusion
operator: may-order
premise text: Court's power

therapeutic-goods-act-1989-sec-42y-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42Y(1) Federal Court may order person to pay pecuniary penalty for

42Y(2) Federal Court may order person to pay pecuniary penalty for
type: Concept
description: pecuniary penalty amount
source: therapeutic-goods-act-1989.pdf, p.281
note: Order to pay pecuniary penalty for contravention of civil penalty provision
asserts: therapeutic-goods-act-1989-sec-42y-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42y-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42y-ss-2
schema version: 2
part of: 42Y Federal Court may order person to pay pecuniary penalty for

therapeutic-goods-act-1989-sec-42y-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Legal obligation to pay pecuniary penalty
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-42y-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42Y(2) Federal Court may order person to pay pecuniary penalty for

42Y(3) Federal Court may order person to pay pecuniary penalty for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.281
note: Court must consider certain factors when determining pecuniary penalty.
asserts: therapeutic-goods-act-1989-sec-42y-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42y-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42y-ss-3
schema version: 2
part of: 42Y Federal Court may order person to pay pecuniary penalty for

therapeutic-goods-act-1989-sec-42y-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Court must consider certain factors.
modality: Deontic
operator: MUST
premise text: (3) In determining the pecuniary penalty, the Court...

therapeutic-goods-act-1989-sec-42y-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42Y(3) Federal Court may order person to pay pecuniary penalty for

42YA What is a civil penalty provision?
type: Concept
source: therapeutic-goods-act-1989.pdf, p.282
note: Defines civil penalty provision
asserts: therapeutic-goods-act-1989-sec-42ya-norm
asserts: therapeutic-goods-act-1989-sec-42ya-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ya
schema version: 2

therapeutic-goods-act-1989-sec-42ya-logic-deontic-1
type: LogicApplication
conclusion text: civil penalty provision
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Defines a concept
modality: Deontic
operator: is defined as

42YC Persons involved in contravening civil penalty provision
type: Concept
source: therapeutic-goods-act-1989.pdf, p.282
curation status: Proposed
has part: 42YC(1) Persons involved in contravening civil penalty provision
has part: 42YC(2) Persons involved in contravening civil penalty provision
proposed by: legis2cml
realized by: sec-42yc
schema version: 2

42YC(1) Persons involved in contravening civil penalty provision
type: Concept
source: therapeutic-goods-act-1989.pdf, p.282
note: Continuation of obligation despite expired period or passed time. Aiding, abetting, or inducing a contravention of a civil penalty provision is prohibited.
asserts: therapeutic-goods-act-1989-sec-42yc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42yc-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42yc-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yc-ss-1
schema version: 2
part of: 42YC Persons involved in contravening civil penalty provision

therapeutic-goods-act-1989-sec-42yc-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Requires a relation between identifiable temporal intervals.
modality: AllenInterval
operator: MEETS
premise text: Conditional commencement is Undertaking, not Prohibition.

therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Continuation of obligation despite expired period or passed time.
modality: Deontic
operator: CONTINUES
premise text: (1) If an act or thing is required under a civil penalty provision to be done:

therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Applicable to obligations.
modality: Deontic
operator: APPLIES_TO
premise text: (1) If an act or thing is required under a civil penalty provision to be done:

therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition
modality: Deontic
operator: Prohibit
premise text: (1) A person must not...

therapeutic-goods-act-1989-sec-42yc-ss-1-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Requires an ordered or recurring trace.
modality: LTL
operator: CONTAINS
premise text: Do not invent a bearer, holder, condition, cross-reference, premise, or conclusion.

therapeutic-goods-act-1989-sec-42yc-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YC(1) Persons involved in contravening civil penalty provision

42YC(2) Persons involved in contravening civil penalty provision
type: Concept
source: therapeutic-goods-act-1989.pdf, p.282
note: Separate contravention for each day of non-compliance Continuing contraventions of civil penalty provisions are obligations on the person involved.
asserts: therapeutic-goods-act-1989-sec-42yc-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42yc-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42yc-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42yc-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-42yc-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-42yc-ss-2-logic-cogai-5
asserts: therapeutic-goods-act-1989-sec-42yc-ss-2-logic-deontic-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yc-ss-2
schema version: 2
part of: 42YC Persons involved in contravening civil penalty provision

therapeutic-goods-act-1989-sec-42yc-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Describes temporal overlap of contraventions
modality: AllenInterval
operator: Overlaps
premise text: (2) A person who contravenes a civil penalty provision...

therapeutic-goods-act-1989-sec-42yc-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Describes recognition of contraventions by AI system
modality: CogAI
operator: Recognizes
premise text: (2) A person who contravenes a civil penalty provision...

therapeutic-goods-act-1989-sec-42yc-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: commits a separate contravention of that provision in respect of each day during which the contravention occurs
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits contravention
modality: Deontic
operator: Prohibition
premise text: (2) A person who contravenes a civil penalty provision...

therapeutic-goods-act-1989-sec-42yc-ss-2-logic-deontic-6
type: LogicApplication
conclusion text: The person involved must comply with the civil penalty provision.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-42yc-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Describes diffusion of contraventions over time
modality: Diffusion
operator: Diffuses
premise text: (2) A person who contravenes a civil penalty provision...

therapeutic-goods-act-1989-sec-42yc-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Describes recurring nature of contraventions
modality: LTL
operator: Repeats
premise text: (2) A person who contravenes a civil penalty provision...

therapeutic-goods-act-1989-sec-42yc-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YC(2) Persons involved in contravening civil penalty provision

42YD Recovery of a pecuniary penalty
type: Concept
source: therapeutic-goods-act-1989.pdf, p.283
note: The Commonwealth may enforce a pecuniary penalty order as if it were a judgment of the Court.
asserts: therapeutic-goods-act-1989-sec-42yd-norm
asserts: therapeutic-goods-act-1989-sec-42yd-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yd
schema version: 2

therapeutic-goods-act-1989-sec-42yd-logic-deontic-1
type: LogicApplication
conclusion text: The Commonwealth may enforce the order as if it were a judgment of the Court.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Commonwealth may enforce the order.
modality: Deontic
operator: MayEnforce
premise text: The penalty is payable to the Commonwealth.

therapeutic-goods-act-1989-sec-42yd-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YD Recovery of a pecuniary penalty

42YE Gathering information for application for pecuniary penalty
type: Concept
source: therapeutic-goods-act-1989.pdf, p.283
curation status: Proposed
has part: 42YE(1) Gathering information for application for pecuniary penalty
has part: 42YE(2) Gathering information for application for pecuniary penalty
proposed by: legis2cml
realized by: sec-42ye
schema version: 2

42YE(1) Gathering information for application for pecuniary penalty
type: Concept
source: therapeutic-goods-act-1989.pdf, p.283
note: Duty to gather information for pecuniary penalty application
asserts: therapeutic-goods-act-1989-sec-42ye-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42ye-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ye-ss-1
schema version: 2
part of: 42YE Gathering information for application for pecuniary penalty

therapeutic-goods-act-1989-sec-42ye-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Duty obligation
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42ye-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YE(1) Gathering information for application for pecuniary penalty

42YE(2) Gathering information for application for pecuniary penalty
type: Concept
source: therapeutic-goods-act-1989.pdf, p.283
note: Secretary may require person to give assistance in connection with application for civil penalty order.
asserts: therapeutic-goods-act-1989-sec-42ye-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42ye-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ye-ss-2
schema version: 2
part of: 42YE Gathering information for application for pecuniary penalty

therapeutic-goods-act-1989-sec-42ye-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide assistance
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-42ye-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YE(2) Gathering information for application for pecuniary penalty

42YF Civil proceedings after criminal proceedings
type: Concept
source: therapeutic-goods-act-1989.pdf, p.285
note: Federal Court cannot impose pecuniary penalty order on a person convicted of an offence substantially similar to the contravention.
asserts: therapeutic-goods-act-1989-sec-42yf-norm
asserts: therapeutic-goods-act-1989-sec-42yf-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42yf-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42yf-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-42yf-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-42yf-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yf
schema version: 2

therapeutic-goods-act-1989-sec-42yf-logic-alleninterval-2
type: LogicApplication
conclusion text: must be considered when imposing pecuniary penalty order
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal intervals of conviction and contravention must overlap
modality: AllenInterval
operator: Temporal overlap
premise text: Conviction of an offence constituting substantially similar conduct to the contravention

therapeutic-goods-act-1989-sec-42yf-logic-cogai-5
type: LogicApplication
conclusion text: must be taken into account when imposing pecuniary penalty order
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Knowledge-based system must consider conviction and contravention
modality: CogAI
operator: Knowledge-based system
premise text: Federal Court must not make a pecuniary penalty order against a person convicted of an offence substantially similar to the contravention

therapeutic-goods-act-1989-sec-42yf-logic-deontic-1
type: LogicApplication
conclusion text: against a person convicted of an offence substantially similar to the contravention
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of pecuniary penalty order
modality: Deontic
operator: Cannot
premise text: Federal Court must not make a pecuniary penalty order

therapeutic-goods-act-1989-sec-42yf-logic-diffusion-4
type: LogicApplication
conclusion text: must be taken into account when imposing pecuniary penalty order
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusive effect of conviction on contravention must be considered
modality: Diffusion
operator: Diffusive effect
premise text: Conviction of an offence substantially similar to the contravention

therapeutic-goods-act-1989-sec-42yf-logic-ltl-3
type: LogicApplication
conclusion text: must be taken into account when imposing pecuniary penalty order
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring traces of conviction and contravention must be considered
modality: LTL
operator: Recurring trace
premise text: Conviction of an offence substantially similar to the contravention

42YG Criminal proceedings during civil proceedings
type: Concept
source: therapeutic-goods-act-1989.pdf, p.285
curation status: Proposed
has part: 42YG(1) Criminal proceedings during civil proceedings
has part: 42YG(2) Criminal proceedings during civil proceedings
proposed by: legis2cml
realized by: sec-42yg
schema version: 2

42YG(1) Criminal proceedings during civil proceedings
type: Concept
source: therapeutic-goods-act-1989.pdf, p.285
note: Stay of pecuniary penalty order proceedings during criminal proceedings for same offence.
asserts: therapeutic-goods-act-1989-sec-42yg-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42yg-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42yg-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42yg-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-42yg-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-42yg-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yg-ss-1
schema version: 2
part of: 42YG Criminal proceedings during civil proceedings

therapeutic-goods-act-1989-sec-42yg-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines a temporal overlap between criminal proceedings and pecuniary penalty order proceedings.
modality: AllenInterval
operator: Overlaps
premise text: (a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention.

therapeutic-goods-act-1989-sec-42yg-ss-1-logic-cogai-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Recognizes the prohibition of pecuniary penalty order proceedings during criminal proceedings for same offence.
modality: CogAI
operator: Recognizes
premise text: (a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention.

therapeutic-goods-act-1989-sec-42yg-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prevents pecuniary penalty order proceedings during criminal proceedings for same offence.
modality: Deontic
operator: Prohibition
premise text: (a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention.

therapeutic-goods-act-1989-sec-42yg-ss-1-logic-diffusion-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses the prohibition of pecuniary penalty order proceedings during criminal proceedings for same offence.
modality: Diffusion
operator: Diffuses
premise text: (a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention.

therapeutic-goods-act-1989-sec-42yg-ss-1-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines a recurring relationship between criminal proceedings and pecuniary penalty order proceedings.
modality: LTL
operator: Recurrently
premise text: (a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention.

therapeutic-goods-act-1989-sec-42yg-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YG(1) Criminal proceedings during civil proceedings

42YG(2) Criminal proceedings during civil proceedings
type: Concept
source: therapeutic-goods-act-1989.pdf, p.285
note: Proceedings for order may be resumed if not convicted.
asserts: therapeutic-goods-act-1989-sec-42yg-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42yg-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yg-ss-2
schema version: 2
part of: 42YG Criminal proceedings during civil proceedings

therapeutic-goods-act-1989-sec-42yg-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...the proceedings for the order are dismissed.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Resumption of proceedings
modality: Deontic
operator: resume
premise text: (2) The proceedings for the order may be resumed...

therapeutic-goods-act-1989-sec-42yg-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YG(2) Criminal proceedings during civil proceedings

42YH Criminal proceedings after civil proceedings
type: Concept
source: therapeutic-goods-act-1989.pdf, p.285
note: Criminal proceedings cannot start against conduct substantially similar to a civil penalty provision if a pecuniary penalty order has been made.
asserts: therapeutic-goods-act-1989-sec-42yh-norm
asserts: therapeutic-goods-act-1989-sec-42yh-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yh
schema version: 2

therapeutic-goods-act-1989-sec-42yh-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits criminal proceedings against similar conduct.
modality: Deontic
operator: forbid

42YI Evidence given in proceedings for civil penalty not admissible
type: Concept
source: therapeutic-goods-act-1989.pdf, p.285
note: Evidence of information given or production of documents by an individual is not admissible in criminal proceedings against the individual.
asserts: therapeutic-goods-act-1989-sec-42yi-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yi
schema version: 2

therapeutic-goods-act-1989-sec-42yi-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YI Evidence given in proceedings for civil penalty not admissible

42YJ Simplified outline of this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.287
note: Secretary can issue infringement notice for contravention of Act or regulations.
asserts: therapeutic-goods-act-1989-sec-42yj-norm
asserts: therapeutic-goods-act-1989-sec-42yj-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yj
schema version: 2

therapeutic-goods-act-1989-sec-42yj-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary can issue infringement notice.
modality: Deontic
operator: can

therapeutic-goods-act-1989-sec-42yj-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YJ Simplified outline of this Part

42YK When an infringement notice may be given
type: Concept
source: therapeutic-goods-act-1989.pdf, p.287
curation status: Proposed
has part: 42YK(1) When an infringement notice may be given
has part: 42YK(2) When an infringement notice may be given
has part: 42YK(3) When an infringement notice may be given
has part: 42YK(4) When an infringement notice may be given
proposed by: legis2cml
realized by: sec-42yk
schema version: 2

42YK(1) When an infringement notice may be given
type: Concept
source: therapeutic-goods-act-1989.pdf, p.287
note: Secretary may give infringement notice for alleged contravention.
asserts: therapeutic-goods-act-1989-sec-42yk-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42yk-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yk-ss-1
schema version: 2
part of: 42YK When an infringement notice may be given

therapeutic-goods-act-1989-sec-42yk-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Implies obligation.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-42yk-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YK(1) When an infringement notice may be given

42YK(2) When an infringement notice may be given
type: Concept
source: therapeutic-goods-act-1989.pdf, p.287
note: Infringement notice must be given within 12 months after contravention.
asserts: therapeutic-goods-act-1989-sec-42yk-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42yk-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yk-ss-2
schema version: 2
part of: 42YK When an infringement notice may be given

therapeutic-goods-act-1989-sec-42yk-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to give infringement notice within 12 months.
modality: Deontic
operator: MUST
premise text: (2) The infringement notice must be given...

therapeutic-goods-act-1989-sec-42yk-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YK(2) When an infringement notice may be given

42YK(3) When an infringement notice may be given
type: Concept
source: therapeutic-goods-act-1989.pdf, p.287
note: A single infringement notice must relate only to a single contravention of a single provision.
asserts: therapeutic-goods-act-1989-sec-42yk-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42yk-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yk-ss-3
schema version: 2
part of: 42YK When an infringement notice may be given

therapeutic-goods-act-1989-sec-42yk-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Single infringement notice must relate to a single contravention.
modality: Deontic
operator: necessity

therapeutic-goods-act-1989-sec-42yk-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YK(3) When an infringement notice may be given

42YK(4) When an infringement notice may be given
type: Concept
source: therapeutic-goods-act-1989.pdf, p.287
note: Secretary may give a person an infringement notice relating to multiple contraventions of a single provision if certain conditions are met.
asserts: therapeutic-goods-act-1989-sec-42yk-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-42yk-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yk-ss-4
schema version: 2
part of: 42YK When an infringement notice may be given

therapeutic-goods-act-1989-sec-42yk-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary may give an infringement notice
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-42yk-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YK(4) When an infringement notice may be given

42YL Enforcement of undertakings
type: Concept
source: therapeutic-goods-act-1989.pdf, p.295
curation status: Proposed
has part: 42YL(1) Enforcement of undertakings
has part: 42YL(2) Enforcement of undertakings
has part: 42YL(3) Enforcement of undertakings
has part: 42YL(4) Enforcement of undertakings
has part: 42YL(5) Enforcement of undertakings
proposed by: legis2cml
realized by: sec-42yl
schema version: 2

42YL(1) Enforcement of undertakings
type: Concept
source: therapeutic-goods-act-1989.pdf, p.295
note: Secretary may accept written undertaking from person in connection with a matter.
asserts: therapeutic-goods-act-1989-sec-42yl-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42yl-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yl-ss-1
schema version: 2
part of: 42YL Enforcement of undertakings

therapeutic-goods-act-1989-sec-42yl-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Acceptance of undertaking
modality: Deontic
operator: acceptance
premise text: (1) The Secretary may accept a written undertaking...

42YL(2) Enforcement of undertakings
type: Concept
source: therapeutic-goods-act-1989.pdf, p.295
note: The person may withdraw or vary the undertaking with consent from the Secretary.
asserts: therapeutic-goods-act-1989-sec-42yl-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yl-ss-2
schema version: 2
part of: 42YL Enforcement of undertakings

therapeutic-goods-act-1989-sec-42yl-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YL(2) Enforcement of undertakings

42YL(3) Enforcement of undertakings
type: Concept
source: therapeutic-goods-act-1989.pdf, p.295
note: Secretary must publish details of undertaking on the internet.
asserts: therapeutic-goods-act-1989-sec-42yl-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-42yl-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yl-ss-3
schema version: 2
part of: 42YL Enforcement of undertakings

therapeutic-goods-act-1989-sec-42yl-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: The Secretary must publish...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must publish details
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-42yl-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YL(3) Enforcement of undertakings

42YL(4) Enforcement of undertakings
type: Concept
source: therapeutic-goods-act-1989.pdf, p.295
note: Secretary may apply for order if undertaking is breached
asserts: therapeutic-goods-act-1989-sec-42yl-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-42yl-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yl-ss-4
schema version: 2
part of: 42YL Enforcement of undertakings

therapeutic-goods-act-1989-sec-42yl-ss-4-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: May apply for order
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-42yl-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YL(4) Enforcement of undertakings

42YL(5) Enforcement of undertakings
type: Concept
source: therapeutic-goods-act-1989.pdf, p.295
note: Court may make orders to enforce breach of undertaking.
asserts: therapeutic-goods-act-1989-sec-42yl-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-42yl-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yl-ss-5
schema version: 2
part of: 42YL Enforcement of undertakings

therapeutic-goods-act-1989-sec-42yl-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Enforcement obligation
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-42yl-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YL(5) Enforcement of undertakings

42YM Simplified outline of this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.296
note: Secretary can seek injunctions from Federal Court or Family Court to restrain contravention of Act or regulations.
asserts: therapeutic-goods-act-1989-sec-42ym-norm
asserts: therapeutic-goods-act-1989-sec-42ym-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ym
schema version: 2

therapeutic-goods-act-1989-sec-42ym-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Possibility of obligation
modality: Deontic
operator: can

therapeutic-goods-act-1989-sec-42ym-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YM Simplified outline of this Part

42YN Grant of injunctions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.296
curation status: Proposed
has part: 42YN(1) Grant of injunctions
has part: 42YN(2) Grant of injunctions
proposed by: legis2cml
realized by: sec-42yn
schema version: 2

42YN(1) Grant of injunctions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.296
note: Grant of injunctions for conduct in contravention of the Act or regulations.
asserts: therapeutic-goods-act-1989-sec-42yn-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42yn-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yn-ss-1
schema version: 2
part of: 42YN Grant of injunctions

therapeutic-goods-act-1989-sec-42yn-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits conduct in contravention of the Act or regulations.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-42yn-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YN(1) Grant of injunctions

42YN(2) Grant of injunctions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.296
note: Grant of injunctions for refusal or failure to comply with the Act
asserts: therapeutic-goods-act-1989-sec-42yn-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42yn-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yn-ss-2
schema version: 2
part of: 42YN Grant of injunctions

therapeutic-goods-act-1989-sec-42yn-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: the Federal Court or Federal Circuit and Family Court of Australia may grant an injunction requiring the person to do that thing.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with the Act
modality: Deontic
operator: obligation
premise text: (2) If...

therapeutic-goods-act-1989-sec-42yn-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YN(2) Grant of injunctions

42YO Interim injunctions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.297
curation status: Proposed
has part: 42YO(1) Interim injunctions
has part: 42YO(2) Interim injunctions
proposed by: legis2cml
realized by: sec-42yo
schema version: 2

42YO(1) Interim injunctions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.297
note: Restraining conduct
asserts: therapeutic-goods-act-1989-sec-42yo-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yo-ss-1
schema version: 2
part of: 42YO Interim injunctions

42YO(2) Interim injunctions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.297
note: Cannot require the Secretary to give an undertaking as a condition of granting an interim injunction.
asserts: therapeutic-goods-act-1989-sec-42yo-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42yo-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yo-ss-2
schema version: 2
part of: 42YO Interim injunctions

therapeutic-goods-act-1989-sec-42yo-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Cannot require the Secretary to give an undertaking as a condition of granting an interim injunction.
modality: Deontic
operator: cannot

42YP Discharging or varying injunctions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.297
note: May discharge or vary an injunction granted by that court under this Part.
asserts: therapeutic-goods-act-1989-sec-42yp-norm
asserts: therapeutic-goods-act-1989-sec-42yp-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yp
schema version: 2

therapeutic-goods-act-1989-sec-42yp-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits discharge or variation of an injunction
modality: Deontic
operator: may

42YQ Certain limits on granting injunctions not to apply
type: Concept
source: therapeutic-goods-act-1989.pdf, p.297
note: Court may grant injunction without considering intent or previous conduct.
asserts: therapeutic-goods-act-1989-sec-42yq-norm
asserts: therapeutic-goods-act-1989-sec-42yq-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yq
schema version: 2

therapeutic-goods-act-1989-sec-42yq-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Court permits exercise of power to grant injunction.
modality: Deontic
operator: Permit

42YR Other powers of court unaffected
type: Concept
source: therapeutic-goods-act-1989.pdf, p.298
note: Court's other powers unaffected
asserts: therapeutic-goods-act-1989-sec-42yr-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yr
schema version: 2

42YS Simplified outline of this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.299
note: Secretary may give directions to a person requiring specified actions in relation to goods.
asserts: therapeutic-goods-act-1989-sec-42ys-norm
asserts: therapeutic-goods-act-1989-sec-42ys-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42ys
schema version: 2

therapeutic-goods-act-1989-sec-42ys-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary may give directions.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-42ys-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YS Simplified outline of this Part

42YT Secretary may give directions if this Act or an instrument is
type: Concept
source: therapeutic-goods-act-1989.pdf, p.299
curation status: Proposed
has part: 42YT(1) Secretary may give directions if this Act or an instrument is
has part: 42YT(2) Secretary may give directions if this Act or an instrument is
proposed by: legis2cml
realized by: sec-42yt
schema version: 2

42YT(1) Secretary may give directions if this Act or an instrument is
type: Concept
source: therapeutic-goods-act-1989.pdf, p.299
note: Secretary may give directions if this Act or an instrument is not complying with the Act in relation to particular goods.
asserts: therapeutic-goods-act-1989-sec-42yt-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-42yt-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yt-ss-1
schema version: 2
part of: 42YT Secretary may give directions if this Act or an instrument is

therapeutic-goods-act-1989-sec-42yt-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Conditional commencement
modality: AllenInterval
operator: if the Secretary believes on reasonable grounds that...
premise text: it is in the interests of public health or safety to give the person directions under this section.

therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary may give directions
modality: Deontic
operator: may
premise text: This section applies if the Secretary believes...

therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Non-compliance with the Act
modality: Deontic
operator: is not complying with this Act or an instrument
premise text: (a) a person is not complying with this Act or an instrument made under this Act in relation to particular goods;

therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Public health or safety interest
modality: Deontic
operator: is in the interests of public health or safety
premise text: it is in the interests of public health or safety to give the person directions under this section.

therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Giving directions
modality: Deontic
operator: to give the person directions
premise text: it is in the interests of public health or safety to give the person directions under this section.

therapeutic-goods-act-1989-sec-42yt-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YT(1) Secretary may give directions if this Act or an instrument is

42YT(2) Secretary may give directions if this Act or an instrument is
type: Concept
source: therapeutic-goods-act-1989.pdf, p.299
note: Secretary may give directions to a person regarding the relabeling, repackaging, or disposal of goods.
asserts: therapeutic-goods-act-1989-sec-42yt-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-42yt-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-42yt-ss-2
schema version: 2
part of: 42YT Secretary may give directions if this Act or an instrument is

therapeutic-goods-act-1989-sec-42yt-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Implies obligation
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-42yt-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 42YT(2) Secretary may give directions if this Act or an instrument is

43 By whom charges payable
type: Concept
source: therapeutic-goods-act-1989.pdf, p.301
curation status: Proposed
has part: 43(1) By whom charges payable
has part: 43(2) By whom charges payable
has part: 43(3) By whom charges payable
proposed by: legis2cml
realized by: sec-43
schema version: 2

43(1) By whom charges payable
type: Concept
source: therapeutic-goods-act-1989.pdf, p.301
note: Annual registration charge payable by person in relation to whom therapeutic goods are registered, listed or included.
asserts: therapeutic-goods-act-1989-sec-43-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-43-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-43-ss-1-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-43-ss-1
schema version: 2
part of: 43 By whom charges payable

therapeutic-goods-act-1989-sec-43-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Specifies the temporal interval during which the annual registration charge must be paid.
modality: AllenInterval
operator: Overlaps
premise text: Annual

therapeutic-goods-act-1989-sec-43-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a duty on the person to pay the annual registration charge.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-43-ss-1-norm
type: Obligation
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 43(1) By whom charges payable

43(2) By whom charges payable
type: Concept
source: therapeutic-goods-act-1989.pdf, p.301
note: Annual licensing charge payable by licence holder
asserts: therapeutic-goods-act-1989-sec-43-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-43-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-43-ss-2
schema version: 2
part of: 43 By whom charges payable

therapeutic-goods-act-1989-sec-43-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: annual licensing charge
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to pay annual licensing charge
modality: Deontic
operator: payable by
premise text: holder of the licence

43(3) By whom charges payable
type: Concept
source: therapeutic-goods-act-1989.pdf, p.301
note: Annual conformity assessment body determination charge payable by Australian corporation
asserts: therapeutic-goods-act-1989-sec-43-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-43-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-43-ss-3
schema version: 2
part of: 43 By whom charges payable

therapeutic-goods-act-1989-sec-43-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Payable obligation
modality: Deontic
operator: Obligation

44 Time for payment of charges
type: Concept
source: therapeutic-goods-act-1989.pdf, p.301
note: Annual registration charge becomes payable on a specific date.
asserts: therapeutic-goods-act-1989-sec-44-norm
asserts: therapeutic-goods-act-1989-sec-44-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-44
schema version: 2

therapeutic-goods-act-1989-sec-44-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-44-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 44 Time for payment of charges

44A Exemptions from liability to pay charges
type: Concept
source: therapeutic-goods-act-1989.pdf, p.302
curation status: Proposed
has part: 44A(1) Exemptions from liability to pay charges
has part: 44A(2) Exemptions from liability to pay charges
has part: 44A(3) Exemptions from liability to pay charges
has part: 44A(4) Exemptions from liability to pay charges
has part: 44A(5) Exemptions from liability to pay charges
proposed by: legis2cml
realized by: sec-44a
schema version: 2

44A(1) Exemptions from liability to pay charges
type: Concept
source: therapeutic-goods-act-1989.pdf, p.302
note: Exemptions from liability to pay charges
asserts: therapeutic-goods-act-1989-sec-44a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-44a-ss-1-logic-alleninterval-4
asserts: therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-44a-ss-1
schema version: 2
part of: 44A Exemptions from liability to pay charges

therapeutic-goods-act-1989-sec-44a-ss-1-logic-alleninterval-4
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for exemptions
modality: AllenInterval
operator: temporal interval
premise text: if the person’s turnover of the therapeutic goods concerned for the financial year specified in the regulations is of low value;

therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exempts a person from liability to pay annual registration charge
modality: Deontic
operator: exemption
premise text: (1) The regulations may make provision for and in relation to:

therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires payment of charge for current year if application is refused
modality: Deontic
operator: requirement
premise text: (b) the making of an application for an exemption and requiring payment of that charge for the current year if the application is refused;

therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-3
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Cancels exemption and requires payment of charge for current year
modality: Deontic
operator: cancellation
premise text: (c) cancelling an exemption and requiring payment of that charge for the current year.

therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-5
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exempts a person from liability to pay annual listing charge or annual charge for inclusion in the Register
modality: Deontic
operator: exemption
premise text: (a) exempting a person from liability to pay annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year (the current year) if the person’s turnover of the therapeutic goods concerned for the financial year specified in the regulations is of low value;

therapeutic-goods-act-1989-sec-44a-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 44A(1) Exemptions from liability to pay charges

44A(2) Exemptions from liability to pay charges
type: Concept
source: therapeutic-goods-act-1989.pdf, p.302
note: Fee for exemption applications must not amount to taxation.
asserts: therapeutic-goods-act-1989-sec-44a-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-44a-ss-2
schema version: 2
part of: 44A Exemptions from liability to pay charges

44A(3) Exemptions from liability to pay charges
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.302
note: Person must provide statement upon exemption application or grant
asserts: therapeutic-goods-act-1989-sec-44a-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-44a-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-44a-ss-3
schema version: 2
part of: 44A Exemptions from liability to pay charges

therapeutic-goods-act-1989-sec-44a-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide statement
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-44a-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 44A(3) Exemptions from liability to pay charges

44A(4) Exemptions from liability to pay charges
type: Concept
source: therapeutic-goods-act-1989.pdf, p.302
note: Regulations may obtain additional information or documents from applicants for exemptions.
asserts: therapeutic-goods-act-1989-sec-44a-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-44a-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-44a-ss-4
schema version: 2
part of: 44A Exemptions from liability to pay charges

therapeutic-goods-act-1989-sec-44a-ss-4-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations may obtain additional information or documents.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-44a-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 44A(4) Exemptions from liability to pay charges

44A(5) Exemptions from liability to pay charges
type: Concept
source: therapeutic-goods-act-1989.pdf, p.302
note: Review of exemptions by Administrative Review Tribunal
asserts: therapeutic-goods-act-1989-sec-44a-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-44a-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-44a-ss-5
schema version: 2
part of: 44A Exemptions from liability to pay charges

therapeutic-goods-act-1989-sec-44a-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to review exemptions
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-44a-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 44A(5) Exemptions from liability to pay charges

44B Recovery of unpaid charges
type: Concept
source: therapeutic-goods-act-1989.pdf, p.304
note: Recovery of unpaid charges after 28 days
asserts: therapeutic-goods-act-1989-sec-44b-norm
asserts: therapeutic-goods-act-1989-sec-44b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-44b
schema version: 2

therapeutic-goods-act-1989-sec-44b-logic-deontic-1
type: LogicApplication
conclusion text: Recovery of charge due to Commonwealth
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to recover unpaid charges
modality: Deontic
operator: Obligation
premise text: Charge becomes payable after 28 days

45 Therapeutic Goods Administration Account
type: Concept
source: therapeutic-goods-act-1989.pdf, p.305
curation status: Proposed
has part: 45(1) Therapeutic Goods Administration Account
has part: 45(2) Therapeutic Goods Administration Account
has part: 45(3) Therapeutic Goods Administration Account
has part: 45(4) Therapeutic Goods Administration Account
proposed by: legis2cml
realized by: sec-45
schema version: 2

45(1) Therapeutic Goods Administration Account
type: Concept
source: therapeutic-goods-act-1989.pdf, p.305
note: Continued existence of Therapeutic Goods Administration Account
asserts: therapeutic-goods-act-1989-sec-45-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-45-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45-ss-1
schema version: 2
part of: 45 Therapeutic Goods Administration Account

therapeutic-goods-act-1989-sec-45-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Account exists
modality: Deontic
operator: Exists

therapeutic-goods-act-1989-sec-45-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45(1) Therapeutic Goods Administration Account

45(2) Therapeutic Goods Administration Account
type: Concept
source: therapeutic-goods-act-1989.pdf, p.305
note: The Account is a special account for the purposes of the Public Governance, Performance and Accountability Act 2013.
asserts: therapeutic-goods-act-1989-sec-45-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-45-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45-ss-2
schema version: 2
part of: 45 Therapeutic Goods Administration Account

therapeutic-goods-act-1989-sec-45-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Account is a special account
modality: Deontic
operator: has

therapeutic-goods-act-1989-sec-45-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45(2) Therapeutic Goods Administration Account

45(3) Therapeutic Goods Administration Account
type: Concept
source: therapeutic-goods-act-1989.pdf, p.305
note: Amounts must be credited to the Account from various sources.
asserts: therapeutic-goods-act-1989-sec-45-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-45-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45-ss-3
schema version: 2
part of: 45 Therapeutic Goods Administration Account

therapeutic-goods-act-1989-sec-45-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Amounts must be provided
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide amounts
modality: Deontic
operator: =
premise text: There must be credited to the Account...

therapeutic-goods-act-1989-sec-45-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45(3) Therapeutic Goods Administration Account

45(4) Therapeutic Goods Administration Account
type: Concept
source: therapeutic-goods-act-1989.pdf, p.305
note: Payment obligations for therapeutic goods administration account
asserts: therapeutic-goods-act-1989-sec-45-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-45-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45-ss-4
schema version: 2
part of: 45 Therapeutic Goods Administration Account

therapeutic-goods-act-1989-sec-45-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Payment obligation
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-45-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45(4) Therapeutic Goods Administration Account

45A Definitions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.313
note: Defines evidential material and occupier for this Part.
asserts: therapeutic-goods-act-1989-sec-45a-norm
asserts: therapeutic-goods-act-1989-sec-45a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-45a-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-45a
schema version: 2

therapeutic-goods-act-1989-sec-45a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Defines terms used in the provision.
modality: Deontic
operator: defines

therapeutic-goods-act-1989-sec-45a-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Includes definitions for occupier and person assisting.
modality: DescriptionLogic
operator: includes

therapeutic-goods-act-1989-sec-45a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45A Definitions

45AA Simplified outline of this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.307
note: The Secretary can gather information or documents relevant to a contravention or possible contravention of this Act.
asserts: therapeutic-goods-act-1989-sec-45aa-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-45aa
schema version: 2

therapeutic-goods-act-1989-sec-45aa-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45AA Simplified outline of this Part

45AB Secretary may require information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.308
curation status: Proposed
has part: 45AB(1) Secretary may require information or documents
has part: 45AB(2) Secretary may require information or documents
has part: 45AB(3) Secretary may require information or documents
has part: 45AB(4) Secretary may require information or documents
proposed by: legis2cml
realized by: sec-45ab
schema version: 2

45AB(1) Secretary may require information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.308
note: Secretary may require information or documents from a person.
asserts: therapeutic-goods-act-1989-sec-45ab-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-45ab-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ab-ss-1
schema version: 2
part of: 45AB Secretary may require information or documents

therapeutic-goods-act-1989-sec-45ab-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires the person to give information or produce documents.
modality: Deontic
operator: requires

therapeutic-goods-act-1989-sec-45ab-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45AB(1) Secretary may require information or documents

45AB(2) Secretary may require information or documents
type: Concept
description: Notice with a reasonable compliance period
source: therapeutic-goods-act-1989.pdf, p.308
note: Secretary must require person to comply within a specified period.
asserts: therapeutic-goods-act-1989-sec-45ab-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-45ab-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ab-ss-2
schema version: 2
part of: 45AB Secretary may require information or documents

therapeutic-goods-act-1989-sec-45ab-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-45ab-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45AB(2) Secretary may require information or documents

45AB(3) Secretary may require information or documents
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.308
note: Secretary must provide notice with specified information
asserts: therapeutic-goods-act-1989-sec-45ab-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-45ab-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ab-ss-3
schema version: 2
part of: 45AB Secretary may require information or documents

therapeutic-goods-act-1989-sec-45ab-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide notice
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-45ab-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45AB(3) Secretary may require information or documents

45AB(4) Secretary may require information or documents
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.308
note: Secretary must require information or documents in specified format.
asserts: therapeutic-goods-act-1989-sec-45ab-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-45ab-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-45ab-ss-4-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ab-ss-4
schema version: 2
part of: 45AB Secretary may require information or documents

therapeutic-goods-act-1989-sec-45ab-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide information or documents.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-45ab-ss-4-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Information must be provided in specified format.
modality: DescriptionLogic
operator: SPECIFIED

therapeutic-goods-act-1989-sec-45ab-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45AB(4) Secretary may require information or documents

45AC Offences for failing to comply with notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.308
curation status: Proposed
has part: 45AC(1) Offences for failing to comply with notice
has part: 45AC(2) Offences for failing to comply with notice
has part: 45AC(3) Offences for failing to comply with notice
proposed by: legis2cml
realized by: sec-45ac
schema version: 2

45AC(1) Offences for failing to comply with notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.308
note: Failure to comply with notice results in an offence.
asserts: therapeutic-goods-act-1989-sec-45ac-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-45ac-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-45ac-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-45ac-ss-1-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-45ac-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-45ac-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ac-ss-1
schema version: 2
part of: 45AC Offences for failing to comply with notice

therapeutic-goods-act-1989-sec-45ac-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: The section overlaps with Chapter 6.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Section 45AC(1) overlaps with Chapter 6.
modality: AllenInterval
operator: Overlaps
premise text: Compilation date: 05/09/2025 Penalty: 500 penalty units. Strict liability offence

therapeutic-goods-act-1989-sec-45ac-ss-1-logic-argumentation-3
type: LogicApplication
conclusion text: If the person fails to comply, they commit an offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Failing to comply with notice implies committing an offence.
modality: Argumentation
operator: Implication
premise text: (1) A person commits an offence if: (a) the person is given a notice under section 45AB; and (b) the person fails to comply with the notice.

therapeutic-goods-act-1989-sec-45ac-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: If the person fails, they are subject to a strict liability offence.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Failing to comply with notice implies being subject to a strict liability offence.
modality: CogAI
operator: Implication
premise text: (1) A person commits an offence if: (a) the person is given a notice under section 45AB; and (b) the person fails to comply with the notice.

therapeutic-goods-act-1989-sec-45ac-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The person commits an offence if they fail to comply with the notice.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits failing to comply with notice.
modality: Deontic
operator: Prohibition
premise text: (1) A person commits an offence if: (a) the person is given a notice under section 45AB; and (b) the person fails to comply with the notice.

therapeutic-goods-act-1989-sec-45ac-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: If the person fails, they are subject to penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Failing to comply with notice implies being subject to penalty units.
modality: Diffusion
operator: Implication
premise text: (1) A person commits an offence if: (a) the person is given a notice under section 45AB; and (b) the person fails to comply with the notice.

therapeutic-goods-act-1989-sec-45ac-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45AC(1) Offences for failing to comply with notice

45AC(2) Offences for failing to comply with notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.308
note: Failure to comply with notice results in an offence of strict liability.
asserts: therapeutic-goods-act-1989-sec-45ac-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-45ac-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ac-ss-2
schema version: 2
part of: 45AC Offences for failing to comply with notice

therapeutic-goods-act-1989-sec-45ac-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Failure to comply results in an offence of strict liability.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with notice.
modality: Deontic
operator: obligation
premise text: Given a notice under section 45AB.

therapeutic-goods-act-1989-sec-45ac-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45AC(2) Offences for failing to comply with notice

45AC(3) Offences for failing to comply with notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.308
note: No obligation if person has a reasonable excuse.
asserts: therapeutic-goods-act-1989-sec-45ac-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-45ac-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-45ac-ss-3-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ac-ss-3
schema version: 2
part of: 45AC Offences for failing to comply with notice

therapeutic-goods-act-1989-sec-45ac-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Reasonable excuse
modality: Deontic
operator: Excuse

therapeutic-goods-act-1989-sec-45ac-ss-3-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Defendant bears evidential burden
modality: Epistemic
operator: Belief

therapeutic-goods-act-1989-sec-45ac-ss-3-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 45AC(3) Offences for failing to comply with notice

45AD Offences and civil penalty for giving false or misleading
type: Concept
source: therapeutic-goods-act-1989.pdf, p.309
curation status: Proposed
has part: 45AD(1) Offences and civil penalty for giving false or misleading
has part: 45AD(2) Offences and civil penalty for giving false or misleading
proposed by: legis2cml
realized by: sec-45ad
schema version: 2

45AD(1) Offences and civil penalty for giving false or misleading
type: Concept
source: therapeutic-goods-act-1989.pdf, p.309
note: Giving false or misleading information in response to a notice is an offence.
asserts: therapeutic-goods-act-1989-sec-45ad-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ad-ss-1
schema version: 2
part of: 45AD Offences and civil penalty for giving false or misleading

therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The person commits an offence if the information or document is false or misleading in a material particular.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of giving false or misleading information.
modality: Deontic
operator: Prohibit
premise text: The person is given a notice under section 45AB.

therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: The provision prohibits imprisonment for 12 months or 1,000 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of imprisonment for 12 months or 1,000 penalty units.
modality: Deontic
operator: Prohibit
premise text: Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.

therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-3
type: LogicApplication
conclusion text: The provision prohibits liability for an executive officer of a body corporate.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of liability for an executive officer of a body corporate.
modality: Deontic
operator: Prohibit
premise text: Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: The provision is classified as a strict liability offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of strict liability offence.
modality: Deontic
operator: Prohibit
premise text: Strict liability offence

therapeutic-goods-act-1989-sec-45ad-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45AD(1) Offences and civil penalty for giving false or misleading

45AD(2) Offences and civil penalty for giving false or misleading
type: Concept
source: therapeutic-goods-act-1989.pdf, p.309
note: Giving false or misleading information is an offence.
asserts: therapeutic-goods-act-1989-sec-45ad-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-45ad-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ad-ss-2
schema version: 2
part of: 45AD Offences and civil penalty for giving false or misleading

therapeutic-goods-act-1989-sec-45ad-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits giving false or misleading information.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-45ad-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45AD(2) Offences and civil penalty for giving false or misleading

45AE Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.310
curation status: Proposed
has part: 45AE(1) Self-incrimination
has part: 45AE(2) Self-incrimination
has part: 45AE(3) Self-incrimination
proposed by: legis2cml
realized by: sec-45ae
schema version: 2

45AE(1) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.310
note: No excuse for self-incrimination
asserts: therapeutic-goods-act-1989-sec-45ae-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-45ae-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ae-ss-1
schema version: 2
part of: 45AE Self-incrimination

therapeutic-goods-act-1989-sec-45ae-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide information
modality: Deontic
operator: Obligation

45AE(2) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.310
note: Protection from self-incrimination in criminal proceedings
asserts: therapeutic-goods-act-1989-sec-45ae-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-45ae-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-45ae-ss-2-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-45ae-ss-2-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-45ae-ss-2-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-45ae-ss-2-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ae-ss-2
schema version: 2
part of: 45AE Self-incrimination

therapeutic-goods-act-1989-sec-45ae-ss-2-logic-alleninterval-3
type: LogicApplication
conclusion text: ... criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines the temporal scope of admissible evidence
modality: AllenInterval
operator: Overlaps
premise text: (2) However: ...; (d) subsection 45AC(1) or (2); or (e) subsection 45AD(1) or (2); or (f) section 137.1 or 137.2 of the Criminal Code

therapeutic-goods-act-1989-sec-45ae-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ... not admissible in evidence against the individual in criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prevents admissibility of self-incriminating information
modality: Deontic
operator: Prohibition
premise text: (2) However: ...; (d) subsection 45AC(1) or (2); or (e) subsection 45AD(1) or (2); or (f) section 137.1 or 137.2 of the Criminal Code

therapeutic-goods-act-1989-sec-45ae-ss-2-logic-deontic-2
type: LogicApplication
conclusion text: ... proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Allows for exceptions to the prohibition on self-incrimination
modality: Deontic
operator: Permission
premise text: (f) section 137.1 or 137.2 of the Criminal Code in relation to giving the information or producing the document.

therapeutic-goods-act-1989-sec-45ae-ss-2-logic-deontic-5
type: LogicApplication
conclusion text: ... against the individual in criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Establishes the duty to protect against self-incrimination
modality: Deontic
operator: Obligation
premise text: (2) However: ...; (d) subsection 45AC(1) or (2); or (e) subsection 45AD(1) or (2); or (f) section 137.1 or 137.2 of the Criminal Code

therapeutic-goods-act-1989-sec-45ae-ss-2-logic-ltl-4
type: LogicApplication
conclusion text: ... criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines the repetition of admissible evidence
modality: LTL
operator: Repeats
premise text: (a) the information given or document produced; and (b) the giving of the information or the production of the document;

therapeutic-goods-act-1989-sec-45ae-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45AE(2) Self-incrimination

45AE(3) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.310
note: No claim of privilege against self-exposure to penalty for giving information or producing document under section 45AB.
asserts: therapeutic-goods-act-1989-sec-45ae-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-45ae-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ae-ss-3
schema version: 2
part of: 45AE Self-incrimination

therapeutic-goods-act-1989-sec-45ae-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits claiming privilege against self-exposure to penalty.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-45ae-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45AE(3) Self-incrimination

45AF Secretary may inspect and copy documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.312
note: The Secretary may inspect and copy documents produced under section 45AB.
asserts: therapeutic-goods-act-1989-sec-45af-norm
asserts: therapeutic-goods-act-1989-sec-45af-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45af
schema version: 2

therapeutic-goods-act-1989-sec-45af-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary may inspect and copy documents.
modality: Deontic
operator: may

45AG Secretary may retain documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.312
curation status: Proposed
has part: 45AG(1) Secretary may retain documents
has part: 45AG(2) Secretary may retain documents
has part: 45AG(3) Secretary may retain documents
has part: 45AG(4) Secretary may retain documents
proposed by: legis2cml
realized by: sec-45ag
schema version: 2

45AG(1) Secretary may retain documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.312
note: The Secretary may retain documents for as long as necessary.
asserts: therapeutic-goods-act-1989-sec-45ag-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-45ag-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ag-ss-1
schema version: 2
part of: 45AG Secretary may retain documents

therapeutic-goods-act-1989-sec-45ag-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The Secretary must retain documents.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Implies an obligation.
modality: Deontic
operator: may

45AG(2) Secretary may retain documents
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.312
note: The Secretary must provide a certified copy of the document as soon as practicable.
asserts: therapeutic-goods-act-1989-sec-45ag-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-45ag-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ag-ss-2
schema version: 2
part of: 45AG Secretary may retain documents

therapeutic-goods-act-1989-sec-45ag-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must provide a certified copy.
modality: Deontic
operator: Must

45AG(3) Secretary may retain documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.312
note: The certified copy must be received in all courts and tribunals as evidence.
asserts: therapeutic-goods-act-1989-sec-45ag-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-45ag-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ag-ss-3
schema version: 2
part of: 45AG Secretary may retain documents

therapeutic-goods-act-1989-sec-45ag-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The state has an obligation to provide the certified copy.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-45ag-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 45AG(3) Secretary may retain documents

45AG(4) Secretary may retain documents
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.312
note: Must provide access to document for inspection and copying.
asserts: therapeutic-goods-act-1989-sec-45ag-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-45ag-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-45ag-ss-4
schema version: 2
part of: 45AG Secretary may retain documents

therapeutic-goods-act-1989-sec-45ag-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide access.
modality: Deontic
operator: MUST

46 Searches to monitor compliance with Act or regulations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.314
curation status: Proposed
has part: 46(1) Searches to monitor compliance with Act or regulations
has part: 46(2) Searches to monitor compliance with Act or regulations
has part: 46(3) Searches to monitor compliance with Act or regulations
proposed by: legis2cml
realized by: sec-46
schema version: 2

46(1) Searches to monitor compliance with Act or regulations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.314
note: Authorized person may enter premises and exercise powers to monitor compliance.
asserts: therapeutic-goods-act-1989-sec-46-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-46-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-46-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-46-ss-1-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-46-ss-1-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-46-ss-1-logic-diffusion-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-46-ss-1
schema version: 2
part of: 46 Searches to monitor compliance with Act or regulations

therapeutic-goods-act-1989-sec-46-ss-1-logic-alleninterval-3
type: LogicApplication
conclusion text: ...for the purpose of finding out whether this Act or the regulations have been complied with:
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation: Authorized person monitors compliance during specific time period
modality: AllenInterval
operator: during
premise text: (1) Subject to subsections (2) and (3), an authorised person may...

therapeutic-goods-act-1989-sec-46-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...an authorised person may, for the purpose of finding out whether this Act or the regulations have been complied with:
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authorization to enter premises
modality: Deontic
operator: can
premise text: (1) Subject to subsections (2) and (3), an authorised person may...

therapeutic-goods-act-1989-sec-46-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: ...and exercise the powers set out in subsection 48(1) and section 48BA.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exercise powers to monitor compliance
modality: Deontic
operator: may
premise text: (a) enter any premises; and (b) exercise the powers set out in subsection 48(1) and section 48BA.

therapeutic-goods-act-1989-sec-46-ss-1-logic-diffusion-5
type: LogicApplication
conclusion text: ...and exercise the powers set out in subsection 48(1) and section 48BA.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Spread of information: Authorized person monitors compliance through specific means
modality: Diffusion
operator: through
premise text: (a) enter any premises; and (b) exercise the powers set out in subsection 48(1) and section 48BA.

therapeutic-goods-act-1989-sec-46-ss-1-logic-ltl-4
type: LogicApplication
conclusion text: ...for the purpose of finding out whether this Act or the regulations have been complied with:
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal relation: Authorized person monitors compliance until specific time period ends
modality: LTL
operator: until
premise text: (1) Subject to subsections (2) and (3), an authorised person may...

therapeutic-goods-act-1989-sec-46-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 46(1) Searches to monitor compliance with Act or regulations

46(2) Searches to monitor compliance with Act or regulations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.314
note: Authorized person cannot enter premises without consent or warrant.
asserts: therapeutic-goods-act-1989-sec-46-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-46-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-46-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-46-ss-2-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-46-ss-2
schema version: 2
part of: 46 Searches to monitor compliance with Act or regulations

therapeutic-goods-act-1989-sec-46-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: Entry requires warrant issued under section 49.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Entry requires warrant issued under section 49
modality: AllenInterval
operator: during
premise text: The entry is made under a warrant issued under section 49.

therapeutic-goods-act-1989-sec-46-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: No entry without consent or warrant.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of entry
modality: Deontic
operator: cannot
premise text: Authorized person must not enter premises.

therapeutic-goods-act-1989-sec-46-ss-2-logic-deontic-3
type: LogicApplication
conclusion text: No unauthorized entry allowed.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of unauthorized entry
modality: Deontic
operator: mustNot
premise text: The authorised person must not enter the premises.

therapeutic-goods-act-1989-sec-46-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 46(2) Searches to monitor compliance with Act or regulations

46(3) Searches to monitor compliance with Act or regulations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.314
note: Authorized person cannot exercise powers under subsection (1) if occupier requests identity card inspection.
asserts: therapeutic-goods-act-1989-sec-46-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-46-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-46-ss-3-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-46-ss-3
schema version: 2
part of: 46 Searches to monitor compliance with Act or regulations

therapeutic-goods-act-1989-sec-46-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Exercise of powers under subsection (1) is prohibited
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of exercising powers under subsection (1)
modality: Deontic
operator: Prohibition
premise text: Authorized person has required identity card inspection

therapeutic-goods-act-1989-sec-46-ss-3-logic-deontic-2
type: LogicApplication
conclusion text: Identity card inspection is permitted
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Occupier's request for identity card inspection is a permission
modality: Deontic
operator: Permission
premise text: Occupier requests identity card inspection

therapeutic-goods-act-1989-sec-46-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 46(3) Searches to monitor compliance with Act or regulations

46A Searches of certain premises to monitor compliance with Act
type: Concept
source: therapeutic-goods-act-1989.pdf, p.314
curation status: Proposed
has part: 46A(1) Searches of certain premises to monitor compliance with Act
has part: 46A(2) Searches of certain premises to monitor compliance with Act
has part: 46A(3) Searches of certain premises to monitor compliance with Act
has part: 46A(4) Searches of certain premises to monitor compliance with Act
proposed by: legis2cml
realized by: sec-46a
schema version: 2

46A(1) Searches of certain premises to monitor compliance with Act
type: Concept
source: therapeutic-goods-act-1989.pdf, p.314
note: Authorized person may enter premises to monitor compliance with Act.
asserts: therapeutic-goods-act-1989-sec-46a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-46a-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-46a-ss-1
schema version: 2
part of: 46A Searches of certain premises to monitor compliance with Act

therapeutic-goods-act-1989-sec-46a-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authorized person can enter premises.
modality: Deontic
operator: can

therapeutic-goods-act-1989-sec-46a-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 46A(1) Searches of certain premises to monitor compliance with Act

46A(2) Searches of certain premises to monitor compliance with Act
type: Concept
source: therapeutic-goods-act-1989.pdf, p.314
note: No unauthorized entry into residential premises without consent or commercial use.
asserts: therapeutic-goods-act-1989-sec-46a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-46a-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-46a-ss-2
schema version: 2
part of: 46A Searches of certain premises to monitor compliance with Act

therapeutic-goods-act-1989-sec-46a-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: (2) An authorised person must not enter premises that are a residence unless: (a) the occupier of the premises has consented to the entry; or (b) the premises are used for commercial purposes in relation to therapeutic goods or vaping goods, in addition to residential purposes.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of unauthorized entry into residential premises.
modality: Deontic
operator: Prohibit
premise text: (2) An authorised person must not, under subsection (1), enter premises that are a residence unless: (a) the occupier of the premises has consented to the entry; or (b) the premises are used for commercial purposes in relation to therapeutic goods or vaping goods, in addition to residential purposes.

therapeutic-goods-act-1989-sec-46a-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 46A(2) Searches of certain premises to monitor compliance with Act

46A(3) Searches of certain premises to monitor compliance with Act
type: Concept
source: therapeutic-goods-act-1989.pdf, p.314
note: Authorized person cannot exercise powers under subsection (1) if occupier requires identity card inspection.
asserts: therapeutic-goods-act-1989-sec-46a-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-46a-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-46a-ss-3-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-46a-ss-3-logic-linearlogic-3
asserts: therapeutic-goods-act-1989-sec-46a-ss-3-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-46a-ss-3
schema version: 2
part of: 46A Searches of certain premises to monitor compliance with Act

therapeutic-goods-act-1989-sec-46a-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of exercising powers under subsection (1)
modality: Deontic
operator: Prohibition
premise text: (a) the occupier of the premises has required the authorised person to produce his or her identity card for inspection by the occupier;

therapeutic-goods-act-1989-sec-46a-ss-3-logic-deontic-2
type: LogicApplication
conclusion text: An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of failing to comply with occupier's requirement
modality: Deontic
operator: Prohibition
premise text: (b) the authorised person fails to comply with the requirement.

therapeutic-goods-act-1989-sec-46a-ss-3-logic-deontic-4
type: LogicApplication
conclusion text: An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of exercising powers under subsection (1)
modality: Deontic
operator: Prohibition
premise text: (3) An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises if:

therapeutic-goods-act-1989-sec-46a-ss-3-logic-linearlogic-3
type: LogicApplication
conclusion text: An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises
confidence: 0.5000
curation status: Proposed
execution surface: modalities::linear
logic summary: Occupier's requirement implies authorized person cannot exercise powers under subsection (1)
modality: LinearLogic
operator: Implication
premise text: (a) the occupier of the premises has required the authorised person to produce his or her identity card for inspection by the occupier;

therapeutic-goods-act-1989-sec-46a-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 46A(3) Searches of certain premises to monitor compliance with Act

46A(4) Searches of certain premises to monitor compliance with Act
type: Concept
source: therapeutic-goods-act-1989.pdf, p.314
note: Searches of certain premises to monitor compliance with Act
asserts: therapeutic-goods-act-1989-sec-46a-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-46a-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-46a-ss-4-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-46a-ss-4
schema version: 2
part of: 46A Searches of certain premises to monitor compliance with Act

therapeutic-goods-act-1989-sec-46a-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: searches occur during compliance
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Searches during compliance period
modality: AllenInterval
operator: during
premise text: This section applies to: (a) premises of a person:

therapeutic-goods-act-1989-sec-46a-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: must comply
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires compliance
modality: Deontic
operator: requires
premise text: (iaa) who is required to comply with a condition of an exemption...

therapeutic-goods-act-1989-sec-46a-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 46A(4) Searches of certain premises to monitor compliance with Act

46B Searches and seizures on public health grounds
type: Concept
source: therapeutic-goods-act-1989.pdf, p.316
curation status: Proposed
has part: 46B(1) Searches and seizures on public health grounds
has part: 46B(2) Searches and seizures on public health grounds
proposed by: legis2cml
realized by: sec-46b
schema version: 2

46B(1) Searches and seizures on public health grounds
type: Concept
source: therapeutic-goods-act-1989.pdf, p.316
note: Prohibition on entering premises without reasonable grounds and in the interests of public health.
asserts: therapeutic-goods-act-1989-sec-46b-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-46b-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-46b-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-46b-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-46b-ss-1-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-46b-ss-1-logic-argumentation-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-46b-ss-1
schema version: 2
part of: 46B Searches and seizures on public health grounds

therapeutic-goods-act-1989-sec-46b-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: The authorised person may enter the premises within a reasonable time frame to search for the item.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for exercising powers under this section.
modality: AllenInterval
operator: Temporal Interval
premise text: (c) search the premises for the thing;

therapeutic-goods-act-1989-sec-46b-ss-1-logic-argumentation-5
type: LogicApplication
conclusion text: The authorised person may enter premises and seize items if there is a risk to public health.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Inference from the text that the authorised person may enter premises and seize items under certain circumstances.
modality: Argumentation
operator: Inference
premise text: (a) there may be on any premises a particular thing in respect of which this Act or the regulations have not been complied (b) it is necessary in the interests of public health to exercise powers under this section in order to avoid an imminent risk of death, serious illness or serious injury;

therapeutic-goods-act-1989-sec-46b-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The authorised person may not enter the premises.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on entering premises.
modality: Deontic
operator: Prohibit
premise text: (a) there may be on any premises a particular thing in respect of which this Act or the regulations have not been complied

therapeutic-goods-act-1989-sec-46b-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: The authorised person has an obligation to exercise their powers if there is a risk to public health.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to exercise powers under this section in certain circumstances.
modality: Deontic
operator: Obligation
premise text: (b) it is necessary in the interests of public health to exercise powers under this section in order to avoid an imminent risk of death, serious illness or serious injury;

therapeutic-goods-act-1989-sec-46b-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: The authorised person may seize the item repeatedly within a reasonable time frame.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of searches and seizures on public health grounds.
modality: LTL
operator: Recurring Trace
premise text: (d) if the authorised person finds the thing on the premises—seize it;

therapeutic-goods-act-1989-sec-46b-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 46B(1) Searches and seizures on public health grounds

46B(2) Searches and seizures on public health grounds
type: Concept
source: therapeutic-goods-act-1989.pdf, p.316
note: Authorized person cannot exercise powers under subsection (1) in relation to premises if occupier requires identity card inspection.
asserts: therapeutic-goods-act-1989-sec-46b-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-46b-ss-2
schema version: 2
part of: 46B Searches and seizures on public health grounds

therapeutic-goods-act-1989-sec-46b-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 46B(2) Searches and seizures on public health grounds

47 Searches and seizures related to offences and civil penalty
type: Concept
source: therapeutic-goods-act-1989.pdf, p.317
curation status: Proposed
has part: 47(1) Searches and seizures related to offences and civil penalty
has part: 47(2) Searches and seizures related to offences and civil penalty
proposed by: legis2cml
realized by: sec-47
schema version: 2

47(1) Searches and seizures related to offences and civil penalty
type: Concept
source: therapeutic-goods-act-1989.pdf, p.317
note: Authorized person may enter premises and seize evidential material if reasonable grounds exist.
asserts: therapeutic-goods-act-1989-sec-47-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-47-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-47-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-47-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-47-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-47-ss-1-logic-argumentation-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-47-ss-1
schema version: 2
part of: 47 Searches and seizures related to offences and civil penalty

therapeutic-goods-act-1989-sec-47-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: Overlaps with time intervals for entering premises.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Overlaps with time intervals for entering premises.
modality: AllenInterval
operator: Overlap
premise text: (1) Subject to subsections (2) and (3), if an authorised person has reasonable grounds for suspecting that there may be evidential material in respect of an offence against this Act, in respect of a contravention of a civil penalty provision or in respect of both on any premises

therapeutic-goods-act-1989-sec-47-ss-1-logic-argumentation-5
type: LogicApplication
conclusion text: Authorized person implies they have authority to enter premises.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Implies that authorized person has authority to enter premises.
modality: Argumentation
operator: Imply
premise text: (a) enter the premises; and (b) exercise the powers set out in subsection (4), subsection 48(1) and section 48C;

therapeutic-goods-act-1989-sec-47-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: May not enter premises without reasonable grounds.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits entering premises without reasonable grounds.
modality: Deontic
operator: Prohibit
premise text: (a) enter the premises;

therapeutic-goods-act-1989-sec-47-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: Diffuses information about reasonable grounds to others.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses information about reasonable grounds to others.
modality: Diffusion
operator: Diffuse
premise text: (a) enter the premises; and (b) exercise the powers set out in subsection (4), subsection 48(1) and section 48C;

therapeutic-goods-act-1989-sec-47-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: Recurring trace for authorized person's actions.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace for authorized person's actions.
modality: LTL
operator: Recurring
premise text: (a) enter the premises; and (b) exercise the powers set out in subsection (4), subsection 48(1) and section 48C;

47(2) Searches and seizures related to offences and civil penalty
type: Concept
source: therapeutic-goods-act-1989.pdf, p.317
note: Authorized person must not enter premises without consent or warrant.
asserts: therapeutic-goods-act-1989-sec-47-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-47-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-47-ss-2
schema version: 2
part of: 47 Searches and seizures related to offences and civil penalty

therapeutic-goods-act-1989-sec-47-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of entry
modality: Deontic
operator: Must Not
premise text: Authorized person must not enter premises.

therapeutic-goods-act-1989-sec-47-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 47(2) Searches and seizures related to offences and civil penalty

48 General powers of authorised persons in relation to premises
type: Concept
source: therapeutic-goods-act-1989.pdf, p.318
curation status: Proposed
has part: 48(1) General powers of authorised persons in relation to premises
has part: 48(3) General powers of authorised persons in relation to premises
has part: 48(3A) General powers of authorised persons in relation to premises
has part: 48(4) General powers of authorised persons in relation to premises
proposed by: legis2cml
realized by: sec-48
schema version: 2

48(1) General powers of authorised persons in relation to premises
type: Concept
source: therapeutic-goods-act-1989.pdf, p.318
note: Authorised persons have powers to search, inspect, and require information from premises.
asserts: therapeutic-goods-act-1989-sec-48-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-48-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-48-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-48-ss-1-logic-linearlogic-3
asserts: therapeutic-goods-act-1989-sec-48-ss-1-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-48-ss-1-logic-alleninterval-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-48-ss-1
schema version: 2
part of: 48 General powers of authorised persons in relation to premises

therapeutic-goods-act-1989-sec-48-ss-1-logic-alleninterval-5
type: LogicApplication
conclusion text: Must be taken onto premises during entry
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Can take equipment onto premises during entry
modality: AllenInterval
operator: during
premise text: Entry is a specific time period.

therapeutic-goods-act-1989-sec-48-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Can search premises
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Has power to search
modality: Deontic
operator: hasPower
premise text: Authorised person has authority to enter premises.

therapeutic-goods-act-1989-sec-48-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: Can require occupier to answer questions
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Can require occupier to answer questions
modality: Deontic
operator: canRequire
premise text: Authorised person has power to enter premises.

therapeutic-goods-act-1989-sec-48-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: Can inspect books and records
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Can inspect books and records
modality: Deontic
operator: canInspect
premise text: Authorised person has power to enter premises.

therapeutic-goods-act-1989-sec-48-ss-1-logic-linearlogic-3
type: LogicApplication
conclusion text: Must produce documents
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Requires occupier to produce documents
modality: LinearLogic
operator: implies
premise text: Occupier is required to provide information.

therapeutic-goods-act-1989-sec-48-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 48(1) General powers of authorised persons in relation to premises

48(3) General powers of authorised persons in relation to premises
type: Concept
source: therapeutic-goods-act-1989.pdf, p.318
note: Must comply with a requirement under paragraph (1)(e)
asserts: therapeutic-goods-act-1989-sec-48-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-48-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-48-ss-3-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-48-ss-3-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-48-ss-3
schema version: 2
part of: 48 General powers of authorised persons in relation to premises

therapeutic-goods-act-1989-sec-48-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: A person must comply with a requirement under paragraph (1)(e)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Mandatory compliance
modality: Deontic
operator: Must
premise text: (3) A person must not refuse or fail to comply...

therapeutic-goods-act-1989-sec-48-ss-3-logic-deontic-2
type: LogicApplication
conclusion text: A person must not refuse or fail to comply with a requirement under paragraph (1)(e)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Refusal or failure to comply is prohibited
modality: Deontic
operator: Prohibition
premise text: (3) A person must not refuse or fail to comply...

therapeutic-goods-act-1989-sec-48-ss-3-logic-deontic-3
type: LogicApplication
conclusion text: A person has an obligation to comply with a requirement under paragraph (1)(e)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Compliance is an obligation
modality: Deontic
operator: Obligation
premise text: (3) A person must not refuse or fail to comply...

therapeutic-goods-act-1989-sec-48-ss-3-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 48(3) General powers of authorised persons in relation to premises

48(3A) General powers of authorised persons in relation to premises
type: Concept
source: therapeutic-goods-act-1989.pdf, p.318
note: Defendant bears evidential burden in relation to reasonable excuse.
asserts: therapeutic-goods-act-1989-sec-48-ss-3a-norm
asserts: therapeutic-goods-act-1989-sec-48-ss-3a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-48-ss-3a-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-48-ss-3a
schema version: 2
part of: 48 General powers of authorised persons in relation to premises

therapeutic-goods-act-1989-sec-48-ss-3a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Defendant bears evidential burden.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-48-ss-3a-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Defendant must provide evidence for reasonable excuse.
modality: Epistemic
operator: Burden of Proof

therapeutic-goods-act-1989-sec-48-ss-3a-norm
type: Obligation
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 48(3A) General powers of authorised persons in relation to premises

48(4) General powers of authorised persons in relation to premises
type: Concept
source: therapeutic-goods-act-1989.pdf, p.318
note: Excuse for refusing or failing to answer a question or produce a document that may incriminate the person.
asserts: therapeutic-goods-act-1989-sec-48-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-48-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-48-ss-4-logic-epistemic-2
asserts: therapeutic-goods-act-1989-sec-48-ss-4-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-48-ss-4-logic-argumentation-4
asserts: therapeutic-goods-act-1989-sec-48-ss-4-logic-alleninterval-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-48-ss-4
schema version: 2
part of: 48 General powers of authorised persons in relation to premises

therapeutic-goods-act-1989-sec-48-ss-4-logic-alleninterval-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Excuse applies to a specific temporal relationship between events.
modality: AllenInterval
operator: Temporal Relationship

therapeutic-goods-act-1989-sec-48-ss-4-logic-argumentation-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Excuse is based on reasoning about the person's situation.
modality: Argumentation
operator: Reasoning

therapeutic-goods-act-1989-sec-48-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Excuse for refusing or failing to answer a question or produce a document.
modality: Deontic
operator: Excuse

therapeutic-goods-act-1989-sec-48-ss-4-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Person has knowledge that answering the question or producing the document may incriminate them.
modality: Epistemic
operator: Knowledge

therapeutic-goods-act-1989-sec-48-ss-4-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Excuse applies to a specific temporal interval.
modality: LTL
operator: Temporal Interval

therapeutic-goods-act-1989-sec-48-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48(4) General powers of authorised persons in relation to premises

48A Details of warrant to be given to occupier etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.320
curation status: Proposed
has part: 48A(1) Details of warrant to be given to occupier etc.
has part: 48A(2) Details of warrant to be given to occupier etc.
has part: 48A(3) Details of warrant to be given to occupier etc.
proposed by: legis2cml
realized by: sec-48a
schema version: 2

48A(1) Details of warrant to be given to occupier etc.
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.320
note: Must provide a copy of the warrant to the occupier or apparent representative.
asserts: therapeutic-goods-act-1989-sec-48a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-48a-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48a-ss-1
schema version: 2
part of: 48A Details of warrant to be given to occupier etc.

therapeutic-goods-act-1989-sec-48a-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide a copy of the warrant.
modality: Deontic
operator: MUST PROVIDE

therapeutic-goods-act-1989-sec-48a-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48A(1) Details of warrant to be given to occupier etc.

48A(2) Details of warrant to be given to occupier etc.
type: Concept
description: Identification
source: therapeutic-goods-act-1989.pdf, p.320
note: Authorised person must identify themselves to the occupier.
asserts: therapeutic-goods-act-1989-sec-48a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-48a-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48a-ss-2
schema version: 2
part of: 48A Details of warrant to be given to occupier etc.

therapeutic-goods-act-1989-sec-48a-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: The authorised person must identify themselves.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide identification
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-48a-ss-2-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 48A(2) Details of warrant to be given to occupier etc.

48A(3) Details of warrant to be given to occupier etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.320
note: No signature of issuing officer is required on warrant copy.
asserts: therapeutic-goods-act-1989-sec-48a-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-48a-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48a-ss-3
schema version: 2
part of: 48A Details of warrant to be given to occupier etc.

therapeutic-goods-act-1989-sec-48a-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: No signature requirement
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-48a-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48A(3) Details of warrant to be given to occupier etc.

48AA Completing execution of warrant under section 50 after
type: Concept
source: therapeutic-goods-act-1989.pdf, p.321
curation status: Proposed
has part: 48AA(1) Completing execution of warrant under section 50 after
has part: 48AA(2) Completing execution of warrant under section 50 after
has part: 48AA(3) Completing execution of warrant under section 50 after
proposed by: legis2cml
realized by: sec-48aa
schema version: 2

48AA(1) Completing execution of warrant under section 50 after
type: Concept
source: therapeutic-goods-act-1989.pdf, p.321
note: Authorized persons must cease execution and leave premises.
asserts: therapeutic-goods-act-1989-sec-48aa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-48aa-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48aa-ss-1
schema version: 2
part of: 48AA Completing execution of warrant under section 50 after

therapeutic-goods-act-1989-sec-48aa-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Authorized persons must cease execution and leave premises.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Mandatory obligation
modality: Deontic
operator: Must
premise text: (1) This section applies...

therapeutic-goods-act-1989-sec-48aa-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48AA(1) Completing execution of warrant under section 50 after

48AA(2) Completing execution of warrant under section 50 after
type: Concept
source: therapeutic-goods-act-1989.pdf, p.321
note: Authorized persons and assistants may complete warrant execution under certain conditions.
asserts: therapeutic-goods-act-1989-sec-48aa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-48aa-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-48aa-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-48aa-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-48aa-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-48aa-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-48aa-ss-2
schema version: 2
part of: 48AA Completing execution of warrant under section 50 after

therapeutic-goods-act-1989-sec-48aa-ss-2-logic-alleninterval-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap between absence and emergency situation
modality: AllenInterval
operator: Overlap
premise text: (i) for not more than 1 hour;

therapeutic-goods-act-1989-sec-48aa-ss-2-logic-cogai-5
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Recognition of occupier's written consent
modality: CogAI
operator: Recognize
premise text: the occupier of the premises consents in writing.

therapeutic-goods-act-1989-sec-48aa-ss-2-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission granted
modality: Deontic
operator: Permit
premise text: (2) One or more of the authorised persons...

therapeutic-goods-act-1989-sec-48aa-ss-2-logic-diffusion-4
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusion of authorized persons' absence to emergency situation
modality: Diffusion
operator: Diffuse
premise text: (iii) for a longer period if the occupier of the premises consents in writing.

therapeutic-goods-act-1989-sec-48aa-ss-2-logic-ltl-3
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of authorized persons' absence
modality: LTL
operator: Recurrent
premise text: (ii) if there is an emergency situation, for not more than 12 hours or such longer period as allowed by an issuing officer under subsection (5);

therapeutic-goods-act-1989-sec-48aa-ss-2-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48AA(2) Completing execution of warrant under section 50 after

48AA(3) Completing execution of warrant under section 50 after
type: Concept
source: therapeutic-goods-act-1989.pdf, p.321
note: Authorized person may apply for extension of warrant execution period under emergency situation.
asserts: therapeutic-goods-act-1989-sec-48aa-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-48aa-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-48aa-ss-3-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-48aa-ss-3-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-48aa-ss-3-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-48aa-ss-3-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-48aa-ss-3
schema version: 2
part of: 48AA Completing execution of warrant under section 50 after

therapeutic-goods-act-1989-sec-48aa-ss-3-logic-alleninterval-2
type: LogicApplication
conclusion text: the authorized person or person assisting the authorized person will not be able to return to the premises within that period.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Extension request overlaps with warrant execution period
modality: AllenInterval
operator: Overlaps
premise text: there is an emergency situation; and

therapeutic-goods-act-1989-sec-48aa-ss-3-logic-cogai-5
type: LogicApplication
conclusion text: the authorized person or person assisting the authorized person will not be able to return to the premises within that period.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: CogAI recognizes extension request as warrant execution process part
modality: CogAI
operator: Recognizes
premise text: The authorized person or person assisting the authorized person believes on reasonable grounds that...

therapeutic-goods-act-1989-sec-48aa-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: for an extension of the warrant execution period
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to apply for extension
modality: Deontic
operator: May
premise text: Authorized person may apply

therapeutic-goods-act-1989-sec-48aa-ss-3-logic-diffusion-4
type: LogicApplication
conclusion text: the authorized person or person assisting the authorized person will not be able to return to the premises within that period.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Extension request diffuses into warrant execution process
modality: Diffusion
operator: Diffuses
premise text: there is an emergency situation; and

therapeutic-goods-act-1989-sec-48aa-ss-3-logic-ltl-3
type: LogicApplication
conclusion text: the authorized person or person assisting the authorized person will not be able to return to the premises within that period.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Extension request until warrant execution period ends
modality: LTL
operator: Until
premise text: there is an emergency situation; and

therapeutic-goods-act-1989-sec-48aa-ss-3-norm
type: Permission
scope note: borne by: LegalPerson
curation status: Proposed
modality: Deontic
borne by: LegalPerson
deontic status: HeuristicDerived
part of: 48AA(3) Completing execution of warrant under section 50 after

48B Announcement before entry
type: Concept
source: therapeutic-goods-act-1989.pdf, p.322
curation status: Proposed
has part: 48B(1) Announcement before entry
has part: 48B(2) Announcement before entry
proposed by: legis2cml
realized by: sec-48b
schema version: 2

48B(1) Announcement before entry
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.322
note: Announcement before entry into premises under warrant.
asserts: therapeutic-goods-act-1989-sec-48b-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-48b-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48b-ss-1
schema version: 2
part of: 48B Announcement before entry

therapeutic-goods-act-1989-sec-48b-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to announce and allow entry.
modality: Deontic
operator: Must

therapeutic-goods-act-1989-sec-48b-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 48B(1) Announcement before entry

48B(2) Announcement before entry
type: Concept
source: therapeutic-goods-act-1989.pdf, p.322
note: Authorized person not required to comply with subsection (1) if believes immediate entry is necessary for safety or warrant execution.
asserts: therapeutic-goods-act-1989-sec-48b-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-48b-ss-2-logic-epistemic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48b-ss-2
schema version: 2
part of: 48B Announcement before entry

therapeutic-goods-act-1989-sec-48b-ss-2-logic-epistemic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Belief on reasonable grounds necessary for exemption
modality: Epistemic
operator: Belief
premise text: Authorized person believes immediate entry is necessary

therapeutic-goods-act-1989-sec-48b-ss-2-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 48B(2) Announcement before entry

48BA Use of electronic equipment at premises for monitoring
type: Concept
source: therapeutic-goods-act-1989.pdf, p.322
curation status: Proposed
has part: 48BA(1) Use of electronic equipment at premises for monitoring
has part: 48BA(2) Use of electronic equipment at premises for monitoring
has part: 48BA(3) Use of electronic equipment at premises for monitoring
has part: 48BA(4) Use of electronic equipment at premises for monitoring
proposed by: legis2cml
realized by: sec-48ba
schema version: 2

48BA(1) Use of electronic equipment at premises for monitoring
type: Concept
source: therapeutic-goods-act-1989.pdf, p.322
note: Authorized person may operate electronic equipment to monitor premises.
asserts: therapeutic-goods-act-1989-sec-48ba-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-48ba-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-48ba-ss-1-logic-epistemic-2
asserts: therapeutic-goods-act-1989-sec-48ba-ss-1-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-48ba-ss-1
schema version: 2
part of: 48BA Use of electronic equipment at premises for monitoring

therapeutic-goods-act-1989-sec-48ba-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authorized operation
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-48ba-ss-1-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Information accessibility
modality: Epistemic
operator: Access

therapeutic-goods-act-1989-sec-48ba-ss-1-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Monitoring for compliance
modality: LTL
operator: Recurring

therapeutic-goods-act-1989-sec-48ba-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 48BA(1) Use of electronic equipment at premises for monitoring

48BA(2) Use of electronic equipment at premises for monitoring
type: Concept
source: therapeutic-goods-act-1989.pdf, p.322
note: Authorized person may operate electronic equipment to gather information.
asserts: therapeutic-goods-act-1989-sec-48ba-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-48ba-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48ba-ss-2
schema version: 2
part of: 48BA Use of electronic equipment at premises for monitoring

therapeutic-goods-act-1989-sec-48ba-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authorization to perform action.
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-48ba-ss-2-norm
type: Permission
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 48BA(2) Use of electronic equipment at premises for monitoring

48BA(3) Use of electronic equipment at premises for monitoring
type: Concept
source: therapeutic-goods-act-1989.pdf, p.322
note: Authorized person may operate electronic equipment under certain conditions.
asserts: therapeutic-goods-act-1989-sec-48ba-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-48ba-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-48ba-ss-3-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-48ba-ss-3
schema version: 2
part of: 48BA Use of electronic equipment at premises for monitoring

therapeutic-goods-act-1989-sec-48ba-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to operate equipment
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-48ba-ss-3-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authorized person must believe conditions are met
modality: Deontic
operator: Believes

therapeutic-goods-act-1989-sec-48ba-ss-3-norm
type: Permission
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 48BA(3) Use of electronic equipment at premises for monitoring

48BA(4) Use of electronic equipment at premises for monitoring
type: Concept
source: therapeutic-goods-act-1989.pdf, p.322
note: Authorized person has obligation to secure electronic equipment.
asserts: therapeutic-goods-act-1989-sec-48ba-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-48ba-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48ba-ss-4
schema version: 2
part of: 48BA Use of electronic equipment at premises for monitoring

therapeutic-goods-act-1989-sec-48ba-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: he or she may do whatever is necessary...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to secure equipment.
modality: Deontic
operator: Obligation
premise text: (4) If the authorised person believes...

therapeutic-goods-act-1989-sec-48ba-ss-4-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 48BA(4) Use of electronic equipment at premises for monitoring

48C Use of electronic equipment at premises relating to offences and
type: Concept
source: therapeutic-goods-act-1989.pdf, p.324
curation status: Proposed
has part: 48C(1) Use of electronic equipment at premises relating to offences and
has part: 48C(2) Use of electronic equipment at premises relating to offences and
has part: 48C(2A) Use of electronic equipment at premises relating to offences and
has part: 48C(3) Use of electronic equipment at premises relating to offences and
has part: 48C(4) Use of electronic equipment at premises relating to offences and
has part: 48C(5) Use of electronic equipment at premises relating to offences and
proposed by: legis2cml
realized by: sec-48c
schema version: 2

48C(1) Use of electronic equipment at premises relating to offences and
type: Concept
source: therapeutic-goods-act-1989.pdf, p.324
note: Authorized person may operate electronic equipment to access evidential material.
asserts: therapeutic-goods-act-1989-sec-48c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-48c-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48c-ss-1
schema version: 2
part of: 48C Use of electronic equipment at premises relating to offences and

therapeutic-goods-act-1989-sec-48c-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission granted by the State.
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-48c-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48C(1) Use of electronic equipment at premises relating to offences and

48C(2) Use of electronic equipment at premises relating to offences and
type: Concept
source: therapeutic-goods-act-1989.pdf, p.324
note: Authorized person may seize equipment or operate electronic equipment to access evidential material.
asserts: therapeutic-goods-act-1989-sec-48c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-48c-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48c-ss-2
schema version: 2
part of: 48C Use of electronic equipment at premises relating to offences and

therapeutic-goods-act-1989-sec-48c-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Seize equipment or operate electronic equipment.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authorized person has permission to seize equipment or operate electronic equipment.
modality: Deontic
operator: May
premise text: Authorized person is authorized to access evidential material.

therapeutic-goods-act-1989-sec-48c-ss-2-norm
type: Permission
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 48C(2) Use of electronic equipment at premises relating to offences and

48C(2A) Use of electronic equipment at premises relating to offences and
type: Concept
source: therapeutic-goods-act-1989.pdf, p.324
note: Authorized person may operate electronic equipment under certain conditions.
asserts: therapeutic-goods-act-1989-sec-48c-ss-2a-norm
asserts: therapeutic-goods-act-1989-sec-48c-ss-2a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-48c-ss-2a-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-48c-ss-2a-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-48c-ss-2a-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-48c-ss-2a-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-48c-ss-2a
schema version: 2
part of: 48C Use of electronic equipment at premises relating to offences and

therapeutic-goods-act-1989-sec-48c-ss-2a-logic-alleninterval-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap between authorized operation and potential damage
modality: AllenInterval
operator: Overlaps
premise text: (2A) An authorised person may operate electronic equipment as mentioned in subsection (1) or (2)

therapeutic-goods-act-1989-sec-48c-ss-2a-logic-cogai-5
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Integration of authorized operation with other conditions
modality: CogAI
operator: Incorporates
premise text: (2A) An authorised person may operate electronic equipment as mentioned in subsection (1) or (2)

therapeutic-goods-act-1989-sec-48c-ss-2a-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to operate electronic equipment
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-48c-ss-2a-logic-diffusion-4
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Spread of authorized operation to other conditions
modality: Diffusion
operator: Diffuses
premise text: (2A) An authorised person may operate electronic equipment as mentioned in subsection (1) or (2)

therapeutic-goods-act-1989-sec-48c-ss-2a-logic-ltl-3
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal relationship between authorized operation and potential damage
modality: LTL
operator: Until
premise text: (2A) An authorised person may operate electronic equipment as mentioned in subsection (1) or (2)

therapeutic-goods-act-1989-sec-48c-ss-2a-norm
type: Permission
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 48C(2A) Use of electronic equipment at premises relating to offences and

48C(3) Use of electronic equipment at premises relating to offences and
type: Concept
source: therapeutic-goods-act-1989.pdf, p.324
note: Seizure of equipment under certain conditions
asserts: therapeutic-goods-act-1989-sec-48c-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-48c-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48c-ss-3
schema version: 2
part of: 48C Use of electronic equipment at premises relating to offences and

therapeutic-goods-act-1989-sec-48c-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits seizure without specified conditions
modality: Deontic
operator: Prohibit
premise text: (3) An authorised person may seize equipment...

therapeutic-goods-act-1989-sec-48c-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48C(3) Use of electronic equipment at premises relating to offences and

48C(4) Use of electronic equipment at premises relating to offences and
type: Concept
source: therapeutic-goods-act-1989.pdf, p.324
note: Authorized person may take necessary actions to secure electronic equipment.
asserts: therapeutic-goods-act-1989-sec-48c-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-48c-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-48c-ss-4-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-48c-ss-4
schema version: 2
part of: 48C Use of electronic equipment at premises relating to offences and

therapeutic-goods-act-1989-sec-48c-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: He or she may do whatever is necessary...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation: authorized action during premises visit.
modality: AllenInterval
operator: during
premise text: (4) If the authorised person believes...

therapeutic-goods-act-1989-sec-48c-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: He or she may do whatever is necessary...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authorization to act.
modality: Deontic
operator: may
premise text: (4) If the authorised person believes...

therapeutic-goods-act-1989-sec-48c-ss-4-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 48C(4) Use of electronic equipment at premises relating to offences and

48C(5) Use of electronic equipment at premises relating to offences and
type: Concept
description: Notice
source: therapeutic-goods-act-1989.pdf, p.324
note: Authorised person must give notice to occupier of premises before securing equipment.
asserts: therapeutic-goods-act-1989-sec-48c-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-48c-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48c-ss-5
schema version: 2
part of: 48C Use of electronic equipment at premises relating to offences and

therapeutic-goods-act-1989-sec-48c-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: The authorised person must give notice...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide notice
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-48c-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48C(5) Use of electronic equipment at premises relating to offences and

48D Compensation for damage to electronic equipment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.326
curation status: Proposed
has part: 48D(1) Compensation for damage to electronic equipment
has part: 48D(2) Compensation for damage to electronic equipment
has part: 48D(3) Compensation for damage to electronic equipment
proposed by: legis2cml
realized by: sec-48d
schema version: 2

48D(1) Compensation for damage to electronic equipment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.326
note: Compensation for damage to electronic equipment if caused by insufficient care.
asserts: therapeutic-goods-act-1989-sec-48d-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-48d-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48d-ss-1
schema version: 2
part of: 48D Compensation for damage to electronic equipment

therapeutic-goods-act-1989-sec-48d-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...compensation for the damage is payable.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to compensate for damage.
modality: Deontic
operator: obligation
premise text: (1) If...

therapeutic-goods-act-1989-sec-48d-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48D(1) Compensation for damage to electronic equipment

48D(2) Compensation for damage to electronic equipment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.326
note: Compensation is payable out of money appropriated by the Parliament for the purpose.
asserts: therapeutic-goods-act-1989-sec-48d-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-48d-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48d-ss-2
schema version: 2
part of: 48D Compensation for damage to electronic equipment

therapeutic-goods-act-1989-sec-48d-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a duty on the State to provide compensation.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-48d-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48D(2) Compensation for damage to electronic equipment

48D(3) Compensation for damage to electronic equipment
type: Concept
description: warning or guidance
source: therapeutic-goods-act-1989.pdf, p.326
note: Occupier must provide warning or guidance about equipment operation.
asserts: therapeutic-goods-act-1989-sec-48d-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-48d-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48d-ss-3
schema version: 2
part of: 48D Compensation for damage to electronic equipment

therapeutic-goods-act-1989-sec-48d-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Mandatory duty
modality: Deontic
operator: OBLIG

therapeutic-goods-act-1989-sec-48d-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48D(3) Compensation for damage to electronic equipment

48E Copies of seized things to be provided
type: Concept
source: therapeutic-goods-act-1989.pdf, p.327
curation status: Proposed
has part: 48E(1) Copies of seized things to be provided
has part: 48E(2) Copies of seized things to be provided
proposed by: legis2cml
realized by: sec-48e
schema version: 2

48E(1) Copies of seized things to be provided
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.327
note: Must provide a copy of seized documents or information to the occupier upon request.
asserts: therapeutic-goods-act-1989-sec-48e-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-48e-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48e-ss-1
schema version: 2
part of: 48E Copies of seized things to be provided

therapeutic-goods-act-1989-sec-48e-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide a copy of seized documents or information.
modality: Deontic
operator: MUST PROVIDE

therapeutic-goods-act-1989-sec-48e-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48E(1) Copies of seized things to be provided

48E(2) Copies of seized things to be provided
type: Concept
source: therapeutic-goods-act-1989.pdf, p.327
note: Possession of seized things may constitute an offence against a law or civil penalty provision.
asserts: therapeutic-goods-act-1989-sec-48e-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-48e-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48e-ss-2
schema version: 2
part of: 48E Copies of seized things to be provided

therapeutic-goods-act-1989-sec-48e-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits possession of seized things
modality: Deontic
operator: Prohibition

48F Occupier entitled to be present during search
type: Concept
source: therapeutic-goods-act-1989.pdf, p.327
curation status: Proposed
has part: 48F(1) Occupier entitled to be present during search
has part: 48F(2) Occupier entitled to be present during search
has part: 48F(3) Occupier entitled to be present during search
proposed by: legis2cml
realized by: sec-48f
schema version: 2

48F(1) Occupier entitled to be present during search
type: Concept
source: therapeutic-goods-act-1989.pdf, p.327
note: Occupier entitled to be present during search
asserts: therapeutic-goods-act-1989-sec-48f-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-48f-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48f-ss-1
schema version: 2
part of: 48F Occupier entitled to be present during search

therapeutic-goods-act-1989-sec-48f-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Occupier has right
modality: Deontic
operator: hasRight

48F(2) Occupier entitled to be present during search
type: Concept
source: therapeutic-goods-act-1989.pdf, p.327
note: Right to observe search ceases if person impedes search.
asserts: therapeutic-goods-act-1989-sec-48f-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-48f-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-48f-ss-2-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-48f-ss-2
schema version: 2
part of: 48F Occupier entitled to be present during search

therapeutic-goods-act-1989-sec-48f-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: Cease right to observe during overlap
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Right to observe ceases during overlap with impediment
modality: AllenInterval
operator: Overlaps
premise text: Search and impediment are temporal intervals

therapeutic-goods-act-1989-sec-48f-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Right to observe ceases
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to observe ceases
modality: Deontic
operator: Cease
premise text: Person impedes search

48F(3) Occupier entitled to be present during search
type: Concept
source: therapeutic-goods-act-1989.pdf, p.327
note: Right to be present during search
asserts: therapeutic-goods-act-1989-sec-48f-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-48f-ss-3
schema version: 2
part of: 48F Occupier entitled to be present during search

48FA Responsibility to provide facilities and assistance
type: Concept
description: yes
source: therapeutic-goods-act-1989.pdf, p.327
note: Occupier must provide facilities and assistance for warrant execution.
asserts: therapeutic-goods-act-1989-sec-48fa-norm
asserts: therapeutic-goods-act-1989-sec-48fa-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48fa
schema version: 2

therapeutic-goods-act-1989-sec-48fa-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide facilities and assistance.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-48fa-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48FA Responsibility to provide facilities and assistance

48G Receipts for things seized under warrant
type: Concept
source: therapeutic-goods-act-1989.pdf, p.328
curation status: Proposed
has part: 48G(1) Receipts for things seized under warrant
has part: 48G(2) Receipts for things seized under warrant
proposed by: legis2cml
realized by: sec-48g
schema version: 2

48G(1) Receipts for things seized under warrant
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.328
note: Authorised person must provide a receipt for seized thing.
asserts: therapeutic-goods-act-1989-sec-48g-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-48g-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48g-ss-1
schema version: 2
part of: 48G Receipts for things seized under warrant

therapeutic-goods-act-1989-sec-48g-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide a receipt.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-48g-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 48G(1) Receipts for things seized under warrant

48G(2) Receipts for things seized under warrant
type: Concept
source: therapeutic-goods-act-1989.pdf, p.328
note: Things seized or moved may be covered in one receipt.
asserts: therapeutic-goods-act-1989-sec-48g-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-48g-ss-2
schema version: 2
part of: 48G Receipts for things seized under warrant

48H Retention of seized things
type: Concept
source: therapeutic-goods-act-1989.pdf, p.328
curation status: Proposed
has part: 48H(1) Retention of seized things
has part: 48H(2) Retention of seized things
has part: 48H(3) Retention of seized things
proposed by: legis2cml
realized by: sec-48h
schema version: 2

48H(1) Retention of seized things
type: Concept
source: therapeutic-goods-act-1989.pdf, p.328
note: Must return seized thing if reason for seizure no longer exists or period ends
asserts: therapeutic-goods-act-1989-sec-48h-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-48h-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-48h-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-48h-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-48h-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-48h-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-48h-ss-1
schema version: 2
part of: 48H Retention of seized things

therapeutic-goods-act-1989-sec-48h-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: Seizure period is an interval that must be considered when determining return of seized thing
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Seizure period is an interval that must be considered when determining return of seized thing
modality: AllenInterval
operator: BETWEEN
premise text: Period of 120 days after seizure ends

therapeutic-goods-act-1989-sec-48h-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: Authorised person must return seized thing if condition is met
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Authorised person must return seized thing if condition is met
modality: CogAI
operator: IF
premise text: Reason for seizure no longer exists or period ends

therapeutic-goods-act-1989-sec-48h-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Must return seized thing
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to return seized thing
modality: Deontic
operator: MUST
premise text: Reason for seizure no longer exists or period ends

therapeutic-goods-act-1989-sec-48h-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: Return of seized thing depends on reason for seizure no longer existing or period ending
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Return of seized thing depends on reason for seizure no longer existing or period ending
modality: Diffusion
operator: IF
premise text: Reason for seizure no longer exists or period ends

therapeutic-goods-act-1989-sec-48h-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: Seizure period is a trace that must be considered when determining return of seized thing
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Seizure period is a trace that must be considered when determining return of seized thing
modality: LTL
operator: BETWEEN
premise text: Period of 120 days after seizure ends

48H(2) Retention of seized things
type: Concept
source: therapeutic-goods-act-1989.pdf, p.328
note: Return seized things after 120 days unless proceedings are ongoing or authorized by law.
asserts: therapeutic-goods-act-1989-sec-48h-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-48h-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-48h-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-48h-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-48h-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-48h-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-48h-ss-2
schema version: 2
part of: 48H Retention of seized things

therapeutic-goods-act-1989-sec-48h-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: Thing must be returned within 120 days unless proceedings are ongoing or authorized by law.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: 120-day temporal interval for return
modality: AllenInterval
operator: Temporal interval
premise text: End of 120 days specified in subsection (1)

therapeutic-goods-act-1989-sec-48h-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: Thing is subject to retention requirements
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Knowledge representation of seized things
modality: CogAI
operator: Knowledge representation
premise text: Thing is classified as a seized thing

therapeutic-goods-act-1989-sec-48h-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Thing must be returned unless proceedings are ongoing or authorized by law.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Duty to return seized things
modality: Deontic
operator: Obligation
premise text: Authorized person must take reasonable steps to return thing

therapeutic-goods-act-1989-sec-48h-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: Thing must be returned unless proceedings are ongoing or authorized by law.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Propagation of retention requirements
modality: Diffusion
operator: Propagation
premise text: Authorized person may retain thing because of order under section 48J

therapeutic-goods-act-1989-sec-48h-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: Thing must be returned unless proceedings are ongoing or authorized by law.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring requirement to return seized things
modality: LTL
operator: Recurring trace
premise text: Proceedings in respect of which thing may afford evidence were instituted before end of 120 days

therapeutic-goods-act-1989-sec-48h-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48H(2) Retention of seized things

48H(3) Retention of seized things
type: Concept
source: therapeutic-goods-act-1989.pdf, p.328
note: The thing may be returned under subsection (2) either unconditionally or on such terms and conditions as the Secretary sees fit.
asserts: therapeutic-goods-act-1989-sec-48h-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-48h-ss-3
schema version: 2
part of: 48H Retention of seized things

48J Issuing officer may permit a thing to be retained
type: Concept
source: therapeutic-goods-act-1989.pdf, p.329
curation status: Proposed
has part: 48J(1) Issuing officer may permit a thing to be retained
has part: 48J(2) Issuing officer may permit a thing to be retained
has part: 48J(3) Issuing officer may permit a thing to be retained
proposed by: legis2cml
realized by: sec-48j
schema version: 2

48J(1) Issuing officer may permit a thing to be retained
type: Concept
source: therapeutic-goods-act-1989.pdf, p.329
note: Issuing officer may permit a thing to be retained for a further period under certain conditions.
asserts: therapeutic-goods-act-1989-sec-48j-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-48j-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48j-ss-1
schema version: 2
part of: 48J Issuing officer may permit a thing to be retained

therapeutic-goods-act-1989-sec-48j-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Thing may be retained for a further period
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Granting permission
modality: Deontic
operator: Permit
premise text: Issuing officer may permit a thing to be retained

therapeutic-goods-act-1989-sec-48j-ss-1-norm
type: Permission
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 48J(1) Issuing officer may permit a thing to be retained

48J(2) Issuing officer may permit a thing to be retained
type: Concept
source: therapeutic-goods-act-1989.pdf, p.329
note: Issuing officer may permit an authorised person to retain a thing for a specified period.
asserts: therapeutic-goods-act-1989-sec-48j-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-48j-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-48j-ss-2
schema version: 2
part of: 48J Issuing officer may permit a thing to be retained

therapeutic-goods-act-1989-sec-48j-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Authorised person may retain the thing for a specified period.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission granted by the issuing officer.
modality: Deontic
operator: Permit
premise text: Issuing officer may permit an authorised person to retain a thing.

therapeutic-goods-act-1989-sec-48j-ss-2-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48J(2) Issuing officer may permit a thing to be retained

48J(3) Issuing officer may permit a thing to be retained
type: Concept
source: therapeutic-goods-act-1989.pdf, p.329
note: Issuing officer may permit a thing to be retained
asserts: therapeutic-goods-act-1989-sec-48j-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-48j-ss-3
schema version: 2
part of: 48J Issuing officer may permit a thing to be retained

therapeutic-goods-act-1989-sec-48j-ss-3-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 48J(3) Issuing officer may permit a thing to be retained

49 Monitoring warrants
type: Concept
source: therapeutic-goods-act-1989.pdf, p.330
curation status: Proposed
has part: 49(1) Monitoring warrants
has part: 49(2) Monitoring warrants
has part: 49(3) Monitoring warrants
has part: 49(4) Monitoring warrants
proposed by: legis2cml
realized by: sec-49
schema version: 2

49(1) Monitoring warrants
type: Concept
source: therapeutic-goods-act-1989.pdf, p.330
note: Authorized person may apply for a warrant under this section.
asserts: therapeutic-goods-act-1989-sec-49-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-49-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-49-ss-1
schema version: 2
part of: 49 Monitoring warrants

therapeutic-goods-act-1989-sec-49-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to apply for a warrant
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-49-ss-1-norm
type: Permission
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 49(1) Monitoring warrants

49(2) Monitoring warrants
type: Concept
source: therapeutic-goods-act-1989.pdf, p.330
note: Issuing officer must issue warrant if satisfied by oath that access is necessary.
asserts: therapeutic-goods-act-1989-sec-49-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-49-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-49-ss-2-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-49-ss-2
schema version: 2
part of: 49 Monitoring warrants

therapeutic-goods-act-1989-sec-49-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Issuing officer must issue warrant.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-49-ss-2-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Information on oath is sufficient for issuing officer to make decision.
modality: Epistemic
operator: REASONABLY NECESSARY

therapeutic-goods-act-1989-sec-49-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 49(2) Monitoring warrants

49(3) Monitoring warrants
type: Concept
description: Further information (if any) as the issuing officer requires concerning the grounds on which the issue of the warrant is being sought.
source: therapeutic-goods-act-1989.pdf, p.330
note: Issuing officer must provide additional information before issuing warrant.
asserts: therapeutic-goods-act-1989-sec-49-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-49-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-49-ss-3
schema version: 2
part of: 49 Monitoring warrants

therapeutic-goods-act-1989-sec-49-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The issuing officer must provide additional information.
modality: Deontic
operator: Must

therapeutic-goods-act-1989-sec-49-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 49(3) Monitoring warrants

49(4) Monitoring warrants
type: Concept
source: therapeutic-goods-act-1989.pdf, p.330
note: Warrant must authorise entry and exercise powers under specified conditions.
asserts: therapeutic-goods-act-1989-sec-49-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-49-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-49-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-49-ss-4-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-49-ss-4-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-49-ss-4-logic-argumentation-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-49-ss-4
schema version: 2
part of: 49 Monitoring warrants

therapeutic-goods-act-1989-sec-49-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: ...on which the warrant ceases to have effect;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Warrant's effect is limited to a specified time period.
modality: AllenInterval
operator: Within
premise text: (4) The warrant must: (c) specify the day (not more than 6 months after the issue of the warrant) on which the warrant ceases to have effect...

therapeutic-goods-act-1989-sec-49-ss-4-logic-argumentation-5
type: LogicApplication
conclusion text: ...with such assistance and by such force as is necessary and reasonable...;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Warrant implies specified conditions for entry.
modality: Argumentation
operator: Imply
premise text: (4) The warrant must: (a) authorise one or more authorised persons...

therapeutic-goods-act-1989-sec-49-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: ...and exercise the powers set out in subsection 48(1)...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits warrant from authorising entry without specified conditions.
modality: Deontic
operator: Prohibit
premise text: (4) The warrant must: (a) authorise one or more authorised persons...

therapeutic-goods-act-1989-sec-49-ss-4-logic-deontic-4
type: LogicApplication
conclusion text: ...with such assistance and by such force as is necessary and reasonable...;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Warrant authorises entry and exercise of powers under specified conditions.
modality: Deontic
operator: Authorise
premise text: (4) The warrant must: (a) authorise one or more authorised persons...

therapeutic-goods-act-1989-sec-49-ss-4-logic-ltl-3
type: LogicApplication
conclusion text: ...on which the warrant ceases to have effect;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Warrant's authority is limited to a specified time period.
modality: LTL
operator: Until
premise text: (4) The warrant must: (c) specify the day (not more than 6 months after the issue of the warrant) on which the warrant ceases to have effect...

5 September 2025
type: Concept
source: therapeutic-goods-act-1989.pdf, p.1
note: Compilation information and notes on amendments, applications, saving, transitional provisions, editorial changes, presentational changes, modifications, and self-repealing provisions.
asserts: therapeutic-goods-act-1989-sec-5-norm
asserts: therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-1
asserts: therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-3
asserts: therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-4
asserts: therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-5
asserts: therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-5
schema version: 2

5 Dec 1999 (gaz 1999,
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: No S584
asserts: therapeutic-goods-act-1989-sec-5-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-5-2
schema version: 2

5 Sept 2006
type: Concept
source: therapeutic-goods-act-1989.pdf, p.401
asserts: therapeutic-goods-act-1989-sec-5-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-5-3
schema version: 2

5 Sept 2006 (s 2)
type: Concept
source: therapeutic-goods-act-1989.pdf, p.401
note: Therapeutic Goods Amendment Act 2007
asserts: therapeutic-goods-act-1989-sec-5-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-5-4
schema version: 2

5 Mar 2018
type: Concept
source: therapeutic-goods-act-1989.pdf, p.407
note: Conditional commencement of certain sections
asserts: therapeutic-goods-act-1989-sec-5-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-5-5
schema version: 2

therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-1
type: LogicApplication
conclusion text: It is a compilation of the law.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies the text as a compilation of the Therapeutic Goods Act 1989.
modality: DescriptionLogic
operator: Applicable
premise text: The text describes itself as a compilation.

therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-2
type: LogicApplication
conclusion text: The compilation date is September 5, 2025, and it includes sections 1-41A and 41B-69.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Identifies the compilation date and contents.
modality: DescriptionLogic
operator: Applicable
premise text: The text mentions the compilation date and contents.

therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-3
type: LogicApplication
conclusion text: Uncommenced amendments are not shown in the text of the compiled law.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Notes on amendments and uncommenced amendments.
modality: DescriptionLogic
operator: Applicable
premise text: The text mentions uncommenced amendments.

therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-4
type: LogicApplication
conclusion text: Details are included in the endnotes.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Application, saving, and transitional provisions.
modality: DescriptionLogic
operator: Applicable
premise text: The text mentions applications, saving, and transitional provisions.

therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-5
type: LogicApplication
conclusion text: Presentational changes are applied to give a more consistent look and feel.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Editorial changes and presentational changes.
modality: DescriptionLogic
operator: Applicable
premise text: The text mentions editorial changes.

therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-6
type: LogicApplication
conclusion text: The compiled law operates as modified but the modification does not amend the text of the law.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Modifications and self-repealing provisions.
modality: DescriptionLogic
operator: Applicable
premise text: The text mentions modifications.

50 Offence and civil penalty provision related warrants
type: Concept
source: therapeutic-goods-act-1989.pdf, p.331
curation status: Proposed
has part: 50(1) Offence and civil penalty provision related warrants
has part: 50(2) Offence and civil penalty provision related warrants
has part: 50(3) Offence and civil penalty provision related warrants
has part: 50(4) Offence and civil penalty provision related warrants
proposed by: legis2cml
realized by: sec-50
schema version: 2

50(1) Offence and civil penalty provision related warrants
type: Concept
source: therapeutic-goods-act-1989.pdf, p.331
note: Authorized person may apply for warrant under this section.
asserts: therapeutic-goods-act-1989-sec-50-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-50-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-50-ss-1
schema version: 2
part of: 50 Offence and civil penalty provision related warrants

therapeutic-goods-act-1989-sec-50-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to apply for warrant
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-50-ss-1-norm
type: Permission
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 50(1) Offence and civil penalty provision related warrants

50(2) Offence and civil penalty provision related warrants
type: Concept
source: therapeutic-goods-act-1989.pdf, p.331
note: Issuing officer may issue warrant if satisfied of reasonable grounds for suspecting evidential material within 72 hours.
asserts: therapeutic-goods-act-1989-sec-50-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-50-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-50-ss-2
schema version: 2
part of: 50 Offence and civil penalty provision related warrants

therapeutic-goods-act-1989-sec-50-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Warrant may be issued
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to issue warrant
modality: Deontic
operator: May
premise text: Issuing officer has reasonable grounds for suspecting evidential material

therapeutic-goods-act-1989-sec-50-ss-2-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 50(2) Offence and civil penalty provision related warrants

50(3) Offence and civil penalty provision related warrants
type: Concept
description: Further information
source: therapeutic-goods-act-1989.pdf, p.331
note: Issuing officer must provide further information before issuing warrant.
asserts: therapeutic-goods-act-1989-sec-50-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-50-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-50-ss-3
schema version: 2
part of: 50 Offence and civil penalty provision related warrants

therapeutic-goods-act-1989-sec-50-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Issuing officer must provide further information.
modality: Deontic
operator: Must

therapeutic-goods-act-1989-sec-50-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 50(3) Offence and civil penalty provision related warrants

50(4) Offence and civil penalty provision related warrants
type: Concept
source: therapeutic-goods-act-1989.pdf, p.331
note: Warrant requirements for entry and seizure of evidential material
asserts: therapeutic-goods-act-1989-sec-50-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-50-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-50-ss-4
schema version: 2
part of: 50 Offence and civil penalty provision related warrants

therapeutic-goods-act-1989-sec-50-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: ...authorise the persons so named...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits warrant issuance without specified conditions
modality: Deontic
operator: Prohibit
premise text: (4) The warrant must...

51 Offence and civil penalty provision related warrants by telephone
type: Concept
source: therapeutic-goods-act-1989.pdf, p.331
note: Authorized person may apply for warrant by telephone in urgent cases.
asserts: therapeutic-goods-act-1989-sec-51-norm
asserts: therapeutic-goods-act-1989-sec-51-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-51
schema version: 2

therapeutic-goods-act-1989-sec-51-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to apply for warrant
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-51-norm
type: Permission
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 51 Offence and civil penalty provision related warrants by telephone

51A Inspections for purposes of Mutual Recognition Convention
type: Concept
source: therapeutic-goods-act-1989.pdf, p.333
note: Request for inspection under Mutual Recognition Convention
asserts: therapeutic-goods-act-1989-sec-51a-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-51a
schema version: 2

therapeutic-goods-act-1989-sec-51a-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 51A Inspections for purposes of Mutual Recognition Convention

51B Offences relating to warrants
type: Concept
source: therapeutic-goods-act-1989.pdf, p.334
curation status: Proposed
has part: 51B(1) Offences relating to warrants
has part: 51B(2) Offences relating to warrants
proposed by: legis2cml
realized by: sec-51b
schema version: 2

51B(1) Offences relating to warrants
type: Concept
source: therapeutic-goods-act-1989.pdf, p.334
note: Making false statements in a warrant application is prohibited.
asserts: therapeutic-goods-act-1989-sec-51b-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-51b-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-51b-ss-1
schema version: 2
part of: 51B Offences relating to warrants

therapeutic-goods-act-1989-sec-51b-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Prohibited
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of false statements
modality: Deontic
operator: Prohibit
premise text: False statement in warrant application

therapeutic-goods-act-1989-sec-51b-ss-1-norm
type: Prohibition
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 51B(1) Offences relating to warrants

51B(2) Offences relating to warrants
type: Concept
source: therapeutic-goods-act-1989.pdf, p.334
note: Prohibits false statements about warrants
asserts: therapeutic-goods-act-1989-sec-51b-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-51b-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-51b-ss-2
schema version: 2
part of: 51B Offences relating to warrants

therapeutic-goods-act-1989-sec-51b-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition
modality: Deontic
operator: forbid

therapeutic-goods-act-1989-sec-51b-ss-2-norm
type: Prohibition
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 51B(2) Offences relating to warrants

51C Issuing officers—personal capacity
type: Concept
source: therapeutic-goods-act-1989.pdf, p.334
curation status: Proposed
has part: 51C(1) Issuing officers—personal capacity
has part: 51C(2) Issuing officers—personal capacity
has part: 51C(3) Issuing officers—personal capacity
proposed by: legis2cml
realized by: sec-51c
schema version: 2

51C(1) Issuing officers—personal capacity
type: Concept
source: therapeutic-goods-act-1989.pdf, p.334
note: Issuing officers must act in a personal capacity when exercising powers under this Part.
asserts: therapeutic-goods-act-1989-sec-51c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-51c-ss-1
schema version: 2
part of: 51C Issuing officers—personal capacity

therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Obligation to act in a personal capacity
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Mandatory action
modality: Deontic
operator: Must
premise text: Issuing officers must act in a personal capacity.

therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: No court or judicial authority can override the issuing officer's personal capacity
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: No court or judicial authority can override this obligation
modality: Deontic
operator: MustNot
premise text: Powers need not be accepted

therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-3
type: LogicApplication
conclusion text: The issuing officer must act in a personal capacity when exercising powers under this Part
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The issuing officer must act in a personal capacity when exercising powers under this Part
modality: Deontic
operator: Must
premise text: (1) A power conferred on an issuing officer by this Part is conferred on the issuing officer: (a) in a personal capacity; and

therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: No court or judicial authority can override the issuing officer's personal capacity
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: No court or judicial authority can override the issuing officer's personal capacity
modality: Deontic
operator: Must
premise text: (b) not as a court, or as a member or an officer of a court.

therapeutic-goods-act-1989-sec-51c-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 51C(1) Issuing officers—personal capacity

51C(2) Issuing officers—personal capacity
type: Concept
source: therapeutic-goods-act-1989.pdf, p.334
note: Issuing officer must accept power conferred.
asserts: therapeutic-goods-act-1989-sec-51c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-51c-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-51c-ss-2
schema version: 2
part of: 51C Issuing officers—personal capacity

therapeutic-goods-act-1989-sec-51c-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: The issuing officer MUST accept the power conferred.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide
modality: Deontic
operator: MUST
premise text: The issuing officer need not accept the power conferred.

therapeutic-goods-act-1989-sec-51c-ss-2-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 51C(2) Issuing officers—personal capacity

51C(3) Issuing officers—personal capacity
type: Concept
source: therapeutic-goods-act-1989.pdf, p.334
note: Issuing officers have protection and immunity in their personal capacity.
asserts: therapeutic-goods-act-1989-sec-51c-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-51c-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-51c-ss-3
schema version: 2
part of: 51C Issuing officers—personal capacity

therapeutic-goods-act-1989-sec-51c-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Same protection and immunity as court or officer
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Protection and immunity
modality: Deontic
operator: has
premise text: Issuing officer exercising power

therapeutic-goods-act-1989-sec-51c-ss-3-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 51C(3) Issuing officers—personal capacity

52 Identity cards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.335
curation status: Proposed
has part: 52(1) Identity cards
has part: 52(3) Identity cards
has part: 52(4) Identity cards
proposed by: legis2cml
realized by: sec-52
schema version: 2

52(1) Identity cards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.335
note: The Secretary must ensure that each authorised person is issued with an identity card.
asserts: therapeutic-goods-act-1989-sec-52-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-52-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52-ss-1
schema version: 2
part of: 52 Identity cards

therapeutic-goods-act-1989-sec-52-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must ensure that each authorised person is issued with an identity card.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-52-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52(1) Identity cards

52(3) Identity cards
type: Concept
description: Identity card
source: therapeutic-goods-act-1989.pdf, p.335
note: Return identity card after ceasing to be authorised person.
asserts: therapeutic-goods-act-1989-sec-52-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-52-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-52-ss-3-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-52-ss-3-logic-argumentation-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-52-ss-3
schema version: 2
part of: 52 Identity cards

therapeutic-goods-act-1989-sec-52-ss-3-logic-alleninterval-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for returning identity card
modality: AllenInterval
operator: CONTAINS

therapeutic-goods-act-1989-sec-52-ss-3-logic-argumentation-3
type: LogicApplication
conclusion text: Return identity card.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Consequence of ceasing to be authorised person
modality: Argumentation
operator: IMPLIES

therapeutic-goods-act-1989-sec-52-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Return identity card.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-52-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52(3) Identity cards

52(4) Identity cards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.335
note: An offence under subsection (3) is prohibited.
asserts: therapeutic-goods-act-1989-sec-52-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-52-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52-ss-4
schema version: 2
part of: 52 Identity cards

therapeutic-goods-act-1989-sec-52-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits an offence under subsection (3)
modality: Deontic
operator: Prohibit
premise text: (4) An offence under subsection (3) is an offence of strict liability.

52A Definitions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.340
curation status: Proposed
has part: 52A(1) Definitions
has part: 52A(2) Definitions
proposed by: legis2cml
realized by: sec-52a
schema version: 2

52A(1) Definitions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.340
note: Defines terms for the current Poisons Standard and substance scheduling.
asserts: therapeutic-goods-act-1989-sec-52a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-52a-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-3
asserts: therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-4
asserts: therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-5
asserts: therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-6
asserts: therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-7
curation status: Proposed
proposed by: legis2cml
realized by: sec-52a-ss-1
schema version: 2
part of: 52A Definitions

therapeutic-goods-act-1989-sec-52a-ss-1-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Defines terms for the current Poisons Standard and substance scheduling.
modality: Deontic
operator: Obligate

therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-2
type: LogicApplication
conclusion text: scheduling in relation to a substance means determining the schedule or schedules...
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies substances into schedules.
modality: DescriptionLogic
operator: =
premise text: substance means an ingredient, compound, material or preparation...

therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-3
type: LogicApplication
conclusion text: the first Poisons Standard is the latest edition at the commencement of this Part of the document known as the Standard for...
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Defines the first Poisons Standard as the latest edition at commencement.
modality: DescriptionLogic
operator: =
premise text: first Poisons Standard means the latest edition at the commencement of this Part of the document known as the Standard for...

therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-4
type: LogicApplication
conclusion text: the substance is an ingredient, compound, material or preparation that may cause death, illness or injury.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Defines substance as an ingredient, compound, material or preparation that may cause death, illness or injury.
modality: DescriptionLogic
operator: =
premise text: substance means: (a) an ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury to persons or animals;

therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-5
type: LogicApplication
conclusion text: the current Poisons Standard is the document last prepared under paragraph 52D(2)(b).
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Defines the current Poisons Standard as the document last prepared under paragraph 52D(2)(b).
modality: DescriptionLogic
operator: =
premise text: (1) In this Part, unless the contrary intention appears: current Poisons Standard means: (a) if no document has been prepared under paragraph 52D(2)(b)—the first Poisons Standard; or (b) otherwise—the document last prepared under that paragraph...

therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-6
type: LogicApplication
conclusion text: scheduling in relation to a substance means determining the schedule or schedules to the current Poisons Standard.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Defines scheduling as determining the schedule or schedules to the current Poisons Standard.
modality: DescriptionLogic
operator: =
premise text: scheduling, in relation to a substance, means determining the schedule or schedules to the current Poisons Standard in which the name or a description of the substance is to be included.

therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-7
type: LogicApplication
conclusion text: the substance is an ingredient, compound, material or preparation specified under subsection (2).
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Defines substance as an ingredient, compound, material or preparation specified under subsection (2).
modality: DescriptionLogic
operator: =
premise text: substance means: (b) an ingredient, compound, material or preparation specified under subsection (2);

therapeutic-goods-act-1989-sec-52a-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52A(1) Definitions

52A(2) Definitions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.340
note: Secretary may specify ingredients for purposes of definition
asserts: therapeutic-goods-act-1989-sec-52a-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-52a-ss-2
schema version: 2
part of: 52A Definitions

52AA Overview
type: Concept
source: therapeutic-goods-act-1989.pdf, p.340
note: Restrictions on supply of scheduled substances for public health and safety
asserts: therapeutic-goods-act-1989-sec-52aa-norm
asserts: therapeutic-goods-act-1989-sec-52aa-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52aa
schema version: 2

therapeutic-goods-act-1989-sec-52aa-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation on the state to restrict supply
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-52aa-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52AA Overview

52B Advisory Committee on Medicines Scheduling
type: Concept
source: therapeutic-goods-act-1989.pdf, p.341
curation status: Proposed
has part: 52B(1) Advisory Committee on Medicines Scheduling
has part: 52B(2) Advisory Committee on Medicines Scheduling
has part: 52B(3) Advisory Committee on Medicines Scheduling
has part: 52B(4) Advisory Committee on Medicines Scheduling
proposed by: legis2cml
realized by: sec-52b
schema version: 2

52B(1) Advisory Committee on Medicines Scheduling
type: Concept
source: therapeutic-goods-act-1989.pdf, p.341
note: Establishment of Advisory Committee on Medicines Scheduling
asserts: therapeutic-goods-act-1989-sec-52b-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-52b-ss-1
schema version: 2
part of: 52B Advisory Committee on Medicines Scheduling

52B(2) Advisory Committee on Medicines Scheduling
type: Concept
source: therapeutic-goods-act-1989.pdf, p.341
note: Committee constitution and meeting requirements
asserts: therapeutic-goods-act-1989-sec-52b-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-52b-ss-2
schema version: 2
part of: 52B Advisory Committee on Medicines Scheduling

52B(3) Advisory Committee on Medicines Scheduling
type: Concept
source: therapeutic-goods-act-1989.pdf, p.341
note: Each State and the Commonwealth can nominate a member of the Advisory Committee on Medicines Scheduling.
asserts: therapeutic-goods-act-1989-sec-52b-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-52b-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-52b-ss-3-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-52b-ss-3-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-52b-ss-3-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-52b-ss-3-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-52b-ss-3
schema version: 2
part of: 52B Advisory Committee on Medicines Scheduling

therapeutic-goods-act-1989-sec-52b-ss-3-logic-alleninterval-2
type: LogicApplication
conclusion text: The nomination and appointment of a member of the Advisory Committee on Medicines Scheduling occur between these entities.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: There is an interval between the nomination and the appointment of a member of the Advisory Committee on Medicines Scheduling.
modality: AllenInterval
operator: between
premise text: (3) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled...

therapeutic-goods-act-1989-sec-52b-ss-3-logic-cogai-5
type: LogicApplication
conclusion text: A State or the Commonwealth can nominate a member of the Advisory Committee on Medicines Scheduling.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: A State or the Commonwealth can nominate a member of the Advisory Committee on Medicines Scheduling.
modality: CogAI
operator: nominating
premise text: (3) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled...

therapeutic-goods-act-1989-sec-52b-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Each State and the Commonwealth can nominate a member of the Advisory Committee on Medicines Scheduling.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Entitlement to nominate a member of the Advisory Committee on Medicines Scheduling.
modality: Deontic
operator: entitlement
premise text: The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled...

therapeutic-goods-act-1989-sec-52b-ss-3-logic-diffusion-4
type: LogicApplication
conclusion text: The information about the nomination of a member of the Advisory Committee on Medicines Scheduling is diffused to the relevant parties.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: The information about the nomination of a member of the Advisory Committee on Medicines Scheduling is diffused to the relevant parties.
modality: Diffusion
operator: diffusion
premise text: (3) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled...

therapeutic-goods-act-1989-sec-52b-ss-3-logic-ltl-3
type: LogicApplication
conclusion text: The nomination and appointment of a member of the Advisory Committee on Medicines Scheduling occur between these entities.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: There is an interval between the nomination and the appointment of a member of the Advisory Committee on Medicines Scheduling.
modality: LTL
operator: between
premise text: (3) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled...

52B(4) Advisory Committee on Medicines Scheduling
type: Concept
source: therapeutic-goods-act-1989.pdf, p.341
note: Makes recommendations to the Secretary on therapeutic goods classification and scheduling.
asserts: therapeutic-goods-act-1989-sec-52b-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-52b-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52b-ss-4
schema version: 2
part of: 52B Advisory Committee on Medicines Scheduling

therapeutic-goods-act-1989-sec-52b-ss-4-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Makes recommendations
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-52b-ss-4-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 52B(4) Advisory Committee on Medicines Scheduling

52C Advisory Committee on Chemicals Scheduling
type: Concept
source: therapeutic-goods-act-1989.pdf, p.342
curation status: Proposed
has part: 52C(1) Advisory Committee on Chemicals Scheduling
has part: 52C(2) Advisory Committee on Chemicals Scheduling
has part: 52C(3) Advisory Committee on Chemicals Scheduling
has part: 52C(4) Advisory Committee on Chemicals Scheduling
has part: 52C(5) Advisory Committee on Chemicals Scheduling
proposed by: legis2cml
realized by: sec-52c
schema version: 2

52C(1) Advisory Committee on Chemicals Scheduling
type: Concept
source: therapeutic-goods-act-1989.pdf, p.342
note: Establishment of Advisory Committee on Chemicals Scheduling
asserts: therapeutic-goods-act-1989-sec-52c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-52c-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52c-ss-1
schema version: 2
part of: 52C Advisory Committee on Chemicals Scheduling

therapeutic-goods-act-1989-sec-52c-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Establishes the Advisory Committee on Chemicals Scheduling
modality: Deontic
operator: establishes

52C(2) Advisory Committee on Chemicals Scheduling
type: Concept
source: therapeutic-goods-act-1989.pdf, p.342
note: Committee constitution and meeting requirements
asserts: therapeutic-goods-act-1989-sec-52c-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-52c-ss-2
schema version: 2
part of: 52C Advisory Committee on Chemicals Scheduling

52C(3) Advisory Committee on Chemicals Scheduling
type: Concept
source: therapeutic-goods-act-1989.pdf, p.342
note: Each State and the Commonwealth can nominate a member to the Advisory Committee on Chemicals Scheduling.
asserts: therapeutic-goods-act-1989-sec-52c-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-52c-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52c-ss-3
schema version: 2
part of: 52C Advisory Committee on Chemicals Scheduling

therapeutic-goods-act-1989-sec-52c-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Entitlement to nominate a member
modality: Deontic
operator: entitlement

52C(4) Advisory Committee on Chemicals Scheduling
type: Concept
source: therapeutic-goods-act-1989.pdf, p.342
note: The Committee must make recommendations to the Secretary on certain matters.
asserts: therapeutic-goods-act-1989-sec-52c-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-52c-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52c-ss-4
schema version: 2
part of: 52C Advisory Committee on Chemicals Scheduling

therapeutic-goods-act-1989-sec-52c-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Committee must make recommendations.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-52c-ss-4-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 52C(4) Advisory Committee on Chemicals Scheduling

52C(5) Advisory Committee on Chemicals Scheduling
type: Concept
source: therapeutic-goods-act-1989.pdf, p.342
note: Exempts therapeutic goods from certain provisions.
asserts: therapeutic-goods-act-1989-sec-52c-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-52c-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-52c-ss-5-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-52c-ss-5
schema version: 2
part of: 52C Advisory Committee on Chemicals Scheduling

therapeutic-goods-act-1989-sec-52c-ss-5-logic-alleninterval-2
type: LogicApplication
conclusion text: ...are included in, therapeutic goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Therapeutic goods include certain substances.
modality: AllenInterval
operator: includes
premise text: (5) Paragraphs (4)(a) and (d)

therapeutic-goods-act-1989-sec-52c-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: do not apply in relation to substances...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exempts substances from certain provisions.
modality: Deontic
operator: exemption
premise text: (5) Paragraphs (4)(a) and (d)

therapeutic-goods-act-1989-sec-52c-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52C(5) Advisory Committee on Chemicals Scheduling

52CA Joint meetings
type: Concept
source: therapeutic-goods-act-1989.pdf, p.343
note: May hold joint meetings
asserts: therapeutic-goods-act-1989-sec-52ca-norm
asserts: therapeutic-goods-act-1989-sec-52ca-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52ca
schema version: 2

therapeutic-goods-act-1989-sec-52ca-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to hold joint meetings
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-52ca-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52CA Joint meetings

52D Poisons Standard
type: Concept
source: therapeutic-goods-act-1989.pdf, p.343
curation status: Proposed
has part: 52D(1) Poisons Standard
has part: 52D(2) Poisons Standard
has part: 52D(3) Poisons Standard
has part: 52D(4A) Poisons Standard
has part: 52D(4B) Poisons Standard
has part: 52D(5) Poisons Standard
proposed by: legis2cml
realized by: sec-52d
schema version: 2

52D(1) Poisons Standard
type: Concept
source: therapeutic-goods-act-1989.pdf, p.343
note: Commences with a prepared Poisons Standard
asserts: therapeutic-goods-act-1989-sec-52d-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-52d-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-52d-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-52d-ss-1-logic-cogai-3
asserts: therapeutic-goods-act-1989-sec-52d-ss-1-logic-n3logic-4
asserts: therapeutic-goods-act-1989-sec-52d-ss-1-logic-shacl-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-52d-ss-1
schema version: 2
part of: 52D Poisons Standard

therapeutic-goods-act-1989-sec-52d-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: the first Poisons Standard is taken to have been prepared and made available at the commencement of this Part
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Describes a temporal relationship between events
modality: AllenInterval
operator: begins-at
premise text: (1) On the commencement of this Part...

therapeutic-goods-act-1989-sec-52d-ss-1-logic-cogai-3
type: LogicApplication
conclusion text: the first Poisons Standard is taken to have been prepared and made available by the then National Drugs and Poisons Schedule Committee
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Describes a fact about the standard's preparation using AI
modality: CogAI
operator: asserts
premise text: (1) On the commencement of this Part...

therapeutic-goods-act-1989-sec-52d-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: the first Poisons Standard is taken to have been prepared and made available
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Establishes the commencement of a standard
modality: Deontic
operator: begins
premise text: (1) On the commencement of this Part...

therapeutic-goods-act-1989-sec-52d-ss-1-logic-n3logic-4
type: LogicApplication
conclusion text: the first Poisons Standard is taken to have been prepared and made available by the then National Drugs and Poisons Schedule Committee
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::n3_compiler
logic summary: Describes a fact about the standard's preparation using N3 logic
modality: N3Logic
operator: asserts
premise text: (1) On the commencement of this Part...

therapeutic-goods-act-1989-sec-52d-ss-1-logic-shacl-5
type: LogicApplication
conclusion text: the first Poisons Standard is taken to have been prepared and made available by the then National Drugs and Poisons Schedule Committee
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::shacl
logic summary: Describes a fact about the standard's preparation using SHACL
modality: SHACL
operator: asserts
premise text: (1) On the commencement of this Part...

52D(2) Poisons Standard
type: Concept
source: therapeutic-goods-act-1989.pdf, p.343
note: Secretary may amend or prepare a new Poisons Standard.
asserts: therapeutic-goods-act-1989-sec-52d-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-52d-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52d-ss-2
schema version: 2
part of: 52D Poisons Standard

therapeutic-goods-act-1989-sec-52d-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to amend the standard.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-52d-ss-2-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52D(2) Poisons Standard

52D(3) Poisons Standard
type: Concept
source: therapeutic-goods-act-1989.pdf, p.343
note: Power to exercise under subsection (2)
asserts: therapeutic-goods-act-1989-sec-52d-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-52d-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52d-ss-3
schema version: 2
part of: 52D Poisons Standard

therapeutic-goods-act-1989-sec-52d-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Grant of permission
modality: Deontic
operator: Permit
premise text: (3) The Secretary may exercise a power...

52D(4A) Poisons Standard
type: Concept
source: therapeutic-goods-act-1989.pdf, p.343
note: Instrument made under paragraph (2)(a) or (b) is a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-52d-ss-4a-norm
asserts: therapeutic-goods-act-1989-sec-52d-ss-4a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52d-ss-4a
schema version: 2
part of: 52D Poisons Standard

therapeutic-goods-act-1989-sec-52d-ss-4a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Instrument is a legislative instrument.
modality: Deontic
operator: is

therapeutic-goods-act-1989-sec-52d-ss-4a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52D(4A) Poisons Standard

52D(4B) Poisons Standard
type: Concept
source: therapeutic-goods-act-1989.pdf, p.343
note: Allows for incorporation of existing provisions from other instruments or writings.
asserts: therapeutic-goods-act-1989-sec-52d-ss-4b-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-52d-ss-4b
schema version: 2
part of: 52D Poisons Standard

52D(5) Poisons Standard
type: Concept
source: therapeutic-goods-act-1989.pdf, p.343
note: Definition of 'Administration' in relation to the current Poisons Standard
asserts: therapeutic-goods-act-1989-sec-52d-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-52d-ss-5
schema version: 2
part of: 52D Poisons Standard

52E Secretary to take certain matters into account in exercising
type: Concept
source: therapeutic-goods-act-1989.pdf, p.344
curation status: Proposed
has part: 52E(1) Secretary to take certain matters into account in exercising
has part: 52E(2) Secretary to take certain matters into account in exercising
has part: 52E(3) Secretary to take certain matters into account in exercising
has part: 52E(4) Secretary to take certain matters into account in exercising
has part: 52E(5) Secretary to take certain matters into account in exercising
proposed by: legis2cml
realized by: sec-52e
schema version: 2

52E(1) Secretary to take certain matters into account in exercising
type: Concept
source: therapeutic-goods-act-1989.pdf, p.344
note: Secretary must consider certain matters when exercising power. Allow person to apply for amendment of current Poisons Standard.
asserts: therapeutic-goods-act-1989-sec-52e-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-52e-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-52e-ss-1-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-52e-ss-1
schema version: 2
part of: 52E Secretary to take certain matters into account in exercising

therapeutic-goods-act-1989-sec-52e-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must consider all relevant factors.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-52e-ss-1-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Grant permission to apply for amendment.
modality: Deontic
operator: Permit

therapeutic-goods-act-1989-sec-52e-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52E(1) Secretary to take certain matters into account in exercising

52E(2) Secretary to take certain matters into account in exercising
type: Concept
description: Application form, amendment sought, office of Department, application fee
source: therapeutic-goods-act-1989.pdf, p.344
note: Application requirements Secretary must comply with guidelines from the Australian Health Ministers’ Advisory Council and the National Coordinating Committee on Therapeutic Goods.
asserts: therapeutic-goods-act-1989-sec-52e-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-52e-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-52e-ss-2-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-52e-ss-2-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-52e-ss-2-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-52e-ss-2-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-52e-ss-2-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-52e-ss-2
schema version: 2
part of: 52E Secretary to take certain matters into account in exercising

therapeutic-goods-act-1989-sec-52e-ss-2-logic-alleninterval-3
type: LogicApplication
conclusion text: The guidelines were notified to the Secretary for at least one year before this section came into effect
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Guidelines are notified to the Secretary for at least one year before this section comes into effect
modality: AllenInterval
operator: >=
premise text: The subcommittee of the Council known as the National Coordinating Committee on Therapeutic Goods is notified to the Secretary

therapeutic-goods-act-1989-sec-52e-ss-2-logic-cogai-6
type: LogicApplication
conclusion text: The guidelines are a type of knowledge that can be used to make decisions
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Guidelines are a type of knowledge that can be used to make decisions
modality: CogAI
operator: IS_A
premise text: The Secretary has a power under subsection 52D(2)

therapeutic-goods-act-1989-sec-52e-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: None
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide required information
modality: Deontic
operator: MUST
premise text: None

therapeutic-goods-act-1989-sec-52e-ss-2-logic-deontic-2
type: LogicApplication
conclusion text: The Secretary must comply with the guidelines
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with guidelines
modality: Deontic
operator: MUST
premise text: The Secretary has a power under subsection 52D(2)

therapeutic-goods-act-1989-sec-52e-ss-2-logic-diffusion-5
type: LogicApplication
conclusion text: The subcommittee of the Council known as the National Coordinating Committee on Therapeutic Goods is a type of guideline that can be shared and applied by others
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Guidelines are a type of guideline that can be shared and applied by others
modality: Diffusion
operator: IS_A
premise text: The Australian Health Ministers’ Advisory Council has guidelines

therapeutic-goods-act-1989-sec-52e-ss-2-logic-ltl-4
type: LogicApplication
conclusion text: All powers under subsection 52D(2) must comply with the guidelines
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Guidelines are applicable to all powers under subsection 52D(2)
modality: LTL
operator: >=
premise text: The Secretary has a power under subsection 52D(2)

therapeutic-goods-act-1989-sec-52e-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52E(2) Secretary to take certain matters into account in exercising

52E(3) Secretary to take certain matters into account in exercising
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.344
note: Must consider recommendations or advice from Advisory Committees Secretary must require person to provide further information within a reasonable time.
asserts: therapeutic-goods-act-1989-sec-52e-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-52e-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52e-ss-3
schema version: 2
part of: 52E Secretary to take certain matters into account in exercising

therapeutic-goods-act-1989-sec-52e-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to consider recommendations
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-52e-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52E(3) Secretary to take certain matters into account in exercising

52E(4) Secretary to take certain matters into account in exercising
type: Concept
description: Information
source: therapeutic-goods-act-1989.pdf, p.344
note: Application may be required or permitted for specified software requirements Secretary may seek advice from committees or persons when exercising power.
asserts: therapeutic-goods-act-1989-sec-52e-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-52e-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-52e-ss-4-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-52e-ss-4-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-52e-ss-4-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-52e-ss-4-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-52e-ss-4-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-52e-ss-4
schema version: 2
part of: 52E Secretary to take certain matters into account in exercising

therapeutic-goods-act-1989-sec-52e-ss-4-logic-alleninterval-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap with exercising power.
modality: AllenInterval
operator: Overlaps
premise text: (4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:

therapeutic-goods-act-1989-sec-52e-ss-4-logic-cogai-6
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Incorporating committees and persons into decision-making.
modality: CogAI
operator: Incorporates
premise text: (4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:

therapeutic-goods-act-1989-sec-52e-ss-4-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to provide information
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-52e-ss-4-logic-descriptionlogic-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Application for specified software requirements
modality: DescriptionLogic
operator: For

therapeutic-goods-act-1989-sec-52e-ss-4-logic-diffusion-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusing information to committees and persons.
modality: Diffusion
operator: Diffuses
premise text: (4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:

therapeutic-goods-act-1989-sec-52e-ss-4-logic-ltl-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Repeating pattern of seeking advice.
modality: LTL
operator: Repeats
premise text: (4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:

therapeutic-goods-act-1989-sec-52e-ss-4-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52E(4) Secretary to take certain matters into account in exercising

52E(5) Secretary to take certain matters into account in exercising
type: Concept
source: therapeutic-goods-act-1989.pdf, p.344
note: Secretary must consider additional information when exercising power
asserts: therapeutic-goods-act-1989-sec-52e-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-52e-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-52e-ss-5-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-52e-ss-5-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-52e-ss-5-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-52e-ss-5-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-52e-ss-5
schema version: 2
part of: 52E Secretary to take certain matters into account in exercising

therapeutic-goods-act-1989-sec-52e-ss-5-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval of consideration
modality: AllenInterval
operator: CONTAINS
premise text: (5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2).

therapeutic-goods-act-1989-sec-52e-ss-5-logic-cogai-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Temporal interval of consideration
modality: CogAI
operator: CONTAINS
premise text: (5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2).

therapeutic-goods-act-1989-sec-52e-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must consider additional information
modality: Deontic
operator: MUST
premise text: (5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2).

therapeutic-goods-act-1989-sec-52e-ss-5-logic-diffusion-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Temporal interval of consideration
modality: Diffusion
operator: CONTAINS
premise text: (5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2).

therapeutic-goods-act-1989-sec-52e-ss-5-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal interval of consideration
modality: LTL
operator: CONTAINS
premise text: (5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2).

therapeutic-goods-act-1989-sec-52e-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52E(5) Secretary to take certain matters into account in exercising

52F Incorporation of current Poisons Standard
type: Concept
source: therapeutic-goods-act-1989.pdf, p.346
curation status: Proposed
has part: 52F(1) Incorporation of current Poisons Standard
has part: 52F(2) Incorporation of current Poisons Standard
proposed by: legis2cml
realized by: sec-52f
schema version: 2

52F(1) Incorporation of current Poisons Standard
type: Concept
source: therapeutic-goods-act-1989.pdf, p.346
note: Legislative instrument may incorporate current Poisons Standard.
asserts: therapeutic-goods-act-1989-sec-52f-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-52f-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52f-ss-1
schema version: 2
part of: 52F Incorporation of current Poisons Standard

therapeutic-goods-act-1989-sec-52f-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Incorporation of matter from current Poisons Standard.
modality: Deontic
operator: incorporate

therapeutic-goods-act-1989-sec-52f-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52F(1) Incorporation of current Poisons Standard

52F(2) Incorporation of current Poisons Standard
type: Concept
source: therapeutic-goods-act-1989.pdf, p.346
note: An instrument under this Act may incorporate the current Poisons Standard with modifications.
asserts: therapeutic-goods-act-1989-sec-52f-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-52f-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52f-ss-2
schema version: 2
part of: 52F Incorporation of current Poisons Standard

therapeutic-goods-act-1989-sec-52f-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Incorporation of current Poisons Standard
modality: Deontic
operator: incorporate

therapeutic-goods-act-1989-sec-52f-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52F(2) Incorporation of current Poisons Standard

52G Exemptions, approvals and authorities to be consistent with
type: Concept
source: therapeutic-goods-act-1989.pdf, p.347
curation status: Proposed
has part: 52G(1) Exemptions, approvals and authorities to be consistent with
has part: 52G(2) Exemptions, approvals and authorities to be consistent with
has part: 52G(3) Exemptions, approvals and authorities to be consistent with
proposed by: legis2cml
realized by: sec-52g
schema version: 2

52G(1) Exemptions, approvals and authorities to be consistent with
type: Concept
source: therapeutic-goods-act-1989.pdf, p.347
note: Absolute prohibitions apply to therapeutic goods or vaping goods.
asserts: therapeutic-goods-act-1989-sec-52g-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-52g-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52g-ss-1
schema version: 2
part of: 52G Exemptions, approvals and authorities to be consistent with

therapeutic-goods-act-1989-sec-52g-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: thing referred to in subsection (3) of this section
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Absolute prohibition
modality: Deontic
operator: =
premise text: subsection 9K(1) or (3)

therapeutic-goods-act-1989-sec-52g-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 52G(1) Exemptions, approvals and authorities to be consistent with

52G(2) Exemptions, approvals and authorities to be consistent with
type: Concept
source: therapeutic-goods-act-1989.pdf, p.347
note: Exemptions and approvals must be consistent with prohibitions
asserts: therapeutic-goods-act-1989-sec-52g-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-52g-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52g-ss-2
schema version: 2
part of: 52G Exemptions, approvals and authorities to be consistent with

therapeutic-goods-act-1989-sec-52g-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Consistency requirement
modality: Deontic
operator: Consistency
premise text: Exemptions and approvals must be consistent with prohibitions

52G(3) Exemptions, approvals and authorities to be consistent with
type: Concept
source: therapeutic-goods-act-1989.pdf, p.347
note: List of exemptions, approvals and authorities to be consistent with
asserts: therapeutic-goods-act-1989-sec-52g-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-52g-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-52g-ss-3
schema version: 2
part of: 52G Exemptions, approvals and authorities to be consistent with

therapeutic-goods-act-1989-sec-52g-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: List of exemptions, approvals and authorities
modality: Deontic
operator: inclusion

53 Retention of material on withdrawal of application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.348
note: Department may retain application and material upon withdrawal.
asserts: therapeutic-goods-act-1989-sec-53-norm
asserts: therapeutic-goods-act-1989-sec-53-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-53-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-53
schema version: 2

therapeutic-goods-act-1989-sec-53-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits Department from releasing application and material.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-53-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies retained application and material as confidential.
modality: DescriptionLogic
operator: Classify

53A Alternative verdicts for various offences
type: Concept
source: therapeutic-goods-act-1989.pdf, p.348
note: If a jury acquits a person of an offence against a provision listed in column 2 of an item in the following table, but is satisfied beyond reasonable doubt of facts that prove that the person is guilty of the offence listed in column 3 of that item, the jury may convict the person of the offence listed in column 3 of that item.
asserts: therapeutic-goods-act-1989-sec-53a-norm
asserts: therapeutic-goods-act-1989-sec-53a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-53a-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-53a-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-53a-logic-argumentation-4
asserts: therapeutic-goods-act-1989-sec-53a-logic-diffusion-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-53a
schema version: 2

therapeutic-goods-act-1989-sec-53a-logic-alleninterval-2
type: LogicApplication
conclusion text: ...the jury may instead convict the person of an offence against...
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The provision specifies a temporal overlap between two events.
modality: AllenInterval
operator: Overlaps
premise text: If a prosecution is for an offence against...

therapeutic-goods-act-1989-sec-53a-logic-argumentation-4
type: LogicApplication
conclusion text: ...the jury may convict the person of the offence listed in column 3 of that item:
confidence: 0.5000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: The provision implies a causal relationship between two events.
modality: Argumentation
operator: Implication
premise text: If a jury acquits a person of an offence against a provision listed in column 2...

therapeutic-goods-act-1989-sec-53a-logic-deontic-1
type: LogicApplication
conclusion text: ...the jury may convict the person of the offence listed in column 3 of that item:
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The provision imposes an obligation on the State to convict a person of an offence if certain conditions are met.
modality: Deontic
operator: Obligation
premise text: If a jury acquits a person of an offence against a provision listed in column 2...

therapeutic-goods-act-1989-sec-53a-logic-diffusion-5
type: LogicApplication
conclusion text: ...the jury may instead convict the person of an offence against...
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: The provision diffuses information from one event to another.
modality: Diffusion
operator: Diffuses
premise text: If a prosecution is for an offence against...

therapeutic-goods-act-1989-sec-53a-logic-ltl-3
type: LogicApplication
conclusion text: ...the jury may instead convict the person of an offence against...
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The provision specifies a recurring pattern.
modality: LTL
operator: Repeats
premise text: If a prosecution is for an offence against...

therapeutic-goods-act-1989-sec-53a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 53A Alternative verdicts for various offences

54 Offences and forfeiture
type: Concept
source: therapeutic-goods-act-1989.pdf, p.351
curation status: Proposed
has part: 54(3) Offences and forfeiture
has part: 54(4) Offences and forfeiture
has part: 54(5) Offences and forfeiture
proposed by: legis2cml
realized by: sec-54
schema version: 2

54(3) Offences and forfeiture
type: Concept
source: therapeutic-goods-act-1989.pdf, p.351
note: Forfeiture of goods in relation to therapeutic or vaping products
asserts: therapeutic-goods-act-1989-sec-54-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-54-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-54-ss-3-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-54-ss-3-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-54-ss-3-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-54-ss-3-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-54-ss-3
schema version: 2
part of: 54 Offences and forfeiture

therapeutic-goods-act-1989-sec-54-ss-3-logic-alleninterval-2
type: LogicApplication
conclusion text: The goods overlap with therapeutic or vaping products
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Goods must overlap with therapeutic or vaping products
modality: AllenInterval
operator: Overlap
premise text: (3) If a court orders that the goods be forfeited in relation to any therapeutic goods or vaping goods

therapeutic-goods-act-1989-sec-54-ss-3-logic-cogai-5
type: LogicApplication
conclusion text: The forfeiture recognizes as a threat
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Forfeiture must recognize as a threat
modality: CogAI
operator: Recognize
premise text: (3) If a court orders that the goods be forfeited in relation to any therapeutic goods or vaping goods

therapeutic-goods-act-1989-sec-54-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: The goods must be forfeited to the Commonwealth
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the possession of goods
modality: Deontic
operator: Prohibit
premise text: (3) If a court orders that the goods be forfeited

therapeutic-goods-act-1989-sec-54-ss-3-logic-diffusion-4
type: LogicApplication
conclusion text: The forfeiture diffuses to all goods
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Forfeiture must diffuse to all goods
modality: Diffusion
operator: Diffuse
premise text: (3) If a court orders that the goods be forfeited in relation to any therapeutic goods or vaping goods

therapeutic-goods-act-1989-sec-54-ss-3-logic-ltl-3
type: LogicApplication
conclusion text: The goods are forfeited repeatedly
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Goods must be forfeited repeatedly
modality: LTL
operator: Recurring
premise text: (3) If a court orders that the goods be forfeited in relation to any therapeutic goods or vaping goods

therapeutic-goods-act-1989-sec-54-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54(3) Offences and forfeiture

54(4) Offences and forfeiture
type: Concept
source: therapeutic-goods-act-1989.pdf, p.351
note: Notice of forfeiture must be published in Gazette or website.
asserts: therapeutic-goods-act-1989-sec-54-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-54-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-54-ss-4
schema version: 2
part of: 54 Offences and forfeiture

therapeutic-goods-act-1989-sec-54-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits publication of notice without Secretary's action.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-54-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54(4) Offences and forfeiture

54(5) Offences and forfeiture
type: Concept
source: therapeutic-goods-act-1989.pdf, p.351
note: Goods forfeited under an order must be disposed of in a manner specified by the Secretary.
asserts: therapeutic-goods-act-1989-sec-54-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-54-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-54-ss-5
schema version: 2
part of: 54 Offences and forfeiture

therapeutic-goods-act-1989-sec-54-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits disposal of goods in a manner other than specified by the Secretary.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-54-ss-5-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54(5) Offences and forfeiture

54A Time for bringing prosecutions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.353
note: Prosecution can be commenced within 3 years after commission of the offence.
asserts: therapeutic-goods-act-1989-sec-54a-norm
asserts: therapeutic-goods-act-1989-sec-54a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-54a
schema version: 2

therapeutic-goods-act-1989-sec-54a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Ability to commence prosecution within specified timeframe.
modality: Deontic
operator: can

therapeutic-goods-act-1989-sec-54a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54A Time for bringing prosecutions

54AA Offences for contravening conditions or requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.352
curation status: Proposed
has part: 54AA(1) Offences for contravening conditions or requirements
has part: 54AA(1A) Offences for contravening conditions or requirements
has part: 54AA(2) Offences for contravening conditions or requirements
has part: 54AA(3) Offences for contravening conditions or requirements
proposed by: legis2cml
realized by: sec-54aa
schema version: 2

54AA(1) Offences for contravening conditions or requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.352
note: Breach of licence or permission conditions results in an offence.
asserts: therapeutic-goods-act-1989-sec-54aa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-54aa-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-54aa-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-54aa-ss-1-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-54aa-ss-1-logic-ltl-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-54aa-ss-1
schema version: 2
part of: 54AA Offences for contravening conditions or requirements

therapeutic-goods-act-1989-sec-54aa-ss-1-logic-alleninterval-3
type: LogicApplication
conclusion text: the conduct occurs during the period of the licence or permission.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Describes temporal overlap between licence/permission and conduct
modality: AllenInterval
operator: Overlaps
premise text: (1) If: (a) a person holds a licence or a permission to import or export therapeutic goods; and (b) the person engages in conduct;

therapeutic-goods-act-1989-sec-54aa-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: the person commits an offence punishable on conviction by a fine of no more than the number of penalty units specified in whichever of subsection (2) or (3) applies.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits conduct
modality: Deontic
operator: Prohibition
premise text: (a) a person holds a licence or a permission to import or export therapeutic goods; and (b) the person engages in conduct; and (c) the conduct breaches a condition or a requirement to which the licence or permission is subject under the regulations;

therapeutic-goods-act-1989-sec-54aa-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: the person commits an offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits breach of conditions or requirements
modality: Deontic
operator: Prohibition
premise text: (c) the conduct breaches a condition or a requirement to which the licence or permission is subject under the regulations;

therapeutic-goods-act-1989-sec-54aa-ss-1-logic-ltl-4
type: LogicApplication
conclusion text: the conduct ends before the period of the licence or permission.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Describes temporal relationship between licence/permission and conduct
modality: LTL
operator: Until
premise text: (1) If: (a) a person holds a licence or a permission to import or export therapeutic goods; and (b) the person engages in conduct;

therapeutic-goods-act-1989-sec-54aa-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54AA(1) Offences for contravening conditions or requirements

54AA(1A) Offences for contravening conditions or requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.352
note: Engaging in conduct means doing an act or omitting to perform an act.
asserts: therapeutic-goods-act-1989-sec-54aa-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-54aa-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-54aa-ss-1a-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-54aa-ss-1a
schema version: 2
part of: 54AA Offences for contravening conditions or requirements

therapeutic-goods-act-1989-sec-54aa-ss-1a-logic-deontic-1
type: LogicApplication
conclusion text: engaging in conduct means doing an act or omitting to perform an act.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Definition of conduct
modality: Deontic
operator: is

therapeutic-goods-act-1989-sec-54aa-ss-1a-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of conduct
modality: DescriptionLogic
operator: subClassOf

therapeutic-goods-act-1989-sec-54aa-ss-1a-norm
type: Obligation
scope note: borne by: LegalPerson
curation status: Proposed
modality: Deontic
borne by: LegalPerson
deontic status: HeuristicDerived
part of: 54AA(1A) Offences for contravening conditions or requirements

54AA(2) Offences for contravening conditions or requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.352
note: Increased penalty for contravention of certain conditions or requirements
asserts: therapeutic-goods-act-1989-sec-54aa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-54aa-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-54aa-ss-2
schema version: 2
part of: 54AA Offences for contravening conditions or requirements

therapeutic-goods-act-1989-sec-54aa-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: 240 penalty units
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Increases the penalty for contravention
modality: Deontic
operator: Increase
premise text: (2) If...

therapeutic-goods-act-1989-sec-54aa-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54AA(2) Offences for contravening conditions or requirements

54AA(3) Offences for contravening conditions or requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.352
note: Penalty for contravention of conditions or requirements
asserts: therapeutic-goods-act-1989-sec-54aa-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-54aa-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-54aa-ss-3
schema version: 2
part of: 54AA Offences for contravening conditions or requirements

therapeutic-goods-act-1989-sec-54aa-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: 50 penalty units
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a penalty
modality: Deontic
operator: =
premise text: Subsection (2) does not apply

therapeutic-goods-act-1989-sec-54aa-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54AA(3) Offences for contravening conditions or requirements

54AB Criminal offence for damaging etc. documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.353
curation status: Proposed
has part: 54AB(1) Criminal offence for damaging etc. documents
has part: 54AB(2) Criminal offence for damaging etc. documents
proposed by: legis2cml
realized by: sec-54ab
schema version: 2

54AB(1) Criminal offence for damaging etc. documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.353
note: Damaging or destroying documents for purposes of this Act is a criminal offence.
asserts: therapeutic-goods-act-1989-sec-54ab-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-54ab-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-54ab-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-54ab-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-54ab-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-54ab-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-54ab-ss-1
schema version: 2
part of: 54AB Criminal offence for damaging etc. documents

therapeutic-goods-act-1989-sec-54ab-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Documents must be created, retained or issued within the same temporal interval as this Act.
modality: AllenInterval
operator: Temporal overlap
premise text: (b) the document is created, retained or issued for the purposes...

therapeutic-goods-act-1989-sec-54ab-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: This Act must be classified as a legal provision.
modality: CogAI
operator: Classify
premise text: Note:

therapeutic-goods-act-1989-sec-54ab-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Penalty: 7 years imprisonment or 2,000 penalty units, or both.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits damaging or destroying documents.
modality: Deontic
operator: Prohibit
premise text: (1) A person commits an offence...

therapeutic-goods-act-1989-sec-54ab-ss-1-logic-diffusion-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: This Act must diffuse to all documents created, retained or issued within its temporal interval.
modality: Diffusion
operator: Diffuse
premise text: (b) the document is created, retained or issued for the purposes...

therapeutic-goods-act-1989-sec-54ab-ss-1-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Documents must be part of a recurring trace that includes this Act.
modality: LTL
operator: Recurring trace
premise text: (b) the document is created, retained or issued for the purposes...

therapeutic-goods-act-1989-sec-54ab-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54AB(1) Criminal offence for damaging etc. documents

54AB(2) Criminal offence for damaging etc. documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.353
note: Strict liability applies for damaging documents
asserts: therapeutic-goods-act-1989-sec-54ab-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-54ab-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-54ab-ss-2
schema version: 2
part of: 54AB Criminal offence for damaging etc. documents

therapeutic-goods-act-1989-sec-54ab-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Strict liability obligation
modality: Deontic
operator: applies

54AC Civil penalty for damaging etc. documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.353
note: Damaging, destroying, altering, concealing or falsifying documents for purposes of the Act.
asserts: therapeutic-goods-act-1989-sec-54ac-norm
asserts: therapeutic-goods-act-1989-sec-54ac-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-54ac-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-54ac-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-54ac
schema version: 2

therapeutic-goods-act-1989-sec-54ac-logic-alleninterval-2
type: LogicApplication
conclusion text: Document is created, retained or issued for the purposes of this Act.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Documents must be created, retained or issued within a specific time frame.
modality: AllenInterval
operator: Overlap
premise text: None

therapeutic-goods-act-1989-sec-54ac-logic-deontic-1
type: LogicApplication
conclusion text: None
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits damaging, destroying, altering, concealing or falsifying documents.
modality: Deontic
operator: Prohibit
premise text: None

therapeutic-goods-act-1989-sec-54ac-logic-ltl-3
type: LogicApplication
conclusion text: Document is created, retained or issued for the purposes of this Act.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Documents must be regularly updated or reviewed.
modality: LTL
operator: Recurring
premise text: None

therapeutic-goods-act-1989-sec-54ac-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54AC Civil penalty for damaging etc. documents

54B Personal liability of an executive officer of a body corporate—
type: Concept
source: therapeutic-goods-act-1989.pdf, p.354
curation status: Proposed
has part: 54B(1) Personal liability of an executive officer of a body corporate—
has part: 54B(2) Personal liability of an executive officer of a body corporate—
has part: 54B(3) Personal liability of an executive officer of a body corporate—
has part: 54B(4) Personal liability of an executive officer of a body corporate—
has part: 54B(5) Personal liability of an executive officer of a body corporate—
proposed by: legis2cml
realized by: sec-54b
schema version: 2

54B(1) Personal liability of an executive officer of a body corporate—
type: Concept
source: therapeutic-goods-act-1989.pdf, p.354
note: Executive officer commits an offence if they knew and failed to prevent the commission of an offence against the Act.
asserts: therapeutic-goods-act-1989-sec-54b-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-54b-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-54b-ss-1-logic-epistemic-2
asserts: therapeutic-goods-act-1989-sec-54b-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-54b-ss-1-logic-descriptionlogic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-54b-ss-1
schema version: 2
part of: 54B Personal liability of an executive officer of a body corporate—

therapeutic-goods-act-1989-sec-54b-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Offence committed.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Executive officer has a duty to prevent commission of offence.
modality: Deontic
operator: obligation
premise text: Knew and failed to act.

therapeutic-goods-act-1989-sec-54b-ss-1-logic-descriptionlogic-4
type: LogicApplication
conclusion text: Offence committed.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Executive officer is part of a class with a specific description.
modality: DescriptionLogic
operator: class
premise text: An executive officer of a body corporate.

therapeutic-goods-act-1989-sec-54b-ss-1-logic-epistemic-2
type: LogicApplication
conclusion text: Offence committed.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Executive officer must know the offence will be committed.
modality: Epistemic
operator: knowledge
premise text: Knew the offence would be committed.

therapeutic-goods-act-1989-sec-54b-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: Offence committed.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Offence occurred within a specific time interval.
modality: LTL
operator: interval
premise text: Failed to take reasonable steps.

therapeutic-goods-act-1989-sec-54b-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 54B(1) Personal liability of an executive officer of a body corporate—

54B(2) Personal liability of an executive officer of a body corporate—
type: Concept
source: therapeutic-goods-act-1989.pdf, p.354
note: Maximum penalty for an offence against subsection (1)
asserts: therapeutic-goods-act-1989-sec-54b-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-54b-ss-2
schema version: 2
part of: 54B Personal liability of an executive officer of a body corporate—

therapeutic-goods-act-1989-sec-54b-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54B(2) Personal liability of an executive officer of a body corporate—

54B(3) Personal liability of an executive officer of a body corporate—
type: Concept
source: therapeutic-goods-act-1989.pdf, p.354
note: Executive officer must take reasonable steps to prevent contravention of civil penalty provision.
asserts: therapeutic-goods-act-1989-sec-54b-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-54b-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-54b-ss-3-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-54b-ss-3-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-54b-ss-3
schema version: 2
part of: 54B Personal liability of an executive officer of a body corporate—

therapeutic-goods-act-1989-sec-54b-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: The executive officer must take reasonable steps to prevent the contravention.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Executive officer has an obligation to prevent contravention.
modality: Deontic
operator: obligation
premise text: The executive officer knew the contravention would occur.

therapeutic-goods-act-1989-sec-54b-ss-3-logic-deontic-2
type: LogicApplication
conclusion text: The executive officer must take reasonable steps to prevent the contravention.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Executive officer has an obligation to prevent contravention.
modality: Deontic
operator: obligation
premise text: The executive officer was in a position to influence the conduct of the body corporate.

therapeutic-goods-act-1989-sec-54b-ss-3-logic-deontic-3
type: LogicApplication
conclusion text: The executive officer must take reasonable steps to prevent the contravention.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Executive officer has an obligation to prevent contravention.
modality: Deontic
operator: obligation
premise text: The executive officer failed to take all reasonable steps to prevent the contravention.

therapeutic-goods-act-1989-sec-54b-ss-3-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 54B(3) Personal liability of an executive officer of a body corporate—

54B(4) Personal liability of an executive officer of a body corporate—
type: Concept
source: therapeutic-goods-act-1989.pdf, p.354
note: Maximum civil penalty for contravention of subsection (3)
asserts: therapeutic-goods-act-1989-sec-54b-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-54b-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-54b-ss-4
schema version: 2
part of: 54B Personal liability of an executive officer of a body corporate—

therapeutic-goods-act-1989-sec-54b-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation on the state
modality: Deontic
operator: hasObligation

therapeutic-goods-act-1989-sec-54b-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54B(4) Personal liability of an executive officer of a body corporate—

54B(5) Personal liability of an executive officer of a body corporate—
type: Concept
source: therapeutic-goods-act-1989.pdf, p.354
note: Defines executive officer of a body corporate
asserts: therapeutic-goods-act-1989-sec-54b-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-54b-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-54b-ss-5-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-54b-ss-5
schema version: 2
part of: 54B Personal liability of an executive officer of a body corporate—

therapeutic-goods-act-1989-sec-54b-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: executive officer of a body corporate
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Defines term
modality: Deontic
operator: is defined as

therapeutic-goods-act-1989-sec-54b-ss-5-logic-descriptionlogic-2
type: LogicApplication
conclusion text: body corporate
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Class hierarchy
modality: DescriptionLogic
operator: has class

therapeutic-goods-act-1989-sec-54b-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54B(5) Personal liability of an executive officer of a body corporate—

54BA Personal liability of an executive officer of a body corporate—
type: Concept
source: therapeutic-goods-act-1989.pdf, p.355
note: Personal liability of an executive officer of a body corporate—
asserts: therapeutic-goods-act-1989-sec-54ba-norm
asserts: therapeutic-goods-act-1989-sec-54ba-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-54ba
schema version: 2

therapeutic-goods-act-1989-sec-54ba-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Personal liability covered by this section
modality: Deontic
operator: coveredBy

therapeutic-goods-act-1989-sec-54ba-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54BA Personal liability of an executive officer of a body corporate—

54C Establishing whether an executive officer took reasonable steps
type: Concept
source: therapeutic-goods-act-1989.pdf, p.358
curation status: Proposed
has part: 54C(1) Establishing whether an executive officer took reasonable steps
has part: 54C(2) Establishing whether an executive officer took reasonable steps
has part: 54C(3) Establishing whether an executive officer took reasonable steps
proposed by: legis2cml
realized by: sec-54c
schema version: 2

54C(1) Establishing whether an executive officer took reasonable steps
type: Concept
source: therapeutic-goods-act-1989.pdf, p.358
note: Executive officer must take reasonable steps to prevent commission of offence.
asserts: therapeutic-goods-act-1989-sec-54c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-54c-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-54c-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-54c-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-54c-ss-1-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-54c-ss-1
schema version: 2
part of: 54C Establishing whether an executive officer took reasonable steps

therapeutic-goods-act-1989-sec-54c-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: The officer's awareness of the body's commission of an offence overlaps with their obligation to prevent the commission of the offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The officer's awareness of the body's commission of an offence is relevant to determining their obligations.
modality: AllenInterval
operator: Overlaps
premise text: The officer became aware that the body was committing an offence against this Act or the regulations.

therapeutic-goods-act-1989-sec-54c-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The officer must take all reasonable steps to prevent the commission of the offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Executive officer has an obligation to take reasonable steps.
modality: Deontic
operator: Obligation
premise text: The executive officer is responsible for preventing the commission of the offence.

therapeutic-goods-act-1989-sec-54c-ss-1-logic-deontic-3
type: LogicApplication
conclusion text: The officer must take action when they become aware that the body is committing an offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The officer has an obligation to take action when they become aware that the body is committing an offence.
modality: Deontic
operator: Obligation
premise text: When the officer became aware that the body was committing an offence against this Act or the regulations, they had an obligation to take action.

therapeutic-goods-act-1989-sec-54c-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: The officer must ensure that employees, agents, and contractors have a reasonable knowledge and understanding of the requirements.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The officer has an obligation to ensure that employees, agents, and contractors have a reasonable knowledge and understanding of the requirements.
modality: Deontic
operator: Obligation
premise text: The officer is responsible for ensuring that employees, agents, and contractors have a reasonable knowledge and understanding of the requirements.

therapeutic-goods-act-1989-sec-54c-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54C(1) Establishing whether an executive officer took reasonable steps

54C(2) Establishing whether an executive officer took reasonable steps
type: Concept
source: therapeutic-goods-act-1989.pdf, p.358
note: Does not limit the generality of section 54B by implication.
asserts: therapeutic-goods-act-1989-sec-54c-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-54c-ss-2
schema version: 2
part of: 54C Establishing whether an executive officer took reasonable steps

therapeutic-goods-act-1989-sec-54c-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 54C(2) Establishing whether an executive officer took reasonable steps

54C(3) Establishing whether an executive officer took reasonable steps
type: Concept
source: therapeutic-goods-act-1989.pdf, p.358
note: Executive officer must take reasonable steps
asserts: therapeutic-goods-act-1989-sec-54c-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-54c-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-54c-ss-3
schema version: 2
part of: 54C Establishing whether an executive officer took reasonable steps

therapeutic-goods-act-1989-sec-54c-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide reasonable steps
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-54c-ss-3-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 54C(3) Establishing whether an executive officer took reasonable steps

55 Conduct by directors, employees and agents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.358
curation status: Proposed
has part: 55(1) Conduct by directors, employees and agents
has part: 55(2) Conduct by directors, employees and agents
has part: 55(3) Conduct by directors, employees and agents
has part: 55(4) Conduct by directors, employees and agents
has part: 55(5) Conduct by directors, employees and agents
has part: 55(6) Conduct by directors, employees and agents
has part: 55(7) Conduct by directors, employees and agents
has part: 55(8) Conduct by directors, employees and agents
proposed by: legis2cml
realized by: sec-55
schema version: 2

55(1) Conduct by directors, employees and agents
type: Concept
description: Director, employee or agent's actual or apparent authority and state of mind
source: therapeutic-goods-act-1989.pdf, p.358
note: Establishing state of mind of a body corporate in relation to conduct
asserts: therapeutic-goods-act-1989-sec-55-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-55-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-55-ss-1
schema version: 2
part of: 55 Conduct by directors, employees and agents

therapeutic-goods-act-1989-sec-55-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Establishing authority
modality: Deontic
operator: hasAuthority

therapeutic-goods-act-1989-sec-55-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 55(1) Conduct by directors, employees and agents

55(2) Conduct by directors, employees and agents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.358
note: Body corporate must take reasonable precautions to avoid conduct by directors, employees and agents.
asserts: therapeutic-goods-act-1989-sec-55-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-55-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-55-ss-2
schema version: 2
part of: 55 Conduct by directors, employees and agents

therapeutic-goods-act-1989-sec-55-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Must take precautions
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to take precautions
modality: Deontic
operator: obligation
premise text: Body corporate has authority

therapeutic-goods-act-1989-sec-55-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 55(2) Conduct by directors, employees and agents

55(3) Conduct by directors, employees and agents
type: Concept
description: state of mind
source: therapeutic-goods-act-1989.pdf, p.358
note: Establishing state of mind for employees or agents
asserts: therapeutic-goods-act-1989-sec-55-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-55-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-55-ss-3
schema version: 2
part of: 55 Conduct by directors, employees and agents

therapeutic-goods-act-1989-sec-55-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: state of mind
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authority relation
modality: Deontic
operator: hasAuthority
premise text: actual or apparent authority

therapeutic-goods-act-1989-sec-55-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 55(3) Conduct by directors, employees and agents

55(4) Conduct by directors, employees and agents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.358
note: Employer liable for conduct of employee/agent within scope of authority
asserts: therapeutic-goods-act-1989-sec-55-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-55-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-55-ss-4
schema version: 2
part of: 55 Conduct by directors, employees and agents

therapeutic-goods-act-1989-sec-55-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: Employer must provide liability
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Employer liable for conduct
modality: Deontic
operator: Liability
premise text: Employee/agent within scope of authority

55(5) Conduct by directors, employees and agents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.358
note: No imprisonment for certain offences if convicted by a non-corporate person
asserts: therapeutic-goods-act-1989-sec-55-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-55-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-55-ss-5-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-55-ss-5-logic-linearlogic-3
asserts: therapeutic-goods-act-1989-sec-55-ss-5-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-55-ss-5
schema version: 2
part of: 55 Conduct by directors, employees and agents

therapeutic-goods-act-1989-sec-55-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are not liable to be punished by imprisonment for that offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: No imprisonment implies obligation to refrain from punishment
modality: Deontic
operator: Implies
premise text: (5) Where: ... the person is not liable to be punished by imprisonment for that offence.

therapeutic-goods-act-1989-sec-55-ss-5-logic-deontic-2
type: LogicApplication
conclusion text: If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are permitted to receive other forms of punishment
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imprisonment permits other forms of punishment
modality: Deontic
operator: Permits
premise text: (5) Where: ... the person is not liable to be punished by imprisonment for that offence.

therapeutic-goods-act-1989-sec-55-ss-5-logic-deontic-4
type: LogicApplication
conclusion text: If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are justified in refraining from punishment
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to refrain from punishment justifies no imprisonment
modality: Deontic
operator: Justifies
premise text: (5) Where: ... the person is not liable to be punished by imprisonment for that offence.

therapeutic-goods-act-1989-sec-55-ss-5-logic-linearlogic-3
type: LogicApplication
conclusion text: If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are permitted to receive other forms of punishment
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: No imprisonment implies obligation to refrain from punishment and permits other forms of punishment
modality: LinearLogic
operator: And
premise text: (5) Where: ... the person is not liable to be punished by imprisonment for that offence.

therapeutic-goods-act-1989-sec-55-ss-5-norm
type: Obligation
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 55(5) Conduct by directors, employees and agents

55(6) Conduct by directors, employees and agents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.358
note: Directors, employees and agents must have certain knowledge or reasons for their intentions.
asserts: therapeutic-goods-act-1989-sec-55-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-55-ss-6-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-55-ss-6-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-55-ss-6-logic-descriptionlogic-3
asserts: therapeutic-goods-act-1989-sec-55-ss-6-logic-alleninterval-4
asserts: therapeutic-goods-act-1989-sec-55-ss-6-logic-argumentation-5
asserts: therapeutic-goods-act-1989-sec-55-ss-6-logic-diffusion-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-55-ss-6
schema version: 2
part of: 55 Conduct by directors, employees and agents

therapeutic-goods-act-1989-sec-55-ss-6-logic-alleninterval-4
type: LogicApplication
conclusion text: The person has that knowledge or reason during the action.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Directors, employees and agents must have certain knowledge or reasons during their actions.
modality: AllenInterval
operator: during
premise text: The person performs an action.

therapeutic-goods-act-1989-sec-55-ss-6-logic-argumentation-5
type: LogicApplication
conclusion text: The person must justify that intention with those reasons.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Directors, employees and agents must justify their intentions with certain reasons.
modality: Argumentation
operator: mustJustify
premise text: The person has an intention.

therapeutic-goods-act-1989-sec-55-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: The person must have that knowledge.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Directors, employees and agents must have certain knowledge.
modality: Deontic
operator: hasKnowledge
premise text: The person has a certain state of mind.

therapeutic-goods-act-1989-sec-55-ss-6-logic-deontic-2
type: LogicApplication
conclusion text: The person must have those reasons.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Directors, employees and agents must have certain reasons for their intentions.
modality: Deontic
operator: hasReasons
premise text: The person has a certain intention or purpose.

therapeutic-goods-act-1989-sec-55-ss-6-logic-descriptionlogic-3
type: LogicApplication
conclusion text: The person has that knowledge or reason.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Directors, employees and agents must have certain knowledge or reasons.
modality: DescriptionLogic
operator: hasProperty
premise text: The person has a certain state of mind.

therapeutic-goods-act-1989-sec-55-ss-6-logic-diffusion-6
type: LogicApplication
conclusion text: The person must inform others of that knowledge or reason.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Directors, employees and agents must inform others of their knowledge or reasons.
modality: Diffusion
operator: mustInform
premise text: The person has certain knowledge or reasons.

therapeutic-goods-act-1989-sec-55-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 55(6) Conduct by directors, employees and agents

55(7) Conduct by directors, employees and agents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.358
note: Directors, employees and agents of a body corporate are subject to this section.
asserts: therapeutic-goods-act-1989-sec-55-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-55-ss-7-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-55-ss-7-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-55-ss-7
schema version: 2
part of: 55 Conduct by directors, employees and agents

therapeutic-goods-act-1989-sec-55-ss-7-logic-deontic-1
type: LogicApplication
conclusion text: The reference to a director includes a reference to a constituent member of a body corporate.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Inclusion in the reference list
modality: Deontic
operator: includes
premise text: A director of a body corporate is included in this section.

therapeutic-goods-act-1989-sec-55-ss-7-logic-descriptionlogic-2
type: LogicApplication
conclusion text: The constituent member is classified as a body corporate.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of the constituent member
modality: DescriptionLogic
operator: subclassOf
premise text: A constituent member is a type of body corporate.

therapeutic-goods-act-1989-sec-55-ss-7-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 55(7) Conduct by directors, employees and agents

55(8) Conduct by directors, employees and agents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.358
note: Directors, employees and agents must engage in conduct.
asserts: therapeutic-goods-act-1989-sec-55-ss-8-norm
asserts: therapeutic-goods-act-1989-sec-55-ss-8-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-55-ss-8-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-55-ss-8
schema version: 2
part of: 55 Conduct by directors, employees and agents

therapeutic-goods-act-1989-sec-55-ss-8-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide obligation
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-55-ss-8-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of conduct
modality: DescriptionLogic
operator: CLASSIFICATION

therapeutic-goods-act-1989-sec-55-ss-8-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 55(8) Conduct by directors, employees and agents

56 Judicial notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.360
note: Courts must take judicial notice of certain pharmacopeias.
asserts: therapeutic-goods-act-1989-sec-56-norm
asserts: therapeutic-goods-act-1989-sec-56-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-56
schema version: 2

therapeutic-goods-act-1989-sec-56-logic-deontic-1
type: LogicApplication
conclusion text: Courts must take judicial notice.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Court obligation
modality: Deontic
operator: MUST
premise text: Courts are required to take judicial notice.

therapeutic-goods-act-1989-sec-56-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 56 Judicial notice

56A Certificates to provide evidence of certain matters
type: Concept
description: Certificates to provide evidence of certain matters
source: therapeutic-goods-act-1989.pdf, p.360
note: The Secretary or authorized person must certify certain matters in writing.
asserts: therapeutic-goods-act-1989-sec-56a-norm
asserts: therapeutic-goods-act-1989-sec-56a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-56a-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-56a
schema version: 2

therapeutic-goods-act-1989-sec-56a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary or authorized person must certify certain matters in writing.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-56a-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Certificates to provide evidence of certain matters
modality: DescriptionLogic
operator: IS_A

therapeutic-goods-act-1989-sec-56a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 56A Certificates to provide evidence of certain matters

57 Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
curation status: Proposed
has part: 57(1) Delegation
has part: 57(1A) Delegation
has part: 57(2) Delegation
has part: 57(3) Delegation
has part: 57(4) Delegation
has part: 57(5) Delegation
has part: 57(5A) Delegation
has part: 57(6) Delegation
has part: 57(7) Delegation
has part: 57(8) Delegation
has part: 57(9) Delegation
has part: 57(10) Delegation
has part: 57(10A) Delegation
has part: 57(11) Delegation
has part: 57(12) Delegation
proposed by: legis2cml
realized by: sec-57
schema version: 2

57(1) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Delegation of powers and functions
asserts: therapeutic-goods-act-1989-sec-57-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-1
schema version: 2
part of: 57 Delegation

57(10) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Delegation of power to certain individuals or positions within the Department.
asserts: therapeutic-goods-act-1989-sec-57-ss-10-norm
asserts: therapeutic-goods-act-1989-sec-57-ss-10-logic-alleninterval-1
asserts: therapeutic-goods-act-1989-sec-57-ss-10-logic-ltl-2
asserts: therapeutic-goods-act-1989-sec-57-ss-10-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-10
schema version: 2
part of: 57 Delegation

therapeutic-goods-act-1989-sec-57-ss-10-logic-alleninterval-1
type: LogicApplication
conclusion text: ...on or after a specified date;
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval
modality: AllenInterval
operator: >=
premise text: (10) The power of the Minister under subsection 18A(1) or 41P(3) may be delegated only to...

therapeutic-goods-act-1989-sec-57-ss-10-logic-deontic-3
type: LogicApplication
conclusion text: ...a specified individual or position;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission
modality: Deontic
operator: =
premise text: The power of the Minister under subsection 18A(1) or 41P(3) may be delegated only to...

therapeutic-goods-act-1989-sec-57-ss-10-logic-ltl-2
type: LogicApplication
conclusion text: ...before a specified date;
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal interval
modality: LTL
operator: <=
premise text: (10AA) The power of the Minister under subsection 30EK(1) may be delegated only to...

57(10A) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Delegation of power to the Minister under subsection 32CB(1)
asserts: therapeutic-goods-act-1989-sec-57-ss-10a-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-10a
schema version: 2
part of: 57 Delegation

therapeutic-goods-act-1989-sec-57-ss-10a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 57(10A) Delegation

57(11) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Delegation of power to specific individuals or positions.
asserts: therapeutic-goods-act-1989-sec-57-ss-11-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-11
schema version: 2
part of: 57 Delegation

57(12) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Delegate must comply with directions of the person who delegated.
asserts: therapeutic-goods-act-1989-sec-57-ss-12-norm
asserts: therapeutic-goods-act-1989-sec-57-ss-12-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-12
schema version: 2
part of: 57 Delegation

therapeutic-goods-act-1989-sec-57-ss-12-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must comply
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-57-ss-12-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 57(12) Delegation

57(1A) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Delegate powers and functions to an officer of a Department, unit or authority with related functions.
asserts: therapeutic-goods-act-1989-sec-57-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-57-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-1a
schema version: 2
part of: 57 Delegation

therapeutic-goods-act-1989-sec-57-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to delegate powers and functions.
modality: Deontic
operator: Permit

57(2) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Delegation of powers to registered medical or dental practitioners or pharmacists.
asserts: therapeutic-goods-act-1989-sec-57-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-57-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-57-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-57-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-57-ss-2-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-57-ss-2-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-2
schema version: 2
part of: 57 Delegation

therapeutic-goods-act-1989-sec-57-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: may be delegated during subsection (1)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relationship of delegation
modality: AllenInterval
operator: during
premise text: (2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)

therapeutic-goods-act-1989-sec-57-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: may be delegated under subsection (1)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authorization of power delegation
modality: Deontic
operator: canDelegate
premise text: (2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)

therapeutic-goods-act-1989-sec-57-ss-2-logic-deontic-4
type: LogicApplication
conclusion text: who is registered, or eligible for registration, in a State or internal Territory
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Registration requirement for delegation
modality: Deontic
operator: mustBeRegistered
premise text: (2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)

therapeutic-goods-act-1989-sec-57-ss-2-logic-deontic-5
type: LogicApplication
conclusion text: or eligible for registration, in a State or internal Territory
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Eligibility requirement for delegation
modality: Deontic
operator: mustBeEligibleForRegistration
premise text: (2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)

therapeutic-goods-act-1989-sec-57-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: may be delegated during subsection (1)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal relationship of delegation
modality: LTL
operator: during
premise text: (2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)

therapeutic-goods-act-1989-sec-57-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 57(2) Delegation

57(3) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Delegation of powers by Secretary to registered medical or dental practitioner
asserts: therapeutic-goods-act-1989-sec-57-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-3
schema version: 2
part of: 57 Delegation

57(4) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Delegate must follow directions from Secretary, officer, or person referred to in paragraph (1)(c).
asserts: therapeutic-goods-act-1989-sec-57-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-57-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-4
schema version: 2
part of: 57 Delegation

therapeutic-goods-act-1989-sec-57-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Delegate has an obligation to follow directions.
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-57-ss-4-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 57(4) Delegation

57(5) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Regulations may make provision for delegates, approvals, and conditions.
asserts: therapeutic-goods-act-1989-sec-57-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-5
schema version: 2
part of: 57 Delegation

therapeutic-goods-act-1989-sec-57-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 57(5) Delegation

57(5A) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Delegation of powers to registered medical or dental practitioners or pharmacists.
asserts: therapeutic-goods-act-1989-sec-57-ss-5a-norm
asserts: therapeutic-goods-act-1989-sec-57-ss-5a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-5a
schema version: 2
part of: 57 Delegation

therapeutic-goods-act-1989-sec-57-ss-5a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Delegation of powers to registered medical or dental practitioners or pharmacists.
modality: Deontic
operator: Permit

therapeutic-goods-act-1989-sec-57-ss-5a-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 57(5A) Delegation

57(6) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Delegation of powers is restricted to registered medical practitioners.
asserts: therapeutic-goods-act-1989-sec-57-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-57-ss-6-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-57-ss-6-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-57-ss-6-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-57-ss-6-logic-cogai-4
asserts: therapeutic-goods-act-1989-sec-57-ss-6-logic-shacl-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-6
schema version: 2
part of: 57 Delegation

therapeutic-goods-act-1989-sec-57-ss-6-logic-alleninterval-2
type: LogicApplication
conclusion text: may only be delegated during the registration period
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal restriction on delegation
modality: AllenInterval
operator: during
premise text: The powers of the Secretary under subsection 32CM(1) or 41HC(1)

therapeutic-goods-act-1989-sec-57-ss-6-logic-cogai-4
type: LogicApplication
conclusion text: is authorized to delegate powers as a registered medical practitioner
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Authorization for delegation by AI system
modality: CogAI
operator: isAuthorizedTo
premise text: The person referred to in paragraph (1)(a) or (c)

therapeutic-goods-act-1989-sec-57-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: may be delegated to a registered medical practitioner
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authorization for delegation
modality: Deontic
operator: canDelegate
premise text: The powers of the Secretary under subsection 32CM(1) or 41HC(1)

therapeutic-goods-act-1989-sec-57-ss-6-logic-ltl-3
type: LogicApplication
conclusion text: are restricted to registered medical practitioners everywhere
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Universal applicability of delegation restriction
modality: LTL
operator: everywhere
premise text: The powers of the Secretary under subsection 32CM(1) or 41HC(1)

therapeutic-goods-act-1989-sec-57-ss-6-logic-shacl-5
type: LogicApplication
conclusion text: must be validated as a registered medical practitioner
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::shacl
logic summary: Validation of delegation restriction
modality: SHACL
operator: hasShape
premise text: The person referred to in paragraph (1)(a) or (c)

therapeutic-goods-act-1989-sec-57-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 57(6) Delegation

57(7) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Regulations may prescribe circumstances for delegate authorities.
asserts: therapeutic-goods-act-1989-sec-57-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-57-ss-7-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-7
schema version: 2
part of: 57 Delegation

therapeutic-goods-act-1989-sec-57-ss-7-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: May prescribe
modality: Deontic
operator: mayPrescribe

therapeutic-goods-act-1989-sec-57-ss-7-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 57(7) Delegation

57(8) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Powers of Secretary can be delegated to a specific person.
asserts: therapeutic-goods-act-1989-sec-57-ss-8-norm
asserts: therapeutic-goods-act-1989-sec-57-ss-8-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-8
schema version: 2
part of: 57 Delegation

therapeutic-goods-act-1989-sec-57-ss-8-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Delegation is permitted.
modality: Deontic
operator: can

therapeutic-goods-act-1989-sec-57-ss-8-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 57(8) Delegation

57(9) Delegation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Powers of Secretary under section 41HD may be delegated to a person holding the prescribed duties.
asserts: therapeutic-goods-act-1989-sec-57-ss-9-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-57-ss-9
schema version: 2
part of: 57 Delegation

58 Export certifications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.367
curation status: Proposed
has part: 58(1) Export certifications
has part: 58(2) Export certifications
has part: 58(2A) Export certifications
has part: 58(2B) Export certifications
has part: 58(3) Export certifications
proposed by: legis2cml
realized by: sec-58
schema version: 2

58(1) Export certifications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.367
note: The Secretary may issue export certification for goods for therapeutic use in humans.
asserts: therapeutic-goods-act-1989-sec-58-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-58-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-58-ss-1
schema version: 2
part of: 58 Export certifications

therapeutic-goods-act-1989-sec-58-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to issue export certification
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-58-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 58(1) Export certifications

58(2) Export certifications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.367
note: No export certifications for therapeutic use in humans.
asserts: therapeutic-goods-act-1989-sec-58-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-58-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-58-ss-2
schema version: 2
part of: 58 Export certifications

therapeutic-goods-act-1989-sec-58-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: No export certifications
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Negative obligation
modality: Deontic
operator: not

58(2A) Export certifications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.367
note: Secretary may issue export certification for vaping goods not covered by subsection (1)
asserts: therapeutic-goods-act-1989-sec-58-ss-2a-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-58-ss-2a
schema version: 2
part of: 58 Export certifications

therapeutic-goods-act-1989-sec-58-ss-2a-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 58(2A) Export certifications

58(2B) Export certifications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.367
note: No export certification for vaping goods under subsection (2A) may be issued.
asserts: therapeutic-goods-act-1989-sec-58-ss-2b-norm
asserts: therapeutic-goods-act-1989-sec-58-ss-2b-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-58-ss-2b-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-58-ss-2b-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-58-ss-2b-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-58-ss-2b-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-58-ss-2b
schema version: 2
part of: 58 Export certifications

therapeutic-goods-act-1989-sec-58-ss-2b-logic-alleninterval-2
type: LogicApplication
conclusion text: ...export certification for vaping goods under subsection (2A).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Restriction on export certification timing
modality: AllenInterval
operator: Temporal Restriction
premise text: (2B) A State or Territory must not issue...

therapeutic-goods-act-1989-sec-58-ss-2b-logic-cogai-5
type: LogicApplication
conclusion text: ...export certification for vaping goods under subsection (2A).
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Representation of prohibition in knowledge base
modality: CogAI
operator: Knowledge Representation
premise text: (2B) A State or Territory must not issue...

therapeutic-goods-act-1989-sec-58-ss-2b-logic-deontic-1
type: LogicApplication
conclusion text: ...export certification for vaping goods under subsection (2A).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of export certification
modality: Deontic
operator: Prohibit
premise text: (2B) A State or Territory must not issue...

therapeutic-goods-act-1989-sec-58-ss-2b-logic-diffusion-4
type: LogicApplication
conclusion text: ...export certification for vaping goods under subsection (2A).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Propagating prohibition of export certification
modality: Diffusion
operator: Propagation
premise text: (2B) A State or Territory must not issue...

therapeutic-goods-act-1989-sec-58-ss-2b-logic-ltl-3
type: LogicApplication
conclusion text: ...export certification for vaping goods under subsection (2A).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Restriction on export certification timing
modality: LTL
operator: Temporal Restriction
premise text: (2B) A State or Territory must not issue...

58(3) Export certifications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.367
note: Fee for certification application and inspection
asserts: therapeutic-goods-act-1989-sec-58-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-58-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-58-ss-3
schema version: 2
part of: 58 Export certifications

therapeutic-goods-act-1989-sec-58-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Payment of fee is obligatory
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-58-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 58(3) Export certifications

59 Fees
type: Concept
source: therapeutic-goods-act-1989.pdf, p.368
curation status: Proposed
has part: 59(1) Fees
has part: 59(2) Fees
proposed by: legis2cml
realized by: sec-59
schema version: 2

59(1) Fees
type: Concept
source: therapeutic-goods-act-1989.pdf, p.368
note: No fees payable before July 1990
asserts: therapeutic-goods-act-1989-sec-59-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-59-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-59-ss-1
schema version: 2
part of: 59 Fees

therapeutic-goods-act-1989-sec-59-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: No fees payable
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits paying fees before July 1990
modality: Deontic
operator: forbid
premise text: No event occurring before July 1990

59(2) Fees
type: Concept
source: therapeutic-goods-act-1989.pdf, p.368
note: Fees must not amount to taxation.
asserts: therapeutic-goods-act-1989-sec-59-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-59-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-59-ss-2
schema version: 2
part of: 59 Fees

therapeutic-goods-act-1989-sec-59-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on taxing fees
modality: Deontic
operator: MustNot

therapeutic-goods-act-1989-sec-59-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 59(2) Fees

60 Review of decisions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.368
note: Refusal to grant consent or impose conditions on a grant of consent under section 14 or 14A.
asserts: therapeutic-goods-act-1989-sec-60-norm
asserts: therapeutic-goods-act-1989-sec-60-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-60-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-60
schema version: 2

therapeutic-goods-act-1989-sec-60-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of refusal to grant consent or impose conditions.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-60-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of decisions under Part 3-2 (registration and listing of therapeutic goods).
modality: DescriptionLogic
operator: Classify

therapeutic-goods-act-1989-sec-60-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 60 Review of decisions

60A New information on review—discretion to remit
type: Concept
source: therapeutic-goods-act-1989.pdf, p.374
curation status: Proposed
has part: 60A(1) New information on review—discretion to remit
has part: 60A(2) New information on review—discretion to remit
has part: 60A(3) New information on review—discretion to remit
has part: 60A(4) New information on review—discretion to remit
has part: 60A(5) New information on review—discretion to remit
has part: 60A(6) New information on review—discretion to remit
has part: 60A(6A) New information on review—discretion to remit
has part: 60A(7) New information on review—discretion to remit
has part: 60A(8) New information on review—discretion to remit
proposed by: legis2cml
realized by: sec-60a
schema version: 2

60A(1) New information on review—discretion to remit
type: Concept
source: therapeutic-goods-act-1989.pdf, p.374
note: Secretary or delegate has discretion to remit a decision.
asserts: therapeutic-goods-act-1989-sec-60a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-60a-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-60a-ss-1-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-60a-ss-1
schema version: 2
part of: 60A New information on review—discretion to remit

therapeutic-goods-act-1989-sec-60a-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Decision must be made within a specific temporal interval.
modality: AllenInterval
operator: withinTemporalInterval

therapeutic-goods-act-1989-sec-60a-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary or delegate has discretion to remit a decision.
modality: Deontic
operator: hasDiscretion

therapeutic-goods-act-1989-sec-60a-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 60A(1) New information on review—discretion to remit

60A(2) New information on review—discretion to remit
type: Concept
source: therapeutic-goods-act-1989.pdf, p.374
note: Minister must reconsider decision or remit to delegate upon new information.
asserts: therapeutic-goods-act-1989-sec-60a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-60a-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-60a-ss-2
schema version: 2
part of: 60A New information on review—discretion to remit

therapeutic-goods-act-1989-sec-60a-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Minister must reconsider decision.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Minister has obligation to reconsider decision.
modality: Deontic
operator: MUST
premise text: Appellant requests reconsideration.

60A(3) New information on review—discretion to remit
type: Concept
source: therapeutic-goods-act-1989.pdf, p.374
note: Tribunal may remit matter to delegate for fresh decision if it thinks fit.
asserts: therapeutic-goods-act-1989-sec-60a-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-60a-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-60a-ss-3
schema version: 2
part of: 60A New information on review—discretion to remit

therapeutic-goods-act-1989-sec-60a-ss-3-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Tribunal has discretion to remit matter.
modality: Deontic
operator: may

60A(4) New information on review—discretion to remit
type: Concept
source: therapeutic-goods-act-1989.pdf, p.374
note: Tribunal must not remit the matter under subsection (3) if all of initial new information is information that the Minister took into account.
asserts: therapeutic-goods-act-1989-sec-60a-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-60a-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-60a-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-60a-ss-4-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-60a-ss-4
schema version: 2
part of: 60A New information on review—discretion to remit

therapeutic-goods-act-1989-sec-60a-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: Tribunal's discretion to remit is limited by this overlap.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Initial new information overlaps with the Minister's decision on reconsideration.
modality: AllenInterval
operator: Overlaps
premise text: Appellant lodges initial new information.

therapeutic-goods-act-1989-sec-60a-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: Tribunal cannot remit the matter.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Tribunal must not remit the matter.
modality: Deontic
operator: MustNot
premise text: Appellant lodges initial new information.

therapeutic-goods-act-1989-sec-60a-ss-4-logic-ltl-3
type: LogicApplication
conclusion text: Tribunal's discretion to remit is limited by this repetition.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The Minister's decision on reconsideration repeats the initial new information.
modality: LTL
operator: Repeats
premise text: Minister took initial new information into account.

60A(5) New information on review—discretion to remit
type: Concept
source: therapeutic-goods-act-1989.pdf, p.374
note: Tribunal must consider initial new information that indicates unacceptable quality, safety or efficacy of therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-60a-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-60a-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-60a-ss-5-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-60a-ss-5
schema version: 2
part of: 60A New information on review—discretion to remit

therapeutic-goods-act-1989-sec-60a-ss-5-logic-alleninterval-2
type: LogicApplication
conclusion text: Initial new information considered within timeframe
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Tribunal must consider initial new information within a certain timeframe
modality: AllenInterval
operator: >=
premise text: Subsection (3)

therapeutic-goods-act-1989-sec-60a-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: Initial new information considered
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Tribunal must consider initial new information
modality: Deontic
operator: MUST
premise text: Subsection (3)

60A(6) New information on review—discretion to remit
type: Concept
source: therapeutic-goods-act-1989.pdf, p.374
note: Authorised delegate must make a decision under section 25 taking into account new information.
asserts: therapeutic-goods-act-1989-sec-60a-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-60a-ss-6-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-60a-ss-6-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-60a-ss-6-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-60a-ss-6-logic-dialectical-4
asserts: therapeutic-goods-act-1989-sec-60a-ss-6-logic-linearlogic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-60a-ss-6
schema version: 2
part of: 60A New information on review—discretion to remit

therapeutic-goods-act-1989-sec-60a-ss-6-logic-alleninterval-2
type: LogicApplication
conclusion text: the authorised delegate must make a decision under section 25... within the timeframe specified by the provision.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The decision must be made within a specific timeframe.
modality: AllenInterval
operator: BETWEEN
premise text: (6) If...

therapeutic-goods-act-1989-sec-60a-ss-6-logic-argumentation-3
type: LogicApplication
conclusion text: the Minister or Tribunal has discretion to remit the matter.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: The provision implies that the Minister or Tribunal has discretion to remit the matter.
modality: Argumentation
operator: IMPLIES
premise text: (6) If...

therapeutic-goods-act-1989-sec-60a-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: the authorised delegate must make a decision under section 25...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide a decision under section 25.
modality: Deontic
operator: MUST
premise text: (6) If...

therapeutic-goods-act-1989-sec-60a-ss-6-logic-dialectical-4
type: LogicApplication
conclusion text: the provision does not prohibit making a new application for registration.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dialectical
logic summary: The provision is not a prohibition on making a new application for registration.
modality: Dialectical
operator: NOT
premise text: (6) If...

therapeutic-goods-act-1989-sec-60a-ss-6-logic-linearlogic-5
type: LogicApplication
conclusion text: the authorised delegate must make a decision under section 25 and include the biological in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: The provision requires the authorised delegate to make a decision under section 25 and include the biological in the Register.
modality: LinearLogic
operator: AND
premise text: (6) If...

60A(6A) New information on review—discretion to remit
type: Concept
source: therapeutic-goods-act-1989.pdf, p.374
note: The authorised delegate must make a decision under section 41EC, taking into account the initial new information or later new information.
asserts: therapeutic-goods-act-1989-sec-60a-ss-6a-norm
asserts: therapeutic-goods-act-1989-sec-60a-ss-6a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-60a-ss-6a
schema version: 2
part of: 60A New information on review—discretion to remit

therapeutic-goods-act-1989-sec-60a-ss-6a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The authorised delegate must make a decision.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-60a-ss-6a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 60A(6A) New information on review—discretion to remit

60A(7) New information on review—discretion to remit
type: Concept
source: therapeutic-goods-act-1989.pdf, p.374
note: Delegates' decisions are treated as decisions under Part 3-2, 3-2A or 4-4 for subsequent applications.
asserts: therapeutic-goods-act-1989-sec-60a-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-60a-ss-7-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-60a-ss-7-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-60a-ss-7-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-60a-ss-7-logic-cogai-4
asserts: therapeutic-goods-act-1989-sec-60a-ss-7-logic-shacl-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-60a-ss-7
schema version: 2
part of: 60A New information on review—discretion to remit

therapeutic-goods-act-1989-sec-60a-ss-7-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Relates to temporal intervals under Part 3-2, 3-2A or 4-4
modality: AllenInterval
operator: Temporal relation
premise text: (7) To remove any doubt...

therapeutic-goods-act-1989-sec-60a-ss-7-logic-cogai-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Involves knowledge representation under Part 3-2, 3-2A or 4-4
modality: CogAI
operator: Knowledge representation
premise text: (7) To remove any doubt...

therapeutic-goods-act-1989-sec-60a-ss-7-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Treated as decisions under Part 3-2, 3-2A or 4-4
modality: Deontic
operator: Treatment
premise text: (7) To remove any doubt...

therapeutic-goods-act-1989-sec-60a-ss-7-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Involves recurring traces under Part 3-2, 3-2A or 4-4
modality: LTL
operator: Recurring trace
premise text: (7) To remove any doubt...

therapeutic-goods-act-1989-sec-60a-ss-7-logic-shacl-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::shacl
logic summary: Validates schema under Part 3-2, 3-2A or 4-4
modality: SHACL
operator: Schema validation
premise text: (7) To remove any doubt...

therapeutic-goods-act-1989-sec-60a-ss-7-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 60A(7) New information on review—discretion to remit

60A(8) New information on review—discretion to remit
type: Concept
source: therapeutic-goods-act-1989.pdf, p.374
note: Defines authorized delegate and conditions for new information.
asserts: therapeutic-goods-act-1989-sec-60a-ss-8-norm
asserts: therapeutic-goods-act-1989-sec-60a-ss-8-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-60a-ss-8-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-60a-ss-8
schema version: 2
part of: 60A New information on review—discretion to remit

therapeutic-goods-act-1989-sec-60a-ss-8-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exercise of power
modality: Deontic
operator: exercising a power to decide
premise text: (a) exercising a power to decide

therapeutic-goods-act-1989-sec-60a-ss-8-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Includes relevant information
modality: DescriptionLogic
operator: includes
premise text: (a) was in existence at the time the decision referred to in subsection (1) was made; and

therapeutic-goods-act-1989-sec-60a-ss-8-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 60A(8) New information on review—discretion to remit

61 Release of information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.377
curation status: Proposed
has part: 61(1) Release of information
has part: 61(2) Release of information
has part: 61(3) Release of information
has part: 61(3A) Release of information
has part: 61(4) Release of information
has part: 61(4A) Release of information
proposed by: legis2cml
realized by: sec-61
schema version: 2

61(1) Release of information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.377
note: Definition of therapeutic goods information and vaping goods information.
asserts: therapeutic-goods-act-1989-sec-61-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-61-ss-1-logic-descriptionlogic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-61-ss-1
schema version: 2
part of: 61 Release of information

therapeutic-goods-act-1989-sec-61-ss-1-logic-descriptionlogic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Defines terms for the purpose of this section.
modality: DescriptionLogic
operator: definition

therapeutic-goods-act-1989-sec-61-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 61(1) Release of information

61(2) Release of information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.377
note: Release of information to World Health Organisation
asserts: therapeutic-goods-act-1989-sec-61-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-61-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-61-ss-2
schema version: 2
part of: 61 Release of information

therapeutic-goods-act-1989-sec-61-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Information can be released to WHO
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission granted by the State
modality: Deontic
operator: Permit
premise text: The Secretary may release information

therapeutic-goods-act-1989-sec-61-ss-2-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 61(2) Release of information

61(3) Release of information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.377
note: Release of information to authorities for therapeutic goods functions
asserts: therapeutic-goods-act-1989-sec-61-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-61-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-61-ss-3
schema version: 2
part of: 61 Release of information

therapeutic-goods-act-1989-sec-61-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission granted
modality: Deontic
operator: Permit

therapeutic-goods-act-1989-sec-61-ss-3-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 61(3) Release of information

61(3A) Release of information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.377
note: Release of information to certain authorities and bodies.
asserts: therapeutic-goods-act-1989-sec-61-ss-3a-norm
asserts: therapeutic-goods-act-1989-sec-61-ss-3a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-61-ss-3a
schema version: 2
part of: 61 Release of information

therapeutic-goods-act-1989-sec-61-ss-3a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission granted.
modality: Deontic
operator: Permit

61(4) Release of information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.377
note: Release of information to national regulatory authorities of other countries.
asserts: therapeutic-goods-act-1989-sec-61-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-61-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-61-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-61-ss-4-logic-diffusion-3
asserts: therapeutic-goods-act-1989-sec-61-ss-4-logic-cogai-4
asserts: therapeutic-goods-act-1989-sec-61-ss-4-logic-shacl-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-61-ss-4
schema version: 2
part of: 61 Release of information

therapeutic-goods-act-1989-sec-61-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: ...of therapeutic goods and their compliance with the manufacturing principles;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines the temporal scope of the permission.
modality: AllenInterval
operator: Temporal Interval
premise text: (4) The Secretary may release to a national regulatory authority...

therapeutic-goods-act-1989-sec-61-ss-4-logic-cogai-4
type: LogicApplication
conclusion text: ...of therapeutic goods and their compliance with the manufacturing principles;
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Describes how the permission is applied.
modality: CogAI
operator: Reasoning
premise text: (4) The Secretary may release to a national regulatory authority...

therapeutic-goods-act-1989-sec-61-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Allows release of information to national regulatory authorities.
modality: Deontic
operator: Permit

therapeutic-goods-act-1989-sec-61-ss-4-logic-diffusion-3
type: LogicApplication
conclusion text: ...of therapeutic goods and their compliance with the manufacturing principles;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Describes how the permission is disseminated.
modality: Diffusion
operator: Spread
premise text: (4) The Secretary may release to a national regulatory authority...

therapeutic-goods-act-1989-sec-61-ss-4-logic-shacl-5
type: LogicApplication
conclusion text: ...of therapeutic goods and their compliance with the manufacturing principles;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::shacl
logic summary: Describes the validation rules for the permission.
modality: SHACL
operator: Validate
premise text: (4) The Secretary may release to a national regulatory authority...

therapeutic-goods-act-1989-sec-61-ss-4-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 61(4) Release of information

61(4A) Release of information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.377
note: Release of information to authorities and international organisations
asserts: therapeutic-goods-act-1989-sec-61-ss-4a-norm
asserts: therapeutic-goods-act-1989-sec-61-ss-4a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-61-ss-4a-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-61-ss-4a-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-61-ss-4a-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-61-ss-4a-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-61-ss-4a
schema version: 2
part of: 61 Release of information

therapeutic-goods-act-1989-sec-61-ss-4a-logic-alleninterval-2
type: LogicApplication
conclusion text: ...contraventions, or possible contraventions, of Part 5-2 or
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap between release and therapeutic goods information
modality: AllenInterval
operator: Temporal overlap
premise text: (4A) The Secretary may release...

therapeutic-goods-act-1989-sec-61-ss-4a-logic-argumentation-3
type: LogicApplication
conclusion text: ...action taken by the Secretary under Part 5-3;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Implication of release on therapeutic goods information
modality: Argumentation
operator: Implication
premise text: (4A) The Secretary may release...

therapeutic-goods-act-1989-sec-61-ss-4a-logic-cogai-5
type: LogicApplication
conclusion text: ...action taken by the Secretary under section 32HA (about notification and recall of biologicals);
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Inference of release on action taken by the Secretary
modality: CogAI
operator: Inference
premise text: (4A) The Secretary may release...

therapeutic-goods-act-1989-sec-61-ss-4a-logic-deontic-1
type: LogicApplication
conclusion text: ...therapeutic goods information relating to one or more of the following:
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission granted by the Secretary
modality: Deontic
operator: Permit
premise text: (4A) The Secretary may release...

therapeutic-goods-act-1989-sec-61-ss-4a-logic-diffusion-4
type: LogicApplication
conclusion text: ...action taken by the Secretary under section 30EA (about notification and recall of therapeutic goods);
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Propagation of release to action taken by the Secretary
modality: Diffusion
operator: Propagation
premise text: (4A) The Secretary may release...

61A Immunity from civil actions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.385
curation status: Proposed
has part: 61A(1) Immunity from civil actions
has part: 61A(2) Immunity from civil actions
has part: 61A(3) Immunity from civil actions
has part: 61A(4) Immunity from civil actions
proposed by: legis2cml
realized by: sec-61a
schema version: 2

61A(1) Immunity from civil actions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.385
note: No civil action against Commonwealth or protected person for loss/damage/injury caused by their actions.
asserts: therapeutic-goods-act-1989-sec-61a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-61a-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-61a-ss-1
schema version: 2
part of: 61A Immunity from civil actions

therapeutic-goods-act-1989-sec-61a-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes duty on Commonwealth and protected persons.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-61a-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 61A(1) Immunity from civil actions

61A(2) Immunity from civil actions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.385
note: Immunity from civil actions in bad faith
asserts: therapeutic-goods-act-1989-sec-61a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-61a-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-61a-ss-2-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-61a-ss-2-logic-linearlogic-3
asserts: therapeutic-goods-act-1989-sec-61a-ss-2-logic-alleninterval-4
asserts: therapeutic-goods-act-1989-sec-61a-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-61a-ss-2
schema version: 2
part of: 61A Immunity from civil actions

therapeutic-goods-act-1989-sec-61a-ss-2-logic-alleninterval-4
type: LogicApplication
conclusion text: The period of exemption includes acts in bad faith
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Acts in bad faith occur during the period of exemption
modality: AllenInterval
operator: during
premise text: (2) Subsection (1) does not apply to an act or omission in bad faith.

therapeutic-goods-act-1989-sec-61a-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: Exemption implies bad faith
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Inferential relationship between exemption and bad faith
modality: CogAI
operator: inference
premise text: (2) Subsection (1) does not apply to an act or omission in bad faith.

therapeutic-goods-act-1989-sec-61a-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Subsection (1) does not apply to an act or omission in bad faith.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exempts acts in bad faith from civil actions
modality: Deontic
operator: exemption
premise text: (2) Subsection (1) does not apply to an act or omission in bad faith.

therapeutic-goods-act-1989-sec-61a-ss-2-logic-deontic-2
type: LogicApplication
conclusion text: Acts in bad faith are permitted without civil liability
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits acts in bad faith without civil liability
modality: Deontic
operator: permission
premise text: (2) Subsection (1) does not apply to an act or omission in bad faith.

therapeutic-goods-act-1989-sec-61a-ss-2-logic-linearlogic-3
type: LogicApplication
conclusion text: Subsection (1) is excluded for acts in bad faith
confidence: 0.5000
curation status: Proposed
execution surface: modalities::linear
logic summary: Excludes acts in bad faith from general applicability of subsection (1)
modality: LinearLogic
operator: exclusion
premise text: (2) Subsection (1) does not apply to an act or omission in bad faith.

therapeutic-goods-act-1989-sec-61a-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 61A(2) Immunity from civil actions

61A(3) Immunity from civil actions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.385
note: A reference to a failure to make a decision includes a reference to anything omitted to be done.
asserts: therapeutic-goods-act-1989-sec-61a-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-61a-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-61a-ss-3-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-61a-ss-3-logic-linearlogic-3
asserts: therapeutic-goods-act-1989-sec-61a-ss-3-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-61a-ss-3-logic-descriptionlogic-5
asserts: therapeutic-goods-act-1989-sec-61a-ss-3-logic-alleninterval-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-61a-ss-3
schema version: 2
part of: 61A Immunity from civil actions

therapeutic-goods-act-1989-sec-61a-ss-3-logic-alleninterval-6
type: LogicApplication
conclusion text: (3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation for Allen intervals
modality: AllenInterval
operator: during
premise text: (x) during (y) if and only if x starts before y ends.

therapeutic-goods-act-1989-sec-61a-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: (3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Inclusion relation for obligations
modality: Deontic
operator: includes
premise text: (x) includes (y) if and only if x is an obligation that requires y.

therapeutic-goods-act-1989-sec-61a-ss-3-logic-deontic-4
type: LogicApplication
conclusion text: (3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requirement relation for obligations
modality: Deontic
operator: requires
premise text: (x) requires (y) if and only if x is an obligation that necessitates y.

therapeutic-goods-act-1989-sec-61a-ss-3-logic-descriptionlogic-2
type: LogicApplication
conclusion text: (3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Inclusion relation for descriptions
modality: DescriptionLogic
operator: includes
premise text: (x) includes (y) if and only if x is a description that contains y.

therapeutic-goods-act-1989-sec-61a-ss-3-logic-descriptionlogic-5
type: LogicApplication
conclusion text: (3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Containment relation for descriptions
modality: DescriptionLogic
operator: contains
premise text: (x) contains (y) if and only if x is a description that encompasses y.

therapeutic-goods-act-1989-sec-61a-ss-3-logic-linearlogic-3
type: LogicApplication
conclusion text: (3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Inclusion relation for linear logic
modality: LinearLogic
operator: includes
premise text: (x) includes (y) if and only if x is a linear logic statement that implies y.

therapeutic-goods-act-1989-sec-61a-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 61A(3) Immunity from civil actions

61A(4) Immunity from civil actions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.385
note: Protected persons are defined for immunity from civil actions.
asserts: therapeutic-goods-act-1989-sec-61a-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-61a-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-61a-ss-4-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-61a-ss-4
schema version: 2
part of: 61A Immunity from civil actions

therapeutic-goods-act-1989-sec-61a-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a duty on the State.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-61a-ss-4-logic-descriptionlogic-2
type: LogicApplication
conclusion text: protected person means any of the following:
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Defines a class of protected persons.
modality: DescriptionLogic
operator: ClassInclusion
premise text: (a) the Minister;

therapeutic-goods-act-1989-sec-61a-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 61A(4) Immunity from civil actions

62 Protection from criminal responsibility
type: Concept
source: therapeutic-goods-act-1989.pdf, p.386
curation status: Proposed
has part: 62(1) Protection from criminal responsibility
has part: 62(2) Protection from criminal responsibility
has part: 62(3) Protection from criminal responsibility
proposed by: legis2cml
realized by: sec-62
schema version: 2

62(1) Protection from criminal responsibility
type: Concept
source: therapeutic-goods-act-1989.pdf, p.386
note: Protected person not criminally responsible for obtaining or possessing goods to comply with laws.
asserts: therapeutic-goods-act-1989-sec-62-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-62-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-62-ss-1-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-62-ss-1
schema version: 2
part of: 62 Protection from criminal responsibility

therapeutic-goods-act-1989-sec-62-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: Not criminally responsible
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap: Protected person's actions overlap with law compliance
modality: AllenInterval
operator: Overlaps
premise text: Protected person obtains goods for compliance

therapeutic-goods-act-1989-sec-62-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Not criminally responsible
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with laws
modality: Deontic
operator: Obligation
premise text: Protected person obtains goods for compliance

therapeutic-goods-act-1989-sec-62-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 62(1) Protection from criminal responsibility

62(2) Protection from criminal responsibility
type: Concept
source: therapeutic-goods-act-1989.pdf, p.386
note: Protected person not criminally responsible for offense related to conveyance of goods
asserts: therapeutic-goods-act-1989-sec-62-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-62-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-62-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-62-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-62-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-62-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-62-ss-2
schema version: 2
part of: 62 Protection from criminal responsibility

therapeutic-goods-act-1989-sec-62-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: The conveyance of goods overlaps with finding out compliance
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Conveyance of goods overlaps with finding out compliance
modality: AllenInterval
operator: Overlaps
premise text: (2) If a protected person, in connection with finding out whether this Act or the regulations have been complied with...

therapeutic-goods-act-1989-sec-62-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: The other person is not criminally responsible for an offence against a law of the Commonwealth, or a State law...
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Protected person not criminally responsible for offense related to conveyance of goods
modality: CogAI
operator: Inferential
premise text: (2) If a protected person, in connection with finding out whether this Act or the regulations have been complied with...

therapeutic-goods-act-1989-sec-62-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: The other person is not criminally responsible for an offence against a law of the Commonwealth, or a State law...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Protected person not criminally responsible for offense related to conveyance of goods
modality: Deontic
operator: Obligation
premise text: (2) If a protected person, in connection with finding out whether this Act or the regulations have been complied with...

therapeutic-goods-act-1989-sec-62-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: The conveyance of goods diffuses to other persons
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Conveyance of goods diffuses to other persons
modality: Diffusion
operator: Diffuses
premise text: (a) the possession of the goods by the other person, to the extent the possession is in connection with that conveyance of the goods

therapeutic-goods-act-1989-sec-62-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: The conveyance of goods repeats in connection with finding out compliance
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Conveyance of goods repeats in connection with finding out compliance
modality: LTL
operator: Repeats
premise text: (2) If a protected person, in connection with finding out whether this Act or the regulations have been complied with...

therapeutic-goods-act-1989-sec-62-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 62(2) Protection from criminal responsibility

62(3) Protection from criminal responsibility
type: Concept
source: therapeutic-goods-act-1989.pdf, p.386
note: Definition of protected person
asserts: therapeutic-goods-act-1989-sec-62-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-62-ss-3-logic-descriptionlogic-1
asserts: therapeutic-goods-act-1989-sec-62-ss-3-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-62-ss-3-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-62-ss-3-logic-ltl-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-62-ss-3
schema version: 2
part of: 62 Protection from criminal responsibility

therapeutic-goods-act-1989-sec-62-ss-3-logic-alleninterval-2
type: LogicApplication
conclusion text: protected person means any of the following:
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap between two events
modality: AllenInterval
operator: Overlaps
premise text: In this section:

therapeutic-goods-act-1989-sec-62-ss-3-logic-deontic-3
type: LogicApplication
conclusion text: protected person means any of the following:
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Defines a term with a specific meaning
modality: Deontic
operator: Definition
premise text: (3) In this section:

therapeutic-goods-act-1989-sec-62-ss-3-logic-descriptionlogic-1
type: LogicApplication
conclusion text: (b) a person of a kind prescribed by the regulations
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Identifies a class hierarchy
modality: DescriptionLogic
operator: ClassInclusion
premise text: (a) an APS employee in the Department

therapeutic-goods-act-1989-sec-62-ss-3-logic-ltl-4
type: LogicApplication
conclusion text: protected person means any of the following:
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Expresses temporal relationships between events
modality: LTL
operator: TemporalConnective
premise text: In this section:

therapeutic-goods-act-1989-sec-62-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 62(3) Protection from criminal responsibility

63 Regulations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.386
curation status: Proposed
has part: 63(1) Regulations
has part: 63(2) Regulations
has part: 63(3) Regulations
has part: 63(3A) Regulations
has part: 63(4) Regulations
has part: 63(5) Regulations
proposed by: legis2cml
realized by: sec-63
schema version: 2

63(1) Regulations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.386
note: Governor-General may make regulations not inconsistent with the Act.
asserts: therapeutic-goods-act-1989-sec-63-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-63-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-63-ss-1
schema version: 2
part of: 63 Regulations

therapeutic-goods-act-1989-sec-63-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations are permitted.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-63-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 63(1) Regulations

63(2) Regulations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.386
note: Regulations for therapeutic goods and vaping goods
asserts: therapeutic-goods-act-1989-sec-63-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-63-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-63-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-63-ss-2
schema version: 2
part of: 63 Regulations

therapeutic-goods-act-1989-sec-63-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide regulations
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-63-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classify therapeutic goods and vaping goods
modality: DescriptionLogic
operator: CLASSIFICATION

therapeutic-goods-act-1989-sec-63-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 63(2) Regulations

63(3) Regulations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.386
note: Regulations may prescribe different fees under this Act.
asserts: therapeutic-goods-act-1989-sec-63-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-63-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-63-ss-3-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-63-ss-3
schema version: 2
part of: 63 Regulations

therapeutic-goods-act-1989-sec-63-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prescribes obligations
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-63-ss-3-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classify goods into classes
modality: DescriptionLogic
operator: classify
premise text: (i) different classes of goods

therapeutic-goods-act-1989-sec-63-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 63(3) Regulations

63(3A) Regulations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.386
note: Licence or permission to import/export therapeutic goods may be granted.
asserts: therapeutic-goods-act-1989-sec-63-ss-3a-norm
asserts: therapeutic-goods-act-1989-sec-63-ss-3a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-63-ss-3a
schema version: 2
part of: 63 Regulations

therapeutic-goods-act-1989-sec-63-ss-3a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to import/export therapeutic goods.
modality: Deontic
operator: Grant

63(4) Regulations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.386
note: Regulations may incorporate existing instruments or writings.
asserts: therapeutic-goods-act-1989-sec-63-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-63-ss-4
schema version: 2
part of: 63 Regulations

63(5) Regulations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.386
note: Regulations may be made before commencement.
asserts: therapeutic-goods-act-1989-sec-63-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-63-ss-5
schema version: 2
part of: 63 Regulations

66 Transitional arrangements for goods required to be registered or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.390
curation status: Proposed
has part: 66(1) Transitional arrangements for goods required to be registered or
has part: 66(2) Transitional arrangements for goods required to be registered or
has part: 66(3) Transitional arrangements for goods required to be registered or
has part: 66(3A) Transitional arrangements for goods required to be registered or
has part: 66(4) Transitional arrangements for goods required to be registered or
has part: 66(4A) Transitional arrangements for goods required to be registered or
has part: 66(4B) Transitional arrangements for goods required to be registered or
has part: 66(4C) Transitional arrangements for goods required to be registered or
has part: 66(5) Transitional arrangements for goods required to be registered or
has part: 66(6) Transitional arrangements for goods required to be registered or
proposed by: legis2cml
realized by: sec-66
schema version: 2

66(1) Transitional arrangements for goods required to be registered or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.390
note: Therapeutic goods supplying person must comply with transitional arrangements.
asserts: therapeutic-goods-act-1989-sec-66-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-66-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-66-ss-1
schema version: 2
part of: 66 Transitional arrangements for goods required to be registered or

therapeutic-goods-act-1989-sec-66-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Therapeutic goods supplying person must comply with transitional arrangements.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-66-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 66(1) Transitional arrangements for goods required to be registered or

66(2) Transitional arrangements for goods required to be registered or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.390
note: Exemptions from subsection 20(1) and (2) for certain individuals
asserts: therapeutic-goods-act-1989-sec-66-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-66-ss-2
schema version: 2
part of: 66 Transitional arrangements for goods required to be registered or

therapeutic-goods-act-1989-sec-66-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 66(2) Transitional arrangements for goods required to be registered or

66(3) Transitional arrangements for goods required to be registered or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.390
note: Therapeutic goods registration application within 3 months after commencement.
asserts: therapeutic-goods-act-1989-sec-66-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-66-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-66-ss-3
schema version: 2
part of: 66 Transitional arrangements for goods required to be registered or

therapeutic-goods-act-1989-sec-66-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Therapeutic goods registration application within 3 months after commencement.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-66-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 66(3) Transitional arrangements for goods required to be registered or

66(3A) Transitional arrangements for goods required to be registered or
type: Concept
description: Written notice
source: therapeutic-goods-act-1989.pdf, p.390
note: Notice must be given to person in relation to whom goods are registered.
asserts: therapeutic-goods-act-1989-sec-66-ss-3a-norm
asserts: therapeutic-goods-act-1989-sec-66-ss-3a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-66-ss-3a
schema version: 2
part of: 66 Transitional arrangements for goods required to be registered or

therapeutic-goods-act-1989-sec-66-ss-3a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Notice must be given
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-66-ss-3a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 66(3A) Transitional arrangements for goods required to be registered or

66(4) Transitional arrangements for goods required to be registered or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.390
note: No application fee for registration or listing of goods.
asserts: therapeutic-goods-act-1989-sec-66-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-66-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-66-ss-4
schema version: 2
part of: 66 Transitional arrangements for goods required to be registered or

therapeutic-goods-act-1989-sec-66-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: No fee for evaluation of goods
modality: Deontic
operator: !

therapeutic-goods-act-1989-sec-66-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 66(4) Transitional arrangements for goods required to be registered or

66(4A) Transitional arrangements for goods required to be registered or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.390
note: Transitional arrangements for goods required to be registered or
asserts: therapeutic-goods-act-1989-sec-66-ss-4a-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-66-ss-4a
schema version: 2
part of: 66 Transitional arrangements for goods required to be registered or

66(4B) Transitional arrangements for goods required to be registered or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.390
note: Secretary may give written notice to person listed goods
asserts: therapeutic-goods-act-1989-sec-66-ss-4b-norm
asserts: therapeutic-goods-act-1989-sec-66-ss-4b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-66-ss-4b
schema version: 2
part of: 66 Transitional arrangements for goods required to be registered or

therapeutic-goods-act-1989-sec-66-ss-4b-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Implies obligation
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-66-ss-4b-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 66(4B) Transitional arrangements for goods required to be registered or

66(4C) Transitional arrangements for goods required to be registered or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.390
note: If notice is given under subsection (4B), section 26 applies as if the person in relation to whom the goods are listed were an applicant for the listing of the goods.
asserts: therapeutic-goods-act-1989-sec-66-ss-4c-norm
asserts: therapeutic-goods-act-1989-sec-66-ss-4c-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-66-ss-4c
schema version: 2
part of: 66 Transitional arrangements for goods required to be registered or

therapeutic-goods-act-1989-sec-66-ss-4c-logic-deontic-1
type: LogicApplication
conclusion text: Section 26 applies
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Conditional obligation
modality: Deontic
operator: if-then
premise text: Notice is given under subsection (4B)

therapeutic-goods-act-1989-sec-66-ss-4c-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 66(4C) Transitional arrangements for goods required to be registered or

66(5) Transitional arrangements for goods required to be registered or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.390
note: Exemption from Section 21 for goods during transitional period
asserts: therapeutic-goods-act-1989-sec-66-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-66-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-66-ss-5
schema version: 2
part of: 66 Transitional arrangements for goods required to be registered or

therapeutic-goods-act-1989-sec-66-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exempts goods from Section 21 during transitional period
modality: Deontic
operator: exemption

therapeutic-goods-act-1989-sec-66-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 66(5) Transitional arrangements for goods required to be registered or

66(6) Transitional arrangements for goods required to be registered or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.390
note: No liability attaches to Commonwealth, Secretary, or delegate for losses caused by therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-66-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-66-ss-6-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-66-ss-6-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-66-ss-6-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-66-ss-6-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-66-ss-6-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-66-ss-6
schema version: 2
part of: 66 Transitional arrangements for goods required to be registered or

therapeutic-goods-act-1989-sec-66-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: No liability attaches
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: No liability implies loss or damage
modality: Deontic
operator: Implies
premise text: Loss or damage occurs

therapeutic-goods-act-1989-sec-66-ss-6-logic-deontic-3
type: LogicApplication
conclusion text: The Commonwealth, Secretary, or delegate is not responsible for losses
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: No liability implies lack of responsibility
modality: Deontic
operator: Implies
premise text: Lack of liability implies no responsibility

therapeutic-goods-act-1989-sec-66-ss-6-logic-deontic-5
type: LogicApplication
conclusion text: The Commonwealth, Secretary, or delegate must provide compensation
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: This section implies a duty to provide compensation for losses caused by therapeutic goods
modality: Deontic
operator: Implies
premise text: Losses are caused by therapeutic goods subject to this section

therapeutic-goods-act-1989-sec-66-ss-6-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Loss or damage is covered by this section
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Therapeutic goods are a subclass of goods subject to this section
modality: DescriptionLogic
operator: SubClassOf
premise text: This section applies to therapeutic goods

therapeutic-goods-act-1989-sec-66-ss-6-logic-ltl-4
type: LogicApplication
conclusion text: No liability attaches until this section applies
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Liability attaches until loss or damage is covered by this section
modality: LTL
operator: Until
premise text: Loss or damage occurs before this section applies

therapeutic-goods-act-1989-sec-66-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 66(6) Transitional arrangements for goods required to be registered or

67 Transitional provision for therapeutic goods for export only
type: Concept
source: therapeutic-goods-act-1989.pdf, p.392
note: Therapeutic goods manufactured in Australia solely for export from Australia are exempt from Section 20 during the first 6 months after commencement.
asserts: therapeutic-goods-act-1989-sec-67-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-67
schema version: 2

68 Transitional arrangements for Part 3-3
type: Concept
source: therapeutic-goods-act-1989.pdf, p.392
curation status: Proposed
has part: 68(1) Transitional arrangements for Part 3-3
has part: 68(2) Transitional arrangements for Part 3-3
has part: 68(3) Transitional arrangements for Part 3-3
proposed by: legis2cml
realized by: sec-68
schema version: 2

68(1) Transitional arrangements for Part 3-3
type: Concept
source: therapeutic-goods-act-1989.pdf, p.392
note: Applicability of transitional arrangements for Part 3-3
asserts: therapeutic-goods-act-1989-sec-68-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-68-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-68-ss-1
schema version: 2
part of: 68 Transitional arrangements for Part 3-3

therapeutic-goods-act-1989-sec-68-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...to a person in relation to premises in Australia if...
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Transitional arrangement applies to a step in the manufacture of therapeutic goods
modality: Deontic
operator: applies
premise text: (1) This section applies...

therapeutic-goods-act-1989-sec-68-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 68(1) Transitional arrangements for Part 3-3

68(2) Transitional arrangements for Part 3-3
type: Concept
source: therapeutic-goods-act-1989.pdf, p.392
note: No prosecution for 4 months after commencement
asserts: therapeutic-goods-act-1989-sec-68-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-68-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-68-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-68-ss-2-logic-diffusion-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-68-ss-2
schema version: 2
part of: 68 Transitional arrangements for Part 3-3

therapeutic-goods-act-1989-sec-68-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: subsection 35(1) does not apply
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap of 4 months
modality: AllenInterval
operator: Overlaps
premise text: (a) this section applies to a step in the manufacture...

therapeutic-goods-act-1989-sec-68-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: subsection 35(1) does not apply
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to not prosecute
modality: Deontic
operator: Obligation
premise text: (2) Where...

therapeutic-goods-act-1989-sec-68-ss-2-logic-diffusion-3
type: LogicApplication
conclusion text: subsection 35(1) does not apply
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusion of obligation to not prosecute
modality: Diffusion
operator: Diffuses
premise text: (2) Where...

therapeutic-goods-act-1989-sec-68-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 68(2) Transitional arrangements for Part 3-3

68(3) Transitional arrangements for Part 3-3
type: Concept
source: therapeutic-goods-act-1989.pdf, p.392
note: Application for licence must be made within 4 months after commencement.
asserts: therapeutic-goods-act-1989-sec-68-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-68-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-68-ss-3
schema version: 2
part of: 68 Transitional arrangements for Part 3-3

therapeutic-goods-act-1989-sec-68-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application for licence must be made within 4 months after commencement.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-68-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 68(3) Transitional arrangements for Part 3-3

69 Continuation of standards and requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.393
note: Continues standards and requirements from Therapeutic Goods Act 1966.
asserts: therapeutic-goods-act-1989-sec-69-norm
asserts: therapeutic-goods-act-1989-sec-69-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-69-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-69
schema version: 2

therapeutic-goods-act-1989-sec-69-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Continues existing standards and requirements.
modality: Deontic
operator: CONTINUE

therapeutic-goods-act-1989-sec-69-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Continues standards and requirements from Therapeutic Goods Act 1966.
modality: DescriptionLogic
operator: SUBCLASS_OF

7 July 1997
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: Amendment of schedule
asserts: therapeutic-goods-act-1989-sec-7-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-7
schema version: 2

9 June 2006
type: Concept
source: therapeutic-goods-act-1989.pdf, p.401
note: Commencement of Sch 1
asserts: therapeutic-goods-act-1989-sec-9-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-9
schema version: 2

Therapeutic Goods Act 1989
type: Document
date: 5 September 2025
identifier: No. 21 of 1990
curation status: Proposed
proposed by: legis2cml
category: AU