1 Short title
type: Concept
source: therapeutic-goods-act-1989.pdf, p.17
note: Citation of the Act
asserts: therapeutic-goods-act-1989-sec-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-1
schema version: 2

1 March 2024 and end on 31 March 2024 (see section 30EIA).
type: Concept
source: therapeutic-goods-act-1989.pdf, p.230
curation status: Proposed
has part: 1(1) March 2024 and end on 31 March 2024 (see section 30EIA).
has part: 1(2) March 2024 and end on 31 March 2024 (see section 30EIA).
has part: 1(3) March 2024 and end on 31 March 2024 (see section 30EIA).
proposed by: legis2cml
realized by: sec-1-2
schema version: 2

1(1) March 2024 and end on 31 March 2024 (see section 30EIA).
type: Concept
description: Change in medicine shortage period
source: therapeutic-goods-act-1989.pdf, p.230
note: Notify Secretary of change to medicine shortage period within specified timeframe.
asserts: therapeutic-goods-act-1989-sec-1-2-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-1-2-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-1-2-ss-1-logic-epistemic-2
asserts: therapeutic-goods-act-1989-sec-1-2-ss-1-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-1-2-ss-1
schema version: 2
part of: 1 March 2024 and end on 31 March 2024 (see section 30EIA).

therapeutic-goods-act-1989-sec-1-2-ss-1-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-1-2-ss-1-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Knowledge of change in shortage period
modality: Epistemic
operator: KNOWS

therapeutic-goods-act-1989-sec-1-2-ss-1-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal relation between notification and change
modality: LTL
operator: BUT

therapeutic-goods-act-1989-sec-1-2-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 1(1) March 2024 and end on 31 March 2024 (see section 30EIA).

1(2) March 2024 and end on 31 March 2024 (see section 30EIA).
type: Concept
description: Notification requirements
source: therapeutic-goods-act-1989.pdf, p.230
note: Notify Secretary of shortage resolution within 2 working days or 10 working days.
asserts: therapeutic-goods-act-1989-sec-1-2-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-1-2-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-1-2-ss-2-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-1-2-ss-2
schema version: 2
part of: 1 March 2024 and end on 31 March 2024 (see section 30EIA).

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

therapeutic-goods-act-1989-sec-1-2-ss-2-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Should reasonably know of shortage end date.
modality: Epistemic
operator: OUGHT

therapeutic-goods-act-1989-sec-1-2-ss-2-norm
type: Obligation
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 1(2) March 2024 and end on 31 March 2024 (see section 30EIA).

1(3) March 2024 and end on 31 March 2024 (see section 30EIA).
type: Concept
description: period of shortage, day period ended
source: therapeutic-goods-act-1989.pdf, p.230
note: Notification requirements for shortage of medicine in Australia.
asserts: therapeutic-goods-act-1989-sec-1-2-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-1-2-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-1-2-ss-3
schema version: 2
part of: 1 March 2024 and end on 31 March 2024 (see section 30EIA).

therapeutic-goods-act-1989-sec-1-2-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Notification requirements
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-1-2-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 1(3) March 2024 and end on 31 March 2024 (see section 30EIA).

10 Determination of standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.74
curation status: Proposed
has part: 10(1) Determination of standards
has part: 10(2) Determination of standards
has part: 10(3) Determination of standards
has part: 10(3A) Determination of standards
has part: 10(4) Determination of standards
proposed by: legis2cml
realized by: sec-10
schema version: 2

10(1) Determination of standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.74
note: The Minister may make an order determining standards for therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-10-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-10-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-10-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-10-ss-1
schema version: 2
part of: 10 Determination of standards

therapeutic-goods-act-1989-sec-10-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to determine standards
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-10-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Therapeutic goods or class of therapeutic goods
modality: DescriptionLogic
operator: Classifies

10(2) Determination of standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.74
note: Establishing standards for therapeutic goods may be specified by reference to various factors.
asserts: therapeutic-goods-act-1989-sec-10-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-10-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-10-ss-2-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-10-ss-2-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-10-ss-2-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-10-ss-2-logic-alleninterval-5
asserts: therapeutic-goods-act-1989-sec-10-ss-2-logic-ltl-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-10-ss-2
schema version: 2
part of: 10 Determination of standards

therapeutic-goods-act-1989-sec-10-ss-2-logic-alleninterval-5
type: LogicApplication
conclusion text: ...or (vii)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Establishing standards for therapeutic goods may be done within a specified time frame.
modality: AllenInterval
operator: within a specified time frame
premise text: (2) Without limiting the generality of subsection (1), an order establishing a standard for therapeutic goods may...

therapeutic-goods-act-1989-sec-10-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...or (vii) a standard published by Standards Australia; or ...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires the specification of standards for therapeutic goods.
modality: Deontic
operator: requires
premise text: (2) Without limiting the generality of subsection (1), an order establishing a standard for therapeutic goods may...

therapeutic-goods-act-1989-sec-10-ss-2-logic-deontic-3
type: LogicApplication
conclusion text: ...or (c)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires the determination of matters relating to standards for therapeutic goods.
modality: Deontic
operator: requires
premise text: (b) require that a matter relating to the standard be determined in accordance with a particular test;...

therapeutic-goods-act-1989-sec-10-ss-2-logic-deontic-4
type: LogicApplication
conclusion text: ...or (d)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires therapeutic goods or a class of therapeutic goods to be labelled or packaged in a manner specified in the order.
modality: Deontic
operator: requires
premise text: (c) require that therapeutic goods or a class of therapeutic goods identified in the order be labelled or packaged in a manner, or kept in containers that comply with requirements, specified in the order.

therapeutic-goods-act-1989-sec-10-ss-2-logic-descriptionlogic-2
type: LogicApplication
conclusion text: ...or (v)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Specifies standards for therapeutic goods by reference to various factors.
modality: DescriptionLogic
operator: is specified by reference to
premise text: (a) be specified by reference to:...

therapeutic-goods-act-1989-sec-10-ss-2-logic-ltl-6
type: LogicApplication
conclusion text: ...or (viii)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Establishing standards for therapeutic goods may be done in a recurring manner.
modality: LTL
operator: recurring trace
premise text: (2) Without limiting the generality of subsection (1), an order establishing a standard for therapeutic goods may...

therapeutic-goods-act-1989-sec-10-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 10(2) Determination of standards

10(3) Determination of standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.74
note: Directs particulars to be set out on a label or package of therapeutic goods
asserts: therapeutic-goods-act-1989-sec-10-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-10-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-10-ss-3-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-10-ss-3-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-10-ss-3-logic-argumentation-4
asserts: therapeutic-goods-act-1989-sec-10-ss-3-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-10-ss-3-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-10-ss-3
schema version: 2
part of: 10 Determination of standards

therapeutic-goods-act-1989-sec-10-ss-3-logic-alleninterval-3
type: LogicApplication
conclusion text: such particulars as are required by the order.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Establishes relation between particulars and order
modality: AllenInterval
operator: between
premise text: (3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard...

therapeutic-goods-act-1989-sec-10-ss-3-logic-argumentation-4
type: LogicApplication
conclusion text: such particulars as are required by the order.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Implies that particulars must be set out if order is established
modality: Argumentation
operator: implies
premise text: (3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard...

therapeutic-goods-act-1989-sec-10-ss-3-logic-cogai-6
type: LogicApplication
conclusion text: such particulars as are required by the order.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Recognizes requirement to set out particulars
modality: CogAI
operator: recognizes
premise text: (3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard...

therapeutic-goods-act-1989-sec-10-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: such particulars as are required by the order.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires particulars to be set out
modality: Deontic
operator: requires
premise text: (3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard...

therapeutic-goods-act-1989-sec-10-ss-3-logic-descriptionlogic-2
type: LogicApplication
conclusion text: or (b) a container or package containing therapeutic goods or a class of therapeutic goods identified in the order;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Identifies particulars to be set out
modality: DescriptionLogic
operator: identifies
premise text: (a) therapeutic goods or a class of therapeutic goods identified in the order;

therapeutic-goods-act-1989-sec-10-ss-3-logic-diffusion-5
type: LogicApplication
conclusion text: such particulars as are required by the order.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses requirement to set out particulars
modality: Diffusion
operator: diffuses
premise text: (3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard...

10(3A) Determination of standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.74
note: Variation or revocation of orders made under subsection (1)
asserts: therapeutic-goods-act-1989-sec-10-ss-3a-norm
asserts: therapeutic-goods-act-1989-sec-10-ss-3a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-10-ss-3a
schema version: 2
part of: 10 Determination of standards

therapeutic-goods-act-1989-sec-10-ss-3a-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to vary or revoke orders
modality: Deontic
operator: may

10(4) Determination of standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.74
note: May incorporate existing provisions from instruments or writings.
asserts: therapeutic-goods-act-1989-sec-10-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-10-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-10-ss-4
schema version: 2
part of: 10 Determination of standards

therapeutic-goods-act-1989-sec-10-ss-4-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to incorporate existing provisions
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-10-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 10(4) Determination of standards

13 Special provisions relating to Ministerial standards and default
type: Concept
source: therapeutic-goods-act-1989.pdf, p.76
curation status: Proposed
has part: 13(1) Special provisions relating to Ministerial standards and default
has part: 13(2) Special provisions relating to Ministerial standards and default
has part: 13(3) Special provisions relating to Ministerial standards and default
has part: 13(4) Special provisions relating to Ministerial standards and default
has part: 13(5) Special provisions relating to Ministerial standards and default
has part: 13(6) Special provisions relating to Ministerial standards and default
has part: 13(7) Special provisions relating to Ministerial standards and default
proposed by: legis2cml
realized by: sec-13
schema version: 2

13(1) Special provisions relating to Ministerial standards and default
type: Concept
source: therapeutic-goods-act-1989.pdf, p.76
note: Statement in one publication is taken to include another statement.
asserts: therapeutic-goods-act-1989-sec-13-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-13-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-13-ss-1
schema version: 2
part of: 13 Special provisions relating to Ministerial standards and default

therapeutic-goods-act-1989-sec-13-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Main statement includes other statement.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Equivalence of statements
modality: Deontic
operator: =
premise text: Statement in one publication is taken to include another statement.

therapeutic-goods-act-1989-sec-13-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 13(1) Special provisions relating to Ministerial standards and default

13(2) Special provisions relating to Ministerial standards and default
type: Concept
source: therapeutic-goods-act-1989.pdf, p.76
note: Disregard inconsistent requirements for therapeutic goods
asserts: therapeutic-goods-act-1989-sec-13-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-13-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-13-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-13-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-13-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-13-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-13-ss-2
schema version: 2
part of: 13 Special provisions relating to Ministerial standards and default

therapeutic-goods-act-1989-sec-13-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: ...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Overlaps with inconsistent requirements
modality: AllenInterval
operator: Overlap
premise text: (2) If...

therapeutic-goods-act-1989-sec-13-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: ...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Overlaps with inconsistent requirements
modality: CogAI
operator: Overlap
premise text: (2) If...

therapeutic-goods-act-1989-sec-13-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits inconsistent requirements
modality: Deontic
operator: Prohibit
premise text: (2) If...

therapeutic-goods-act-1989-sec-13-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: ...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Overlaps with inconsistent requirements
modality: Diffusion
operator: Overlap
premise text: (2) If...

therapeutic-goods-act-1989-sec-13-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: ...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Overlaps with inconsistent requirements
modality: LTL
operator: Overlap
premise text: (2) If...

13(3) Special provisions relating to Ministerial standards and default
type: Concept
source: therapeutic-goods-act-1989.pdf, p.76
note: If two default standards apply to different parts of a class of therapeutic goods, the more restrictive standard applies.
asserts: therapeutic-goods-act-1989-sec-13-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-13-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-13-ss-3-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-13-ss-3
schema version: 2
part of: 13 Special provisions relating to Ministerial standards and default

therapeutic-goods-act-1989-sec-13-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: (3) If: (a) a default standard applies to a class of therapeutic goods; and (b) another default standard applies to only some of the therapeutic goods within that class; and (c) those standards are inconsistent; then the standard referred to in paragraph (a) does not apply in relation to the goods referred to in paragraph (b).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: If A implies B and C, then if A, B.
modality: Deontic
operator: implies
premise text: (a) a default standard applies to a class of therapeutic goods; (b) another default standard applies to only some of the therapeutic goods within that class; (c) those standards are inconsistent;

therapeutic-goods-act-1989-sec-13-ss-3-logic-descriptionlogic-2
type: LogicApplication
conclusion text: the standard referred to in paragraph (a) does not apply in relation to the goods referred to in paragraph (b).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: The excerpt defines a subclass relationship between two default standards.
modality: DescriptionLogic
operator: subClassOf
premise text: (a) a default standard applies to a class of therapeutic goods; and (b) another default standard applies to only some of the therapeutic goods within that class;

therapeutic-goods-act-1989-sec-13-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 13(3) Special provisions relating to Ministerial standards and default

13(4) Special provisions relating to Ministerial standards and default
type: Concept
source: therapeutic-goods-act-1989.pdf, p.76
note: Therapeutic goods with a mixture of ingredients or component parts do not have to meet the default standard.
asserts: therapeutic-goods-act-1989-sec-13-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-13-ss-4-logic-alleninterval-1
asserts: therapeutic-goods-act-1989-sec-13-ss-4-logic-ltl-2
asserts: therapeutic-goods-act-1989-sec-13-ss-4-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-13-ss-4-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-13-ss-4
schema version: 2
part of: 13 Special provisions relating to Ministerial standards and default

therapeutic-goods-act-1989-sec-13-ss-4-logic-alleninterval-1
type: LogicApplication
conclusion text: The default standard does not apply if it is not applicable at the time of manufacture.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for applicability
modality: AllenInterval
operator: <
premise text: (4) If a default standard is applicable to one or more of the ingredients or one or more of the component parts; and

therapeutic-goods-act-1989-sec-13-ss-4-logic-deontic-3
type: LogicApplication
conclusion text: The standard does not apply if it is not applicable at the time of manufacture.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to meet standard
modality: Deontic
operator: =
premise text: If a default standard is applicable to one or more of the ingredients or one or more of the component parts; and

therapeutic-goods-act-1989-sec-13-ss-4-logic-deontic-4
type: LogicApplication
conclusion text: The standard does not apply if it is not applicable at the time of manufacture.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to meet standard
modality: Deontic
operator: =
premise text: (c) a default standard is applicable to the mixture or combination;

therapeutic-goods-act-1989-sec-13-ss-4-logic-ltl-2
type: LogicApplication
conclusion text: The default standard does not apply if it is not applicable at the time of manufacture.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal interval for applicability
modality: LTL
operator: <
premise text: (4) If a default standard is applicable to one or more of the ingredients or one or more of the component parts; and

therapeutic-goods-act-1989-sec-13-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 13(4) Special provisions relating to Ministerial standards and default

13(5) Special provisions relating to Ministerial standards and default
type: Concept
source: therapeutic-goods-act-1989.pdf, p.76
note: Minister may determine standard does not apply to therapeutic goods
asserts: therapeutic-goods-act-1989-sec-13-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-13-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-13-ss-5
schema version: 2
part of: 13 Special provisions relating to Ministerial standards and default

therapeutic-goods-act-1989-sec-13-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Minister has the power to determine a standard does not apply
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-13-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 13(5) Special provisions relating to Ministerial standards and default

13(6) Special provisions relating to Ministerial standards and default
type: Concept
source: therapeutic-goods-act-1989.pdf, p.76
note: An order under subsection (5) is not a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-13-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-13-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-13-ss-6
schema version: 2
part of: 13 Special provisions relating to Ministerial standards and default

therapeutic-goods-act-1989-sec-13-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: is not a legislative instrument.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Negative obligation
modality: Deontic
operator: not
premise text: (6) An order under subsection (5)

13(7) Special provisions relating to Ministerial standards and default
type: Concept
source: therapeutic-goods-act-1989.pdf, p.76
note: If multiple default standards apply, they are taken not to apply if goods conform with at least one but not all.
asserts: therapeutic-goods-act-1989-sec-13-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-13-ss-7-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-13-ss-7
schema version: 2
part of: 13 Special provisions relating to Ministerial standards and default

therapeutic-goods-act-1989-sec-13-ss-7-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Negation of obligation
modality: Deontic
operator: ¬

13A Special provisions relating to homoeopathic standards and
type: Concept
source: therapeutic-goods-act-1989.pdf, p.77
note: If a statement in a monograph refers to another statement, the main statement includes the other statement.
asserts: therapeutic-goods-act-1989-sec-13a-norm
asserts: therapeutic-goods-act-1989-sec-13a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-13a
schema version: 2

therapeutic-goods-act-1989-sec-13a-logic-deontic-1
type: LogicApplication
conclusion text: Statement A includes Statement B
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Includes other statement when referring to it
modality: Deontic
operator: includes
premise text: Statement A refers to Statement B

therapeutic-goods-act-1989-sec-13a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 13A Special provisions relating to homoeopathic standards and

14 Criminal offences for importing, supplying or exporting goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.78
curation status: Proposed
has part: 14(1) Criminal offences for importing, supplying or exporting goods
has part: 14(4) Criminal offences for importing, supplying or exporting goods
has part: 14(4A) Criminal offences for importing, supplying or exporting goods
has part: 14(4B) Criminal offences for importing, supplying or exporting goods
has part: 14(5A) Criminal offences for importing, supplying or exporting goods
has part: 14(6) Criminal offences for importing, supplying or exporting goods
proposed by: legis2cml
realized by: sec-14
schema version: 2

14(1) Criminal offences for importing, supplying or exporting goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.78
note: Importing therapeutic goods without consent is prohibited.
asserts: therapeutic-goods-act-1989-sec-14-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-14-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-14-ss-1
schema version: 2
part of: 14 Criminal offences for importing, supplying or exporting goods

therapeutic-goods-act-1989-sec-14-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the importation of therapeutic goods without consent.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-14-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 14(1) Criminal offences for importing, supplying or exporting goods

14(4) Criminal offences for importing, supplying or exporting goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.78
note: Importing therapeutic goods without consent is prohibited.
asserts: therapeutic-goods-act-1989-sec-14-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-14-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-14-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-14-ss-4-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-14-ss-4
schema version: 2
part of: 14 Criminal offences for importing, supplying or exporting goods

therapeutic-goods-act-1989-sec-14-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: The person commits an offence if they import therapeutic goods during this time.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The prohibition applies during the time of importing therapeutic goods.
modality: AllenInterval
operator: During
premise text: (4) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging). Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.

therapeutic-goods-act-1989-sec-14-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: The person commits an offence if they import therapeutic goods without consent.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits importing therapeutic goods without consent.
modality: Deontic
operator: Prohibit
premise text: (4) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging). Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.

therapeutic-goods-act-1989-sec-14-ss-4-logic-ltl-3
type: LogicApplication
conclusion text: The person commits an offence if they import therapeutic goods repeatedly without consent.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The prohibition is recurring and applies to each instance of importing therapeutic goods.
modality: LTL
operator: Recurring
premise text: (4) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging). Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.

therapeutic-goods-act-1989-sec-14-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 14(4) Criminal offences for importing, supplying or exporting goods

14(4A) Criminal offences for importing, supplying or exporting goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.78
note: Importing therapeutic goods without consent is prohibited.
asserts: therapeutic-goods-act-1989-sec-14-ss-4a-norm
asserts: therapeutic-goods-act-1989-sec-14-ss-4a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-14-ss-4a
schema version: 2
part of: 14 Criminal offences for importing, supplying or exporting goods

therapeutic-goods-act-1989-sec-14-ss-4a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits importing therapeutic goods without consent.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-14-ss-4a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 14(4A) Criminal offences for importing, supplying or exporting goods

14(4B) Criminal offences for importing, supplying or exporting goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.78
note: Criminal offences for importing, supplying or exporting goods
asserts: therapeutic-goods-act-1989-sec-14-ss-4b-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-14-ss-4b
schema version: 2
part of: 14 Criminal offences for importing, supplying or exporting goods

therapeutic-goods-act-1989-sec-14-ss-4b-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 14(4B) Criminal offences for importing, supplying or exporting goods

14(5A) Criminal offences for importing, supplying or exporting goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.78
note: Exemptions from subsection (1), (4) or (4A)
asserts: therapeutic-goods-act-1989-sec-14-ss-5a-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-14-ss-5a
schema version: 2
part of: 14 Criminal offences for importing, supplying or exporting goods

14(6) Criminal offences for importing, supplying or exporting goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.78
note: Importing, supplying or exporting goods without a license is prohibited.
asserts: therapeutic-goods-act-1989-sec-14-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-14-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-14-ss-6
schema version: 2
part of: 14 Criminal offences for importing, supplying or exporting goods

therapeutic-goods-act-1989-sec-14-ss-6-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the action.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-14-ss-6-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 14(6) Criminal offences for importing, supplying or exporting goods

14A Civil penalties for importing, supplying or exporting goods that
type: Concept
source: therapeutic-goods-act-1989.pdf, p.83
curation status: Proposed
has part: 14A(1) Civil penalties for importing, supplying or exporting goods that
has part: 14A(1A) Civil penalties for importing, supplying or exporting goods that
proposed by: legis2cml
realized by: sec-14a
schema version: 2

14A(1) Civil penalties for importing, supplying or exporting goods that
type: Concept
source: therapeutic-goods-act-1989.pdf, p.83
note: Importing therapeutic goods without consent
asserts: therapeutic-goods-act-1989-sec-14a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-14a-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-14a-ss-1
schema version: 2
part of: 14A Civil penalties for importing, supplying or exporting goods that

therapeutic-goods-act-1989-sec-14a-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits importing therapeutic goods without consent
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-14a-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 14A(1) Civil penalties for importing, supplying or exporting goods that

14A(1A) Civil penalties for importing, supplying or exporting goods that
type: Concept
source: therapeutic-goods-act-1989.pdf, p.83
note: Exempts biological goods from subsection (1) of section 14A(1)
asserts: therapeutic-goods-act-1989-sec-14a-ss-1a-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-14a-ss-1a
schema version: 2
part of: 14A Civil penalties for importing, supplying or exporting goods that

therapeutic-goods-act-1989-sec-14a-ss-1a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 14A(1A) Civil penalties for importing, supplying or exporting goods that

14B Application of Customs Act 1901
type: Concept
source: therapeutic-goods-act-1989.pdf, p.85
note: Customs Act 1901 applies to importation or exportation of goods if notified by Secretary.
asserts: therapeutic-goods-act-1989-sec-14b-norm
asserts: therapeutic-goods-act-1989-sec-14b-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-14b-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-14b-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-14b-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-14b-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-14b
schema version: 2

therapeutic-goods-act-1989-sec-14b-logic-alleninterval-2
type: LogicApplication
conclusion text: Customs Act 1901 has effect.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Customs Act 1901 applies during importation or exportation.
modality: AllenInterval
operator: during
premise text: Importation or exportation occurs.

therapeutic-goods-act-1989-sec-14b-logic-argumentation-3
type: LogicApplication
conclusion text: Customs Act 1901 has effect.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Secretary's notification implies Customs Act 1901 applies.
modality: Argumentation
operator: implies
premise text: Secretary notifies Comptroller-General of Customs.

therapeutic-goods-act-1989-sec-14b-logic-cogai-5
type: LogicApplication
conclusion text: Goods are subject to Customs Act 1901.
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Customs Act 1901 recognizes goods described as forfeited to the Crown.
modality: CogAI
operator: recognizes
premise text: Goods are forfeited to the Crown.

therapeutic-goods-act-1989-sec-14b-logic-deontic-1
type: LogicApplication
conclusion text: Customs Act 1901 has effect.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Customs Act 1901 obliges the Secretary to notify Comptroller-General of Customs.
modality: Deontic
operator: obliges
premise text: Secretary wishes Customs Act 1901 to apply.

therapeutic-goods-act-1989-sec-14b-logic-diffusion-4
type: LogicApplication
conclusion text: Goods are subject to Customs Act 1901.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Customs Act 1901 diffuses to goods described as forfeited to the Crown.
modality: Diffusion
operator: diffuses
premise text: Goods are forfeited to the Crown.

therapeutic-goods-act-1989-sec-14b-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 14B Application of Customs Act 1901

15 Criminal offences relating to breaching a condition of a consent
type: Concept
source: therapeutic-goods-act-1989.pdf, p.86
curation status: Proposed
has part: 15(1) Criminal offences relating to breaching a condition of a consent
has part: 15(2) Criminal offences relating to breaching a condition of a consent
has part: 15(5) Criminal offences relating to breaching a condition of a consent
has part: 15(6) Criminal offences relating to breaching a condition of a consent
has part: 15(7) Criminal offences relating to breaching a condition of a consent
proposed by: legis2cml
realized by: sec-15
schema version: 2

15(1) Criminal offences relating to breaching a condition of a consent
type: Concept
source: therapeutic-goods-act-1989.pdf, p.86
note: Secretary's consent may be given unconditionally or subject to conditions.
asserts: therapeutic-goods-act-1989-sec-15-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-15-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-15-ss-1
schema version: 2
part of: 15 Criminal offences relating to breaching a condition of a consent

therapeutic-goods-act-1989-sec-15-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-15-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 15(1) Criminal offences relating to breaching a condition of a consent

15(2) Criminal offences relating to breaching a condition of a consent
type: Concept
source: therapeutic-goods-act-1989.pdf, p.86
note: A person commits an offence if they breach a condition of consent.
asserts: therapeutic-goods-act-1989-sec-15-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-15-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-15-ss-2-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-15-ss-2-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-15-ss-2-logic-argumentation-4
asserts: therapeutic-goods-act-1989-sec-15-ss-2-logic-diffusion-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-15-ss-2
schema version: 2
part of: 15 Criminal offences relating to breaching a condition of a consent

therapeutic-goods-act-1989-sec-15-ss-2-logic-alleninterval-3
type: LogicApplication
conclusion text: The act and the harm are temporally related.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relationship between the act and the harm.
modality: AllenInterval
operator: Between
premise text: (2) A person commits an offence if: (a) the person does an act or omits to do an act; (b) the act or omission breaches a condition of a consent; (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-15-ss-2-logic-argumentation-4
type: LogicApplication
conclusion text: If the breach occurs, then the offence is committed.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Implication of breach on offence commitment.
modality: Argumentation
operator: Implication
premise text: (2) A person commits an offence if: (a) the person does an act or omits to do an act; (b) the act or omission breaches a condition of a consent; (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-15-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: A person commits an offence if they breach a condition of consent.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to not breach a condition of consent.
modality: Deontic
operator: Obligation
premise text: (2) A person commits an offence if: (a) the person does an act or omits to do an act; (b) the act or omission breaches a condition of a consent; (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-15-ss-2-logic-deontic-2
type: LogicApplication
conclusion text: Breaching a condition of consent is prohibited.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on breaching a condition 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; (b) the act or omission breaches a condition of a consent; (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-15-ss-2-logic-diffusion-5
type: LogicApplication
conclusion text: The effect of the breach propagates.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Propagating the effect of the breach.
modality: Diffusion
operator: Propagation
premise text: (2) A person commits an offence if: (a) the person does an act or omits to do an act; (b) the act or omission breaches a condition of a consent; (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-15-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 15(2) Criminal offences relating to breaching a condition of a consent

15(5) Criminal offences relating to breaching a condition of a consent
type: Concept
source: therapeutic-goods-act-1989.pdf, p.86
note: Breach of consent condition results in an offence.
asserts: therapeutic-goods-act-1989-sec-15-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-15-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-15-ss-5-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-15-ss-5-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-15-ss-5-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-15-ss-5-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-15-ss-5
schema version: 2
part of: 15 Criminal offences relating to breaching a condition of a consent

therapeutic-goods-act-1989-sec-15-ss-5-logic-alleninterval-2
type: LogicApplication
conclusion text: The temporal interval for breach of consent is not specified.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for breach of consent.
modality: AllenInterval
operator: Between
premise text: (5) 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.

therapeutic-goods-act-1989-sec-15-ss-5-logic-cogai-5
type: LogicApplication
conclusion text: The cognitive AI application is not specified.
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Cognitive AI application for consent conditions.
modality: CogAI
operator: Recognizes
premise text: (5) 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.

therapeutic-goods-act-1989-sec-15-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: If an act or omission breaches a consent condition, it is an offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with consent conditions.
modality: Deontic
operator: Obligation
premise text: (5) 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.

therapeutic-goods-act-1989-sec-15-ss-5-logic-diffusion-4
type: LogicApplication
conclusion text: The diffusion of obligation is not specified.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusion of obligation to comply with consent conditions.
modality: Diffusion
operator: Diffuses
premise text: (5) 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.

therapeutic-goods-act-1989-sec-15-ss-5-logic-ltl-3
type: LogicApplication
conclusion text: The temporal logic for consent conditions is not specified.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal logic for consent conditions.
modality: LTL
operator: Until
premise text: (5) 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.

therapeutic-goods-act-1989-sec-15-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 15(5) Criminal offences relating to breaching a condition of a consent

15(6) Criminal offences relating to breaching a condition of a consent
type: Concept
source: therapeutic-goods-act-1989.pdf, p.86
note: Breach of consent condition results in an offence.
asserts: therapeutic-goods-act-1989-sec-15-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-15-ss-6-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-15-ss-6-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-15-ss-6-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-15-ss-6-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-15-ss-6-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-15-ss-6
schema version: 2
part of: 15 Criminal offences relating to breaching a condition of a consent

therapeutic-goods-act-1989-sec-15-ss-6-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for breach of consent.
modality: AllenInterval
operator: Between
premise text: (6) 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.

therapeutic-goods-act-1989-sec-15-ss-6-logic-cogai-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Artificial agent's knowledge for breach of consent.
modality: CogAI
operator: Knowledge
premise text: (6) 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.

therapeutic-goods-act-1989-sec-15-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with consent conditions.
modality: Deontic
operator: Obligation
premise text: (6) 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.

therapeutic-goods-act-1989-sec-15-ss-6-logic-diffusion-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Conditional diffusion for breach of consent.
modality: Diffusion
operator: If
premise text: (6) 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.

therapeutic-goods-act-1989-sec-15-ss-6-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal constraint for breach of consent.
modality: LTL
operator: Until
premise text: (6) 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.

therapeutic-goods-act-1989-sec-15-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 15(6) Criminal offences relating to breaching a condition of a consent

15(7) Criminal offences relating to breaching a condition of a consent
type: Concept
source: therapeutic-goods-act-1989.pdf, p.86
note: An offence against subsection (6) is an offence of strict liability.
asserts: therapeutic-goods-act-1989-sec-15-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-15-ss-7-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-15-ss-7
schema version: 2
part of: 15 Criminal offences relating to breaching a condition of a consent

therapeutic-goods-act-1989-sec-15-ss-7-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-15-ss-7-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 15(7) Criminal offences relating to breaching a condition of a consent

15A Part does not apply to a medical device
type: Concept
source: therapeutic-goods-act-1989.pdf, p.88
note: Part does not apply to medical devices.
asserts: therapeutic-goods-act-1989-sec-15a-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-15a
schema version: 2

15AA Civil penalty relating to breaching a condition of a consent
type: Concept
source: therapeutic-goods-act-1989.pdf, p.87
note: Breach of consent condition results in civil penalty
asserts: therapeutic-goods-act-1989-sec-15aa-norm
asserts: therapeutic-goods-act-1989-sec-15aa-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-15aa
schema version: 2

therapeutic-goods-act-1989-sec-15aa-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits breach of consent condition
modality: Deontic
operator: forbid

therapeutic-goods-act-1989-sec-15aa-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 15AA Civil penalty relating to breaching a condition of a consent

15AB Conditions relating to exceptional release of biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.87
curation status: Proposed
has part: 15AB(1) Conditions relating to exceptional release of biologicals
has part: 15AB(2) Conditions relating to exceptional release of biologicals
has part: 15AB(3) Conditions relating to exceptional release of biologicals
proposed by: legis2cml
realized by: sec-15ab
schema version: 2

15AB(1) Conditions relating to exceptional release of biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.87
note: Regulations may prescribe conditions for the supply of a biological after specified circumstances have occurred.
asserts: therapeutic-goods-act-1989-sec-15ab-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-15ab-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-15ab-ss-1
schema version: 2
part of: 15AB Conditions relating to exceptional release of biologicals

therapeutic-goods-act-1989-sec-15ab-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations may prescribe conditions.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-15ab-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 15AB(1) Conditions relating to exceptional release of biologicals

15AB(2) Conditions relating to exceptional release of biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.87
note: Conditions must apply only to the person supplying biologicals.
asserts: therapeutic-goods-act-1989-sec-15ab-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-15ab-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-15ab-ss-2
schema version: 2
part of: 15AB Conditions relating to exceptional release of biologicals

therapeutic-goods-act-1989-sec-15ab-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Mandatory application of conditions.
modality: Deontic
operator: mustApply

therapeutic-goods-act-1989-sec-15ab-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 15AB(2) Conditions relating to exceptional release of biologicals

15AB(3) Conditions relating to exceptional release of biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.87
note: Committing an offence for breach of conditions
asserts: therapeutic-goods-act-1989-sec-15ab-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-15ab-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-15ab-ss-3-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-15ab-ss-3-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-15ab-ss-3-logic-ltl-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-15ab-ss-3
schema version: 2
part of: 15AB Conditions relating to exceptional release of biologicals

therapeutic-goods-act-1989-sec-15ab-ss-3-logic-alleninterval-3
type: LogicApplication
conclusion text: Penalty for contravention of this subsection:60 penalty units.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relationship between breach and penalty
modality: AllenInterval
operator: Between
premise text: (3) A person commits an offence if: (a) the person does an act or omits to do an act;

therapeutic-goods-act-1989-sec-15ab-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Penalty for contravention of this subsection:60 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with conditions
modality: Deontic
operator: Obligation
premise text: (3) A person commits an offence if: (a) the person does an act or omits to do an act;

therapeutic-goods-act-1989-sec-15ab-ss-3-logic-deontic-2
type: LogicApplication
conclusion text: Penalty for contravention of this subsection:60 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on breach of conditions
modality: Deontic
operator: Prohibition
premise text: (3) A person commits an offence if: (a) the person does an act or omits to do an act;

therapeutic-goods-act-1989-sec-15ab-ss-3-logic-ltl-4
type: LogicApplication
conclusion text: Penalty for contravention of this subsection:60 penalty units.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of breach and penalty
modality: LTL
operator: Recurring
premise text: (3) A person commits an offence if: (a) the person does an act or omits to do an act;

therapeutic-goods-act-1989-sec-15ab-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 15AB(3) Conditions relating to exceptional release of biologicals

15B Application of this Part to a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.88
curation status: Proposed
has part: 15B(1) Application of this Part to a biological
has part: 15B(2) Application of this Part to a biological
has part: 15B(3) Application of this Part to a biological
proposed by: legis2cml
realized by: sec-15b
schema version: 2

15B(1) Application of this Part to a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.88
note: Application of this Part to biologicals on and after commencement.
asserts: therapeutic-goods-act-1989-sec-15b-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-15b-ss-1
schema version: 2
part of: 15B Application of this Part to a biological

15B(2) Application of this Part to a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.88
note: Continues application of this Part to biological goods after commencement.
asserts: therapeutic-goods-act-1989-sec-15b-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-15b-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-15b-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-15b-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-15b-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-15b-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-15b-ss-2
schema version: 2
part of: 15B Application of this Part to a biological

therapeutic-goods-act-1989-sec-15b-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3-2A.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relationship between commencement and application.
modality: AllenInterval
operator: BEFORE
premise text: (2) If, immediately before the commencement of this section,

therapeutic-goods-act-1989-sec-15b-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: the therapeutic goods that are a biological were registered goods or listed goods.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Classification of biological goods.
modality: CogAI
operator: CLASSIFICATION
premise text: (2) If, immediately before the commencement of this section,

therapeutic-goods-act-1989-sec-15b-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3-2A.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Continues application of this Part.
modality: Deontic
operator: CONTINUES
premise text: (2) If, immediately before the commencement of this section,

therapeutic-goods-act-1989-sec-15b-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3-2A.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Continued application of this Part.
modality: Diffusion
operator: CONTINUES
premise text: (2) If, immediately before the commencement of this section,

therapeutic-goods-act-1989-sec-15b-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3-2A.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal relationship between application and inclusion in Register.
modality: LTL
operator: UNTIL
premise text: (2) If, immediately before the commencement of this section,

therapeutic-goods-act-1989-sec-15b-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 15B(2) Application of this Part to a biological

15B(3) Application of this Part to a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.88
note: Continuation of Part application to biological on commencement
asserts: therapeutic-goods-act-1989-sec-15b-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-15b-ss-3
schema version: 2
part of: 15B Application of this Part to a biological

16 Therapeutic goods and gazetted groups
type: Concept
source: therapeutic-goods-act-1989.pdf, p.89
note: Therapeutic goods must be taken to be separate and distinct from other therapeutic goods if they have a different formulation, composition or design specification; or a different strength or size (disregarding pack size); or a different dosage form or model; or a different name;
asserts: therapeutic-goods-act-1989-sec-16-norm
asserts: therapeutic-goods-act-1989-sec-16-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-16
schema version: 2

therapeutic-goods-act-1989-sec-16-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation to classify therapeutic goods based on the specified criteria.
modality: Deontic
operator: !

therapeutic-goods-act-1989-sec-16-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 16 Therapeutic goods and gazetted groups

18 Exempt goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.91
curation status: Proposed
has part: 18(1) Exempt goods
has part: 18(2) Exempt goods
has part: 18(3) Exempt goods
proposed by: legis2cml
realized by: sec-18
schema version: 2

18(1) Exempt goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.91
note: Exempts therapeutic goods from operation of this Part
asserts: therapeutic-goods-act-1989-sec-18-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-18-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-18-ss-1-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-18-ss-1-logic-descriptionlogic-3
asserts: therapeutic-goods-act-1989-sec-18-ss-1-logic-descriptionlogic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-18-ss-1
schema version: 2
part of: 18 Exempt goods

therapeutic-goods-act-1989-sec-18-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes duty to exempt goods
modality: Deontic
operator: exempt

therapeutic-goods-act-1989-sec-18-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies goods into subclasses
modality: DescriptionLogic
operator: subclassOf
premise text: (a) all therapeutic goods, except those included in a class of goods prescribed for the purposes of this paragraph;

therapeutic-goods-act-1989-sec-18-ss-1-logic-descriptionlogic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies goods into subclasses
modality: DescriptionLogic
operator: subclassOf
premise text: (b) specified therapeutic goods;

therapeutic-goods-act-1989-sec-18-ss-1-logic-descriptionlogic-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies goods into subclasses
modality: DescriptionLogic
operator: subclassOf
premise text: (c) a specified class of therapeutic goods;

therapeutic-goods-act-1989-sec-18-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 18(1) Exempt goods

18(2) Exempt goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.91
note: Exemptions apply only to specified classes of persons.
asserts: therapeutic-goods-act-1989-sec-18-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-18-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-18-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-18-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-18-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-18-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-18-ss-2
schema version: 2
part of: 18 Exempt goods

therapeutic-goods-act-1989-sec-18-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: relation to such classes of persons as are prescribed for the purposes of this subsection.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal scope of exemptions
modality: AllenInterval
operator: during
premise text: (2) An exemption in terms of paragraph (1)(a)

therapeutic-goods-act-1989-sec-18-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: relation to such classes of persons as are prescribed for the purposes of this subsection.
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Classification of exempt goods
modality: CogAI
operator: classify
premise text: (2) An exemption in terms of paragraph (1)(a)

therapeutic-goods-act-1989-sec-18-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: has effect only in relation to such classes of persons as are prescribed for the purposes of this subsection.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Conditional obligation
modality: Deontic
operator: onlyIf
premise text: (2) An exemption in terms of paragraph (1)(a)

therapeutic-goods-act-1989-sec-18-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: relation to such classes of persons as are prescribed for the purposes of this subsection.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Scope of exemptions
modality: Diffusion
operator: influence
premise text: (2) An exemption in terms of paragraph (1)(a)

therapeutic-goods-act-1989-sec-18-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: relation to such classes of persons as are prescribed for the purposes of this subsection.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal scope of exemptions
modality: LTL
operator: during
premise text: (2) An exemption in terms of paragraph (1)(a)

therapeutic-goods-act-1989-sec-18-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 18(2) Exempt goods

18(3) Exempt goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.91
note: Revocation of exemption takes effect after 28 days
asserts: therapeutic-goods-act-1989-sec-18-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-18-ss-3-logic-alleninterval-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-18-ss-3
schema version: 2
part of: 18 Exempt goods

therapeutic-goods-act-1989-sec-18-ss-3-logic-alleninterval-1
type: LogicApplication
conclusion text: After 28 days from the regulations' effective date
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines temporal interval for revocation
modality: AllenInterval
operator: Applicable
premise text: Revocation takes effect on a specified day

18A Exemption because of emergency
type: Concept
source: therapeutic-goods-act-1989.pdf, p.91
curation status: Proposed
has part: 18A(1) Exemption because of emergency
has part: 18A(1A) Exemption because of emergency
has part: 18A(2) Exemption because of emergency
proposed by: legis2cml
realized by: sec-18a
schema version: 2

18A(1) Exemption because of emergency
type: Concept
source: therapeutic-goods-act-1989.pdf, p.91
note: Exemption from Division 2 operation due to emergency
asserts: therapeutic-goods-act-1989-sec-18a-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-18a-ss-1
schema version: 2
part of: 18A Exemption because of emergency

18A(1A) Exemption because of emergency
type: Concept
source: therapeutic-goods-act-1989.pdf, p.91
note: Exemption from goods under subsection (1) based on Minister's satisfaction
asserts: therapeutic-goods-act-1989-sec-18a-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-18a-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-18a-ss-1a
schema version: 2
part of: 18A Exemption because of emergency

therapeutic-goods-act-1989-sec-18a-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Granting permission
modality: Deontic
operator: Permit
premise text: (1A) The Minister may exempt goods under subsection (1)

18A(2) Exemption because of emergency
type: Concept
source: therapeutic-goods-act-1989.pdf, p.91
note: Exemption for stockpiling goods in emergency
asserts: therapeutic-goods-act-1989-sec-18a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-18a-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-18a-ss-2
schema version: 2
part of: 18A Exemption because of emergency

therapeutic-goods-act-1989-sec-18a-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Creates an obligation for the state to make exemptions
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-18a-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 18A(2) Exemption because of emergency

19 Approvals or authorities for certain uses
type: Concept
source: therapeutic-goods-act-1989.pdf, p.96
curation status: Proposed
has part: 19(1) Approvals or authorities for certain uses
has part: 19(1A) Approvals or authorities for certain uses
has part: 19(2) Approvals or authorities for certain uses
has part: 19(3) Approvals or authorities for certain uses
has part: 19(4) Approvals or authorities for certain uses
has part: 19(4A) Approvals or authorities for certain uses
has part: 19(4B) Approvals or authorities for certain uses
proposed by: legis2cml
realized by: sec-19
schema version: 2

19(1) Approvals or authorities for certain uses
type: Concept
source: therapeutic-goods-act-1989.pdf, p.96
note: Approval for therapeutic goods importation or exportation with conditions.
asserts: therapeutic-goods-act-1989-sec-19-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-19-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-19-ss-1
schema version: 2
part of: 19 Approvals or authorities for certain uses

therapeutic-goods-act-1989-sec-19-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Approval granted
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Approval grant
modality: Deontic
operator: Grant
premise text: Secretary may grant approval

therapeutic-goods-act-1989-sec-19-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 19(1) Approvals or authorities for certain uses

19(1A) Approvals or authorities for certain uses
type: Concept
source: therapeutic-goods-act-1989.pdf, p.96
note: Approval conditions are subject to additional regulations.
asserts: therapeutic-goods-act-1989-sec-19-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-19-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-19-ss-1a
schema version: 2
part of: 19 Approvals or authorities for certain uses

therapeutic-goods-act-1989-sec-19-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Conditional obligation
modality: Deontic
operator: SUBJUNCTIVE

therapeutic-goods-act-1989-sec-19-ss-1a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 19(1A) Approvals or authorities for certain uses

19(2) Approvals or authorities for certain uses
type: Concept
description: Information relating to goods subject to application, evaluation fee
source: therapeutic-goods-act-1989.pdf, p.96
note: Application for approval must be made to the Secretary and meet certain requirements.
asserts: therapeutic-goods-act-1989-sec-19-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-19-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-19-ss-2
schema version: 2
part of: 19 Approvals or authorities for certain uses

therapeutic-goods-act-1989-sec-19-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application must be made
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-19-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 19(2) Approvals or authorities for certain uses

19(3) Approvals or authorities for certain uses
type: Concept
source: therapeutic-goods-act-1989.pdf, p.96
note: Approval conditions may include charges for therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-19-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-19-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-19-ss-3
schema version: 2
part of: 19 Approvals or authorities for certain uses

therapeutic-goods-act-1989-sec-19-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Includes charges in approval conditions.
modality: Deontic
operator: includes

therapeutic-goods-act-1989-sec-19-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 19(3) Approvals or authorities for certain uses

19(4) Approvals or authorities for certain uses
type: Concept
description: Reasons for decision (if not granting approval)
source: therapeutic-goods-act-1989.pdf, p.96
note: Notify applicant of decision on approval within 28 days.
asserts: therapeutic-goods-act-1989-sec-19-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-19-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-19-ss-4-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-19-ss-4
schema version: 2
part of: 19 Approvals or authorities for certain uses

therapeutic-goods-act-1989-sec-19-ss-4-logic-alleninterval-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for decision notification.
modality: AllenInterval
operator: >=

therapeutic-goods-act-1989-sec-19-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must notify applicant within 28 days.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-19-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 19(4) Approvals or authorities for certain uses

19(4A) Approvals or authorities for certain uses
type: Concept
source: therapeutic-goods-act-1989.pdf, p.96
note: Conditions for experimental use of therapeutic goods in humans
asserts: therapeutic-goods-act-1989-sec-19-ss-4a-norm
asserts: therapeutic-goods-act-1989-sec-19-ss-4a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-19-ss-4a
schema version: 2
part of: 19 Approvals or authorities for certain uses

therapeutic-goods-act-1989-sec-19-ss-4a-logic-deontic-1
type: LogicApplication
conclusion text: is subject to the conditions specified in the regulations
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulation of experimental use
modality: Deontic
operator: Obligation
premise text: Use by a person for experimental purposes in humans

therapeutic-goods-act-1989-sec-19-ss-4a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 19(4A) Approvals or authorities for certain uses

19(4B) Approvals or authorities for certain uses
type: Concept
source: therapeutic-goods-act-1989.pdf, p.96
note: Request for variation of therapeutic goods approval
asserts: therapeutic-goods-act-1989-sec-19-ss-4b-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-19-ss-4b
schema version: 2
part of: 19 Approvals or authorities for certain uses

therapeutic-goods-act-1989-sec-19-ss-4b-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 19(4B) Approvals or authorities for certain uses

19A Approvals where unavailability etc. of therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.101
note: Secretary may grant approval for importation or supply of therapeutic goods under certain conditions.
asserts: therapeutic-goods-act-1989-sec-19a-norm
asserts: therapeutic-goods-act-1989-sec-19a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-19a-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-19a-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-19a-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-19a-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-19a
schema version: 2

therapeutic-goods-act-1989-sec-19a-logic-alleninterval-2
type: LogicApplication
conclusion text: ...the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3);...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Approval is granted during a specific period
modality: AllenInterval
operator: during
premise text: (1) The Secretary may, by notice in writing...

therapeutic-goods-act-1989-sec-19a-logic-cogai-5
type: LogicApplication
conclusion text: ...an application under section 23 has been made for registration of the goods and the application has passed preliminary assessment;...
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Approval is conditional on preliminary assessment of registration application
modality: CogAI
operator: if-then
premise text: (b) either: (i) the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3); or...

therapeutic-goods-act-1989-sec-19a-logic-deontic-1
type: LogicApplication
conclusion text: ...the goods that are the subject of the application are registered or approved for general marketing...
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-19a-logic-diffusion-4
type: LogicApplication
conclusion text: ...the Secretary is satisfied that: (i) the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3); or...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Approval is conditional on certain conditions being met
modality: Diffusion
operator: if-then
premise text: (a) registered goods that could act as a substitute for the goods...

therapeutic-goods-act-1989-sec-19a-logic-ltl-3
type: LogicApplication
conclusion text: ...the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3);...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Approval applies to all therapeutic goods
modality: LTL
operator: everywhere
premise text: (1) The Secretary may, by notice in writing...

therapeutic-goods-act-1989-sec-19a-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 19A Approvals where unavailability etc. of therapeutic goods

19B Criminal offences relating to registration or listing etc. of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.105
note: Offences relating to importing, exporting, manufacturing or supplying goods for use in humans
asserts: therapeutic-goods-act-1989-sec-19b-norm
asserts: therapeutic-goods-act-1989-sec-19b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-19b
schema version: 2

therapeutic-goods-act-1989-sec-19b-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits importing, exporting, manufacturing or supplying goods for use in humans
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-19b-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 19B Criminal offences relating to registration or listing etc. of

19C Notice required to adduce evidence in support of exception
type: Concept
source: therapeutic-goods-act-1989.pdf, p.109
curation status: Proposed
has part: 19C(1) Notice required to adduce evidence in support of exception
has part: 19C(2) Notice required to adduce evidence in support of exception
proposed by: legis2cml
realized by: sec-19c
schema version: 2

19C(1) Notice required to adduce evidence in support of exception
type: Concept
source: therapeutic-goods-act-1989.pdf, p.109
note: Defendant must be informed of requirements and given a copy of the section.
asserts: therapeutic-goods-act-1989-sec-19c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-19c-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-19c-ss-1
schema version: 2
part of: 19C Notice required to adduce evidence in support of exception

therapeutic-goods-act-1989-sec-19c-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Defendant must be informed.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-19c-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 19C(1) Notice required to adduce evidence in support of exception

19C(2) Notice required to adduce evidence in support of exception
type: Concept
description: Notice of particulars of the exception
source: therapeutic-goods-act-1989.pdf, p.109
note: No evidence in support of exception can be adduced without notice.
asserts: therapeutic-goods-act-1989-sec-19c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-19c-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-19c-ss-2
schema version: 2
part of: 19C Notice required to adduce evidence in support of exception

therapeutic-goods-act-1989-sec-19c-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition
modality: Deontic
operator: Prohibit

19D Civil penalties relating to registration or listing etc. of imported,
type: Concept
source: therapeutic-goods-act-1989.pdf, p.111
note: Importing, exporting, manufacturing or supplying therapeutic goods for use in humans is prohibited.
asserts: therapeutic-goods-act-1989-sec-19d-norm
asserts: therapeutic-goods-act-1989-sec-19d-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-19d
schema version: 2

therapeutic-goods-act-1989-sec-19d-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of importing, exporting, manufacturing or supplying therapeutic goods for use in humans.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-19d-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 19D Civil penalties relating to registration or listing etc. of imported,

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

20 Criminal offences relating to notifying the Secretary and to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.114
curation status: Proposed
has part: 20(1B) Criminal offences relating to notifying the Secretary and to
has part: 20(1C) Criminal offences relating to notifying the Secretary and to
has part: 20(2A) Criminal offences relating to notifying the Secretary and to
has part: 20(2B) Criminal offences relating to notifying the Secretary and to
has part: 20(2C) Criminal offences relating to notifying the Secretary and to
has part: 20(2D) Criminal offences relating to notifying the Secretary and to
proposed by: legis2cml
realized by: sec-20
schema version: 2

20(1B) Criminal offences relating to notifying the Secretary and to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.114
note: Importing, exporting, manufacturing, or supplying therapeutic goods without proper notification is prohibited.
asserts: therapeutic-goods-act-1989-sec-20-ss-1b-norm
asserts: therapeutic-goods-act-1989-sec-20-ss-1b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-20-ss-1b
schema version: 2
part of: 20 Criminal offences relating to notifying the Secretary and to

therapeutic-goods-act-1989-sec-20-ss-1b-logic-deontic-1
type: LogicApplication
conclusion text: An offence is committed.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of actions
modality: Deontic
operator: Prohibit
premise text: The person has not properly notified...

therapeutic-goods-act-1989-sec-20-ss-1b-norm
type: Prohibition
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 20(1B) Criminal offences relating to notifying the Secretary and to

20(1C) Criminal offences relating to notifying the Secretary and to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.114
note: Manufacturer and premises must be notified to the Secretary.
asserts: therapeutic-goods-act-1989-sec-20-ss-1c-norm
asserts: therapeutic-goods-act-1989-sec-20-ss-1c-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-20-ss-1c
schema version: 2
part of: 20 Criminal offences relating to notifying the Secretary and to

therapeutic-goods-act-1989-sec-20-ss-1c-logic-deontic-1
type: LogicApplication
conclusion text: Manufacturer and premises must be notified
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide notification
modality: Deontic
operator: MUST
premise text: Notification is required

therapeutic-goods-act-1989-sec-20-ss-1c-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 20(1C) Criminal offences relating to notifying the Secretary and to

20(2A) Criminal offences relating to notifying the Secretary and to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.114
note: Importation of therapeutic goods into Australia without exemption breaches a condition.
asserts: therapeutic-goods-act-1989-sec-20-ss-2a-norm
asserts: therapeutic-goods-act-1989-sec-20-ss-2a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-20-ss-2a-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-20-ss-2a-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-20-ss-2a-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-20-ss-2a-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-20-ss-2a
schema version: 2
part of: 20 Criminal offences relating to notifying the Secretary and to

therapeutic-goods-act-1989-sec-20-ss-2a-logic-alleninterval-2
type: LogicApplication
conclusion text: ...if the importation breaches a condition of the exemption.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Identifies overlap between exemption conditions and importation.
modality: AllenInterval
operator: Overlap
premise text: (2A) A person commits an offence...

therapeutic-goods-act-1989-sec-20-ss-2a-logic-cogai-5
type: LogicApplication
conclusion text: ...if the goods are exempt under section 18A; and...
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Analyzes importation of therapeutic goods without exemption.
modality: CogAI
operator: Analyze
premise text: (2A) A person commits an offence...

therapeutic-goods-act-1989-sec-20-ss-2a-logic-deontic-1
type: LogicApplication
conclusion text: ...breaches a condition of the exemption.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits importation of therapeutic goods without exemption.
modality: Deontic
operator: Prohibit
premise text: (2A) A person commits an offence...

therapeutic-goods-act-1989-sec-20-ss-2a-logic-diffusion-4
type: LogicApplication
conclusion text: ...breaches a condition of the exemption.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses breach of exemption conditions.
modality: Diffusion
operator: Diffuse
premise text: (2A) A person commits an offence...

therapeutic-goods-act-1989-sec-20-ss-2a-logic-ltl-3
type: LogicApplication
conclusion text: ...if the goods are exempt under section 18A; and...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Identifies recurring breach of exemption conditions.
modality: LTL
operator: Recurring
premise text: (2A) A person commits an offence...

therapeutic-goods-act-1989-sec-20-ss-2a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 20(2A) Criminal offences relating to notifying the Secretary and to

20(2B) Criminal offences relating to notifying the Secretary and to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.114
note: Prohibition on strict liability for notifying the Secretary
asserts: therapeutic-goods-act-1989-sec-20-ss-2b-norm
asserts: therapeutic-goods-act-1989-sec-20-ss-2b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-20-ss-2b
schema version: 2
part of: 20 Criminal offences relating to notifying the Secretary and to

therapeutic-goods-act-1989-sec-20-ss-2b-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits strict liability
modality: Deontic
operator: forbid

20(2C) Criminal offences relating to notifying the Secretary and to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.114
note: Importation of therapeutic goods exempt under section 18A breaches a condition, committing an offence.
asserts: therapeutic-goods-act-1989-sec-20-ss-2c-norm
asserts: therapeutic-goods-act-1989-sec-20-ss-2c-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-20-ss-2c-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-20-ss-2c-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-20-ss-2c-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-20-ss-2c-logic-argumentation-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-20-ss-2c
schema version: 2
part of: 20 Criminal offences relating to notifying the Secretary and to

therapeutic-goods-act-1989-sec-20-ss-2c-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Importation occurs during the period when therapeutic goods are exempt.
modality: AllenInterval
operator: During
premise text: (a) The person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption.

therapeutic-goods-act-1989-sec-20-ss-2c-logic-argumentation-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Importation implies that therapeutic goods are not exempt.
modality: Argumentation
operator: Implicates
premise text: (a) The person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption.

therapeutic-goods-act-1989-sec-20-ss-2c-logic-deontic-1
type: LogicApplication
conclusion text: Penalty: 60 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits importation of therapeutic goods exempt under section 18A.
modality: Deontic
operator: Prohibition
premise text: (2C) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption.

therapeutic-goods-act-1989-sec-20-ss-2c-logic-diffusion-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Importation spreads to other actions that breach a condition.
modality: Diffusion
operator: Spreads
premise text: (a) The person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption.

therapeutic-goods-act-1989-sec-20-ss-2c-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Importation is a recurring action that breaches a condition.
modality: LTL
operator: Recurring
premise text: (a) The person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption.

therapeutic-goods-act-1989-sec-20-ss-2c-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 20(2C) Criminal offences relating to notifying the Secretary and to

20(2D) Criminal offences relating to notifying the Secretary and to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.114
note: Offence of strict liability for notifying the Secretary and to
asserts: therapeutic-goods-act-1989-sec-20-ss-2d-norm
asserts: therapeutic-goods-act-1989-sec-20-ss-2d-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-20-ss-2d
schema version: 2
part of: 20 Criminal offences relating to notifying the Secretary and to

therapeutic-goods-act-1989-sec-20-ss-2d-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits an offence under subsection (2C)
modality: Deontic
operator: Prohibit
premise text: An offence under subsection (2C) is an offence of strict liability.

20A Civil penalty relating to the importation, exportation,
type: Concept
source: therapeutic-goods-act-1989.pdf, p.116
curation status: Proposed
has part: 20A(1) Civil penalty relating to the importation, exportation,
has part: 20A(2) Civil penalty relating to the importation, exportation,
proposed by: legis2cml
realized by: sec-20a
schema version: 2

20A(1) Civil penalty relating to the importation, exportation,
type: Concept
source: therapeutic-goods-act-1989.pdf, p.116
note: Importation, exportation, manufacture, or supply of therapeutic goods without proper notification.
asserts: therapeutic-goods-act-1989-sec-20a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-20a-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-20a-ss-1
schema version: 2
part of: 20A Civil penalty relating to the importation, exportation,

therapeutic-goods-act-1989-sec-20a-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
premise text: Importation, exportation, manufacture, or supply of therapeutic goods without proper notification.

therapeutic-goods-act-1989-sec-20a-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 20A(1) Civil penalty relating to the importation, exportation,

20A(2) Civil penalty relating to the importation, exportation,
type: Concept
source: therapeutic-goods-act-1989.pdf, p.116
note: Manufacturer and premises must be notified to the Secretary.
asserts: therapeutic-goods-act-1989-sec-20a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-20a-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-20a-ss-2
schema version: 2
part of: 20A Civil penalty relating to the importation, exportation,

therapeutic-goods-act-1989-sec-20a-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must notify the Secretary.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-20a-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 20A(2) Civil penalty relating to the importation, exportation,

21 Offence relating to wholesale supply
type: Concept
source: therapeutic-goods-act-1989.pdf, p.117
note: Supplying therapeutic goods without proper authorization is prohibited.
asserts: therapeutic-goods-act-1989-sec-21-norm
asserts: therapeutic-goods-act-1989-sec-21-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-21
schema version: 2

therapeutic-goods-act-1989-sec-21-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying therapeutic goods without proper authorization.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-21-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 21 Offence relating to wholesale supply

21A General criminal offences relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.117
note: Making false or misleading statements in certification is prohibited.
asserts: therapeutic-goods-act-1989-sec-21a-norm
asserts: therapeutic-goods-act-1989-sec-21a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-21a-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-21a-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-21a-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-21a-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-21a
schema version: 2

therapeutic-goods-act-1989-sec-21a-logic-alleninterval-2
type: LogicApplication
conclusion text: ...or (ii)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The use of the medicine has resulted in, will result in, or is likely to result in harm or injury.
modality: AllenInterval
operator: Overlap
premise text: (i) the use of the medicine has resulted in, will result in, or is likely to result in, harm or injury to any person;

therapeutic-goods-act-1989-sec-21a-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 or misleading statements in certification.
modality: Deontic
operator: Prohibit
premise text: The statement is made in or in connection with a certification.

therapeutic-goods-act-1989-sec-21a-logic-deontic-4
type: LogicApplication
conclusion text: ...or (ii)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The use of the medicine has resulted in, will result in, or is likely to result in harm or injury.
modality: Deontic
operator: Prohibit
premise text: (i) the use of the medicine has resulted in, will result in, or is likely to result in, harm or injury to any person;

therapeutic-goods-act-1989-sec-21a-logic-deontic-5
type: LogicApplication
conclusion text: ...or (ii)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The use of the medicine would result in, or would be likely to result in, harm or injury.
modality: Deontic
operator: Prohibit
premise text: (ii) the use of the medicine, if the medicine were used, would result in, or would be likely to result in, harm or injury to any person.

therapeutic-goods-act-1989-sec-21a-logic-ltl-3
type: LogicApplication
conclusion text: ...or (ii)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The use of the medicine would result in, or would be likely to result in, harm or injury.
modality: LTL
operator: Recurring
premise text: (ii) the use of the medicine, if the medicine were used, would result in, or would be likely to result in, harm or injury to any person.

therapeutic-goods-act-1989-sec-21a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 21A General criminal offences relating to this Part

21B General civil penalties relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.125
curation status: Proposed
has part: 21B(1) General civil penalties relating to this Part
has part: 21B(2) General civil penalties relating to this Part
has part: 21B(3) General civil penalties relating to this Part
proposed by: legis2cml
realized by: sec-21b
schema version: 2

21B(1) General civil penalties relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.125
note: False statement in certification is prohibited
asserts: therapeutic-goods-act-1989-sec-21b-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-21b-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-21b-ss-1
schema version: 2
part of: 21B General civil penalties relating to this Part

therapeutic-goods-act-1989-sec-21b-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of false statements
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-21b-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 21B(1) General civil penalties relating to this Part

21B(2) General civil penalties relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.125
note: Falsely representing therapeutic goods is prohibited.
asserts: therapeutic-goods-act-1989-sec-21b-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-21b-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-21b-ss-2
schema version: 2
part of: 21B General civil penalties relating to this Part

therapeutic-goods-act-1989-sec-21b-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of falsely representing therapeutic goods.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-21b-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 21B(2) General civil penalties relating to this Part

21B(3) General civil penalties relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.125
note: Representing false information about therapeutic goods is prohibited.
asserts: therapeutic-goods-act-1989-sec-21b-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-21b-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-21b-ss-3
schema version: 2
part of: 21B General civil penalties relating to this Part

therapeutic-goods-act-1989-sec-21b-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: This subsection prohibits representing false information about therapeutic goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of representing false information about therapeutic goods.
modality: Deontic
operator: Prohibit
premise text: Representing false information is generally prohibited.

therapeutic-goods-act-1989-sec-21b-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 21B(3) General civil penalties relating to this Part

22 General offences relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.126
curation status: Proposed
has part: 22(1) General offences relating to this Part
has part: 22(2) General offences relating to this Part
has part: 22(3) General offences relating to this Part
has part: 22(5) General offences relating to this Part
has part: 22(5A) General offences relating to this Part
has part: 22(6) General offences relating to this Part
proposed by: legis2cml
realized by: sec-22
schema version: 2

22(1) General offences relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.126
note: Do not misrepresent therapeutic goods registration numbers.
asserts: therapeutic-goods-act-1989-sec-22-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-22-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22-ss-1
schema version: 2
part of: 22 General offences relating to this Part

therapeutic-goods-act-1989-sec-22-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: No registration number may be misrepresented.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of false representation
modality: Deontic
operator: Prohibit
premise text: Registration number misrepresentation

therapeutic-goods-act-1989-sec-22-ss-1-norm
type: Prohibition
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 22(1) General offences relating to this Part

22(2) General offences relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.126
note: Advertising therapeutic goods for an unaccepted indication without harm risk
asserts: therapeutic-goods-act-1989-sec-22-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-22-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-22-ss-2-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-22-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-22-ss-2-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-22-ss-2
schema version: 2
part of: 22 General offences relating to this Part

therapeutic-goods-act-1989-sec-22-ss-2-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 advertising therapeutic goods for an unaccepted indication without harm risk
modality: Deontic
operator: Prohibit
premise text: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion;

therapeutic-goods-act-1989-sec-22-ss-2-logic-deontic-4
type: LogicApplication
conclusion text: The therapeutic goods are included in the Register;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of advertising therapeutic goods for an unaccepted indication without harm risk
modality: Deontic
operator: Prohibit
premise text: (a) the use of the goods for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the goods for the advertised indication, 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-22-ss-2-logic-descriptionlogic-2
type: LogicApplication
conclusion text: The therapeutic goods are included in the Register;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of therapeutic goods based on indications
modality: DescriptionLogic
operator: Classify
premise text: (a) the use of the goods for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the goods for the advertised indication, 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-22-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: The use of the goods for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal tracing of advertising and harm risk
modality: LTL
operator: Trace
premise text: (a) the person, by any means, advertises therapeutic goods for an indication; (b) the therapeutic goods are included in the Register; (c) the indication is not an indication accepted in relation to that inclusion;

therapeutic-goods-act-1989-sec-22-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22(2) General offences relating to this Part

22(3) General offences relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.126
note: Advertising therapeutic goods for an unaccepted indication is prohibited.
asserts: therapeutic-goods-act-1989-sec-22-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-22-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-22-ss-3-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-22-ss-3-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-22-ss-3-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-22-ss-3-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-22-ss-3-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-22-ss-3
schema version: 2
part of: 22 General offences relating to this Part

therapeutic-goods-act-1989-sec-22-ss-3-logic-alleninterval-3
type: LogicApplication
conclusion text: (3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval of prohibited advertising.
modality: AllenInterval
operator: Temporal Interval
premise text: (3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-22-ss-3-logic-cogai-6
type: LogicApplication
conclusion text: (3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Knowledge representation of prohibited advertising.
modality: CogAI
operator: Knowledge Representation
premise text: (3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-22-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: (3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of advertising therapeutic goods for an unaccepted indication.
modality: Deontic
operator: Prohibit
premise text: (3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-22-ss-3-logic-descriptionlogic-2
type: LogicApplication
conclusion text: (3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of advertising as a general offence relating to this Part.
modality: DescriptionLogic
operator: Classify
premise text: (3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-22-ss-3-logic-diffusion-5
type: LogicApplication
conclusion text: (3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Spread of prohibited advertising.
modality: Diffusion
operator: Spread
premise text: (3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-22-ss-3-logic-ltl-4
type: LogicApplication
conclusion text: (3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of prohibited advertising.
modality: LTL
operator: Recurring Trace
premise text: (3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-22-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22(3) General offences relating to this Part

22(5) General offences relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.126
note: Advertising therapeutic goods for an unaccepted indication is prohibited.
asserts: therapeutic-goods-act-1989-sec-22-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-22-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-22-ss-5-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-22-ss-5-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-22-ss-5-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-22-ss-5-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-22-ss-5-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-22-ss-5
schema version: 2
part of: 22 General offences relating to this Part

therapeutic-goods-act-1989-sec-22-ss-5-logic-alleninterval-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for advertising therapeutic goods.
modality: AllenInterval
operator: Temporal Interval
premise text: (5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-22-ss-5-logic-cogai-6
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Classification of therapeutic goods into the Register.
modality: CogAI
operator: Classification
premise text: (5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-22-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: Prohibition of advertising therapeutic goods for an unaccepted indication.
modality: Deontic
operator: Prohibit
premise text: (5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-22-ss-5-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of therapeutic goods into the Register.
modality: DescriptionLogic
operator: Classify
premise text: (5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-22-ss-5-logic-diffusion-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusion of advertising therapeutic goods for unaccepted indications.
modality: Diffusion
operator: Diffusion
premise text: (5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-22-ss-5-logic-ltl-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of advertising therapeutic goods for unaccepted indications.
modality: LTL
operator: Recurring Trace
premise text: (5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-22-ss-5-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22(5) General offences relating to this Part

22(5A) General offences relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.126
note: An offence against subsection (5) is an obligation.
asserts: therapeutic-goods-act-1989-sec-22-ss-5a-norm
asserts: therapeutic-goods-act-1989-sec-22-ss-5a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22-ss-5a
schema version: 2
part of: 22 General offences relating to this Part

therapeutic-goods-act-1989-sec-22-ss-5a-logic-deontic-1
type: LogicApplication
conclusion text: An offence against subsection (5) is an obligation.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Definition of Obligation
modality: Deontic
operator: is
premise text: (5A) An offence against subsection (5)

therapeutic-goods-act-1989-sec-22-ss-5a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22(5A) General offences relating to this Part

22(6) General offences relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.126
note: Committing an offence requires doing or omitting an act.
asserts: therapeutic-goods-act-1989-sec-22-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-22-ss-6-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-22-ss-6-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-22-ss-6-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-22-ss-6
schema version: 2
part of: 22 General offences relating to this Part

therapeutic-goods-act-1989-sec-22-ss-6-logic-alleninterval-2
type: LogicApplication
conclusion text: Act or omission overlaps with the provision's scope.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The act or omission must overlap with the provision's scope.
modality: AllenInterval
operator: Overlaps
premise text: Doing or omitting an act.

therapeutic-goods-act-1989-sec-22-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: Committing an offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits committing an offence.
modality: Deontic
operator: Prohibition
premise text: Doing or omitting an act.

therapeutic-goods-act-1989-sec-22-ss-6-logic-ltl-3
type: LogicApplication
conclusion text: Act or omission is recurring.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The act or omission must be recurring.
modality: LTL
operator: Recurring
premise text: Committing an offence requires doing or omitting an act.

therapeutic-goods-act-1989-sec-22-ss-6-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22(6) General offences relating to this Part

22A Criminal offences for false statements in applications for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.131
curation status: Proposed
has part: 22A(1) Criminal offences for false statements in applications for
has part: 22A(4) Criminal offences for false statements in applications for
has part: 22A(5) Criminal offences for false statements in applications for
proposed by: legis2cml
realized by: sec-22a
schema version: 2

22A(1) Criminal offences for false statements in applications for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.131
note: Making false statements in applications for registration of therapeutic goods is a criminal offence.
asserts: therapeutic-goods-act-1989-sec-22a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-22a-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22a-ss-1
schema version: 2
part of: 22A Criminal offences for false statements in applications for

therapeutic-goods-act-1989-sec-22a-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 applications for registration of therapeutic goods.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-22a-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22A(1) Criminal offences for false statements in applications for

22A(4) Criminal offences for false statements in applications for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.131
note: Making false statements in applications for registration of therapeutic goods is a criminal offence.
asserts: therapeutic-goods-act-1989-sec-22a-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-22a-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22a-ss-4
schema version: 2
part of: 22A Criminal offences for false statements in applications for

therapeutic-goods-act-1989-sec-22a-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making false statements in applications for registration of therapeutic goods.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-22a-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22A(4) Criminal offences for false statements in applications for

22A(5) Criminal offences for false statements in applications for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.131
note: Making false statements in applications for registration of therapeutic goods is an offence.
asserts: therapeutic-goods-act-1989-sec-22a-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-22a-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22a-ss-5
schema version: 2
part of: 22A Criminal offences for false statements in applications for

therapeutic-goods-act-1989-sec-22a-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making false statements in applications for registration of therapeutic goods.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-22a-ss-5-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22A(5) Criminal offences for false statements in applications for

22AA Civil penalty for breaching conditions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.130
curation status: Proposed
has part: 22AA(1) Civil penalty for breaching conditions
has part: 22AA(2) Civil penalty for breaching conditions
proposed by: legis2cml
realized by: sec-22aa
schema version: 2

22AA(1) Civil penalty for breaching conditions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.130
note: Civil penalty for breaching conditions
asserts: therapeutic-goods-act-1989-sec-22aa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-22aa-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-22aa-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-22aa-ss-1-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-22aa-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-22aa-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-22aa-ss-1
schema version: 2
part of: 22AA Civil penalty for breaching conditions

therapeutic-goods-act-1989-sec-22aa-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: ...and (c) the act or omission breaches a condition of the exemption.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Identifies overlapping conditions and exemptions
modality: AllenInterval
operator: Overlap
premise text: (b) the goods are exempt under section 18A;

therapeutic-goods-act-1989-sec-22aa-ss-1-logic-argumentation-3
type: LogicApplication
conclusion text: ...and (c) the act or omission breaches a condition of the exemption.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Implies breach of conditions from exemptions
modality: Argumentation
operator: Imply
premise text: (b) the goods are exempt under section 18A;

therapeutic-goods-act-1989-sec-22aa-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: ...and (c) the act or omission breaches a condition of the exemption.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Analyzes breach of conditions from exemptions
modality: CogAI
operator: Analyze
premise text: (a) the person does an act or omits to do an act in relation to...

therapeutic-goods-act-1989-sec-22aa-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...breaches a condition of the exemption.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits breach of conditions
modality: Deontic
operator: Prohibit
premise text: (1) A person contravenes this subsection...

therapeutic-goods-act-1989-sec-22aa-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: ...and (c) the act or omission breaches a condition of the exemption.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Spreads breach of conditions to exemptions
modality: Diffusion
operator: Spread
premise text: (a) the person does an act or omits to do an act in relation to...

therapeutic-goods-act-1989-sec-22aa-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22AA(1) Civil penalty for breaching conditions

22AA(2) Civil penalty for breaching conditions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.130
note: Civil penalty for breaching conditions
asserts: therapeutic-goods-act-1989-sec-22aa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-22aa-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22aa-ss-2
schema version: 2
part of: 22AA Civil penalty for breaching conditions

therapeutic-goods-act-1989-sec-22aa-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: Prohibit
premise text: (2) A person contravenes this subsection if...

therapeutic-goods-act-1989-sec-22aa-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22AA(2) Civil penalty for breaching conditions

22B Civil penalty for false statements in applications for registration
type: Concept
source: therapeutic-goods-act-1989.pdf, p.132
note: False statements in applications for registration are prohibited.
asserts: therapeutic-goods-act-1989-sec-22b-norm
asserts: therapeutic-goods-act-1989-sec-22b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22b
schema version: 2

therapeutic-goods-act-1989-sec-22b-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of false statements
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-22b-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22B Civil penalty for false statements in applications for registration

22C Applications for provisional determination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.133
curation status: Proposed
has part: 22C(1) Applications for provisional determination
has part: 22C(2) Applications for provisional determination
has part: 22C(3) Applications for provisional determination
proposed by: legis2cml
realized by: sec-22c
schema version: 2

22C(1) Applications for provisional determination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.133
note: Application for provisional determination of a medicine
asserts: therapeutic-goods-act-1989-sec-22c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-22c-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-22c-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-22c-ss-1
schema version: 2
part of: 22C Applications for provisional determination

therapeutic-goods-act-1989-sec-22c-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to apply for provisional determination
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-22c-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Relates to a medicine of a kind prescribed by the regulations
modality: DescriptionLogic
operator: HasPart

therapeutic-goods-act-1989-sec-22c-ss-1-norm
type: Permission
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 22C(1) Applications for provisional determination

22C(2) Applications for provisional determination
type: Concept
description: Information, application fee, and required documents
source: therapeutic-goods-act-1989.pdf, p.133
note: Application requirements for provisional determination
asserts: therapeutic-goods-act-1989-sec-22c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-22c-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22c-ss-2
schema version: 2
part of: 22C Applications for provisional determination

therapeutic-goods-act-1989-sec-22c-ss-2-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-22c-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22C(2) Applications for provisional determination

22C(3) Applications for provisional determination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.133
note: Application for provisional determination may be required or permitted
asserts: therapeutic-goods-act-1989-sec-22c-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22c-ss-3
schema version: 2
part of: 22C Applications for provisional determination

therapeutic-goods-act-1989-sec-22c-ss-3-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22C(3) Applications for provisional determination

22D Provisional determinations
type: Concept
source: therapeutic-goods-act-1989.pdf, p.133
note: Secretary must decide on provisional determination
asserts: therapeutic-goods-act-1989-sec-22d-norm
asserts: therapeutic-goods-act-1989-sec-22d-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22d
schema version: 2

therapeutic-goods-act-1989-sec-22d-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must decide
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-22d-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22D Provisional determinations

22E Period during which provisional determination is in force
type: Concept
source: therapeutic-goods-act-1989.pdf, p.134
curation status: Proposed
has part: 22E(1) Period during which provisional determination is in force
has part: 22E(2) Period during which provisional determination is in force
has part: 22E(3) Period during which provisional determination is in force
has part: 22E(4) Period during which provisional determination is in force
has part: 22E(5) Period during which provisional determination is in force
has part: 22E(6) Period during which provisional determination is in force
has part: 22E(7) Period during which provisional determination is in force
has part: 22E(8) Period during which provisional determination is in force
has part: 22E(9) Period during which provisional determination is in force
proposed by: legis2cml
realized by: sec-22e
schema version: 2

22E(1) Period during which provisional determination is in force
type: Concept
source: therapeutic-goods-act-1989.pdf, p.134
note: Provisional determination period
asserts: therapeutic-goods-act-1989-sec-22e-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22e-ss-1
schema version: 2
part of: 22E Period during which provisional determination is in force

22E(2) Period during which provisional determination is in force
type: Concept
source: therapeutic-goods-act-1989.pdf, p.134
note: Defines initial period for provisional determination
asserts: therapeutic-goods-act-1989-sec-22e-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22e-ss-2
schema version: 2
part of: 22E Period during which provisional determination is in force

22E(3) Period during which provisional determination is in force
type: Concept
source: therapeutic-goods-act-1989.pdf, p.134
note: Application for extension of initial period
asserts: therapeutic-goods-act-1989-sec-22e-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22e-ss-3
schema version: 2
part of: 22E Period during which provisional determination is in force

therapeutic-goods-act-1989-sec-22e-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22E(3) Period during which provisional determination is in force

22E(4) Period during which provisional determination is in force
type: Concept
description: Application must be in a form approved by the Secretary, accompanied by the prescribed application fee, and made at least 28 days before the determination would otherwise cease to be in force.
source: therapeutic-goods-act-1989.pdf, p.134
note: Application requirements for provisional determination
asserts: therapeutic-goods-act-1989-sec-22e-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-22e-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-22e-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-22e-ss-4-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-22e-ss-4-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-22e-ss-4
schema version: 2
part of: 22E Period during which provisional determination is in force

therapeutic-goods-act-1989-sec-22e-ss-4-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Application must be made within a certain time frame
modality: AllenInterval
operator: BETWEEN
premise text: (4) The application must: (a) be in a form approved, in writing, by the Secretary; and (b) be made at least 28 days before the determination would otherwise cease to be in force; and (c) be accompanied by the prescribed application fee.

therapeutic-goods-act-1989-sec-22e-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application must meet certain requirements
modality: Deontic
operator: MUST
premise text: The application must be in a form approved by the Secretary, accompanied by the prescribed application fee, and made at least 28 days before the determination would otherwise cease to be in force.

therapeutic-goods-act-1989-sec-22e-ss-4-logic-deontic-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application must meet certain requirements
modality: Deontic
operator: MUST
premise text: (4) The application must: (a) be in a form approved, in writing, by the Secretary; and (b) be made at least 28 days before the determination would otherwise cease to be in force; and (c) be accompanied by the prescribed application fee.

therapeutic-goods-act-1989-sec-22e-ss-4-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Application must be made within a certain time frame
modality: LTL
operator: BETWEEN
premise text: (4) The application must: (a) be in a form approved, in writing, by the Secretary; and (b) be made at least 28 days before the determination would otherwise cease to be in force; and (c) be accompanied by the prescribed application fee.

therapeutic-goods-act-1989-sec-22e-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22E(4) Period during which provisional determination is in force

22E(5) Period during which provisional determination is in force
type: Concept
source: therapeutic-goods-act-1989.pdf, p.134
note: Secretary must decide to extend or refuse initial period
asserts: therapeutic-goods-act-1989-sec-22e-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-22e-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22e-ss-5
schema version: 2
part of: 22E Period during which provisional determination is in force

therapeutic-goods-act-1989-sec-22e-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must decide
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-22e-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22E(5) Period during which provisional determination is in force

22E(6) Period during which provisional determination is in force
type: Concept
source: therapeutic-goods-act-1989.pdf, p.134
note: Secretary may extend provisional determination period
asserts: therapeutic-goods-act-1989-sec-22e-ss-6-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22e-ss-6
schema version: 2
part of: 22E Period during which provisional determination is in force

22E(7) Period during which provisional determination is in force
type: Concept
description: yes
source: therapeutic-goods-act-1989.pdf, p.134
note: Provide written notice of decision and reasons for refusal
asserts: therapeutic-goods-act-1989-sec-22e-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-22e-ss-7-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22e-ss-7
schema version: 2
part of: 22E Period during which provisional determination is in force

therapeutic-goods-act-1989-sec-22e-ss-7-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide notice
modality: Deontic
operator: MUST

22E(8) Period during which provisional determination is in force
type: Concept
source: therapeutic-goods-act-1989.pdf, p.134
note: Limitation on extension of provisional determination
asserts: therapeutic-goods-act-1989-sec-22e-ss-8-norm
asserts: therapeutic-goods-act-1989-sec-22e-ss-8-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22e-ss-8
schema version: 2
part of: 22E Period during which provisional determination is in force

therapeutic-goods-act-1989-sec-22e-ss-8-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on multiple extensions
modality: Deontic
operator: NOT
premise text: (8) Only one extension may be given.

22E(9) Period during which provisional determination is in force
type: Concept
source: therapeutic-goods-act-1989.pdf, p.134
note: Provisional determination remains in force until application for provisional registration is made.
asserts: therapeutic-goods-act-1989-sec-22e-ss-9-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22e-ss-9
schema version: 2
part of: 22E Period during which provisional determination is in force

22F Revocation of provisional determination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.136
curation status: Proposed
has part: 22F(1) Revocation of provisional determination
has part: 22F(2) Revocation of provisional determination
has part: 22F(3) Revocation of provisional determination
has part: 22F(4) Revocation of provisional determination
proposed by: legis2cml
realized by: sec-22f
schema version: 2

22F(1) Revocation of provisional determination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.136
note: Secretary may revoke provisional determination under certain conditions.
asserts: therapeutic-goods-act-1989-sec-22f-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-22f-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22f-ss-1
schema version: 2
part of: 22F Revocation of provisional determination

therapeutic-goods-act-1989-sec-22f-ss-1-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: May revoke
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-22f-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22F(1) Revocation of provisional determination

22F(2) Revocation of provisional determination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.136
note: Secretary must revoke provisional determination upon request.
asserts: therapeutic-goods-act-1989-sec-22f-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-22f-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22f-ss-2
schema version: 2
part of: 22F Revocation of provisional determination

therapeutic-goods-act-1989-sec-22f-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide revocation notice
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-22f-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22F(2) Revocation of provisional determination

22F(3) Revocation of provisional determination
type: Concept
description: written notice, reasons for revocation
source: therapeutic-goods-act-1989.pdf, p.136
note: Secretary must give written notice of revocation and set out reasons for revocation.
asserts: therapeutic-goods-act-1989-sec-22f-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-22f-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22f-ss-3
schema version: 2
part of: 22F Revocation of provisional determination

therapeutic-goods-act-1989-sec-22f-ss-3-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-22f-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22F(3) Revocation of provisional determination

22F(4) Revocation of provisional determination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.136
note: Revocation of provisional determination takes effect on the day notice is given.
asserts: therapeutic-goods-act-1989-sec-22f-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-22f-ss-4-logic-alleninterval-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22f-ss-4
schema version: 2
part of: 22F Revocation of provisional determination

therapeutic-goods-act-1989-sec-22f-ss-4-logic-alleninterval-1
type: LogicApplication
conclusion text: revocation takes effect
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines temporal interval for revocation
modality: AllenInterval
operator: Applicable
premise text: day on which the Secretary gives notice

22G Scientific advice about aspects of quality, safety or efficacy of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
curation status: Proposed
has part: 22G(1) Scientific advice about aspects of quality, safety or efficacy of
has part: 22G(2) Scientific advice about aspects of quality, safety or efficacy of
has part: 22G(3) Scientific advice about aspects of quality, safety or efficacy of
has part: 22G(4) Scientific advice about aspects of quality, safety or efficacy of
has part: 22G(5) Scientific advice about aspects of quality, safety or efficacy of
has part: 22G(6) Scientific advice about aspects of quality, safety or efficacy of
has part: 22G(7) Scientific advice about aspects of quality, safety or efficacy of
has part: 22G(8) Scientific advice about aspects of quality, safety or efficacy of
has part: 22G(9) Scientific advice about aspects of quality, safety or efficacy of
proposed by: legis2cml
realized by: sec-22g
schema version: 2

22G(1) Scientific advice about aspects of quality, safety or efficacy of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Request for scientific advice on medicine registration
asserts: therapeutic-goods-act-1989-sec-22g-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22g-ss-1
schema version: 2
part of: 22G Scientific advice about aspects of quality, safety or efficacy of

therapeutic-goods-act-1989-sec-22g-ss-1-norm
type: Permission
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 22G(1) Scientific advice about aspects of quality, safety or efficacy of

22G(2) Scientific advice about aspects of quality, safety or efficacy of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Each request must relate only to one aspect of the quality of the medicine.
asserts: therapeutic-goods-act-1989-sec-22g-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-22g-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22g-ss-2
schema version: 2
part of: 22G Scientific advice about aspects of quality, safety or efficacy of

therapeutic-goods-act-1989-sec-22g-ss-2-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-22g-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22G(2) Scientific advice about aspects of quality, safety or efficacy of

22G(3) Scientific advice about aspects of quality, safety or efficacy of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Request for scientific advice on medicine safety
asserts: therapeutic-goods-act-1989-sec-22g-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22g-ss-3
schema version: 2
part of: 22G Scientific advice about aspects of quality, safety or efficacy of

therapeutic-goods-act-1989-sec-22g-ss-3-norm
type: Permission
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 22G(3) Scientific advice about aspects of quality, safety or efficacy of

22G(4) Scientific advice about aspects of quality, safety or efficacy of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Each request must relate only to one aspect of the safety of the medicine.
asserts: therapeutic-goods-act-1989-sec-22g-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-22g-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-22g-ss-4-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-22g-ss-4
schema version: 2
part of: 22G Scientific advice about aspects of quality, safety or efficacy of

therapeutic-goods-act-1989-sec-22g-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: relate only to one aspect of the safety of the medicine.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for requests
modality: AllenInterval
operator: CONTAINS
premise text: (4) Each request under subsection (3)

therapeutic-goods-act-1989-sec-22g-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: relate only to one aspect of the safety of the medicine.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must relate only to one aspect
modality: Deontic
operator: MUST
premise text: (4) Each request under subsection (3)

therapeutic-goods-act-1989-sec-22g-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22G(4) Scientific advice about aspects of quality, safety or efficacy of

22G(5) Scientific advice about aspects of quality, safety or efficacy of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Request for scientific advice on efficacy of medicine
asserts: therapeutic-goods-act-1989-sec-22g-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22g-ss-5
schema version: 2
part of: 22G Scientific advice about aspects of quality, safety or efficacy of

22G(6) Scientific advice about aspects of quality, safety or efficacy of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Each request must relate only to one aspect of the efficacy of the medicine.
asserts: therapeutic-goods-act-1989-sec-22g-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-22g-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22g-ss-6
schema version: 2
part of: 22G Scientific advice about aspects of quality, safety or efficacy of

therapeutic-goods-act-1989-sec-22g-ss-6-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must relate only to one aspect
modality: Deontic
operator: MUST

22G(7) Scientific advice about aspects of quality, safety or efficacy of
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.138
note: Secretary must provide scientific advice in response to a request.
asserts: therapeutic-goods-act-1989-sec-22g-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-22g-ss-7-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22g-ss-7
schema version: 2
part of: 22G Scientific advice about aspects of quality, safety or efficacy of

therapeutic-goods-act-1989-sec-22g-ss-7-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-22g-ss-7-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22G(7) Scientific advice about aspects of quality, safety or efficacy of

22G(8) Scientific advice about aspects of quality, safety or efficacy of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Request must be made in accordance with a form approved by the Secretary and accompanied by the prescribed fee.
asserts: therapeutic-goods-act-1989-sec-22g-ss-8-norm
asserts: therapeutic-goods-act-1989-sec-22g-ss-8-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-22g-ss-8
schema version: 2
part of: 22G Scientific advice about aspects of quality, safety or efficacy of

therapeutic-goods-act-1989-sec-22g-ss-8-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Request must be made in accordance with a form approved by the Secretary.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-22g-ss-8-norm
type: Obligation
scope note: borne by: LegalPerson
curation status: Proposed
modality: Deontic
borne by: LegalPerson
deontic status: HeuristicDerived
part of: 22G(8) Scientific advice about aspects of quality, safety or efficacy of

22G(9) Scientific advice about aspects of quality, safety or efficacy of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.138
note: Request for information or document may be required or permitted
asserts: therapeutic-goods-act-1989-sec-22g-ss-9-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-22g-ss-9
schema version: 2
part of: 22G Scientific advice about aspects of quality, safety or efficacy of

therapeutic-goods-act-1989-sec-22g-ss-9-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 22G(9) Scientific advice about aspects of quality, safety or efficacy of

23 Applications generally
type: Concept
source: therapeutic-goods-act-1989.pdf, p.140
note: A person may make an application to the Secretary for registration or listing of therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-23-norm
asserts: therapeutic-goods-act-1989-sec-23-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-23
schema version: 2

therapeutic-goods-act-1989-sec-23-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-23-norm
type: Permission
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 23 Applications generally

23A Classes of therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.141
curation status: Proposed
has part: 23A(1) Classes of therapeutic goods
has part: 23A(2) Classes of therapeutic goods
proposed by: legis2cml
realized by: sec-23a
schema version: 2

23A(1) Classes of therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.141
note: The Secretary may specify different classes of therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-23a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-23a-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-23a-ss-1
schema version: 2
part of: 23A Classes of therapeutic goods

therapeutic-goods-act-1989-sec-23a-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits the Secretary to take action.
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-23a-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 23A(1) Classes of therapeutic goods

23A(2) Classes of therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.141
note: Specifies classes of therapeutic goods by reference to certain matters.
asserts: therapeutic-goods-act-1989-sec-23a-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-23a-ss-2
schema version: 2
part of: 23A Classes of therapeutic goods

23AA Applications for provisional registration of medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.140
curation status: Proposed
has part: 23AA(1) Applications for provisional registration of medicine
has part: 23AA(2) Applications for provisional registration of medicine
proposed by: legis2cml
realized by: sec-23aa
schema version: 2

23AA(1) Applications for provisional registration of medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.140
note: Application for provisional registration of medicine is taken to be an application for provisional registration if certain conditions are met.
asserts: therapeutic-goods-act-1989-sec-23aa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-23aa-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-23aa-ss-1
schema version: 2
part of: 23AA Applications for provisional registration of medicine

therapeutic-goods-act-1989-sec-23aa-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Provisional determination under section 22D is in force
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Conditional obligation
modality: Deontic
operator: >
premise text: Application made under section 23 for registration of medicine

therapeutic-goods-act-1989-sec-23aa-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 23AA(1) Applications for provisional registration of medicine

23AA(2) Applications for provisional registration of medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.140
note: Application for provisional registration of new medicine must be made before end of provisional registration period.
asserts: therapeutic-goods-act-1989-sec-23aa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-23aa-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-23aa-ss-2
schema version: 2
part of: 23AA Applications for provisional registration of medicine

therapeutic-goods-act-1989-sec-23aa-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application for provisional registration of new medicine must be made before end of provisional registration period.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-23aa-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 23AA(2) Applications for provisional registration of medicine

23B Requirements relating to applications for registration of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.141
curation status: Proposed
has part: 23B(1) Requirements relating to applications for registration of
has part: 23B(2) Requirements relating to applications for registration of
proposed by: legis2cml
realized by: sec-23b
schema version: 2

23B(1) Requirements relating to applications for registration of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.141
note: Secretary must carry out assessment of requirements met in relation to application.
asserts: therapeutic-goods-act-1989-sec-23b-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-23b-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-23b-ss-1
schema version: 2
part of: 23B Requirements relating to applications for registration of

therapeutic-goods-act-1989-sec-23b-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must carry out assessment
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-23b-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 23B(1) Requirements relating to applications for registration of

23B(2) Requirements relating to applications for registration of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.141
note: Application must be made in a specific manner
asserts: therapeutic-goods-act-1989-sec-23b-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-23b-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-23b-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-23b-ss-2
schema version: 2
part of: 23B Requirements relating to applications for registration of

therapeutic-goods-act-1989-sec-23b-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must be made in accordance with the approved form
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-23b-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Application must be made in a manner that is approved by the Secretary
modality: DescriptionLogic
operator: IS

therapeutic-goods-act-1989-sec-23b-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 23B(2) Requirements relating to applications for registration of

23C Requirements relating to applications for listing of therapeutic
type: Concept
source: therapeutic-goods-act-1989.pdf, p.144
curation status: Proposed
has part: 23C(1) Requirements relating to applications for listing of therapeutic
has part: 23C(2) Requirements relating to applications for listing of therapeutic
has part: 23C(3) Requirements relating to applications for listing of therapeutic
proposed by: legis2cml
realized by: sec-23c
schema version: 2

23C(1) Requirements relating to applications for listing of therapeutic
type: Concept
source: therapeutic-goods-act-1989.pdf, p.144
note: Application requirement for listing of therapeutic goods under section 26 or 26A.
asserts: therapeutic-goods-act-1989-sec-23c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-23c-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-23c-ss-1
schema version: 2
part of: 23C Requirements relating to applications for listing of therapeutic

therapeutic-goods-act-1989-sec-23c-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application requirement
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-23c-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 23C(1) Requirements relating to applications for listing of therapeutic

23C(2) Requirements relating to applications for listing of therapeutic
type: Concept
description: Information, application fee, and samples (if required)
source: therapeutic-goods-act-1989.pdf, p.144
note: Application must comply with requirements to be listed.
asserts: therapeutic-goods-act-1989-sec-23c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-23c-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-23c-ss-2
schema version: 2
part of: 23C Requirements relating to applications for listing of therapeutic

therapeutic-goods-act-1989-sec-23c-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application must comply with requirements.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-23c-ss-2-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 23C(2) Requirements relating to applications for listing of therapeutic

23C(3) Requirements relating to applications for listing of therapeutic
type: Concept
source: therapeutic-goods-act-1989.pdf, p.144
note: Secretary may determine forms of information for application purposes.
asserts: therapeutic-goods-act-1989-sec-23c-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-23c-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-23c-ss-3
schema version: 2
part of: 23C Requirements relating to applications for listing of therapeutic

therapeutic-goods-act-1989-sec-23c-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: May impose obligation on the Secretary.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-23c-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 23C(3) Requirements relating to applications for listing of therapeutic

24 Applications for registration
type: Concept
source: therapeutic-goods-act-1989.pdf, p.146
curation status: Proposed
has part: 24(1) Applications for registration
has part: 24(1A) Applications for registration
has part: 24(2) Applications for registration
has part: 24(3) Applications for registration
proposed by: legis2cml
realized by: sec-24
schema version: 2

24(1) Applications for registration
type: Concept
source: therapeutic-goods-act-1989.pdf, p.146
note: Application for registration of therapeutic goods under section 23 is required if certain conditions are met.
asserts: therapeutic-goods-act-1989-sec-24-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-24-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-24-ss-1
schema version: 2
part of: 24 Applications for registration

therapeutic-goods-act-1989-sec-24-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application for registration is required
modality: Deontic
operator: requires
premise text: (a) an application is made for the registration of therapeutic goods under section 23; and (b) the goods are goods that are required to be registered; and (c) the application has passed preliminary assessment.

therapeutic-goods-act-1989-sec-24-ss-1-norm
type: Obligation
scope note: borne by: LegalPerson
curation status: Proposed
modality: Deontic
borne by: LegalPerson
deontic status: HeuristicDerived
part of: 24(1) Applications for registration

24(1A) Applications for registration
type: Concept
description: evaluation fee amount
source: therapeutic-goods-act-1989.pdf, p.146
note: Applicant must pay evaluation fee
asserts: therapeutic-goods-act-1989-sec-24-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-24-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-24-ss-1a
schema version: 2
part of: 24 Applications for registration

therapeutic-goods-act-1989-sec-24-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Duty to pay evaluation fee
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-24-ss-1a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 24(1A) Applications for registration

24(2) Applications for registration
type: Concept
source: therapeutic-goods-act-1989.pdf, p.146
note: Application for registration lapses if fee remains unpaid or application contains inaccurate information.
asserts: therapeutic-goods-act-1989-sec-24-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-24-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-24-ss-2-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-24-ss-2
schema version: 2
part of: 24 Applications for registration

therapeutic-goods-act-1989-sec-24-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: ...the day on which the amount became due and payable;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap between application lapse and fee payment deadline.
modality: AllenInterval
operator: Overlap
premise text: (2) An application for registration of therapeutic goods lapses if...

therapeutic-goods-act-1989-sec-24-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...the amount became due and payable;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application lapse due to non-payment or inaccuracy.
modality: Deontic
operator: Prohibit
premise text: (2) An application for registration of therapeutic goods lapses if...

therapeutic-goods-act-1989-sec-24-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 24(2) Applications for registration

24(3) Applications for registration
type: Concept
source: therapeutic-goods-act-1989.pdf, p.146
note: Defines individual patient data in relation to therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-24-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-24-ss-3-logic-descriptionlogic-1
asserts: therapeutic-goods-act-1989-sec-24-ss-3-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-24-ss-3
schema version: 2
part of: 24 Applications for registration

therapeutic-goods-act-1989-sec-24-ss-3-logic-alleninterval-2
type: LogicApplication
conclusion text: Clinical trials
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Describes temporal relationship between administration of goods and collection of data
modality: AllenInterval
operator: during
premise text: Before, during and after the administration of the goods

therapeutic-goods-act-1989-sec-24-ss-3-logic-descriptionlogic-1
type: LogicApplication
conclusion text: Individual patient data
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies individuals into categories
modality: DescriptionLogic
operator: =
premise text: Demographic, biochemical and haematological information

therapeutic-goods-act-1989-sec-24-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 24(3) Applications for registration

24A When evaluation fee due for payment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.147
note: Evaluation fee due on notification of amount
asserts: therapeutic-goods-act-1989-sec-24a-norm
asserts: therapeutic-goods-act-1989-sec-24a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-24a
schema version: 2

therapeutic-goods-act-1989-sec-24a-logic-deontic-1
type: LogicApplication
conclusion text: Evaluation fee is due
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to pay evaluation fee
modality: Deontic
operator: due
premise text: Section 24A

therapeutic-goods-act-1989-sec-24a-norm
type: Obligation
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 24A When evaluation fee due for payment

24B Payment of evaluation fee by instalments
type: Concept
source: therapeutic-goods-act-1989.pdf, p.147
curation status: Proposed
has part: 24B(1) Payment of evaluation fee by instalments
has part: 24B(2) Payment of evaluation fee by instalments
has part: 24B(3) Payment of evaluation fee by instalments
proposed by: legis2cml
realized by: sec-24b
schema version: 2

24B(1) Payment of evaluation fee by instalments
type: Concept
source: therapeutic-goods-act-1989.pdf, p.147
note: Payment of evaluation fee by instalments
asserts: therapeutic-goods-act-1989-sec-24b-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-24b-ss-1
schema version: 2
part of: 24B Payment of evaluation fee by instalments

24B(2) Payment of evaluation fee by instalments
type: Concept
source: therapeutic-goods-act-1989.pdf, p.147
note: Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid.
asserts: therapeutic-goods-act-1989-sec-24b-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-24b-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-24b-ss-2-logic-linearlogic-2
asserts: therapeutic-goods-act-1989-sec-24b-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-24b-ss-2-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-24b-ss-2
schema version: 2
part of: 24B Payment of evaluation fee by instalments

therapeutic-goods-act-1989-sec-24b-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-24b-ss-2-logic-deontic-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid.
modality: Deontic
operator: forbid
premise text: (2) Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an evaluation fee under section 24 by instalments...

therapeutic-goods-act-1989-sec-24b-ss-2-logic-linearlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid.
modality: LinearLogic
operator: ¬(A ∧ B)
premise text: (2) Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an evaluation fee under section 24 by instalments...

therapeutic-goods-act-1989-sec-24b-ss-2-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid.
modality: LTL
operator: ¬(A ∧ B)
premise text: (2) Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an evaluation fee under section 24 by instalments...

therapeutic-goods-act-1989-sec-24b-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 24B(2) Payment of evaluation fee by instalments

24B(3) Payment of evaluation fee by instalments
type: Concept
source: therapeutic-goods-act-1989.pdf, p.147
note: Payment of evaluation fee by instalments is obligatory.
asserts: therapeutic-goods-act-1989-sec-24b-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-24b-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-24b-ss-3
schema version: 2
part of: 24B Payment of evaluation fee by instalments

therapeutic-goods-act-1989-sec-24b-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-24b-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 24B(3) Payment of evaluation fee by instalments

24C Recovery of evaluation fee
type: Concept
source: therapeutic-goods-act-1989.pdf, p.147
note: Recovery of evaluation fee is an obligation for the Commonwealth.
asserts: therapeutic-goods-act-1989-sec-24c-norm
asserts: therapeutic-goods-act-1989-sec-24c-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-24c
schema version: 2

therapeutic-goods-act-1989-sec-24c-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Recovery of evaluation fee is an obligation.
modality: Deontic
operator: Obligation

24D Refund of evaluation fee where evaluation not completed within
type: Concept
source: therapeutic-goods-act-1989.pdf, p.148
curation status: Proposed
has part: 24D(1) Refund of evaluation fee where evaluation not completed within
has part: 24D(2) Refund of evaluation fee where evaluation not completed within
has part: 24D(3) Refund of evaluation fee where evaluation not completed within
proposed by: legis2cml
realized by: sec-24d
schema version: 2

24D(1) Refund of evaluation fee where evaluation not completed within
type: Concept
source: therapeutic-goods-act-1989.pdf, p.148
note: This section applies to an application under section 23 in relation to therapeutic goods for the evaluation of which a period is prescribed under paragraph 63(2)(da).
asserts: therapeutic-goods-act-1989-sec-24d-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-24d-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-24d-ss-1
schema version: 2
part of: 24D Refund of evaluation fee where evaluation not completed within

therapeutic-goods-act-1989-sec-24d-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Section applies to an application under section 23
modality: Deontic
operator: applies

therapeutic-goods-act-1989-sec-24d-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 24D(1) Refund of evaluation fee where evaluation not completed within

24D(2) Refund of evaluation fee where evaluation not completed within
type: Concept
source: therapeutic-goods-act-1989.pdf, p.148
note: Refund of evaluation fee if not completed within period
asserts: therapeutic-goods-act-1989-sec-24d-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-24d-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-24d-ss-2-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-24d-ss-2
schema version: 2
part of: 24D Refund of evaluation fee where evaluation not completed within

therapeutic-goods-act-1989-sec-24d-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: 25% of the evaluation fee must be refunded
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Evaluation period is a temporal interval
modality: AllenInterval
operator: >=
premise text: but not within the period referred to in subsection (1)

therapeutic-goods-act-1989-sec-24d-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: 25% of the evaluation fee must be refunded
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to refund evaluation fee
modality: Deontic
operator: MUST
premise text: (2) If...

therapeutic-goods-act-1989-sec-24d-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 24D(2) Refund of evaluation fee where evaluation not completed within

24D(3) Refund of evaluation fee where evaluation not completed within
type: Concept
source: therapeutic-goods-act-1989.pdf, p.148
note: Notification of decision constitutes completion of evaluation.
asserts: therapeutic-goods-act-1989-sec-24d-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-24d-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-24d-ss-3
schema version: 2
part of: 24D Refund of evaluation fee where evaluation not completed within

therapeutic-goods-act-1989-sec-24d-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Notification of decision constitutes completion of evaluation.
modality: Deontic
operator: Obligate

therapeutic-goods-act-1989-sec-24d-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 24D(3) Refund of evaluation fee where evaluation not completed within

24E Deemed refusal of application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.148
curation status: Proposed
has part: 24E(1) Deemed refusal of application
has part: 24E(2) Deemed refusal of application
has part: 24E(3) Deemed refusal of application
has part: 24E(4) Deemed refusal of application
proposed by: legis2cml
realized by: sec-24e
schema version: 2

24E(1) Deemed refusal of application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.148
note: Deemed refusal of application
asserts: therapeutic-goods-act-1989-sec-24e-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-24e-ss-1
schema version: 2
part of: 24E Deemed refusal of application

therapeutic-goods-act-1989-sec-24e-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 24E(1) Deemed refusal of application

24E(2) Deemed refusal of application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.148
note: Applicant may give notice to treat application as refused if evaluation not completed
asserts: therapeutic-goods-act-1989-sec-24e-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-24e-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-24e-ss-2
schema version: 2
part of: 24E Deemed refusal of application

therapeutic-goods-act-1989-sec-24e-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Applicant may give notice to treat application as refused
modality: Deontic
operator: May

24E(3) Deemed refusal of application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.148
note: Notice may be given at any time before evaluation is completed.
asserts: therapeutic-goods-act-1989-sec-24e-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-24e-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-24e-ss-3
schema version: 2
part of: 24E Deemed refusal of application

therapeutic-goods-act-1989-sec-24e-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to give notice at any time
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-24e-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 24E(3) Deemed refusal of application

24E(4) Deemed refusal of application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.148
note: Deemed refusal of application
asserts: therapeutic-goods-act-1989-sec-24e-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-24e-ss-4
schema version: 2
part of: 24E Deemed refusal of application

25 Evaluation of therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.149
note: The Secretary must evaluate therapeutic goods for registration having regard to the quality, safety and efficacy of the goods.
asserts: therapeutic-goods-act-1989-sec-25-norm
asserts: therapeutic-goods-act-1989-sec-25-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-25
schema version: 2

therapeutic-goods-act-1989-sec-25-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must evaluate therapeutic goods for registration.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-25-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 25 Evaluation of therapeutic goods

25A When the Secretary must not use protected information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.159
curation status: Proposed
has part: 25A(1) When the Secretary must not use protected information
has part: 25A(2) When the Secretary must not use protected information
proposed by: legis2cml
realized by: sec-25a
schema version: 2

25A(1) When the Secretary must not use protected information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.159
note: Prohibition on using protected information when evaluating therapeutic goods for registration
asserts: therapeutic-goods-act-1989-sec-25a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-25a-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-25a-ss-1-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-25a-ss-1
schema version: 2
part of: 25A When the Secretary must not use protected information

therapeutic-goods-act-1989-sec-25a-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on using protected information
modality: Deontic
operator: prohibition
premise text: (1) When evaluating therapeutic goods for registration, the Secretary must not use information about other therapeutic goods that is protected information.

therapeutic-goods-act-1989-sec-25a-ss-1-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Duty to refrain from using protected information
modality: Deontic
operator: duty
premise text: (1) When evaluating therapeutic goods for registration, the Secretary must not use information about other therapeutic goods that is protected information.

25A(2) When the Secretary must not use protected information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.159
note: The Secretary must not use protected information.
asserts: therapeutic-goods-act-1989-sec-25a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-25a-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-25a-ss-2
schema version: 2
part of: 25A When the Secretary must not use protected information

therapeutic-goods-act-1989-sec-25a-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...the Secretary must not use protected information.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of using protected information.
modality: Deontic
operator: Prohibit
premise text: (2) Information is protected information if...

therapeutic-goods-act-1989-sec-25a-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 25A(2) When the Secretary must not use protected information

25AA Approved product information for medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.155
curation status: Proposed
has part: 25AA(1) Approved product information for medicine
has part: 25AA(1A) Approved product information for medicine
has part: 25AA(1B) Approved product information for medicine
has part: 25AA(1C) Approved product information for medicine
proposed by: legis2cml
realized by: sec-25aa
schema version: 2

25AA(1) Approved product information for medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.155
note: The Secretary must approve product information for therapeutic goods if certain conditions are met.
asserts: therapeutic-goods-act-1989-sec-25aa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-25aa-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-25aa-ss-1
schema version: 2
part of: 25AA Approved product information for medicine

therapeutic-goods-act-1989-sec-25aa-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary has a duty to approve product information.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-25aa-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 25AA(1) Approved product information for medicine

25AA(1A) Approved product information for medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.155
note: Secretary must approve product information reflecting basis for registration.
asserts: therapeutic-goods-act-1989-sec-25aa-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-25aa-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-25aa-ss-1a
schema version: 2
part of: 25AA Approved product information for medicine

therapeutic-goods-act-1989-sec-25aa-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Mandatory approval requirement.
modality: Deontic
operator: Must

therapeutic-goods-act-1989-sec-25aa-ss-1a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 25AA(1A) Approved product information for medicine

25AA(1B) Approved product information for medicine
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.155
note: Require person to provide product information for restricted medicine.
asserts: therapeutic-goods-act-1989-sec-25aa-ss-1b-norm
asserts: therapeutic-goods-act-1989-sec-25aa-ss-1b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-25aa-ss-1b
schema version: 2
part of: 25AA Approved product information for medicine

therapeutic-goods-act-1989-sec-25aa-ss-1b-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide product information.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-25aa-ss-1b-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 25AA(1B) Approved product information for medicine

25AA(1C) Approved product information for medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.155
note: Secretary must approve product information if person complies with subsection (1B)
asserts: therapeutic-goods-act-1989-sec-25aa-ss-1c-norm
asserts: therapeutic-goods-act-1989-sec-25aa-ss-1c-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-25aa-ss-1c
schema version: 2
part of: 25AA Approved product information for medicine

therapeutic-goods-act-1989-sec-25aa-ss-1c-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to approve product information
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-25aa-ss-1c-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 25AA(1C) Approved product information for medicine

25AB Registration of therapeutic goods etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.158
curation status: Proposed
has part: 25AB(2) Registration of therapeutic goods etc.
has part: 25AB(3) Registration of therapeutic goods etc.
has part: 25AB(4) Registration of therapeutic goods etc.
has part: 25AB(5) Registration of therapeutic goods etc.
has part: 25AB(6) Registration of therapeutic goods etc.
proposed by: legis2cml
realized by: sec-25ab
schema version: 2

25AB(2) Registration of therapeutic goods etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.158
note: Secretary must notify applicant within 28 days of decision to register therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-25ab-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-25ab-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-25ab-ss-2
schema version: 2
part of: 25AB Registration of therapeutic goods etc.

therapeutic-goods-act-1989-sec-25ab-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must notify applicant within 28 days.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-25ab-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 25AB(2) Registration of therapeutic goods etc.

25AB(3) Registration of therapeutic goods etc.
type: Concept
description: (a) and (b)
source: therapeutic-goods-act-1989.pdf, p.158
note: The notice must set out certain information about the decision to register goods.
asserts: therapeutic-goods-act-1989-sec-25ab-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-25ab-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-25ab-ss-3
schema version: 2
part of: 25AB Registration of therapeutic goods etc.

therapeutic-goods-act-1989-sec-25ab-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: (a) and (b)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The notice must contain certain information.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-25ab-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 25AB(3) Registration of therapeutic goods etc.

25AB(4) Registration of therapeutic goods etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.158
note: Secretary must include goods in Register and give applicant a certificate of registration.
asserts: therapeutic-goods-act-1989-sec-25ab-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-25ab-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-25ab-ss-4
schema version: 2
part of: 25AB Registration of therapeutic goods etc.

therapeutic-goods-act-1989-sec-25ab-ss-4-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-25ab-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 25AB(4) Registration of therapeutic goods etc.

25AB(5) Registration of therapeutic goods etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.158
note: Secretary must register therapeutic goods without inquiry into correctness of certificate or notice.
asserts: therapeutic-goods-act-1989-sec-25ab-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-25ab-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-25ab-ss-5
schema version: 2
part of: 25AB Registration of therapeutic goods etc.

therapeutic-goods-act-1989-sec-25ab-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must register therapeutic goods.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-25ab-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 25AB(5) Registration of therapeutic goods etc.

25AB(6) Registration of therapeutic goods etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.158
note: Commencement of therapeutic goods registration
asserts: therapeutic-goods-act-1989-sec-25ab-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-25ab-ss-6-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-25ab-ss-6-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-25ab-ss-6-logic-linearlogic-3
asserts: therapeutic-goods-act-1989-sec-25ab-ss-6-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-25ab-ss-6-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-25ab-ss-6
schema version: 2
part of: 25AB Registration of therapeutic goods etc.

therapeutic-goods-act-1989-sec-25ab-ss-6-logic-alleninterval-2
type: LogicApplication
conclusion text: The registration occurs during the specified day.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Indicates a temporal relationship between two events
modality: AllenInterval
operator: during
premise text: (6) The registration of therapeutic goods commences on the day specified in the certificate of registration.

therapeutic-goods-act-1989-sec-25ab-ss-6-logic-cogai-5
type: LogicApplication
conclusion text: The registration is processed by the specified day.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Indicates a means of processing or application
modality: CogAI
operator: by
premise text: (6) The registration of therapeutic goods commences on the day specified in the certificate of registration.

therapeutic-goods-act-1989-sec-25ab-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: The registration of therapeutic goods begins on the specified day.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Indicates the start of a process
modality: Deontic
operator: begins
premise text: (6) The registration of therapeutic goods commences on the day specified in the certificate of registration.

therapeutic-goods-act-1989-sec-25ab-ss-6-logic-diffusion-4
type: LogicApplication
conclusion text: The registration is transmitted through the specified day.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Indicates a means of transmission or application
modality: Diffusion
operator: through
premise text: (6) The registration of therapeutic goods commences on the day specified in the certificate of registration.

therapeutic-goods-act-1989-sec-25ab-ss-6-logic-linearlogic-3
type: LogicApplication
conclusion text: The registration then occurs on the specified day.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Indicates a causal relationship between two events
modality: LinearLogic
operator: then
premise text: (6) The registration of therapeutic goods commences on the day specified in the certificate of registration.

25AC Notice of decision not to register therapeutic goods
type: Concept
description: Reasons for the decision
source: therapeutic-goods-act-1989.pdf, p.159
note: Secretary must notify applicant of decision within 28 days.
asserts: therapeutic-goods-act-1989-sec-25ac-norm
asserts: therapeutic-goods-act-1989-sec-25ac-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-25ac
schema version: 2

therapeutic-goods-act-1989-sec-25ac-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must notify applicant
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-25ac-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 25AC Notice of decision not to register therapeutic goods

26 Listing of therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.160
note: Listing of therapeutic goods
asserts: therapeutic-goods-act-1989-sec-26-norm
asserts: therapeutic-goods-act-1989-sec-26-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-26-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-26
schema version: 2

therapeutic-goods-act-1989-sec-26-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-26-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Listing of therapeutic goods
modality: Deontic
operator: Obligate

therapeutic-goods-act-1989-sec-26-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26 Listing of therapeutic goods

26A Listing of certain medicines
type: Concept
source: therapeutic-goods-act-1989.pdf, p.164
curation status: Proposed
has part: 26A(1) Listing of certain medicines
has part: 26A(1A) Listing of certain medicines
has part: 26A(2) Listing of certain medicines
proposed by: legis2cml
realized by: sec-26a
schema version: 2

26A(1) Listing of certain medicines
type: Concept
source: therapeutic-goods-act-1989.pdf, p.164
note: The Secretary must list a medicine if certain conditions are met.
asserts: therapeutic-goods-act-1989-sec-26a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-26a-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26a-ss-1
schema version: 2
part of: 26A Listing of certain medicines

therapeutic-goods-act-1989-sec-26a-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must list the medicine.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-26a-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26A(1) Listing of certain medicines

26A(1A) Listing of certain medicines
type: Concept
source: therapeutic-goods-act-1989.pdf, p.164
note: Secretary must list medicine under subsection (1) without inquiring into the correctness of the certificate or notice.
asserts: therapeutic-goods-act-1989-sec-26a-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-26a-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26a-ss-1a
schema version: 2
part of: 26A Listing of certain medicines

therapeutic-goods-act-1989-sec-26a-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Duty to list medicine
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-26a-ss-1a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26A(1A) Listing of certain medicines

26A(2) Listing of certain medicines
type: Concept
description: Certification of eligibility, safety, and presentation.
source: therapeutic-goods-act-1989.pdf, p.164
note: Certify that medicine meets certain requirements.
asserts: therapeutic-goods-act-1989-sec-26a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-26a-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26a-ss-2
schema version: 2
part of: 26A Listing of certain medicines

therapeutic-goods-act-1989-sec-26a-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to certify
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-26a-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26A(2) Listing of certain medicines

26AB Application for listing of certain medicines following efficacy
type: Concept
source: therapeutic-goods-act-1989.pdf, p.169
note: Application for listing of certain medicines following efficacy
asserts: therapeutic-goods-act-1989-sec-26ab-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26ab
schema version: 2

therapeutic-goods-act-1989-sec-26ab-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26AB Application for listing of certain medicines following efficacy

26AC Evaluation fees for listing of medicine under section 26AE
type: Concept
source: therapeutic-goods-act-1989.pdf, p.173
curation status: Proposed
has part: 26AC(1) Evaluation fees for listing of medicine under section 26AE
has part: 26AC(2) Evaluation fees for listing of medicine under section 26AE
has part: 26AC(3) Evaluation fees for listing of medicine under section 26AE
has part: 26AC(4) Evaluation fees for listing of medicine under section 26AE
has part: 26AC(5) Evaluation fees for listing of medicine under section 26AE
proposed by: legis2cml
realized by: sec-26ac
schema version: 2

26AC(1) Evaluation fees for listing of medicine under section 26AE
type: Concept
source: therapeutic-goods-act-1989.pdf, p.173
note: Application must pass preliminary assessment to be eligible for listing under section 26AE.
asserts: therapeutic-goods-act-1989-sec-26ac-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-26ac-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-26ac-ss-1-logic-linearlogic-2
asserts: therapeutic-goods-act-1989-sec-26ac-ss-1-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-26ac-ss-1-logic-cogai-4
asserts: therapeutic-goods-act-1989-sec-26ac-ss-1-logic-shacl-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-26ac-ss-1
schema version: 2
part of: 26AC Evaluation fees for listing of medicine under section 26AE

therapeutic-goods-act-1989-sec-26ac-ss-1-logic-alleninterval-3
type: LogicApplication
conclusion text: Eligible for listing under section 26AE.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Preliminary assessment must occur before listing under section 26AE.
modality: AllenInterval
operator: BETWEEN
premise text: Section 23 application

therapeutic-goods-act-1989-sec-26ac-ss-1-logic-cogai-4
type: LogicApplication
conclusion text: Eligible for listing under section 26AE.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Preliminary assessment is a type of evaluation required for listing under section 26AE.
modality: CogAI
operator: IS_A
premise text: Section 23 application

therapeutic-goods-act-1989-sec-26ac-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Eligible for listing under section 26AE.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application must pass preliminary assessment.
modality: Deontic
operator: MUST
premise text: Section 23 application

therapeutic-goods-act-1989-sec-26ac-ss-1-logic-linearlogic-2
type: LogicApplication
conclusion text: Eligible for listing under section 26AE.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Preliminary assessment is a necessary condition for listing under section 26AE.
modality: LinearLogic
operator: ⇒
premise text: Section 23 application

therapeutic-goods-act-1989-sec-26ac-ss-1-logic-shacl-5
type: LogicApplication
conclusion text: Eligible for listing under section 26AE.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::shacl
logic summary: Preliminary assessment is a schema required for listing under section 26AE.
modality: SHACL
operator: IS_A
premise text: Section 23 application

therapeutic-goods-act-1989-sec-26ac-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26AC(1) Evaluation fees for listing of medicine under section 26AE

26AC(2) Evaluation fees for listing of medicine under section 26AE
type: Concept
description: Evaluation fee
source: therapeutic-goods-act-1989.pdf, p.173
note: Payable evaluation fee for listing of medicine under section 26AE
asserts: therapeutic-goods-act-1989-sec-26ac-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-26ac-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26ac-ss-2
schema version: 2
part of: 26AC Evaluation fees for listing of medicine under section 26AE

therapeutic-goods-act-1989-sec-26ac-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Pay evaluation fee
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Payable obligation
modality: Deontic
operator: Obligation

26AC(3) Evaluation fees for listing of medicine under section 26AE
type: Concept
description: Evaluation fee amount
source: therapeutic-goods-act-1989.pdf, p.173
note: Secretary must notify applicant of evaluation fee amount.
asserts: therapeutic-goods-act-1989-sec-26ac-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-26ac-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26ac-ss-3
schema version: 2
part of: 26AC Evaluation fees for listing of medicine under section 26AE

therapeutic-goods-act-1989-sec-26ac-ss-3-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-26ac-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26AC(3) Evaluation fees for listing of medicine under section 26AE

26AC(4) Evaluation fees for listing of medicine under section 26AE
type: Concept
source: therapeutic-goods-act-1989.pdf, p.173
note: Evaluation fee payable by applicant on notification of evaluation fee amount
asserts: therapeutic-goods-act-1989-sec-26ac-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-26ac-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-26ac-ss-4-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-26ac-ss-4
schema version: 2
part of: 26AC Evaluation fees for listing of medicine under section 26AE

therapeutic-goods-act-1989-sec-26ac-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Due payment obligation
modality: Deontic
operator: due
premise text: (4) The evaluation fee payable by an applicant:

therapeutic-goods-act-1989-sec-26ac-ss-4-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Recoverable debt due to Commonwealth
modality: Deontic
operator: recoverable
premise text: (b) may be recovered by the Commonwealth as a debt due to the Commonwealth.

26AC(5) Evaluation fees for listing of medicine under section 26AE
type: Concept
source: therapeutic-goods-act-1989.pdf, p.173
note: Pay evaluation fee before listing medicine under section 26AE
asserts: therapeutic-goods-act-1989-sec-26ac-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-26ac-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26ac-ss-5
schema version: 2
part of: 26AC Evaluation fees for listing of medicine under section 26AE

therapeutic-goods-act-1989-sec-26ac-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must pay evaluation fee
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-26ac-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26AC(5) Evaluation fees for listing of medicine under section 26AE

26AD Lapsing and deemed refusal of applications for listing of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.174
curation status: Proposed
has part: 26AD(1) Lapsing and deemed refusal of applications for listing of
has part: 26AD(2) Lapsing and deemed refusal of applications for listing of
has part: 26AD(3) Lapsing and deemed refusal of applications for listing of
has part: 26AD(4) Lapsing and deemed refusal of applications for listing of
proposed by: legis2cml
realized by: sec-26ad
schema version: 2

26AD(1) Lapsing and deemed refusal of applications for listing of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.174
note: Application lapses if evaluation fee remains unpaid or application contains inaccurate information.
asserts: therapeutic-goods-act-1989-sec-26ad-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-26ad-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26ad-ss-1
schema version: 2
part of: 26AD Lapsing and deemed refusal of applications for listing of

therapeutic-goods-act-1989-sec-26ad-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application lapses if evaluation fee remains unpaid or application contains inaccurate information.
modality: Deontic
operator: Forbid

therapeutic-goods-act-1989-sec-26ad-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26AD(1) Lapsing and deemed refusal of applications for listing of

26AD(2) Lapsing and deemed refusal of applications for listing of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.174
note: Applicant may give notice to treat application as refused if evaluation not completed within prescribed period.
asserts: therapeutic-goods-act-1989-sec-26ad-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-26ad-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-26ad-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-26ad-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-26ad-ss-2-logic-cogai-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-26ad-ss-2
schema version: 2
part of: 26AD Lapsing and deemed refusal of applications for listing of

therapeutic-goods-act-1989-sec-26ad-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: ...the applicant may give the Secretary written notice...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Prescribed period within which evaluation must be completed.
modality: AllenInterval
operator: Temporal Interval
premise text: (a) regulations made for the purposes of paragraph 63(2)(daaaa)...

therapeutic-goods-act-1989-sec-26ad-ss-2-logic-cogai-4
type: LogicApplication
conclusion text: ...the applicant wishes to treat the application as having been refused.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Classification and evaluation process.
modality: CogAI
operator: Knowledge Representation
premise text: (2) If...

therapeutic-goods-act-1989-sec-26ad-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: the applicant may give the Secretary written notice...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to complete evaluation within prescribed period.
modality: Deontic
operator: Obligation
premise text: (2) If...

therapeutic-goods-act-1989-sec-26ad-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: ...the applicant may give the Secretary written notice...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Evaluation must be completed within prescribed period.
modality: LTL
operator: Recurring Trace
premise text: (b) at the end of that period, the evaluation has not been completed;

therapeutic-goods-act-1989-sec-26ad-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26AD(2) Lapsing and deemed refusal of applications for listing of

26AD(3) Lapsing and deemed refusal of applications for listing of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.174
note: Notice may be given at any time before evaluation is completed.
asserts: therapeutic-goods-act-1989-sec-26ad-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26ad-ss-3
schema version: 2
part of: 26AD Lapsing and deemed refusal of applications for listing of

26AD(4) Lapsing and deemed refusal of applications for listing of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.174
note: Refusal of listing of medicine without notice
asserts: therapeutic-goods-act-1989-sec-26ad-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-26ad-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26ad-ss-4
schema version: 2
part of: 26AD Lapsing and deemed refusal of applications for listing of

therapeutic-goods-act-1989-sec-26ad-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits listing of medicine
modality: Deontic
operator: Prohibit
premise text: (4) If a notice has been given

therapeutic-goods-act-1989-sec-26ad-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26AD(4) Lapsing and deemed refusal of applications for listing of

26AE Evaluation and listing of certain medicines
type: Concept
source: therapeutic-goods-act-1989.pdf, p.175
curation status: Proposed
has part: 26AE(1) Evaluation and listing of certain medicines
has part: 26AE(2) Evaluation and listing of certain medicines
has part: 26AE(3) Evaluation and listing of certain medicines
proposed by: legis2cml
realized by: sec-26ae
schema version: 2

26AE(1) Evaluation and listing of certain medicines
type: Concept
source: therapeutic-goods-act-1989.pdf, p.175
note: The Secretary must evaluate a medicine if an application has passed preliminary assessment.
asserts: therapeutic-goods-act-1989-sec-26ae-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-26ae-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-26ae-ss-1-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-26ae-ss-1
schema version: 2
part of: 26AE Evaluation and listing of certain medicines

therapeutic-goods-act-1989-sec-26ae-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: the Secretary must evaluate the medicine having regard to...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must evaluate the medicine.
modality: Deontic
operator: MUST
premise text: (a) an application is made under section 23 for the listing of a medicine in relation to a person under this section; and (b) the application has passed preliminary assessment;

therapeutic-goods-act-1989-sec-26ae-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: the Secretary must not use restricted information when evaluating the medicine for listing:
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must not use restricted information when evaluating the medicine.
modality: Deontic
operator: MUST NOT
premise text: Note: The Secretary must not use restricted information when evaluating the medicine for listing: see section 26AF;

therapeutic-goods-act-1989-sec-26ae-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26AE(1) Evaluation and listing of certain medicines

26AE(2) Evaluation and listing of certain medicines
type: Concept
source: therapeutic-goods-act-1989.pdf, p.175
note: Evaluation must be completed within a prescribed period.
asserts: therapeutic-goods-act-1989-sec-26ae-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-26ae-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26ae-ss-2
schema version: 2
part of: 26AE Evaluation and listing of certain medicines

therapeutic-goods-act-1989-sec-26ae-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to complete evaluation
modality: Deontic
operator: MUST

26AE(3) Evaluation and listing of certain medicines
type: Concept
source: therapeutic-goods-act-1989.pdf, p.175
note: Secretary must decide whether to list a medicine after evaluation.
asserts: therapeutic-goods-act-1989-sec-26ae-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-26ae-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26ae-ss-3
schema version: 2
part of: 26AE Evaluation and listing of certain medicines

therapeutic-goods-act-1989-sec-26ae-ss-3-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-26ae-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26AE(3) Evaluation and listing of certain medicines

26AF When the Secretary must not use restricted information in
type: Concept
source: therapeutic-goods-act-1989.pdf, p.177
curation status: Proposed
has part: 26AF(1) When the Secretary must not use restricted information in
has part: 26AF(2) When the Secretary must not use restricted information in
proposed by: legis2cml
realized by: sec-26af
schema version: 2

26AF(1) When the Secretary must not use restricted information in
type: Concept
source: therapeutic-goods-act-1989.pdf, p.177
note: Must not use restricted information in evaluating a medicine under section 26AE.
asserts: therapeutic-goods-act-1989-sec-26af-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-26af-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-26af-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-26af-ss-1-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-26af-ss-1-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-26af-ss-1-logic-diffusion-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-26af-ss-1
schema version: 2
part of: 26AF When the Secretary must not use restricted information in

therapeutic-goods-act-1989-sec-26af-ss-1-logic-alleninterval-3
type: LogicApplication
conclusion text: Evaluating the medicine under section 26AE
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Use of restricted information during evaluation of a medicine under section 26AE
modality: AllenInterval
operator: During
premise text: Section 23 application for listing a medicine under section 26AE

therapeutic-goods-act-1989-sec-26af-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Evaluating the medicine under section 26AE
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on using restricted information
modality: Deontic
operator: MustNotUse
premise text: Application for listing a medicine under section 26AE

therapeutic-goods-act-1989-sec-26af-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: Evaluating the medicine under section 26AE
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on using restricted information in evaluating a medicine under section 26AE
modality: Deontic
operator: MustNotUse
premise text: Section 23 application for listing a medicine under section 26AE

therapeutic-goods-act-1989-sec-26af-ss-1-logic-diffusion-5
type: LogicApplication
conclusion text: Evaluating the medicine under section 26AE
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Use of restricted information through evaluation of a medicine under section 26AE
modality: Diffusion
operator: Through
premise text: Section 23 application for listing a medicine under section 26AE

therapeutic-goods-act-1989-sec-26af-ss-1-logic-ltl-4
type: LogicApplication
conclusion text: Evaluating the medicine under section 26AE
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Prohibition on using restricted information until evaluation of a medicine under section 26AE is complete
modality: LTL
operator: Until
premise text: Section 23 application for listing a medicine under section 26AE

26AF(2) When the Secretary must not use restricted information in
type: Concept
source: therapeutic-goods-act-1989.pdf, p.177
note: The Secretary must not use restricted information in certain circumstances.
asserts: therapeutic-goods-act-1989-sec-26af-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-26af-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26af-ss-2
schema version: 2
part of: 26AF When the Secretary must not use restricted information in

therapeutic-goods-act-1989-sec-26af-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...in certain circumstances.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of using restricted information
modality: Deontic
operator: Prohibit
premise text: The Secretary must not use...

therapeutic-goods-act-1989-sec-26af-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26AF(2) When the Secretary must not use restricted information in

26B Certificates required in relation to patents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.179
curation status: Proposed
has part: 26B(1A) Certificates required in relation to patents
has part: 26B(1) Certificates required in relation to patents
has part: 26B(2) Certificates required in relation to patents
proposed by: legis2cml
realized by: sec-26b
schema version: 2

26B(1) Certificates required in relation to patents
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.179
note: Applicant must provide a certificate stating their intentions regarding patent infringement.
asserts: therapeutic-goods-act-1989-sec-26b-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-26b-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26b-ss-1
schema version: 2
part of: 26B Certificates required in relation to patents

therapeutic-goods-act-1989-sec-26b-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 provide a certificate.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-26b-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 26B(1) Certificates required in relation to patents

26B(1A) Certificates required in relation to patents
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.179
note: Applicant must provide evidence or information submitted by another person.
asserts: therapeutic-goods-act-1989-sec-26b-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-26b-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26b-ss-1a
schema version: 2
part of: 26B Certificates required in relation to patents

therapeutic-goods-act-1989-sec-26b-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide evidence or information.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-26b-ss-1a-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 26B(1A) Certificates required in relation to patents

26B(2) Certificates required in relation to patents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.179
note: Giving a false or misleading certificate is an offence.
asserts: therapeutic-goods-act-1989-sec-26b-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-26b-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-26b-ss-2-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-26b-ss-2
schema version: 2
part of: 26B Certificates required in relation to patents

therapeutic-goods-act-1989-sec-26b-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: The person commits an offence if the certificate is false or misleading in a material particular.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits giving a false or misleading certificate.
modality: Deontic
operator: Prohibition
premise text: The person gives a certificate required under subsection (1).

therapeutic-goods-act-1989-sec-26b-ss-2-logic-deontic-2
type: LogicApplication
conclusion text: The person must give a true and accurate certificate.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires giving a true and accurate certificate.
modality: Deontic
operator: Obligation
premise text: A person commits an offence if: (a) the person gives a certificate required under subsection (1);

therapeutic-goods-act-1989-sec-26b-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26B(2) Certificates required in relation to patents

26BA Approved form for notices
type: Concept
source: therapeutic-goods-act-1989.pdf, p.180
note: Permits notice to be given in accordance with specified software requirements.
asserts: therapeutic-goods-act-1989-sec-26ba-norm
asserts: therapeutic-goods-act-1989-sec-26ba-logic-descriptionlogic-1
asserts: therapeutic-goods-act-1989-sec-26ba-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-26ba
schema version: 2

therapeutic-goods-act-1989-sec-26ba-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires notice to be given in accordance with specified software requirements
modality: Deontic
operator: requires

therapeutic-goods-act-1989-sec-26ba-logic-descriptionlogic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Defines a class for notices
modality: DescriptionLogic
operator: hasClass

26BB Permissible ingredients
type: Concept
source: therapeutic-goods-act-1989.pdf, p.180
curation status: Proposed
has part: 26BB(1) Permissible ingredients
has part: 26BB(2) Permissible ingredients
has part: 26BB(2A) Permissible ingredients
has part: 26BB(3) Permissible ingredients
has part: 26BB(4) Permissible ingredients
has part: 26BB(5) Permissible ingredients
has part: 26BB(6) Permissible ingredients
has part: 26BB(7) Permissible ingredients
has part: 26BB(8) Permissible ingredients
proposed by: legis2cml
realized by: sec-26bb
schema version: 2

26BB(1) Permissible ingredients
type: Concept
source: therapeutic-goods-act-1989.pdf, p.180
note: The Minister may make a determination specifying ingredients for medicine.
asserts: therapeutic-goods-act-1989-sec-26bb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-26bb-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bb-ss-1
schema version: 2
part of: 26BB Permissible ingredients

therapeutic-goods-act-1989-sec-26bb-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to specify ingredients
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-26bb-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26BB(1) Permissible ingredients

26BB(2) Permissible ingredients
type: Concept
source: therapeutic-goods-act-1989.pdf, p.180
note: Permits particular ingredients not being contained in particular medicine.
asserts: therapeutic-goods-act-1989-sec-26bb-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bb-ss-2
schema version: 2
part of: 26BB Permissible ingredients

26BB(2A) Permissible ingredients
type: Concept
source: therapeutic-goods-act-1989.pdf, p.180
note: Permits specific circumstances for a particular ingredient in medicine.
asserts: therapeutic-goods-act-1989-sec-26bb-ss-2a-norm
asserts: therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bb-ss-2a
schema version: 2
part of: 26BB Permissible ingredients

therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-alleninterval-2
type: LogicApplication
conclusion text: The requirements relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient at some point in time.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines temporal scope.
modality: AllenInterval
operator: Temporal Interval
premise text: (2A) The requirements referred to in paragraph (1)(b)

therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-cogai-5
type: LogicApplication
conclusion text: The requirements relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient.
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Describes knowledge representation.
modality: CogAI
operator: Knowledge Representation
premise text: (2A) The requirements referred to in paragraph (1)(b)

therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-deontic-1
type: LogicApplication
conclusion text: may relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Allows specified conditions.
modality: Deontic
operator: Permit
premise text: (2A) The requirements referred to in paragraph (1)(b)

therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-diffusion-4
type: LogicApplication
conclusion text: The requirements relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient over some period of time.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Describes information spread.
modality: Diffusion
operator: Spread
premise text: (2A) The requirements referred to in paragraph (1)(b)

therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-ltl-3
type: LogicApplication
conclusion text: The requirements relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient over some period of time.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines temporal relationship.
modality: LTL
operator: Temporal Trace
premise text: (2A) The requirements referred to in paragraph (1)(b)

26BB(3) Permissible ingredients
type: Concept
source: therapeutic-goods-act-1989.pdf, p.180
note: Permitted concentrations or amounts of ingredients
asserts: therapeutic-goods-act-1989-sec-26bb-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bb-ss-3
schema version: 2
part of: 26BB Permissible ingredients

26BB(4) Permissible ingredients
type: Concept
source: therapeutic-goods-act-1989.pdf, p.180
note: Permits certain subsections not to limit paragraph (1)(b)
asserts: therapeutic-goods-act-1989-sec-26bb-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bb-ss-4
schema version: 2
part of: 26BB Permissible ingredients

26BB(5) Permissible ingredients
type: Concept
source: therapeutic-goods-act-1989.pdf, p.180
note: Determination may make different provision for different classes of medicine.
asserts: therapeutic-goods-act-1989-sec-26bb-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bb-ss-5
schema version: 2
part of: 26BB Permissible ingredients

26BB(6) Permissible ingredients
type: Concept
source: therapeutic-goods-act-1989.pdf, p.180
note: The Minister may make a determination specifying ingredients and requirements.
asserts: therapeutic-goods-act-1989-sec-26bb-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-26bb-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bb-ss-6
schema version: 2
part of: 26BB Permissible ingredients

therapeutic-goods-act-1989-sec-26bb-ss-6-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to determine ingredients and requirements.
modality: Deontic
operator: May

26BB(7) Permissible ingredients
type: Concept
source: therapeutic-goods-act-1989.pdf, p.180
note: Different classes of medicine may be treated differently under a determination.
asserts: therapeutic-goods-act-1989-sec-26bb-ss-7-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bb-ss-7
schema version: 2
part of: 26BB Permissible ingredients

26BB(8) Permissible ingredients
type: Concept
source: therapeutic-goods-act-1989.pdf, p.180
note: Allows provision in relation to a matter by applying, adopting or incorporating any matter contained in an instrument or other writing.
asserts: therapeutic-goods-act-1989-sec-26bb-ss-8-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bb-ss-8
schema version: 2
part of: 26BB Permissible ingredients

26BC Variation of determination under section 26BB—Minister’s
type: Concept
source: therapeutic-goods-act-1989.pdf, p.181
note: Minister may vary a determination under section 26BB.
asserts: therapeutic-goods-act-1989-sec-26bc-norm
asserts: therapeutic-goods-act-1989-sec-26bc-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bc
schema version: 2

therapeutic-goods-act-1989-sec-26bc-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Expresses permission or obligation.
modality: Deontic
operator: may

26BD Requirements relating to an application for variation of a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.182
curation status: Proposed
has part: 26BD(1) Requirements relating to an application for variation of a
has part: 26BD(2) Requirements relating to an application for variation of a
has part: 26BD(3) Requirements relating to an application for variation of a
has part: 26BD(4) Requirements relating to an application for variation of a
has part: 26BD(5) Requirements relating to an application for variation of a
has part: 26BD(6) Requirements relating to an application for variation of a
has part: 26BD(7) Requirements relating to an application for variation of a
has part: 26BD(8) Requirements relating to an application for variation of a
has part: 26BD(9) Requirements relating to an application for variation of a
proposed by: legis2cml
realized by: sec-26bd
schema version: 2

26BD(1) Requirements relating to an application for variation of a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.182
note: A person may make an application to the Secretary for a recommendation by the Secretary that the Minister vary a section 26BB determination.
asserts: therapeutic-goods-act-1989-sec-26bd-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-26bd-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bd-ss-1
schema version: 2
part of: 26BD Requirements relating to an application for variation of a

therapeutic-goods-act-1989-sec-26bd-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-26bd-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26BD(1) Requirements relating to an application for variation of a

26BD(2) Requirements relating to an application for variation of a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.182
note: Secretary must carry out assessment of requirements met in relation to application.
asserts: therapeutic-goods-act-1989-sec-26bd-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-26bd-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bd-ss-2
schema version: 2
part of: 26BD Requirements relating to an application for variation of a

therapeutic-goods-act-1989-sec-26bd-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must carry out assessment
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-26bd-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26BD(2) Requirements relating to an application for variation of a

26BD(3) Requirements relating to an application for variation of a
type: Concept
description: information determined under subsection (8) and in a form determined under subsection (9)
source: therapeutic-goods-act-1989.pdf, p.182
note: Application requirements for variation of a
asserts: therapeutic-goods-act-1989-sec-26bd-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-26bd-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bd-ss-3
schema version: 2
part of: 26BD Requirements relating to an application for variation of a

therapeutic-goods-act-1989-sec-26bd-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application must meet certain requirements
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-26bd-ss-3-norm
type: Obligation
scope note: borne by: LegalPerson
curation status: Proposed
modality: Deontic
borne by: LegalPerson
deontic status: HeuristicDerived
part of: 26BD(3) Requirements relating to an application for variation of a

26BD(4) Requirements relating to an application for variation of a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.182
note: The Secretary must be satisfied that the requirements have been met.
asserts: therapeutic-goods-act-1989-sec-26bd-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-26bd-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-26bd-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-26bd-ss-4-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-26bd-ss-4-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-26bd-ss-4-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bd-ss-4
schema version: 2
part of: 26BD Requirements relating to an application for variation of a

therapeutic-goods-act-1989-sec-26bd-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: The assessment occurs during this time period.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The assessment must occur during a specific time period.
modality: AllenInterval
operator: During
premise text: (a) has carried out an assessment, under subsection (2), in relation to the application;

therapeutic-goods-act-1989-sec-26bd-ss-4-logic-cogai-5
type: LogicApplication
conclusion text: The assessment implies that the requirements are met.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: There is a logical implication between the assessment and the satisfaction of the requirements.
modality: CogAI
operator: Implication
premise text: (a) has carried out an assessment, under subsection (2), in relation to the application;

therapeutic-goods-act-1989-sec-26bd-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: is satisfied that the requirements set out in subsection (3) have been met in relation to the application.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must be satisfied.
modality: Deontic
operator: Satisfies
premise text: (a) has carried out an assessment, under subsection (2), in relation to the application;

therapeutic-goods-act-1989-sec-26bd-ss-4-logic-diffusion-4
type: LogicApplication
conclusion text: The assessment implies that the requirements are met.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: There is a conditional relationship between the assessment and the satisfaction of the requirements.
modality: Diffusion
operator: If-Then
premise text: (a) has carried out an assessment, under subsection (2), in relation to the application;

therapeutic-goods-act-1989-sec-26bd-ss-4-logic-ltl-3
type: LogicApplication
conclusion text: The requirements are met until this point in time.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The requirements must be met until a specific point in time.
modality: LTL
operator: Until
premise text: (b) is satisfied that the requirements set out in subsection (3) have been met in relation to the application;

therapeutic-goods-act-1989-sec-26bd-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26BD(4) Requirements relating to an application for variation of a

26BD(5) Requirements relating to an application for variation of a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.182
note: Secretary must give written notice to applicant stating application has passed preliminary assessment.
asserts: therapeutic-goods-act-1989-sec-26bd-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-26bd-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bd-ss-5
schema version: 2
part of: 26BD Requirements relating to an application for variation of a

therapeutic-goods-act-1989-sec-26bd-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide written notice
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-26bd-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26BD(5) Requirements relating to an application for variation of a

26BD(6) Requirements relating to an application for variation of a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.182
note: Refuse application if not passed preliminary assessment.
asserts: therapeutic-goods-act-1989-sec-26bd-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-26bd-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bd-ss-6
schema version: 2
part of: 26BD Requirements relating to an application for variation of a

therapeutic-goods-act-1989-sec-26bd-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: Refuse application.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition
modality: Deontic
operator: Prohibit
premise text: Application not passed preliminary assessment.

therapeutic-goods-act-1989-sec-26bd-ss-6-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26BD(6) Requirements relating to an application for variation of a

26BD(7) Requirements relating to an application for variation of a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.182
note: Specify software requirements for an application or information
asserts: therapeutic-goods-act-1989-sec-26bd-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-26bd-ss-7-logic-descriptionlogic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bd-ss-7
schema version: 2
part of: 26BD Requirements relating to an application for variation of a

therapeutic-goods-act-1989-sec-26bd-ss-7-logic-descriptionlogic-1
type: LogicApplication
conclusion text: may require or permit an application or information to be given in accordance with specified software requirements
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Requires specified software requirements
modality: DescriptionLogic
operator: requires
premise text: (7) An approval of a form mentioned in paragraph (3)(a)

therapeutic-goods-act-1989-sec-26bd-ss-7-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26BD(7) Requirements relating to an application for variation of a

26BD(8) Requirements relating to an application for variation of a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.182
note: The Secretary may determine a kind of information for the purposes of subparagraph (3)(e)(i).
asserts: therapeutic-goods-act-1989-sec-26bd-ss-8-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bd-ss-8
schema version: 2
part of: 26BD Requirements relating to an application for variation of a

therapeutic-goods-act-1989-sec-26bd-ss-8-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26BD(8) Requirements relating to an application for variation of a

26BD(9) Requirements relating to an application for variation of a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.182
note: Application lapse due to inaccurate or misleading information
asserts: therapeutic-goods-act-1989-sec-26bd-ss-9-norm
asserts: therapeutic-goods-act-1989-sec-26bd-ss-9-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bd-ss-9
schema version: 2
part of: 26BD Requirements relating to an application for variation of a

therapeutic-goods-act-1989-sec-26bd-ss-9-logic-deontic-1
type: LogicApplication
conclusion text: If an application made under subsection 26BD(1) has passed preliminary assessment, the application lapses if: (a) the application contains information that is inaccurate or misleading in a material particular; or (b) information given to the Secretary by, or on behalf of, the applicant in connection with the application is inaccurate or misleading in a material particular; or (c) the evaluation fee prescribed for the purposes of paragraph 26BE(3)(b) has not been paid before the end of the period worked out in accordance with the regulations.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of application lapse due to inaccurate or misleading information
modality: Deontic
operator: Prohibit
premise text: (9) The Secretary may, by legislative instrument, determine a form of information for the purposes of subparagraph (3)(e)(ii).

therapeutic-goods-act-1989-sec-26bd-ss-9-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26BD(9) Requirements relating to an application for variation of a

26BE Evaluation of whether to make recommendation for variation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.183
note: Evaluation of whether to make recommendation for variation of a section 26BB determination
asserts: therapeutic-goods-act-1989-sec-26be-norm
asserts: therapeutic-goods-act-1989-sec-26be-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26be
schema version: 2

therapeutic-goods-act-1989-sec-26be-logic-deontic-1
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 obligation, prohibition, permission, or right explicitly stated

26BF Permissible indications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.186
curation status: Proposed
has part: 26BF(1) Permissible indications
has part: 26BF(2) Permissible indications
has part: 26BF(3) Permissible indications
has part: 26BF(4) Permissible indications
has part: 26BF(5) Permissible indications
has part: 26BF(6) Permissible indications
proposed by: legis2cml
realized by: sec-26bf
schema version: 2

26BF(1) Permissible indications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.186
note: The Minister may make a determination in relation to indications.
asserts: therapeutic-goods-act-1989-sec-26bf-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-26bf-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bf-ss-1
schema version: 2
part of: 26BF Permissible indications

therapeutic-goods-act-1989-sec-26bf-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to make a determination
modality: Deontic
operator: may

26BF(2) Permissible indications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.186
note: The Minister may consider therapeutic uses of a substance when making a determination.
asserts: therapeutic-goods-act-1989-sec-26bf-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bf-ss-2
schema version: 2
part of: 26BF Permissible indications

26BF(3) Permissible indications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.186
note: The Minister may have regard in deciding whether to make a determination under subsection (1) in relation to a particular indication.
asserts: therapeutic-goods-act-1989-sec-26bf-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bf-ss-3
schema version: 2
part of: 26BF Permissible indications

therapeutic-goods-act-1989-sec-26bf-ss-3-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26BF(3) Permissible indications

26BF(4) Permissible indications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.186
note: Permits use of particular indications in specified circumstances or under certain conditions.
asserts: therapeutic-goods-act-1989-sec-26bf-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-26bf-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-26bf-ss-4-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bf-ss-4
schema version: 2
part of: 26BF Permissible indications

therapeutic-goods-act-1989-sec-26bf-ss-4-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Describes the temporal relationship between the use of indications and specified circumstances or conditions.
modality: AllenInterval
operator: during

therapeutic-goods-act-1989-sec-26bf-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Specifies the permitted use of particular indications.
modality: Deontic
operator: permittedBy

26BF(5) Permissible indications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.186
note: Permits different classes of medicines to have varying determinations.
asserts: therapeutic-goods-act-1989-sec-26bf-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bf-ss-5
schema version: 2
part of: 26BF Permissible indications

26BF(6) Permissible indications
type: Concept
source: therapeutic-goods-act-1989.pdf, p.186
note: Allows for incorporation of existing instruments or writings with modifications.
asserts: therapeutic-goods-act-1989-sec-26bf-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-26bf-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bf-ss-6
schema version: 2
part of: 26BF Permissible indications

therapeutic-goods-act-1989-sec-26bf-ss-6-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits modification of incorporated matter
modality: Deontic
operator: permitted

26BG Limitations on determination under section 26BF
type: Concept
source: therapeutic-goods-act-1989.pdf, p.187
curation status: Proposed
has part: 26BG(1) Limitations on determination under section 26BF
has part: 26BG(2) Limitations on determination under section 26BF
has part: 26BG(3) Limitations on determination under section 26BF
proposed by: legis2cml
realized by: sec-26bg
schema version: 2

26BG(1) Limitations on determination under section 26BF
type: Concept
source: therapeutic-goods-act-1989.pdf, p.187
note: Minister may make a determination specifying indications that must not be covered by a determination under section 26BF(1)(a).
asserts: therapeutic-goods-act-1989-sec-26bg-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bg-ss-1
schema version: 2
part of: 26BG Limitations on determination under section 26BF

26BG(2) Limitations on determination under section 26BF
type: Concept
source: therapeutic-goods-act-1989.pdf, p.187
note: The determination may specify an indication either generally or in relation to specified circumstances.
asserts: therapeutic-goods-act-1989-sec-26bg-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bg-ss-2
schema version: 2
part of: 26BG Limitations on determination under section 26BF

therapeutic-goods-act-1989-sec-26bg-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26BG(2) Limitations on determination under section 26BF

26BG(3) Limitations on determination under section 26BF
type: Concept
source: therapeutic-goods-act-1989.pdf, p.187
note: Minister may vary or revoke determination under subsection (1)
asserts: therapeutic-goods-act-1989-sec-26bg-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-26bg-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bg-ss-3
schema version: 2
part of: 26BG Limitations on determination under section 26BF

therapeutic-goods-act-1989-sec-26bg-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
modality: Deontic
operator: May

26BH Variation of determination under section 26BF—Minister’s
type: Concept
source: therapeutic-goods-act-1989.pdf, p.187
note: Minister may vary determination under section 26BF on own initiative.
asserts: therapeutic-goods-act-1989-sec-26bh-norm
asserts: therapeutic-goods-act-1989-sec-26bh-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bh
schema version: 2

therapeutic-goods-act-1989-sec-26bh-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Expresses permission or obligation.
modality: Deontic
operator: may

26BJ Variation of determination under section 26BF—application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.188
curation status: Proposed
has part: 26BJ(1) Variation of determination under section 26BF—application
has part: 26BJ(2) Variation of determination under section 26BF—application
has part: 26BJ(3) Variation of determination under section 26BF—application
proposed by: legis2cml
realized by: sec-26bj
schema version: 2

26BJ(1) Variation of determination under section 26BF—application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.188
note: A person may apply for a recommendation to vary a determination under section 26BF.
asserts: therapeutic-goods-act-1989-sec-26bj-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bj-ss-1
schema version: 2
part of: 26BJ Variation of determination under section 26BF—application

therapeutic-goods-act-1989-sec-26bj-ss-1-norm
type: Permission
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 26BJ(1) Variation of determination under section 26BF—application

26BJ(2) Variation of determination under section 26BF—application
type: Concept
description: Form, application fee (if any), recommendation sought
source: therapeutic-goods-act-1989.pdf, p.188
note: Application requirements for variation of determination under section 26BF
asserts: therapeutic-goods-act-1989-sec-26bj-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-26bj-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bj-ss-2
schema version: 2
part of: 26BJ Variation of determination under section 26BF—application

therapeutic-goods-act-1989-sec-26bj-ss-2-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-26bj-ss-2-norm
type: Obligation
scope note: borne by: LegalPerson
curation status: Proposed
modality: Deontic
borne by: LegalPerson
deontic status: HeuristicDerived
part of: 26BJ(2) Variation of determination under section 26BF—application

26BJ(3) Variation of determination under section 26BF—application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.188
note: Cannot make an application for a recommendation that would affect certain types of indications.
asserts: therapeutic-goods-act-1989-sec-26bj-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-26bj-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26bj-ss-3
schema version: 2
part of: 26BJ Variation of determination under section 26BF—application

therapeutic-goods-act-1989-sec-26bj-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: for the effect of which would be for the determination to cover any of the following:
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on making an application for a recommendation that would affect certain types of indications.
modality: Deontic
operator: Prohibit
premise text: (3) A person cannot make an application under subsection (1)

therapeutic-goods-act-1989-sec-26bj-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26BJ(3) Variation of determination under section 26BF—application

26C Certificates required in relation to patent infringement
type: Concept
source: therapeutic-goods-act-1989.pdf, p.191
curation status: Proposed
has part: 26C(1) Certificates required in relation to patent infringement
has part: 26C(2) Certificates required in relation to patent infringement
has part: 26C(3) Certificates required in relation to patent infringement
has part: 26C(4) Certificates required in relation to patent infringement
proposed by: legis2cml
realized by: sec-26c
schema version: 2

26C(1) Certificates required in relation to patent infringement
type: Concept
source: therapeutic-goods-act-1989.pdf, p.191
note: Certificate required for therapeutic goods patent infringement proceedings
asserts: therapeutic-goods-act-1989-sec-26c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-26c-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26c-ss-1
schema version: 2
part of: 26C Certificates required in relation to patent infringement

therapeutic-goods-act-1989-sec-26c-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: (1) This section applies if: (a) a person gives a certificate required under subsection 26B(1) in relation to therapeutic goods; and (b) another person (the second person) intends to commence proceedings under the Patents Act 1990 against the person referred to in paragraph (1)(a) for infringement of a patent that has been granted in relation to the therapeutic goods (the proceedings).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires certificate for patent infringement proceedings
modality: Deontic
operator: requires
premise text: (1) This section applies if: (a) a person gives a certificate required under subsection 26B(1) in relation to therapeutic goods; and (b) another person (the second person) intends to commence proceedings under the Patents Act 1990 against the person referred to in paragraph (1)(a) for infringement of a patent that has been granted in relation to the therapeutic goods (the proceedings).

therapeutic-goods-act-1989-sec-26c-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26C(1) Certificates required in relation to patent infringement

26C(2) Certificates required in relation to patent infringement
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.191
note: Second person must provide certificate before commencement of proceedings.
asserts: therapeutic-goods-act-1989-sec-26c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-26c-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26c-ss-2
schema version: 2
part of: 26C Certificates required in relation to patent infringement

therapeutic-goods-act-1989-sec-26c-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide certificate
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-26c-ss-2-norm
type: Obligation
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 26C(2) Certificates required in relation to patent infringement

26C(3) Certificates required in relation to patent infringement
type: Concept
source: therapeutic-goods-act-1989.pdf, p.191
note: Certificate must be signed in good faith, with reasonable prospects of success, and without unreasonable delay.
asserts: therapeutic-goods-act-1989-sec-26c-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-26c-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26c-ss-3
schema version: 2
part of: 26C Certificates required in relation to patent infringement

therapeutic-goods-act-1989-sec-26c-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to sign certificate in good faith, with reasonable prospects of success, and without unreasonable delay.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-26c-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26C(3) Certificates required in relation to patent infringement

26C(4) Certificates required in relation to patent infringement
type: Concept
source: therapeutic-goods-act-1989.pdf, p.191
note: Second person must have reasonable grounds for proceedings to have a chance of success
asserts: therapeutic-goods-act-1989-sec-26c-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-26c-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-26c-ss-4-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-26c-ss-4
schema version: 2
part of: 26C Certificates required in relation to patent infringement

therapeutic-goods-act-1989-sec-26c-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: Second person has a duty to investigate
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Second person must have reasonable grounds
modality: Deontic
operator: Obligation
premise text: Reasonable prospects of success

therapeutic-goods-act-1989-sec-26c-ss-4-logic-epistemic-2
type: LogicApplication
conclusion text: Second person has knowledge of circumstances
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Second person must know the circumstances
modality: Epistemic
operator: Possibility
premise text: Circumstances known to the second person

therapeutic-goods-act-1989-sec-26c-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26C(4) Certificates required in relation to patent infringement

26D Requirements for interlocutory injunction
type: Concept
source: therapeutic-goods-act-1989.pdf, p.193
curation status: Proposed
has part: 26D(1) Requirements for interlocutory injunction
has part: 26D(2) Requirements for interlocutory injunction
proposed by: legis2cml
realized by: sec-26d
schema version: 2

26D(1) Requirements for interlocutory injunction
type: Concept
source: therapeutic-goods-act-1989.pdf, p.193
note: Notice to patentee required before applying for interlocutory injunction.
asserts: therapeutic-goods-act-1989-sec-26d-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-26d-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26d-ss-1
schema version: 2
part of: 26D Requirements for interlocutory injunction

therapeutic-goods-act-1989-sec-26d-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Patentee must be notified.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Notice is a requirement.
modality: Deontic
operator: Requires
premise text: Application for interlocutory injunction.

therapeutic-goods-act-1989-sec-26d-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26D(1) Requirements for interlocutory injunction

26D(2) Requirements for interlocutory injunction
type: Concept
source: therapeutic-goods-act-1989.pdf, p.193
note: No application for interlocutory relief can be instituted without prior notification to the Attorney-General.
asserts: therapeutic-goods-act-1989-sec-26d-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-26d-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-26d-ss-2
schema version: 2
part of: 26D Requirements for interlocutory injunction

therapeutic-goods-act-1989-sec-26d-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: No application can be instituted without prior notification.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of instituting an application without prior notification.
modality: Deontic
operator: Prohibit
premise text: The patentee must notify the Attorney-General before applying for interlocutory relief.

therapeutic-goods-act-1989-sec-26d-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 26D(2) Requirements for interlocutory injunction

27 Registration or listing number
type: Concept
source: therapeutic-goods-act-1989.pdf, p.195
curation status: Proposed
has part: 27(1) Registration or listing number
has part: 27(2) Registration or listing number
proposed by: legis2cml
realized by: sec-27
schema version: 2

27(1) Registration or listing number
type: Concept
source: therapeutic-goods-act-1989.pdf, p.195
note: Secretary must assign a unique registration or listing number to therapeutic goods included in the Register.
asserts: therapeutic-goods-act-1989-sec-27-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-27-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-27-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-27-ss-1
schema version: 2
part of: 27 Registration or listing number

therapeutic-goods-act-1989-sec-27-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-27-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of therapeutic goods
modality: DescriptionLogic
operator: CLASSIFICATION

therapeutic-goods-act-1989-sec-27-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 27(1) Registration or listing number

27(2) Registration or listing number
type: Concept
description: Registration or listing number
source: therapeutic-goods-act-1989.pdf, p.195
note: Secretary must assign a unique registration or listing number to grouped therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-27-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-27-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-27-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-27-ss-2
schema version: 2
part of: 27 Registration or listing number

therapeutic-goods-act-1989-sec-27-ss-2-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-27-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of grouped therapeutic goods
modality: DescriptionLogic
operator: CLASSIFICATION

therapeutic-goods-act-1989-sec-27-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 27(2) Registration or listing number

28 Conditions of registration or listing
type: Concept
source: therapeutic-goods-act-1989.pdf, p.195
note: Conditions for registration or listing of therapeutic goods
asserts: therapeutic-goods-act-1989-sec-28-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-28
schema version: 2

28A Certification of manufacturing steps outside Australia following
type: Concept
source: therapeutic-goods-act-1989.pdf, p.201
curation status: Proposed
has part: 28A(1) Certification of manufacturing steps outside Australia following
has part: 28A(2) Certification of manufacturing steps outside Australia following
has part: 28A(3) Certification of manufacturing steps outside Australia following
proposed by: legis2cml
realized by: sec-28a
schema version: 2

28A(1) Certification of manufacturing steps outside Australia following
type: Concept
description: Step in manufacture of medicine to be carried out outside Australia
source: therapeutic-goods-act-1989.pdf, p.201
note: Certification required for manufacture of medicine outside Australia
asserts: therapeutic-goods-act-1989-sec-28a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-28a-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-28a-ss-1
schema version: 2
part of: 28A Certification of manufacturing steps outside Australia following

therapeutic-goods-act-1989-sec-28a-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide certification
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-28a-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 28A(1) Certification of manufacturing steps outside Australia following

28A(2) Certification of manufacturing steps outside Australia following
type: Concept
description: written notice
source: therapeutic-goods-act-1989.pdf, p.201
note: Secretary must give written notice of certification.
asserts: therapeutic-goods-act-1989-sec-28a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-28a-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-28a-ss-2
schema version: 2
part of: 28A Certification of manufacturing steps outside Australia following

therapeutic-goods-act-1989-sec-28a-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: The Secretary must give the person written notice of the certification.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide written notice.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-28a-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 28A(2) Certification of manufacturing steps outside Australia following

28A(3) Certification of manufacturing steps outside Australia following
type: Concept
source: therapeutic-goods-act-1989.pdf, p.201
note: Certification requirement for manufacturing steps outside Australia
asserts: therapeutic-goods-act-1989-sec-28a-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-28a-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-28a-ss-3
schema version: 2
part of: 28A Certification of manufacturing steps outside Australia following

therapeutic-goods-act-1989-sec-28a-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Certification is required
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-28a-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 28A(3) Certification of manufacturing steps outside Australia following

29 Duration of registration or listing
type: Concept
source: therapeutic-goods-act-1989.pdf, p.202
curation status: Proposed
has part: 29(1) Duration of registration or listing
has part: 29(2) Duration of registration or listing
has part: 29(3) Duration of registration or listing
has part: 29(3A) Duration of registration or listing
has part: 29(4) Duration of registration or listing
has part: 29(5) Duration of registration or listing
proposed by: legis2cml
realized by: sec-29
schema version: 2

29(1) Duration of registration or listing
type: Concept
source: therapeutic-goods-act-1989.pdf, p.202
note: Goods remain in the Register until registration or listing is cancelled.
asserts: therapeutic-goods-act-1989-sec-29-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-29-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29-ss-1
schema version: 2
part of: 29 Duration of registration or listing

therapeutic-goods-act-1989-sec-29-ss-1-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-29-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29(1) Duration of registration or listing

29(2) Duration of registration or listing
type: Concept
source: therapeutic-goods-act-1989.pdf, p.202
note: Medicine provisional registration period
asserts: therapeutic-goods-act-1989-sec-29-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-29-ss-2
schema version: 2
part of: 29 Duration of registration or listing

29(3) Duration of registration or listing
type: Concept
source: therapeutic-goods-act-1989.pdf, p.202
note: Defines provisional registration period for medicines
asserts: therapeutic-goods-act-1989-sec-29-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-29-ss-3
schema version: 2
part of: 29 Duration of registration or listing

29(3A) Duration of registration or listing
type: Concept
source: therapeutic-goods-act-1989.pdf, p.202
note: Defines provisional registration period for a new medicine
asserts: therapeutic-goods-act-1989-sec-29-ss-3a-norm
asserts: therapeutic-goods-act-1989-sec-29-ss-3a-logic-alleninterval-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29-ss-3a
schema version: 2
part of: 29 Duration of registration or listing

therapeutic-goods-act-1989-sec-29-ss-3a-logic-alleninterval-1
type: LogicApplication
conclusion text: The original period
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines a temporal interval for the provisional registration period
modality: AllenInterval
operator: ⊆
premise text: (3A) Subject to this section, the provisional registration period...

29(4) Duration of registration or listing
type: Concept
source: therapeutic-goods-act-1989.pdf, p.202
note: Application for extension of provisional registration period
asserts: therapeutic-goods-act-1989-sec-29-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-29-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29-ss-4
schema version: 2
part of: 29 Duration of registration or listing

therapeutic-goods-act-1989-sec-29-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: May apply
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-29-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29(4) Duration of registration or listing

29(5) Duration of registration or listing
type: Concept
description: The application must be in a form approved by the Secretary and contain all required information.
source: therapeutic-goods-act-1989.pdf, p.202
note: Application must be in a specific form and contain required information.
asserts: therapeutic-goods-act-1989-sec-29-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-29-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29-ss-5
schema version: 2
part of: 29 Duration of registration or listing

therapeutic-goods-act-1989-sec-29-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application must meet specific requirements.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-29-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29(5) Duration of registration or listing

29A Criminal offence for failing to notify adverse effects etc. of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.206
curation status: Proposed
has part: 29A(1) Criminal offence for failing to notify adverse effects etc. of
has part: 29A(2) Criminal offence for failing to notify adverse effects etc. of
proposed by: legis2cml
realized by: sec-29a
schema version: 2

29A(1) Criminal offence for failing to notify adverse effects etc. of
type: Concept
description: Information of a kind mentioned in subsection (2)
source: therapeutic-goods-act-1989.pdf, p.206
note: Notify adverse effects of therapeutic goods to the Secretary.
asserts: therapeutic-goods-act-1989-sec-29a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-29a-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29a-ss-1
schema version: 2
part of: 29A Criminal offence for failing to notify adverse effects etc. of

therapeutic-goods-act-1989-sec-29a-ss-1-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-29a-ss-1-norm
type: Obligation
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 29A(1) Criminal offence for failing to notify adverse effects etc. of

29A(2) Criminal offence for failing to notify adverse effects etc. of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.206
note: Failing to notify adverse effects of goods may be a criminal offence.
asserts: therapeutic-goods-act-1989-sec-29a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-29a-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29a-ss-2
schema version: 2
part of: 29A Criminal offence for failing to notify adverse effects etc. of

therapeutic-goods-act-1989-sec-29a-ss-2-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-29a-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29A(2) Criminal offence for failing to notify adverse effects etc. of

29AA Civil penalty for failing to notify adverse effects etc. of goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.207
curation status: Proposed
has part: 29AA(1) Civil penalty for failing to notify adverse effects etc. of goods
has part: 29AA(2) Civil penalty for failing to notify adverse effects etc. of goods
proposed by: legis2cml
realized by: sec-29aa
schema version: 2

29AA(1) Civil penalty for failing to notify adverse effects etc. of goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.207
note: Failure to notify adverse effects of goods is prohibited.
asserts: therapeutic-goods-act-1989-sec-29aa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-29aa-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29aa-ss-1
schema version: 2
part of: 29AA Civil penalty for failing to notify adverse effects etc. of goods

therapeutic-goods-act-1989-sec-29aa-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-29aa-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29AA(1) Civil penalty for failing to notify adverse effects etc. of goods

29AA(2) Civil penalty for failing to notify adverse effects etc. of goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.207
note: Failing to notify adverse effects of goods is a civil penalty.
asserts: therapeutic-goods-act-1989-sec-29aa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-29aa-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29aa-ss-2
schema version: 2
part of: 29AA Civil penalty for failing to notify adverse effects etc. of goods

therapeutic-goods-act-1989-sec-29aa-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Failing to do so is a civil penalty.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits failing to notify adverse effects of goods.
modality: Deontic
operator: Prohibit
premise text: The person under this Act must provide information about adverse effects.

therapeutic-goods-act-1989-sec-29aa-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29AA(2) Civil penalty for failing to notify adverse effects etc. of goods

29B Notification of adverse effects etc. where application withdrawn
type: Concept
description: written notice
source: therapeutic-goods-act-1989.pdf, p.207
note: Secretary must give applicant written notice requiring action upon withdrawal or lapse of application.
asserts: therapeutic-goods-act-1989-sec-29b-norm
asserts: therapeutic-goods-act-1989-sec-29b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29b
schema version: 2

therapeutic-goods-act-1989-sec-29b-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide written notice
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-29b-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29B Notification of adverse effects etc. where application withdrawn

29C Civil penalties for failing to notify adverse effects etc. where
type: Concept
source: therapeutic-goods-act-1989.pdf, p.208
curation status: Proposed
has part: 29C(1) Civil penalties for failing to notify adverse effects etc. where
has part: 29C(2) Civil penalties for failing to notify adverse effects etc. where
proposed by: legis2cml
realized by: sec-29c
schema version: 2

29C(1) Civil penalties for failing to notify adverse effects etc. where
type: Concept
source: therapeutic-goods-act-1989.pdf, p.208
note: Failure to comply with notice requirements within 30 days
asserts: therapeutic-goods-act-1989-sec-29c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-29c-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29c-ss-1
schema version: 2
part of: 29C Civil penalties for failing to notify adverse effects etc. where

therapeutic-goods-act-1989-sec-29c-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of non-compliance
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-29c-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29C(1) Civil penalties for failing to notify adverse effects etc. where

29C(2) Civil penalties for failing to notify adverse effects etc. where
type: Concept
source: therapeutic-goods-act-1989.pdf, p.208
note: False or misleading information in purported compliance with a notice
asserts: therapeutic-goods-act-1989-sec-29c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-29c-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29c-ss-2
schema version: 2
part of: 29C Civil penalties for failing to notify adverse effects etc. where

therapeutic-goods-act-1989-sec-29c-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Contravention of subsection (2)
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: Subsection 29B(1) notice

therapeutic-goods-act-1989-sec-29c-ss-2-norm
type: Prohibition
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 29C(2) Civil penalties for failing to notify adverse effects etc. where

29D Suspension of registration or listing
type: Concept
source: therapeutic-goods-act-1989.pdf, p.209
curation status: Proposed
has part: 29D(1) Suspension of registration or listing
has part: 29D(2) Suspension of registration or listing
proposed by: legis2cml
realized by: sec-29d
schema version: 2

29D(1) Suspension of registration or listing
type: Concept
source: therapeutic-goods-act-1989.pdf, p.209
note: Suspension of registration or listing of therapeutic goods
asserts: therapeutic-goods-act-1989-sec-29d-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-29d-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29d-ss-1
schema version: 2
part of: 29D Suspension of registration or listing

therapeutic-goods-act-1989-sec-29d-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on therapeutic goods registration or listing
modality: Deontic
operator: Prohibit
premise text: (1) The Secretary may, by written notice...

therapeutic-goods-act-1989-sec-29d-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29D(1) Suspension of registration or listing

29D(2) Suspension of registration or listing
type: Concept
description: written notice, reasons for suspension
source: therapeutic-goods-act-1989.pdf, p.209
note: Secretary must inform person of proposed suspension and set out reasons.
asserts: therapeutic-goods-act-1989-sec-29d-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-29d-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29d-ss-2
schema version: 2
part of: 29D Suspension of registration or listing

therapeutic-goods-act-1989-sec-29d-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Duty to inform and provide reasons
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-29d-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29D(2) Suspension of registration or listing

29E When suspension takes effect etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.210
curation status: Proposed
has part: 29E(1) When suspension takes effect etc.
has part: 29E(2) When suspension takes effect etc.
has part: 29E(3) When suspension takes effect etc.
has part: 29E(4) When suspension takes effect etc.
proposed by: legis2cml
realized by: sec-29e
schema version: 2

29E(1) When suspension takes effect etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.210
note: Suspension takes effect on specified day under certain conditions.
asserts: therapeutic-goods-act-1989-sec-29e-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-29e-ss-1
schema version: 2
part of: 29E When suspension takes effect etc.

therapeutic-goods-act-1989-sec-29e-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29E(1) When suspension takes effect etc.

29E(2) When suspension takes effect etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.210
note: Suspension duration
asserts: therapeutic-goods-act-1989-sec-29e-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-29e-ss-2
schema version: 2
part of: 29E When suspension takes effect etc.

29E(3) When suspension takes effect etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.210
note: Secretary may extend period specified in notice under subsection 29D(4) by a further specified period not exceeding 6 months.
asserts: therapeutic-goods-act-1989-sec-29e-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-29e-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29e-ss-3
schema version: 2
part of: 29E When suspension takes effect etc.

therapeutic-goods-act-1989-sec-29e-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to extend period
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-29e-ss-3-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29E(3) When suspension takes effect etc.

29E(4) When suspension takes effect etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.210
note: Publish notice of extension particulars
asserts: therapeutic-goods-act-1989-sec-29e-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-29e-ss-4
schema version: 2
part of: 29E When suspension takes effect etc.

29F Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.211
curation status: Proposed
has part: 29F(1) Revocation of suspension
has part: 29F(2) Revocation of suspension
has part: 29F(3) Revocation of suspension
proposed by: legis2cml
realized by: sec-29f
schema version: 2

29F(1) Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.211
note: Secretary must revoke suspension upon certain conditions.
asserts: therapeutic-goods-act-1989-sec-29f-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-29f-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29f-ss-1
schema version: 2
part of: 29F Revocation of suspension

therapeutic-goods-act-1989-sec-29f-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...revocation of suspension under section 29D
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to revoke suspension
modality: Deontic
operator: MUST
premise text: (1) The Secretary must...

therapeutic-goods-act-1989-sec-29f-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29F(1) Revocation of suspension

29F(2) Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.211
note: Secretary's power to revoke suspension may be exercised
asserts: therapeutic-goods-act-1989-sec-29f-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-29f-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29f-ss-2
schema version: 2
part of: 29F Revocation of suspension

therapeutic-goods-act-1989-sec-29f-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission granted by Secretary
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-29f-ss-2-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29F(2) Revocation of suspension

29F(3) Revocation of suspension
type: Concept
description: Notice setting out particulars of the revocation
source: therapeutic-goods-act-1989.pdf, p.211
note: Publish notice of revocation within a specified timeframe.
asserts: therapeutic-goods-act-1989-sec-29f-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-29f-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29f-ss-3
schema version: 2
part of: 29F Revocation of suspension

therapeutic-goods-act-1989-sec-29f-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: The Secretary must cause to be published...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Duty to publish notice
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-29f-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29F(3) Revocation of suspension

29G Effect of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.212
note: Therapeutic goods not included in Register during suspension.
asserts: therapeutic-goods-act-1989-sec-29g-norm
asserts: therapeutic-goods-act-1989-sec-29g-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-29g
schema version: 2

therapeutic-goods-act-1989-sec-29g-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits dealing with suspended goods.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-29g-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 29G Effect of suspension

3 Interpretation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.17
curation status: Proposed
has part: 3(1) Interpretation
has part: 3(2) Interpretation
has part: 3(2A) Interpretation
has part: 3(2B) Interpretation
has part: 3(4) Interpretation
has part: 3(5) Interpretation
has part: 3(5A) Interpretation
has part: 3(5B) Interpretation
has part: 3(6) Interpretation
has part: 3(7) Interpretation
has part: 3(7A) Interpretation
has part: 3(8) Interpretation
proposed by: legis2cml
realized by: sec-3
schema version: 2

3(1) Interpretation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.17
note: Accessory means a thing specifically intended to be used with the device. Defines terms used in the Act State or Territory must issue search warrants. Definition of 'private hospital' Goods that have a tradition of use as foods for humans in the form in which they are presented, or goods covered by a determination under subsection 7AA(1) or (2), must be used, advertised, or presented for supply in the way specified in the determination.
asserts: therapeutic-goods-act-1989-sec-3-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-3-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-3
asserts: therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-4
asserts: therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-5
asserts: therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-6
asserts: therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-7
asserts: therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-8
asserts: therapeutic-goods-act-1989-sec-3-ss-1-logic-deontic-9
asserts: therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-10
asserts: therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-11
asserts: therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-12
asserts: therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-13
asserts: therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-14
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-ss-1
schema version: 2
part of: 3 Interpretation

therapeutic-goods-act-1989-sec-3-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Accessory means a thing specifically intended to be used with the device.
modality: Deontic
operator: Obligate

therapeutic-goods-act-1989-sec-3-ss-1-logic-deontic-9
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide
modality: Deontic
operator: MUST
premise text: State or Territory must issue search warrants.

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-10
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Labeling requirements
modality: DescriptionLogic
operator: label
premise text: label, in relation to therapeutic goods, means a display of printed information:

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-11
type: LogicApplication
conclusion text: product information, in relation to therapeutic goods, means information relating to the safe and effective use of the goods
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Class hierarchy for therapeutic goods
modality: DescriptionLogic
operator: =
premise text: therapeutic goods are goods that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be...

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-12
type: LogicApplication
conclusion text: reportable medicine has the meaning given by section 30EH
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Class hierarchy for reportable medical device
modality: DescriptionLogic
operator: =
premise text: reportable medical device means a medical device of a kind prescribed by regulations made for the purposes of this definition

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-13
type: LogicApplication
conclusion text: reportable medicine has the meaning given by section 30EH
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Class hierarchy for reportable medicine
modality: DescriptionLogic
operator: =
premise text: restricted medicine means: (a) a medicine specified in an instrument under subsection (2A); or (b) a medicine included in a class of medicine specified in an instrument under subsection (2B)

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-14
type: LogicApplication
conclusion text: biologicals, medical devices and goods declared to be therapeutic goods under an order in force under section 7 but do not include...
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Class hierarchy for therapeutic goods
modality: DescriptionLogic
operator: =
premise text: therapeutic goods means goods: (a) that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be...

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Accessory is an obligation.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies 'accessory'
modality: DescriptionLogic
operator: =
premise text: Accessory means a thing that the manufacturer of the thing specifically intended to be used together with the device.

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-3
type: LogicApplication
conclusion text: Customs officer means an officer of Customs within the meaning of the Customs Act 1901.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies terms into categories
modality: DescriptionLogic
operator: =
premise text: The term 'customs officer' is defined as an officer of Customs within the meaning of the Customs Act 1901.

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-4
type: LogicApplication
conclusion text: Data processing device means any article or material (for example, a disc) from which information is capable of being reproduced with or without the aid of any other article or device.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies terms into categories
modality: DescriptionLogic
operator: =
premise text: The term 'data processing device' is defined as any article or material from which information is capable of being reproduced with or without the aid of any other article or device.

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-5
type: LogicApplication
conclusion text: Default standard means any of the following: (a) a standard referred to in paragraph (b) of the definition of standard in this subsection; (b) a standard referred to in paragraph (c) of that definition; (c) a standard referred to in paragraph (d) of that definition.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies terms into categories
modality: DescriptionLogic
operator: =
premise text: The term 'default standard' is defined as any of the following: (a) a standard referred to in paragraph (b) of the definition of standard in this subsection; (b) a standard referred to in paragraph (c) of that definition; (c) a standard referred to in paragraph (d) of that definition.

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-6
type: LogicApplication
conclusion text: Directions for use, in relation to therapeutic goods, includes information on: (a) appropriate doses of the goods; and (b) the method of administration or use of the goods; and (c) the frequency and duration of treatment for each indication of the goods; and (d) the use of the goods by persons of particular ages or by persons having particular medical conditions.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies terms into categories
modality: DescriptionLogic
operator: =
premise text: The term 'directions for use' is defined as information on: (a) appropriate doses of the goods; and (b) the method of administration or use of the goods; and (c) the frequency and duration of treatment for each indication of the goods; and (d) the use of the goods by persons of particular ages or by persons having particular medical conditions.

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-7
type: LogicApplication
conclusion text: Export only biological means a biological that is: (a) manufactured in Australia for export only; or (b) imported into Australia for export only.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies terms into categories
modality: DescriptionLogic
operator: =
premise text: The term 'export only biological' is defined as a biological that is: (a) manufactured in Australia for export only; or (b) imported into Australia for export only.

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-8
type: LogicApplication
conclusion text: Export only medicine means a medicine that: (a) is manufactured in Australia for export only, or imported into Australia for export only; and (b) is listable goods only because it is so manufactured or imported (and not for any other reason).
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies terms into categories
modality: DescriptionLogic
operator: =
premise text: The term 'export only medicine' is defined as a medicine that: (a) is manufactured in Australia for export only, or imported into Australia for export only; and (b) is listable goods only because it is so manufactured or imported (and not for any other reason).

3(2) Interpretation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.17
note: Therapeutic goods are taken to be for use in humans if they are not solely for use in animals.
asserts: therapeutic-goods-act-1989-sec-3-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-3-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-3-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-3-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-3-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-3-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-ss-2
schema version: 2
part of: 3 Interpretation

therapeutic-goods-act-1989-sec-3-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: Therapeutic goods are taken to be for use in humans during the period when they are not solely for use in animals.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between definitions
modality: AllenInterval
operator: during
premise text: (2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals.

therapeutic-goods-act-1989-sec-3-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: Therapeutic goods are taken to be for use in humans if they are not solely for use in animals.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Conditional obligation with CogAI
modality: CogAI
operator: if
premise text: (2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals.

therapeutic-goods-act-1989-sec-3-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Therapeutic goods are taken to be for use in humans if they are not solely for use in animals.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Conditional obligation
modality: Deontic
operator: if
premise text: (2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals.

therapeutic-goods-act-1989-sec-3-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: Therapeutic goods are taken to be for use in humans if they are not solely for use in animals.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Conditional obligation with diffusion
modality: Diffusion
operator: if
premise text: (2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals.

therapeutic-goods-act-1989-sec-3-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: Therapeutic goods are taken to be for use in humans during the period when they are not solely for use in animals.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal relation between definitions
modality: LTL
operator: during
premise text: (2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals.

3(2A) Interpretation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.17
note: Specify medicines for restricted medicine purposes
asserts: therapeutic-goods-act-1989-sec-3-ss-2a-norm
asserts: therapeutic-goods-act-1989-sec-3-ss-2a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-ss-2a
schema version: 2
part of: 3 Interpretation

therapeutic-goods-act-1989-sec-3-ss-2a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to specify medicines
modality: Deontic
operator: May

3(2B) Interpretation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.17
note: Specify classes of medicine for restricted medicine purposes
asserts: therapeutic-goods-act-1989-sec-3-ss-2b-norm
asserts: therapeutic-goods-act-1989-sec-3-ss-2b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-ss-2b
schema version: 2
part of: 3 Interpretation

therapeutic-goods-act-1989-sec-3-ss-2b-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to specify classes of medicine
modality: Deontic
operator: May

3(4) Interpretation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.17
note: Provisions of this Act are in addition to, and not in substitution for, the provisions of any other Act that relate to therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-3-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-ss-4
schema version: 2
part of: 3 Interpretation

therapeutic-goods-act-1989-sec-3-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 3(4) Interpretation

3(5) Interpretation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.17
note: Presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing.
asserts: therapeutic-goods-act-1989-sec-3-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-3-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-3-ss-5-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-3-ss-5-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-3-ss-5-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-3-ss-5-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-3-ss-5-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-ss-5
schema version: 2
part of: 3 Interpretation

therapeutic-goods-act-1989-sec-3-ss-5-logic-alleninterval-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines a temporal interval for when presentation of therapeutic goods is unacceptable.
modality: AllenInterval
operator: Temporal Interval
premise text: (5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and

therapeutic-goods-act-1989-sec-3-ss-5-logic-cogai-6
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Recognizes the presentation of therapeutic goods that is misleading or confusing.
modality: CogAI
operator: Recognize
premise text: (5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and

therapeutic-goods-act-1989-sec-3-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the presentation of therapeutic goods that is misleading or confusing.
modality: Deontic
operator: Prohibit
premise text: (5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and

therapeutic-goods-act-1989-sec-3-ss-5-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies presentation of therapeutic goods as unacceptable if it is misleading or confusing.
modality: DescriptionLogic
operator: Classify
premise text: (5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and

therapeutic-goods-act-1989-sec-3-ss-5-logic-diffusion-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses the prohibition on presentation of therapeutic goods that is misleading or confusing.
modality: Diffusion
operator: Diffuse
premise text: (5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and

therapeutic-goods-act-1989-sec-3-ss-5-logic-ltl-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines a recurring trace for when presentation of therapeutic goods is unacceptable.
modality: LTL
operator: Recurring Trace
premise text: (5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and

3(5A) Interpretation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.17
note: Specify advisory statements in relation to medicine
asserts: therapeutic-goods-act-1989-sec-3-ss-5a-norm
asserts: therapeutic-goods-act-1989-sec-3-ss-5a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-ss-5a
schema version: 2
part of: 3 Interpretation

therapeutic-goods-act-1989-sec-3-ss-5a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to specify advisory statements
modality: Deontic
operator: May

3(5B) Interpretation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.17
note: Specify different advisory statements for medicines or classes of medicine.
asserts: therapeutic-goods-act-1989-sec-3-ss-5b-norm
asserts: therapeutic-goods-act-1989-sec-3-ss-5b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-ss-5b
schema version: 2
part of: 3 Interpretation

therapeutic-goods-act-1989-sec-3-ss-5b-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to specify advisory statements
modality: Deontic
operator: May

3(6) Interpretation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.17
note: References charges under Therapeutic Goods (Charges) Act 1989.
asserts: therapeutic-goods-act-1989-sec-3-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-3-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-ss-6
schema version: 2
part of: 3 Interpretation

therapeutic-goods-act-1989-sec-3-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: Charge reference defined as such a charge imposed under the Act
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Definition of charge reference
modality: Deontic
operator: =
premise text: Annual charges under Therapeutic Goods (Charges) Act 1989

therapeutic-goods-act-1989-sec-3-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 3(6) Interpretation

3(7) Interpretation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.17
note: References an offence against this Act to related offences under other laws.
asserts: therapeutic-goods-act-1989-sec-3-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-1
asserts: therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-ss-7
schema version: 2
part of: 3 Interpretation

therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-1
type: LogicApplication
conclusion text: an offence against section 6 of the Crimes Act 1914, or section 11.1, 11.4 or 11.5 of the Criminal Code
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies the subject of the reference
modality: DescriptionLogic
operator: =
premise text: A reference to an offence against this Act includes a reference to...

therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-2
type: LogicApplication
conclusion text: an offence against section 136.1, 137.1 or 137.2 of the Criminal Code
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies the subject of the reference
modality: DescriptionLogic
operator: =
premise text: A reference to an offence against this Act includes a reference to...

therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-3
type: LogicApplication
conclusion text: an offence against the regulations
confidence: 0.5000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies the subject of the reference
modality: DescriptionLogic
operator: =
premise text: A reference to an offence against this Act includes a reference to...

therapeutic-goods-act-1989-sec-3-ss-7-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 3(7) Interpretation

3(7A) Interpretation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.17
note: Imposes a duty on Commonwealth authorities if corresponding State law confers function or power and gives rise to obligation.
asserts: therapeutic-goods-act-1989-sec-3-ss-7a-norm
asserts: therapeutic-goods-act-1989-sec-3-ss-7a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-ss-7a
schema version: 2
part of: 3 Interpretation

therapeutic-goods-act-1989-sec-3-ss-7a-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
premise text: (7A) For the purposes of this Act, a corresponding State law imposes a duty...

therapeutic-goods-act-1989-sec-3-ss-7a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 3(7A) Interpretation

3(8) Interpretation
type: Concept
source: therapeutic-goods-act-1989.pdf, p.17
note: Clarifies interpretation of registered therapeutic goods and provisional registration.
asserts: therapeutic-goods-act-1989-sec-3-ss-8-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-3-ss-8
schema version: 2
part of: 3 Interpretation

30 Cancellation of registration or listing
type: Concept
source: therapeutic-goods-act-1989.pdf, p.212
note: Cancellation of registration or listing of therapeutic goods under certain conditions.
asserts: therapeutic-goods-act-1989-sec-30-norm
asserts: therapeutic-goods-act-1989-sec-30-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-30-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-30-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-30
schema version: 2

therapeutic-goods-act-1989-sec-30-logic-alleninterval-2
type: LogicApplication
conclusion text: within 24 hours after the request was made
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Timeframe for record availability
modality: AllenInterval
operator: <
premise text: if the person was requested under that paragraph to make the record in question available at or before a requested time—before the end of the period of 24 hours after that time;

therapeutic-goods-act-1989-sec-30-logic-deontic-1
type: LogicApplication
conclusion text: the person requests in writing the cancellation of the registration or listing
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Risk assessment for cancellation
modality: Deontic
operator: >
premise text: it appears to the Secretary that failure to cancel the registration or listing would create an imminent risk of death...

therapeutic-goods-act-1989-sec-30-logic-deontic-3
type: LogicApplication
conclusion text: the requirements under subsection 26A(3) or (4A) are not fulfilled
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Certification requirements for medicines
modality: Deontic
operator: =
premise text: in the case of a medicine listed under section 26A, it appears to the Secretary that any of the certifications under paragraph 26A(2)(a), (ca), (cb), (e), (fba), (fd), (fe) or (g) are incorrect or...

therapeutic-goods-act-1989-sec-30-logic-deontic-4
type: LogicApplication
conclusion text: the Secretary is satisfied that the contravention is significant
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Advertising regulations
modality: Deontic
operator: =
premise text: there is a breach, involving the goods, of an applicable provision of the Therapeutic Goods Advertising Code or any other requirement relating to advertising applicable under

therapeutic-goods-act-1989-sec-30-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30 Cancellation of registration or listing

30A Revocation of cancellation of registration or listing upon
type: Concept
source: therapeutic-goods-act-1989.pdf, p.218
curation status: Proposed
has part: 30A(1) Revocation of cancellation of registration or listing upon
has part: 30A(2) Revocation of cancellation of registration or listing upon
proposed by: legis2cml
realized by: sec-30a
schema version: 2

30A(1) Revocation of cancellation of registration or listing upon
type: Concept
source: therapeutic-goods-act-1989.pdf, p.218
note: Secretary may revoke cancellation upon request and payment of fee.
asserts: therapeutic-goods-act-1989-sec-30a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30a-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30a-ss-1
schema version: 2
part of: 30A Revocation of cancellation of registration or listing upon

therapeutic-goods-act-1989-sec-30a-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits Secretary to revoke cancellation.
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-30a-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30A(1) Revocation of cancellation of registration or listing upon

30A(2) Revocation of cancellation of registration or listing upon
type: Concept
source: therapeutic-goods-act-1989.pdf, p.218
note: Cancellation is taken never to have occurred upon revocation.
asserts: therapeutic-goods-act-1989-sec-30a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30a-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30a-ss-2
schema version: 2
part of: 30A Revocation of cancellation of registration or listing upon

therapeutic-goods-act-1989-sec-30a-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Cancellation is taken never to have occurred.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: If cancellation is revoked, then it is never taken to have occurred.
modality: Deontic
operator: Implies
premise text: Cancellation is revoked.

therapeutic-goods-act-1989-sec-30a-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30A(2) Revocation of cancellation of registration or listing upon

30AA Revocation of cancellation of registration or listing—payment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.218
curation status: Proposed
has part: 30AA(1) Revocation of cancellation of registration or listing—payment
has part: 30AA(2) Revocation of cancellation of registration or listing—payment
proposed by: legis2cml
realized by: sec-30aa
schema version: 2

30AA(1) Revocation of cancellation of registration or listing—payment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.218
note: Secretary may revoke cancellation of registration or listing under certain conditions.
asserts: therapeutic-goods-act-1989-sec-30aa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30aa-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30aa-ss-1
schema version: 2
part of: 30AA Revocation of cancellation of registration or listing—payment

therapeutic-goods-act-1989-sec-30aa-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to revoke cancellation
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-30aa-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30AA(1) Revocation of cancellation of registration or listing—payment

30AA(2) Revocation of cancellation of registration or listing—payment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.218
note: If cancellation is revoked, it is taken never to have occurred.
asserts: therapeutic-goods-act-1989-sec-30aa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30aa-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30aa-ss-2-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-30aa-ss-2
schema version: 2
part of: 30AA Revocation of cancellation of registration or listing—payment

therapeutic-goods-act-1989-sec-30aa-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: It is taken never to have occurred.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval overlap.
modality: AllenInterval
operator: Overlaps
premise text: Cancellation is revoked.

therapeutic-goods-act-1989-sec-30aa-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: It is taken never to have occurred.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: If A, then B.
modality: Deontic
operator: Implies
premise text: Cancellation is revoked.

therapeutic-goods-act-1989-sec-30aa-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30AA(2) Revocation of cancellation of registration or listing—payment

30B Publication of cancellation of registration or listing
type: Concept
description: Notice setting out particulars of the cancellation.
source: therapeutic-goods-act-1989.pdf, p.219
note: Secretary must publish notice after cancellation of registration or listing.
asserts: therapeutic-goods-act-1989-sec-30b-norm
asserts: therapeutic-goods-act-1989-sec-30b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30b
schema version: 2

therapeutic-goods-act-1989-sec-30b-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-30b-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30B Publication of cancellation of registration or listing

30C Consultation with Gene Technology Regulator
type: Concept
source: therapeutic-goods-act-1989.pdf, p.219
curation status: Proposed
has part: 30C(1) Consultation with Gene Technology Regulator
has part: 30C(2) Consultation with Gene Technology Regulator
has part: 30C(3) Consultation with Gene Technology Regulator
has part: 30C(4) Consultation with Gene Technology Regulator
has part: 30C(5) Consultation with Gene Technology Regulator
proposed by: legis2cml
realized by: sec-30c
schema version: 2

30C(1) Consultation with Gene Technology Regulator
type: Concept
source: therapeutic-goods-act-1989.pdf, p.219
note: Application for listing or registration of a therapeutic good must pass preliminary assessment.
asserts: therapeutic-goods-act-1989-sec-30c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30c-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30c-ss-1
schema version: 2
part of: 30C Consultation with Gene Technology Regulator

therapeutic-goods-act-1989-sec-30c-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Therapeutic good must meet conditions.
modality: Deontic
operator: MUST
premise text: (1) This section applies to an application for listing or registration of a therapeutic good under section 23 if:

therapeutic-goods-act-1989-sec-30c-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30C(1) Consultation with Gene Technology Regulator

30C(2) Consultation with Gene Technology Regulator
type: Concept
description: Advice on application
source: therapeutic-goods-act-1989.pdf, p.219
note: Secretary must give written notice to Gene Technology Regulator about application.
asserts: therapeutic-goods-act-1989-sec-30c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30c-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30c-ss-2
schema version: 2
part of: 30C Consultation with Gene Technology Regulator

therapeutic-goods-act-1989-sec-30c-ss-2-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-30c-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30C(2) Consultation with Gene Technology Regulator

30C(3) Consultation with Gene Technology Regulator
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.219
note: The Gene Technology Regulator must provide written advice to the Secretary about a gene technology application.
asserts: therapeutic-goods-act-1989-sec-30c-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-30c-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30c-ss-3
schema version: 2
part of: 30C Consultation with Gene Technology Regulator

therapeutic-goods-act-1989-sec-30c-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Gene Technology Regulator must provide written advice.
modality: Deontic
operator: MUST

30C(4) Consultation with Gene Technology Regulator
type: Concept
source: therapeutic-goods-act-1989.pdf, p.219
note: Consultation with Gene Technology Regulator within specified period.
asserts: therapeutic-goods-act-1989-sec-30c-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-30c-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30c-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-30c-ss-4-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-30c-ss-4-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-30c-ss-4-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-30c-ss-4
schema version: 2
part of: 30C Consultation with Gene Technology Regulator

therapeutic-goods-act-1989-sec-30c-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: Period defined as containing the time of consultation
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for consultation
modality: AllenInterval
operator: CONTAINS
premise text: The advice is to be given within the period specified in the notice.

therapeutic-goods-act-1989-sec-30c-ss-4-logic-argumentation-3
type: LogicApplication
conclusion text: If advice is given, then it must be within a period
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Implication from consultation requirement
modality: Argumentation
operator: IMPLIES
premise text: The advice is to be given within the period specified in the notice.

therapeutic-goods-act-1989-sec-30c-ss-4-logic-cogai-5
type: LogicApplication
conclusion text: Consultation defined as a cognitive process
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Definition of consultation as a cognitive process
modality: CogAI
operator: IS_A
premise text: The advice is to be given within the period specified in the notice.

therapeutic-goods-act-1989-sec-30c-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: Obligation to consult
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide consultation
modality: Deontic
operator: MUST
premise text: The advice is to be given within the period specified in the notice.

therapeutic-goods-act-1989-sec-30c-ss-4-logic-diffusion-4
type: LogicApplication
conclusion text: Consultation defined as giving advice
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Definition of consultation as giving advice
modality: Diffusion
operator: IS_A
premise text: The advice is to be given within the period specified in the notice.

30C(5) Consultation with Gene Technology Regulator
type: Concept
source: therapeutic-goods-act-1989.pdf, p.219
note: No notification required for therapeutic goods belonging to a class with an active advice from the Gene Technology Regulator.
asserts: therapeutic-goods-act-1989-sec-30c-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-30c-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30c-ss-5-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-30c-ss-5
schema version: 2
part of: 30C Consultation with Gene Technology Regulator

therapeutic-goods-act-1989-sec-30c-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: No notification required
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exemption from notification
modality: Deontic
operator: exemption
premise text: Advice from the Gene Technology Regulator is in force

therapeutic-goods-act-1989-sec-30c-ss-5-logic-descriptionlogic-2
type: LogicApplication
conclusion text: Subclass of goods subject to exemption
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Therapeutic goods belonging to a class with an active advice
modality: DescriptionLogic
operator: subclassOf
premise text: Class of therapeutic goods

30D Secretary may seek advice about classes of GM products or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.220
curation status: Proposed
has part: 30D(1) Secretary may seek advice about classes of GM products or
has part: 30D(2) Secretary may seek advice about classes of GM products or
has part: 30D(3) Secretary may seek advice about classes of GM products or
has part: 30D(4) Secretary may seek advice about classes of GM products or
proposed by: legis2cml
realized by: sec-30d
schema version: 2

30D(1) Secretary may seek advice about classes of GM products or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.220
note: The Secretary may request advice from the Gene Technology Regulator.
asserts: therapeutic-goods-act-1989-sec-30d-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30d-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30d-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-30d-ss-1
schema version: 2
part of: 30D Secretary may seek advice about classes of GM products or

therapeutic-goods-act-1989-sec-30d-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary may request advice.
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-30d-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classes of GM products specified in the request.
modality: DescriptionLogic
operator: CLASSIFICATION

30D(2) Secretary may seek advice about classes of GM products or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.220
note: Request for advice must specify matters to which the advice is to relate.
asserts: therapeutic-goods-act-1989-sec-30d-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30d-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30d-ss-2
schema version: 2
part of: 30D Secretary may seek advice about classes of GM products or

therapeutic-goods-act-1989-sec-30d-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Specify matters for advice
modality: Deontic
operator: MUST

30D(3) Secretary may seek advice about classes of GM products or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.220
note: Secretary must seek advice from Gene Technology Regulator on specified matters.
asserts: therapeutic-goods-act-1989-sec-30d-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-30d-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30d-ss-3
schema version: 2
part of: 30D Secretary may seek advice about classes of GM products or

therapeutic-goods-act-1989-sec-30d-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Gene Technology Regulator must provide written advice
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide written advice
modality: Deontic
operator: MUST
premise text: Secretary requests advice

therapeutic-goods-act-1989-sec-30d-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30D(3) Secretary may seek advice about classes of GM products or

30D(4) Secretary may seek advice about classes of GM products or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.220
note: Advice from the Gene Technology Regulator remains in force until withdrawn.
asserts: therapeutic-goods-act-1989-sec-30d-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-30d-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30d-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-30d-ss-4-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-30d-ss-4-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-30d-ss-4-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-30d-ss-4
schema version: 2
part of: 30D Secretary may seek advice about classes of GM products or

therapeutic-goods-act-1989-sec-30d-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: The advice remains in force until it is withdrawn by the Gene Technology Regulator.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Advice from the Gene Technology Regulator lasts during its validity.
modality: AllenInterval
operator: during
premise text: The Gene Technology Regulator gives advice to the Secretary.

therapeutic-goods-act-1989-sec-30d-ss-4-logic-cogai-5
type: LogicApplication
conclusion text: The advice remains in force until it is withdrawn by the Gene Technology Regulator.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: The Secretary cognizes the advice from the Gene Technology Regulator.
modality: CogAI
operator: cognizes
premise text: The Gene Technology Regulator gives advice to the Secretary.

therapeutic-goods-act-1989-sec-30d-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: The advice remains in force until it is withdrawn by the Gene Technology Regulator.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Holds advice from the Gene Technology Regulator.
modality: Deontic
operator: holds
premise text: The Gene Technology Regulator gives advice to the Secretary.

therapeutic-goods-act-1989-sec-30d-ss-4-logic-diffusion-4
type: LogicApplication
conclusion text: The advice remains in force until it is withdrawn by the Gene Technology Regulator.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Advice from the Gene Technology Regulator diffuses to the Secretary.
modality: Diffusion
operator: diffuses
premise text: The Gene Technology Regulator gives advice to the Secretary.

therapeutic-goods-act-1989-sec-30d-ss-4-logic-ltl-3
type: LogicApplication
conclusion text: The advice remains in force until it is withdrawn by the Gene Technology Regulator.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Advice from the Gene Technology Regulator ends when it is withdrawn.
modality: LTL
operator: until
premise text: The Gene Technology Regulator gives advice to the Secretary.

30E Secretary to take advice into account
type: Concept
source: therapeutic-goods-act-1989.pdf, p.220
note: Secretary must take advice from Gene Technology Regulator into account when making decisions on applications.
asserts: therapeutic-goods-act-1989-sec-30e-norm
asserts: therapeutic-goods-act-1989-sec-30e-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30e
schema version: 2

therapeutic-goods-act-1989-sec-30e-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must take advice into account
modality: Deontic
operator: MUST

30EA Public notification, and recall, of therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.222
note: The Secretary may impose requirements on a person if certain circumstances occur.
asserts: therapeutic-goods-act-1989-sec-30ea-norm
asserts: therapeutic-goods-act-1989-sec-30ea-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ea
schema version: 2

therapeutic-goods-act-1989-sec-30ea-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposition of obligations
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-30ea-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EA Public notification, and recall, of therapeutic goods

30EB Publication of requirements
type: Concept
description: Notice setting out particulars of the requirement
source: therapeutic-goods-act-1989.pdf, p.225
note: Secretary must publish notice after imposing requirement.
asserts: therapeutic-goods-act-1989-sec-30eb-norm
asserts: therapeutic-goods-act-1989-sec-30eb-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30eb
schema version: 2

therapeutic-goods-act-1989-sec-30eb-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-30eb-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EB Publication of requirements

30EC Criminal offences for non-compliance with requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.225
note: Non-compliance with requirements is a criminal offence.
asserts: therapeutic-goods-act-1989-sec-30ec-norm
asserts: therapeutic-goods-act-1989-sec-30ec-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ec
schema version: 2

therapeutic-goods-act-1989-sec-30ec-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits non-compliance with requirements.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-30ec-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EC Criminal offences for non-compliance with requirements

30ED Powers of suspension and cancellation unaffected
type: Concept
source: therapeutic-goods-act-1989.pdf, p.226
note: Imposition of requirement under section 30EA does not affect suspension or cancellation power.
asserts: therapeutic-goods-act-1989-sec-30ed-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ed
schema version: 2

therapeutic-goods-act-1989-sec-30ed-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30ED Powers of suspension and cancellation unaffected

30EE Saving of other laws
type: Concept
source: therapeutic-goods-act-1989.pdf, p.227
note: No exclusion or limitation of other laws
asserts: therapeutic-goods-act-1989-sec-30ee-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ee
schema version: 2

30EF Reporting medicine shortages
type: Concept
source: therapeutic-goods-act-1989.pdf, p.228
curation status: Proposed
has part: 30EF(1) Reporting medicine shortages
has part: 30EF(2) Reporting medicine shortages
has part: 30EF(3) Reporting medicine shortages
has part: 30EF(4) Reporting medicine shortages
has part: 30EF(5) Reporting medicine shortages
has part: 30EF(6) Reporting medicine shortages
has part: 30EF(7) Reporting medicine shortages
proposed by: legis2cml
realized by: sec-30ef
schema version: 2

30EF(1) Reporting medicine shortages
type: Concept
description: True
source: therapeutic-goods-act-1989.pdf, p.228
note: Notify shortage of reportable medicine within 2 working days or 10 working days.
asserts: therapeutic-goods-act-1989-sec-30ef-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30ef-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30ef-ss-1-logic-epistemic-2
asserts: therapeutic-goods-act-1989-sec-30ef-ss-1-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ef-ss-1
schema version: 2
part of: 30EF Reporting medicine shortages

therapeutic-goods-act-1989-sec-30ef-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must notify shortage within specified timeframe.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-30ef-ss-1-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Ought to reasonably know of shortage before notification.
modality: Epistemic
operator: OUGHT

therapeutic-goods-act-1989-sec-30ef-ss-1-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Notification within timeframe is but not required.
modality: LTL
operator: BUT

therapeutic-goods-act-1989-sec-30ef-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 30EF(1) Reporting medicine shortages

30EF(2) Reporting medicine shortages
type: Concept
source: therapeutic-goods-act-1989.pdf, p.228
note: Reporting medicine shortages when included in an instrument under section 30EJ has a critical impact.
asserts: therapeutic-goods-act-1989-sec-30ef-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30ef-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ef-ss-2
schema version: 2
part of: 30EF Reporting medicine shortages

therapeutic-goods-act-1989-sec-30ef-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Reporting medicine shortages when included in an instrument under section 30EJ is obligatory.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-30ef-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EF(2) Reporting medicine shortages

30EF(3) Reporting medicine shortages
type: Concept
description: Notification requirements
source: therapeutic-goods-act-1989.pdf, p.228
note: Reporting medicine shortages when there is a critical impact on health or functioning.
asserts: therapeutic-goods-act-1989-sec-30ef-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-30ef-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ef-ss-3
schema version: 2
part of: 30EF Reporting medicine shortages

therapeutic-goods-act-1989-sec-30ef-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Notification requirements must be provided.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Reporting medicine shortages is a duty.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-30ef-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EF(3) Reporting medicine shortages

30EF(4) Reporting medicine shortages
type: Concept
description: Specific period of shortage, approved form, and required information
source: therapeutic-goods-act-1989.pdf, p.228
note: Notification requirements for medicine shortages
asserts: therapeutic-goods-act-1989-sec-30ef-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-30ef-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ef-ss-4
schema version: 2
part of: 30EF Reporting medicine shortages

therapeutic-goods-act-1989-sec-30ef-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Notification requirements are mandatory
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-30ef-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EF(4) Reporting medicine shortages

30EF(5) Reporting medicine shortages
type: Concept
source: therapeutic-goods-act-1989.pdf, p.228
note: Specify software requirements for reporting medicine shortages
asserts: therapeutic-goods-act-1989-sec-30ef-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-30ef-ss-5-logic-descriptionlogic-1
asserts: therapeutic-goods-act-1989-sec-30ef-ss-5-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ef-ss-5
schema version: 2
part of: 30EF Reporting medicine shortages

therapeutic-goods-act-1989-sec-30ef-ss-5-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Describes the temporal relationship between software requirements and reporting medicine shortages
modality: AllenInterval
operator: during

therapeutic-goods-act-1989-sec-30ef-ss-5-logic-descriptionlogic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies the provision as a descriptive clause
modality: DescriptionLogic
operator: hasClass

30EF(6) Reporting medicine shortages
type: Concept
source: therapeutic-goods-act-1989.pdf, p.228
note: Reporting medicine shortages is prohibited for individuals and bodies corporate.
asserts: therapeutic-goods-act-1989-sec-30ef-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-30ef-ss-6-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30ef-ss-6-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-30ef-ss-6-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-30ef-ss-6-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-30ef-ss-6-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ef-ss-6
schema version: 2
part of: 30EF Reporting medicine shortages

therapeutic-goods-act-1989-sec-30ef-ss-6-logic-alleninterval-2
type: LogicApplication
conclusion text: ...if the person is subject to a requirement under subsection (1);
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval of reporting medicine shortages
modality: AllenInterval
operator: Temporal Interval
premise text: (6) A person contravenes this subsection...

therapeutic-goods-act-1989-sec-30ef-ss-6-logic-cogai-5
type: LogicApplication
conclusion text: ...and (b) for a body corporate—1,000 penalty units.
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Knowledge representation of reporting medicine shortages
modality: CogAI
operator: Knowledge Representation
premise text: (a) for an individual—100 penalty units;

therapeutic-goods-act-1989-sec-30ef-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: ...the person contravenes the requirement.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of reporting medicine shortages
modality: Deontic
operator: Prohibit
premise text: (6) A person contravenes this subsection...

therapeutic-goods-act-1989-sec-30ef-ss-6-logic-diffusion-4
type: LogicApplication
conclusion text: ...Maximum civil penalty:
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Information diffusion of reporting medicine shortages
modality: Diffusion
operator: Information Diffusion
premise text: (6) A person contravenes this subsection...

therapeutic-goods-act-1989-sec-30ef-ss-6-logic-ltl-3
type: LogicApplication
conclusion text: ...and the person contravenes the requirement.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of reporting medicine shortages
modality: LTL
operator: Recurring Trace
premise text: (6) A person contravenes this subsection...

therapeutic-goods-act-1989-sec-30ef-ss-6-norm
type: Prohibition
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 30EF(6) Reporting medicine shortages

30EF(7) Reporting medicine shortages
type: Concept
source: therapeutic-goods-act-1989.pdf, p.228
note: Exemption from reporting medicine shortages under certain conditions
asserts: therapeutic-goods-act-1989-sec-30ef-ss-7-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ef-ss-7
schema version: 2
part of: 30EF Reporting medicine shortages

therapeutic-goods-act-1989-sec-30ef-ss-7-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EF(7) Reporting medicine shortages

30EG Reporting discontinuation of supply of medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.232
curation status: Proposed
has part: 30EG(1) Reporting discontinuation of supply of medicine
has part: 30EG(2) Reporting discontinuation of supply of medicine
has part: 30EG(3) Reporting discontinuation of supply of medicine
has part: 30EG(4) Reporting discontinuation of supply of medicine
has part: 30EG(5) Reporting discontinuation of supply of medicine
proposed by: legis2cml
realized by: sec-30eg
schema version: 2

30EG(1) Reporting discontinuation of supply of medicine
type: Concept
description: Notification
source: therapeutic-goods-act-1989.pdf, p.232
note: Notify Secretary of discontinuation decision at least 6 months before proposed date.
asserts: therapeutic-goods-act-1989-sec-30eg-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30eg-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30eg-ss-1
schema version: 2
part of: 30EG Reporting discontinuation of supply of medicine

therapeutic-goods-act-1989-sec-30eg-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: Obligation to notify
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-30eg-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EG(1) Reporting discontinuation of supply of medicine

30EG(2) Reporting discontinuation of supply of medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.232
note: Reporting required when discontinuation of supply of medicine is made under section 30EJ
asserts: therapeutic-goods-act-1989-sec-30eg-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30eg-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30eg-ss-2
schema version: 2
part of: 30EG Reporting discontinuation of supply of medicine

therapeutic-goods-act-1989-sec-30eg-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Reporting obligation
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-30eg-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EG(2) Reporting discontinuation of supply of medicine

30EG(3) Reporting discontinuation of supply of medicine
type: Concept
description: Notification requirements
source: therapeutic-goods-act-1989.pdf, p.232
note: Notify discontinuation of medicine supply if critical impact on health or functioning
asserts: therapeutic-goods-act-1989-sec-30eg-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-30eg-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30eg-ss-3
schema version: 2
part of: 30EG Reporting discontinuation of supply of medicine

therapeutic-goods-act-1989-sec-30eg-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Notification requirements
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-30eg-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EG(3) Reporting discontinuation of supply of medicine

30EG(4) Reporting discontinuation of supply of medicine
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.232
note: Notification must be in a specified form and contain required information.
asserts: therapeutic-goods-act-1989-sec-30eg-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-30eg-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30eg-ss-4
schema version: 2
part of: 30EG Reporting discontinuation of supply of medicine

therapeutic-goods-act-1989-sec-30eg-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Notification must be in a specified form.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-30eg-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EG(4) Reporting discontinuation of supply of medicine

30EG(5) Reporting discontinuation of supply of medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.232
note: Specify software requirements for information transmission
asserts: therapeutic-goods-act-1989-sec-30eg-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-30eg-ss-5-logic-descriptionlogic-1
asserts: therapeutic-goods-act-1989-sec-30eg-ss-5-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-30eg-ss-5
schema version: 2
part of: 30EG Reporting discontinuation of supply of medicine

therapeutic-goods-act-1989-sec-30eg-ss-5-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Identifies the temporal relation of software requirements
modality: AllenInterval
operator: during

therapeutic-goods-act-1989-sec-30eg-ss-5-logic-descriptionlogic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies the provision as a descriptive clause
modality: DescriptionLogic
operator: hasClass

30EH What is a reportable medicine?
type: Concept
source: therapeutic-goods-act-1989.pdf, p.234
curation status: Proposed
has part: 30EH(1) What is a reportable medicine?
has part: 30EH(2) What is a reportable medicine?
has part: 30EH(3) What is a reportable medicine?
proposed by: legis2cml
realized by: sec-30eh
schema version: 2

30EH(1) What is a reportable medicine?
type: Concept
source: therapeutic-goods-act-1989.pdf, p.234
note: Defines reportable medicine under the Act.
asserts: therapeutic-goods-act-1989-sec-30eh-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30eh-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30eh-ss-1-logic-linearlogic-2
asserts: therapeutic-goods-act-1989-sec-30eh-ss-1-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-30eh-ss-1-logic-ltl-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-30eh-ss-1
schema version: 2
part of: 30EH What is a reportable medicine?

therapeutic-goods-act-1989-sec-30eh-ss-1-logic-alleninterval-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Includes temporal intervals for substance inclusion.
modality: AllenInterval
operator: contains
premise text: (i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard;

therapeutic-goods-act-1989-sec-30eh-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Identifies a reportable medicine.
modality: Deontic
operator: is
premise text: (1) For the purposes of this Act, registered goods are a reportable medicine if:

therapeutic-goods-act-1989-sec-30eh-ss-1-logic-linearlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Combines conditions for a reportable medicine.
modality: LinearLogic
operator: and
premise text: (a) the goods are medicine; and (b) either: (i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard;

therapeutic-goods-act-1989-sec-30eh-ss-1-logic-ltl-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Combines conditions for a reportable medicine using LTL.
modality: LTL
operator: or
premise text: (b) either: (i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard;

therapeutic-goods-act-1989-sec-30eh-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EH(1) What is a reportable medicine?

30EH(2) What is a reportable medicine?
type: Concept
source: therapeutic-goods-act-1989.pdf, p.234
note: The Minister may determine medicine for the purposes of subparagraph (1)(b)(ii).
asserts: therapeutic-goods-act-1989-sec-30eh-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-30eh-ss-2
schema version: 2
part of: 30EH What is a reportable medicine?

30EH(3) What is a reportable medicine?
type: Concept
source: therapeutic-goods-act-1989.pdf, p.234
note: The Minister must determine a medicine if it is critical to patient health and notification of shortage would be in public health interests.
asserts: therapeutic-goods-act-1989-sec-30eh-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-30eh-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30eh-ss-3-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-30eh-ss-3
schema version: 2
part of: 30EH What is a reportable medicine?

therapeutic-goods-act-1989-sec-30eh-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Minister must determine a medicine.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-30eh-ss-3-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Notification of shortage would be in public health interests.
modality: Epistemic
operator: SUFFICIENT

30EI When is there a medicine shortage?
type: Concept
source: therapeutic-goods-act-1989.pdf, p.235
note: Defines when there is a medicine shortage in Australia.
asserts: therapeutic-goods-act-1989-sec-30ei-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ei
schema version: 2

30EJ Medicines Watch List
type: Concept
source: therapeutic-goods-act-1989.pdf, p.235
curation status: Proposed
has part: 30EJ(1) Medicines Watch List
has part: 30EJ(2) Medicines Watch List
proposed by: legis2cml
realized by: sec-30ej
schema version: 2

30EJ(1) Medicines Watch List
type: Concept
source: therapeutic-goods-act-1989.pdf, p.235
note: Minister may determine medicine for purposes of subsections 30EF(2) and 30EG(2)
asserts: therapeutic-goods-act-1989-sec-30ej-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30ej-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ej-ss-1
schema version: 2
part of: 30EJ Medicines Watch List

therapeutic-goods-act-1989-sec-30ej-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Expresses permission or obligation
modality: Deontic
operator: May

30EJ(2) Medicines Watch List
type: Concept
source: therapeutic-goods-act-1989.pdf, p.235
note: The Minister must not determine a medicine unless certain conditions are met.
asserts: therapeutic-goods-act-1989-sec-30ej-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30ej-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30ej-ss-2-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-30ej-ss-2-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-30ej-ss-2-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-30ej-ss-2-logic-diffusion-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ej-ss-2
schema version: 2
part of: 30EJ Medicines Watch List

therapeutic-goods-act-1989-sec-30ej-ss-2-logic-alleninterval-3
type: LogicApplication
conclusion text: ...the Minister is satisfied that any shortage of the medicine...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines a temporal overlap between the conditions and the determination of a medicine.
modality: AllenInterval
operator: TemporalOverlap
premise text: (2) The Minister must not determine a medicine unless...

therapeutic-goods-act-1989-sec-30ej-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...unless the Minister is satisfied that any shortage of the medicine...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the Minister from determining a medicine without satisfying certain conditions.
modality: Deontic
operator: Prohibition
premise text: (2) The Minister must not determine a medicine...

therapeutic-goods-act-1989-sec-30ej-ss-2-logic-deontic-2
type: LogicApplication
conclusion text: ...unless the Minister is satisfied that any shortage of the medicine...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation on the Minister to satisfy certain conditions before determining a medicine.
modality: Deontic
operator: Obligation
premise text: (2) The Minister must not determine a medicine...

therapeutic-goods-act-1989-sec-30ej-ss-2-logic-diffusion-5
type: LogicApplication
conclusion text: ...the Minister is satisfied that any shortage of the medicine...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Defines an information flow between the conditions and the determination of a medicine.
modality: Diffusion
operator: InformationFlow
premise text: (2) The Minister must not determine a medicine unless...

therapeutic-goods-act-1989-sec-30ej-ss-2-logic-ltl-4
type: LogicApplication
conclusion text: ...the Minister is satisfied that any shortage of the medicine...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines a temporal relevance between the conditions and the determination of a medicine.
modality: LTL
operator: TemporalRelevance
premise text: (2) The Minister must not determine a medicine unless...

therapeutic-goods-act-1989-sec-30ej-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EJ(2) Medicines Watch List

30EK Minister may declare a serious scarcity of medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.236
curation status: Proposed
has part: 30EK(1) Minister may declare a serious scarcity of medicine
has part: 30EK(2) Minister may declare a serious scarcity of medicine
has part: 30EK(3) Minister may declare a serious scarcity of medicine
has part: 30EK(4) Minister may declare a serious scarcity of medicine
has part: 30EK(5) Minister may declare a serious scarcity of medicine
proposed by: legis2cml
realized by: sec-30ek
schema version: 2

30EK(1) Minister may declare a serious scarcity of medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.236
note: Minister may declare a serious scarcity of medicine and specify substitution rules.
asserts: therapeutic-goods-act-1989-sec-30ek-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-30ek-ss-1-logic-alleninterval-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ek-ss-1
schema version: 2
part of: 30EK Minister may declare a serious scarcity of medicine

therapeutic-goods-act-1989-sec-30ek-ss-1-logic-alleninterval-4
type: LogicApplication
conclusion text: The declaration and substitution rules overlap in time.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap between declaration and substitution rules.
modality: AllenInterval
operator: Overlaps
premise text: The Minister may, by legislative instrument:

therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: (b) specify the medicine (the substitutable medicine)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to dispense substitutable medicine.
modality: Deontic
operator: Permit
premise text: (a) declare that there is a serious scarcity of specified medicine

therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: Substitution permitted under specified circumstances.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Pharmacists permitted to dispense substitutable medicine under specified circumstances.
modality: Deontic
operator: Permit
premise text: (b) specify the circumstances in which that substitution is permitted.

therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-3
type: LogicApplication
conclusion text: No prohibition.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: No prohibition on declaring scarcity or specifying substitution rules.
modality: Deontic
operator: Prohibit
premise text: (a) declare that there is a serious scarcity of specified medicine

therapeutic-goods-act-1989-sec-30ek-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EK(1) Minister may declare a serious scarcity of medicine

30EK(2) Minister may declare a serious scarcity of medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.236
note: The Minister may declare a serious scarcity of medicine under certain conditions.
asserts: therapeutic-goods-act-1989-sec-30ek-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30ek-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30ek-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ek-ss-2
schema version: 2
part of: 30EK Minister may declare a serious scarcity of medicine

therapeutic-goods-act-1989-sec-30ek-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Minister may declare a serious scarcity of medicine.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-30ek-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: The supply of the scarce medicine in Australia is not currently meeting the demand for that medicine for all of the patients in Australia who take that medicine.
modality: DescriptionLogic
operator: is

therapeutic-goods-act-1989-sec-30ek-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EK(2) Minister may declare a serious scarcity of medicine

30EK(3) Minister may declare a serious scarcity of medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.236
note: Minister must declare a serious scarcity of medicine if certain conditions are met.
asserts: therapeutic-goods-act-1989-sec-30ek-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-30ek-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ek-ss-3
schema version: 2
part of: 30EK Minister may declare a serious scarcity of medicine

therapeutic-goods-act-1989-sec-30ek-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Minister must declare a serious scarcity of medicine
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-30ek-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EK(3) Minister may declare a serious scarcity of medicine

30EK(4) Minister may declare a serious scarcity of medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.236
note: Minister must declare a serious scarcity of medicine under certain circumstances.
asserts: therapeutic-goods-act-1989-sec-30ek-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-30ek-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30ek-ss-4-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-30ek-ss-4-logic-alleninterval-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ek-ss-4
schema version: 2
part of: 30EK Minister may declare a serious scarcity of medicine

therapeutic-goods-act-1989-sec-30ek-ss-4-logic-alleninterval-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for declaration.
modality: AllenInterval
operator: CONTAINS
premise text: (4)

therapeutic-goods-act-1989-sec-30ek-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Minister must declare a serious scarcity of medicine.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-30ek-ss-4-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of persons for whom the substitutable medicine is suitable or not suitable.
modality: DescriptionLogic
operator: CLASSIFICATION
premise text: (a) the class of persons for whom the substitutable medicine is suitable; or (b) the class of persons for whom the substitutable medicine is not suitable.

therapeutic-goods-act-1989-sec-30ek-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30EK(4) Minister may declare a serious scarcity of medicine

30EK(5) Minister may declare a serious scarcity of medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.236
note: Instrument remains in force for a specified period unless revoked.
asserts: therapeutic-goods-act-1989-sec-30ek-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-30ek-ss-5
schema version: 2
part of: 30EK Minister may declare a serious scarcity of medicine

30EL Substitution of prescription medicine by pharmacists
type: Concept
source: therapeutic-goods-act-1989.pdf, p.237
note: Pharmacist may dispense scarce medicine in substitution for another
asserts: therapeutic-goods-act-1989-sec-30el-norm
asserts: therapeutic-goods-act-1989-sec-30el-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30el
schema version: 2

therapeutic-goods-act-1989-sec-30el-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to dispense
modality: Deontic
operator: may

30F Criminal offences for goods exempt under section 18A not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.238
curation status: Proposed
has part: 30F(1) Criminal offences for goods exempt under section 18A not
has part: 30F(2) Criminal offences for goods exempt under section 18A not
has part: 30F(3) Criminal offences for goods exempt under section 18A not
has part: 30F(4) Criminal offences for goods exempt under section 18A not
has part: 30F(4A) Criminal offences for goods exempt under section 18A not
has part: 30F(4B) Criminal offences for goods exempt under section 18A not
has part: 30F(5) Criminal offences for goods exempt under section 18A not
has part: 30F(6) Criminal offences for goods exempt under section 18A not
proposed by: legis2cml
realized by: sec-30f
schema version: 2

30F(1) Criminal offences for goods exempt under section 18A not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.238
note: Supplying goods of a particular kind that do not conform to a standard or are not fit for their intended purposes is prohibited.
asserts: therapeutic-goods-act-1989-sec-30f-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30f-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30f-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-30f-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-30f-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-30f-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-30f-ss-1
schema version: 2
part of: 30F Criminal offences for goods exempt under section 18A not

therapeutic-goods-act-1989-sec-30f-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: ...overlap with the supply of goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap between the supply of goods and the Secretary's satisfaction that the goods included in that batch do not conform to a standard or are not fit for their intended purposes.
modality: AllenInterval
operator: Overlap
premise text: (c) the Secretary is satisfied that the goods included in that batch: ...

therapeutic-goods-act-1989-sec-30f-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: ...are classified as not conforming to a standard or being unfit for their intended purposes.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Classification of goods as not conforming to a standard or being unfit for their intended purposes using artificial intelligence.
modality: CogAI
operator: Classify
premise text: (i) do not conform to a standard applicable to goods of that kind; or (ii) are otherwise not fit to be used for their intended purposes.

therapeutic-goods-act-1989-sec-30f-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...is prohibited.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of supplying goods that do not conform to a standard or are not fit for their intended purposes.
modality: Deontic
operator: Prohibit
premise text: (a) therapeutic goods of a particular kind are exempt under section 18A; and (b) a person supplies a batch of goods of that kind; and (c) the Secretary is satisfied that the goods included in that batch: ...

therapeutic-goods-act-1989-sec-30f-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: ...diffuse to all persons.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusion of the prohibition on supplying goods that do not conform to a standard or are not fit for their intended purposes.
modality: Diffusion
operator: Diffuse
premise text: (a) therapeutic goods of a particular kind are exempt under section 18A; and (b) a person supplies a batch of goods of that kind; and (c) the Secretary is satisfied that the goods included in that batch: ...

therapeutic-goods-act-1989-sec-30f-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: ...are recurring traces of supplying goods that do not conform to a standard or are not fit for their intended purposes.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of supplying goods that do not conform to a standard or are not fit for their intended purposes.
modality: LTL
operator: Recurring
premise text: (a) therapeutic goods of a particular kind are exempt under section 18A; and (b) a person supplies a batch of goods of that kind; and (c) the Secretary is satisfied that the goods included in that batch: ...

therapeutic-goods-act-1989-sec-30f-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30F(1) Criminal offences for goods exempt under section 18A not

30F(2) Criminal offences for goods exempt under section 18A not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.238
note: Require person to take steps to recall goods
asserts: therapeutic-goods-act-1989-sec-30f-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30f-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30f-ss-2
schema version: 2
part of: 30F Criminal offences for goods exempt under section 18A not

therapeutic-goods-act-1989-sec-30f-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: The person must take steps to recall the goods
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a duty on the state
modality: Deontic
operator: require

therapeutic-goods-act-1989-sec-30f-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30F(2) Criminal offences for goods exempt under section 18A not

30F(3) Criminal offences for goods exempt under section 18A not
type: Concept
description: Steps to be taken, manner of taking, reasonable period
source: therapeutic-goods-act-1989.pdf, p.238
note: Specify steps for recall of goods
asserts: therapeutic-goods-act-1989-sec-30f-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-30f-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30f-ss-3-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-30f-ss-3-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-30f-ss-3-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-30f-ss-3-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-30f-ss-3
schema version: 2
part of: 30F Criminal offences for goods exempt under section 18A not

therapeutic-goods-act-1989-sec-30f-ss-3-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for recall
modality: AllenInterval
operator: CONTAINS
premise text: (a) the steps to be taken, (b) the manner in which the steps are to be taken, (c) a reasonable period within which the steps are to be taken

therapeutic-goods-act-1989-sec-30f-ss-3-logic-cogai-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Artificial intelligence application for recall requirements
modality: CogAI
operator: CONTAINS
premise text: (a) the steps to be taken, (b) the manner in which the steps are to be taken, (c) a reasonable period within which the steps are to be taken

therapeutic-goods-act-1989-sec-30f-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Specify steps for recall of goods
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-30f-ss-3-logic-diffusion-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusion of recall requirements
modality: Diffusion
operator: CONTAINS
premise text: (a) the steps to be taken, (b) the manner in which the steps are to be taken, (c) a reasonable period within which the steps are to be taken

therapeutic-goods-act-1989-sec-30f-ss-3-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal interval for recall
modality: LTL
operator: CONTAINS
premise text: (a) the steps to be taken, (b) the manner in which the steps are to be taken, (c) a reasonable period within which the steps are to be taken

therapeutic-goods-act-1989-sec-30f-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30F(3) Criminal offences for goods exempt under section 18A not

30F(4) Criminal offences for goods exempt under section 18A not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.238
note: Publish notice in Gazette or Department's website
asserts: therapeutic-goods-act-1989-sec-30f-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-30f-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30f-ss-4
schema version: 2
part of: 30F Criminal offences for goods exempt under section 18A not

therapeutic-goods-act-1989-sec-30f-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must publish notice
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-30f-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30F(4) Criminal offences for goods exempt under section 18A not

30F(4A) Criminal offences for goods exempt under section 18A not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.238
note: A written notice given to a person by the Secretary under this section is not a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-30f-ss-4a-norm
asserts: therapeutic-goods-act-1989-sec-30f-ss-4a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30f-ss-4a
schema version: 2
part of: 30F Criminal offences for goods exempt under section 18A not

therapeutic-goods-act-1989-sec-30f-ss-4a-logic-deontic-1
type: LogicApplication
conclusion text: None
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits notices from being considered legislative instruments.
modality: Deontic
operator: Prohibition
premise text: None

therapeutic-goods-act-1989-sec-30f-ss-4a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30F(4A) Criminal offences for goods exempt under section 18A not

30F(4B) Criminal offences for goods exempt under section 18A not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.238
note: Failure to comply with a notice results in harm or injury.
asserts: therapeutic-goods-act-1989-sec-30f-ss-4b-norm
asserts: therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30f-ss-4b-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-30f-ss-4b-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-30f-ss-4b
schema version: 2
part of: 30F Criminal offences for goods exempt under section 18A not

therapeutic-goods-act-1989-sec-30f-ss-4b-logic-alleninterval-2
type: LogicApplication
conclusion text: because the person failed to comply with that requirement.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The provision applies to temporal intervals where harm or injury occurs.
modality: AllenInterval
operator: Overlaps
premise text: the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the person failed to comply with that requirement.

therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-1
type: LogicApplication
conclusion text: the person fails to comply with that requirement; and
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits non-compliance with a notice.
modality: Deontic
operator: Prohibition
premise text: The Secretary gives a notice to the person under subsection (2); and

therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-4
type: LogicApplication
conclusion text: the person fails to comply with that requirement; and
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation on the person to comply with the notice.
modality: Deontic
operator: Obligation
premise text: A person commits an offence if:

therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-5
type: LogicApplication
conclusion text: the person fails to comply with that requirement; and
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits non-compliance with the notice.
modality: Deontic
operator: Prohibition
premise text: A person commits an offence if:

therapeutic-goods-act-1989-sec-30f-ss-4b-logic-ltl-3
type: LogicApplication
conclusion text: or would be likely to result in, harm or injury to any person;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The provision is repeated for each occurrence of harm or injury.
modality: LTL
operator: Repeats
premise text: the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or

therapeutic-goods-act-1989-sec-30f-ss-4b-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30F(4B) Criminal offences for goods exempt under section 18A not

30F(5) Criminal offences for goods exempt under section 18A not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.238
note: Failure to comply with notice requirement is an offence.
asserts: therapeutic-goods-act-1989-sec-30f-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-30f-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30f-ss-5-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-30f-ss-5-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-30f-ss-5-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-30f-ss-5
schema version: 2
part of: 30F Criminal offences for goods exempt under section 18A not

therapeutic-goods-act-1989-sec-30f-ss-5-logic-alleninterval-2
type: LogicApplication
conclusion text: the person fails to comply with that requirement.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Compliance with notice requirement overlaps with the offence of failing to comply.
modality: AllenInterval
operator: Overlaps
premise text: The person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and

therapeutic-goods-act-1989-sec-30f-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: the person fails to comply with that requirement.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply with notice requirement.
modality: Deontic
operator: Obligation
premise text: The Secretary gives a notice to the person under subsection (2); and

therapeutic-goods-act-1989-sec-30f-ss-5-logic-deontic-4
type: LogicApplication
conclusion text: the person fails to comply with that requirement.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to pay penalty for failing to comply with notice requirement.
modality: Deontic
operator: Obligation
premise text: Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.

therapeutic-goods-act-1989-sec-30f-ss-5-logic-ltl-3
type: LogicApplication
conclusion text: the person fails to comply with that requirement.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Compliance with notice requirement is recurrently related to the offence of failing to comply.
modality: LTL
operator: Recurrently
premise text: The person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and

therapeutic-goods-act-1989-sec-30f-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30F(5) Criminal offences for goods exempt under section 18A not

30F(6) Criminal offences for goods exempt under section 18A not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.238
note: A person commits an offence if the Secretary gives a notice to the person under subsection (2)
asserts: therapeutic-goods-act-1989-sec-30f-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-30f-ss-6-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-30f-ss-6-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-30f-ss-6
schema version: 2
part of: 30F Criminal offences for goods exempt under section 18A not

therapeutic-goods-act-1989-sec-30f-ss-6-logic-alleninterval-2
type: LogicApplication
conclusion text: Section 30F(6)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Overlaps with
modality: AllenInterval
operator: overlaps
premise text: Chapter 3 Medicines and other therapeutic goods that are not medical devices

therapeutic-goods-act-1989-sec-30f-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: A person commits an offence
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Has obligation
modality: Deontic
operator: hasObligation
premise text: The Secretary gives a notice to the person under subsection (2)

therapeutic-goods-act-1989-sec-30f-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30F(6) Criminal offences for goods exempt under section 18A not

30FA Civil penalty for goods exempt under section 18A not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.240
note: Civil penalty for non-compliance with standards
asserts: therapeutic-goods-act-1989-sec-30fa-norm
asserts: therapeutic-goods-act-1989-sec-30fa-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30fa
schema version: 2

therapeutic-goods-act-1989-sec-30fa-logic-deontic-1
type: LogicApplication
conclusion text: Non-compliance is prohibited
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits non-compliance
modality: Deontic
operator: Prohibit
premise text: Notice specifies requirement

therapeutic-goods-act-1989-sec-30fa-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30FA Civil penalty for goods exempt under section 18A not

30G Disposal of unused goods exempt under section 18A
type: Concept
source: therapeutic-goods-act-1989.pdf, p.240
curation status: Proposed
has part: 30G(1) Disposal of unused goods exempt under section 18A
has part: 30G(2) Disposal of unused goods exempt under section 18A
has part: 30G(3) Disposal of unused goods exempt under section 18A
has part: 30G(4) Disposal of unused goods exempt under section 18A
proposed by: legis2cml
realized by: sec-30g
schema version: 2

30G(1) Disposal of unused goods exempt under section 18A
type: Concept
source: therapeutic-goods-act-1989.pdf, p.240
note: Therapeutic goods must be used before an exemption ceases to have effect.
asserts: therapeutic-goods-act-1989-sec-30g-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30g-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30g-ss-1
schema version: 2
part of: 30G Disposal of unused goods exempt under section 18A

therapeutic-goods-act-1989-sec-30g-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Therapeutic goods must be used before an exemption ceases to have effect.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-30g-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30G(1) Disposal of unused goods exempt under section 18A

30G(2) Disposal of unused goods exempt under section 18A
type: Concept
source: therapeutic-goods-act-1989.pdf, p.240
note: The Secretary must arrange for disposal of unused goods.
asserts: therapeutic-goods-act-1989-sec-30g-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30g-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30g-ss-2
schema version: 2
part of: 30G Disposal of unused goods exempt under section 18A

therapeutic-goods-act-1989-sec-30g-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to arrange for disposal
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-30g-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30G(2) Disposal of unused goods exempt under section 18A

30G(3) Disposal of unused goods exempt under section 18A
type: Concept
source: therapeutic-goods-act-1989.pdf, p.240
note: Methods for disposal of goods
asserts: therapeutic-goods-act-1989-sec-30g-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-30g-ss-3
schema version: 2
part of: 30G Disposal of unused goods exempt under section 18A

30G(4) Disposal of unused goods exempt under section 18A
type: Concept
source: therapeutic-goods-act-1989.pdf, p.240
note: No benefit can be conferred on a person other than the owner of goods
asserts: therapeutic-goods-act-1989-sec-30g-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-30g-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30g-ss-4
schema version: 2
part of: 30G Disposal of unused goods exempt under section 18A

therapeutic-goods-act-1989-sec-30g-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: No benefit can be conferred
modality: Deontic
operator: Cannot

therapeutic-goods-act-1989-sec-30g-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30G(4) Disposal of unused goods exempt under section 18A

30H Record for goods exempt under section 18A
type: Concept
source: therapeutic-goods-act-1989.pdf, p.241
curation status: Proposed
has part: 30H(1) Record for goods exempt under section 18A
has part: 30H(2) Record for goods exempt under section 18A
has part: 30H(3) Record for goods exempt under section 18A
proposed by: legis2cml
realized by: sec-30h
schema version: 2

30H(1) Record for goods exempt under section 18A
type: Concept
description: Record keeping
source: therapeutic-goods-act-1989.pdf, p.241
note: Keeping a record of therapeutic goods exempt under section 18A is required.
asserts: therapeutic-goods-act-1989-sec-30h-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30h-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30h-ss-1
schema version: 2
part of: 30H Record for goods exempt under section 18A

therapeutic-goods-act-1989-sec-30h-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The exemption requires record keeping.
modality: Deontic
operator: Requires

therapeutic-goods-act-1989-sec-30h-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30H(1) Record for goods exempt under section 18A

30H(2) Record for goods exempt under section 18A
type: Concept
source: therapeutic-goods-act-1989.pdf, p.241
note: Strict liability applies to paragraph (1)(b)
asserts: therapeutic-goods-act-1989-sec-30h-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30h-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30h-ss-2
schema version: 2
part of: 30H Record for goods exempt under section 18A

therapeutic-goods-act-1989-sec-30h-ss-2-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Strict liability obligation
modality: Deontic
operator: applies
premise text: (2) Strict liability applies to paragraph (1)(b)

30H(3) Record for goods exempt under section 18A
type: Concept
description: Record keeping
source: therapeutic-goods-act-1989.pdf, p.241
note: Keeping a record about therapeutic goods exempt under section 18A is required.
asserts: therapeutic-goods-act-1989-sec-30h-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-30h-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-30h-ss-3
schema version: 2
part of: 30H Record for goods exempt under section 18A

therapeutic-goods-act-1989-sec-30h-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to keep a record
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-30h-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 30H(3) Record for goods exempt under section 18A

31 Secretary may require information or documents
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.242
note: The Secretary may require information or documents from a person.
asserts: therapeutic-goods-act-1989-sec-31-norm
asserts: therapeutic-goods-act-1989-sec-31-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-31
schema version: 2

therapeutic-goods-act-1989-sec-31-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary may require information or documents.
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-31-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31 Secretary may require information or documents

31A Secretary may require information etc. about goods exempt
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.249
note: Secretary may require sponsor to provide specified information about exempt goods for experimental purposes in humans.
asserts: therapeutic-goods-act-1989-sec-31a-norm
asserts: therapeutic-goods-act-1989-sec-31a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-31a
schema version: 2

therapeutic-goods-act-1989-sec-31a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary may require information
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-31a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31A Secretary may require information etc. about goods exempt

31AA Secretary may require information etc. about goods exempt
type: Concept
source: therapeutic-goods-act-1989.pdf, p.251
curation status: Proposed
has part: 31AA(1) Secretary may require information etc. about goods exempt
has part: 31AA(2) Secretary may require information etc. about goods exempt
has part: 31AA(3) Secretary may require information etc. about goods exempt
has part: 31AA(4) Secretary may require information etc. about goods exempt
proposed by: legis2cml
realized by: sec-31aa
schema version: 2

31AA(1) Secretary may require information etc. about goods exempt
type: Concept
source: therapeutic-goods-act-1989.pdf, p.251
note: Secretary may require information about goods exempt
asserts: therapeutic-goods-act-1989-sec-31aa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-31aa-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-31aa-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-31aa-ss-1-logic-argumentation-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-31aa-ss-1
schema version: 2
part of: 31AA Secretary may require information etc. about goods exempt

therapeutic-goods-act-1989-sec-31aa-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Between a condition and a person
modality: AllenInterval
operator: between
premise text: (1) This section applies to a person who is required to comply with a condition of an exemption of therapeutic goods under section 18A.

therapeutic-goods-act-1989-sec-31aa-ss-1-logic-argumentation-3
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: May lead to further action
modality: Argumentation
operator: may lead to

therapeutic-goods-act-1989-sec-31aa-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires information
modality: Deontic
operator: requires

therapeutic-goods-act-1989-sec-31aa-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31AA(1) Secretary may require information etc. about goods exempt

31AA(2) Secretary may require information etc. about goods exempt
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.251
note: The Secretary may require information from a person about goods exempt.
asserts: therapeutic-goods-act-1989-sec-31aa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-31aa-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-31aa-ss-2
schema version: 2
part of: 31AA Secretary may require information etc. about goods exempt

therapeutic-goods-act-1989-sec-31aa-ss-2-logic-deontic-1
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-31aa-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31AA(2) Secretary may require information etc. about goods exempt

31AA(3) Secretary may require information etc. about goods exempt
type: Concept
description: Information about goods exempt
source: therapeutic-goods-act-1989.pdf, p.251
note: Secretary must require information within a specified period.
asserts: therapeutic-goods-act-1989-sec-31aa-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-31aa-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-31aa-ss-3
schema version: 2
part of: 31AA Secretary may require information etc. about goods exempt

therapeutic-goods-act-1989-sec-31aa-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-31aa-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31AA(3) Secretary may require information etc. about goods exempt

31AA(4) Secretary may require information etc. about goods exempt
type: Concept
description: Information
source: therapeutic-goods-act-1989.pdf, p.251
note: Secretary must require information about goods exempt
asserts: therapeutic-goods-act-1989-sec-31aa-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-31aa-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-31aa-ss-4-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-31aa-ss-4
schema version: 2
part of: 31AA Secretary may require information etc. about goods exempt

therapeutic-goods-act-1989-sec-31aa-ss-4-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-31aa-ss-4-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies goods exempt
modality: DescriptionLogic
operator: hasPart

therapeutic-goods-act-1989-sec-31aa-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31AA(4) Secretary may require information etc. about goods exempt

31B Secretary may require information relating to approvals and
type: Concept
source: therapeutic-goods-act-1989.pdf, p.251
note: Secretary may require information from a person granted an approval under subsection 19(1)
asserts: therapeutic-goods-act-1989-sec-31b-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-31b
schema version: 2

therapeutic-goods-act-1989-sec-31b-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31B Secretary may require information relating to approvals and

31BA Secretary may require information about therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.254
curation status: Proposed
has part: 31BA(1) Secretary may require information about therapeutic goods
has part: 31BA(2) Secretary may require information about therapeutic goods
has part: 31BA(3) Secretary may require information about therapeutic goods
proposed by: legis2cml
realized by: sec-31ba
schema version: 2

31BA(1) Secretary may require information about therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.254
note: The Secretary may require information about therapeutic goods from a person granted an approval.
asserts: therapeutic-goods-act-1989-sec-31ba-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-31ba-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-31ba-ss-1
schema version: 2
part of: 31BA Secretary may require information about therapeutic goods

therapeutic-goods-act-1989-sec-31ba-ss-1-logic-deontic-1
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-31ba-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31BA(1) Secretary may require information about therapeutic goods

31BA(2) Secretary may require information about therapeutic goods
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.254
note: Must provide information within a specified period and in the form specified by the notice.
asserts: therapeutic-goods-act-1989-sec-31ba-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-31ba-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-31ba-ss-2
schema version: 2
part of: 31BA Secretary may require information about therapeutic goods

therapeutic-goods-act-1989-sec-31ba-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide information within a specified period and in the form specified by the notice.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-31ba-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31BA(2) Secretary may require information about therapeutic goods

31BA(3) Secretary may require information about therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.254
note: Secretary may require information about therapeutic goods in specified ways.
asserts: therapeutic-goods-act-1989-sec-31ba-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-31ba-ss-3
schema version: 2
part of: 31BA Secretary may require information about therapeutic goods

therapeutic-goods-act-1989-sec-31ba-ss-3-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31BA(3) Secretary may require information about therapeutic goods

31C Criminal offences for failing to give information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.254
curation status: Proposed
has part: 31C(1) Criminal offences for failing to give information or documents
has part: 31C(2) Criminal offences for failing to give information or documents
has part: 31C(3) Criminal offences for failing to give information or documents
proposed by: legis2cml
realized by: sec-31c
schema version: 2

31C(1) Criminal offences for failing to give information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.254
note: Failure to comply with a notice results in an offence.
asserts: therapeutic-goods-act-1989-sec-31c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-31c-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-31c-ss-1
schema version: 2
part of: 31C Criminal offences for failing to give information or documents

therapeutic-goods-act-1989-sec-31c-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-31c-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31C(1) Criminal offences for failing to give information or documents

31C(2) Criminal offences for failing to give information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.254
note: Failure to comply with a notice results in an offence.
asserts: therapeutic-goods-act-1989-sec-31c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-31c-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-31c-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-31c-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-31c-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-31c-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-31c-ss-2
schema version: 2
part of: 31C Criminal offences for failing to give information or documents

therapeutic-goods-act-1989-sec-31c-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: ...Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Indicates that failing to comply with a notice overlaps with committing an offence.
modality: AllenInterval
operator: Overlaps
premise text: (2) A person commits an offence if...

therapeutic-goods-act-1989-sec-31c-ss-2-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 pattern of failing to comply with a notice resulting in an offence.
modality: CogAI
operator: Recognizes
premise text: (2) A person commits an offence if...

therapeutic-goods-act-1989-sec-31c-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 failing to comply with a notice.
modality: Deontic
operator: Prohibition
premise text: (2) A person commits an offence if...

therapeutic-goods-act-1989-sec-31c-ss-2-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 information that failing to comply with a notice results in an offence.
modality: Diffusion
operator: Diffuses
premise text: (2) A person commits an offence if...

therapeutic-goods-act-1989-sec-31c-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: ...Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Indicates that failing to comply with a notice repeats the action of committing an offence.
modality: LTL
operator: Repeats
premise text: (2) A person commits an offence if...

therapeutic-goods-act-1989-sec-31c-ss-2-norm
type: Prohibition
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 31C(2) Criminal offences for failing to give information or documents

31C(3) Criminal offences for failing to give information or documents
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.254
note: Duty to provide information or documents
asserts: therapeutic-goods-act-1989-sec-31c-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-31c-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-31c-ss-3
schema version: 2
part of: 31C Criminal offences for failing to give information or documents

therapeutic-goods-act-1989-sec-31c-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide information or documents
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-31c-ss-3-norm
type: Obligation
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 31C(3) Criminal offences for failing to give information or documents

31D False or misleading information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.255
curation status: Proposed
has part: 31D(1) False or misleading information
has part: 31D(1A) False or misleading information
proposed by: legis2cml
realized by: sec-31d
schema version: 2

31D(1) False or misleading information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.255
note: Giving false or misleading information in compliance with a notice is an offence.
asserts: therapeutic-goods-act-1989-sec-31d-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-31d-ss-1
schema version: 2
part of: 31D False or misleading information

therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The person commits an offence if they do so knowing that the information is false or misleading.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits giving false or misleading information in compliance with a notice.
modality: Deontic
operator: Prohibition
premise text: The person gives information to the Secretary in compliance or purported compliance with the notice.

therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: The person commits an offence if they do so.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a duty on the person to not give false or misleading information in compliance with a notice.
modality: Deontic
operator: Obligation
premise text: The person does so knowing that the information is false or misleading.

therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-3
type: LogicApplication
conclusion text: The person commits an offence if they do so knowing that the information is false or misleading.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits giving false or misleading information in purported compliance with a notice.
modality: Deontic
operator: Prohibition
premise text: The person gives information to the Secretary in purported compliance with the notice.

therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: The person commits an offence if they do so knowing that the information is false or misleading.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a duty on the person to not give false or misleading information in purported compliance with a notice.
modality: Deontic
operator: Obligation
premise text: The person gives information to the Secretary in purported compliance with the notice.

therapeutic-goods-act-1989-sec-31d-ss-1-norm
type: Prohibition
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 31D(1) False or misleading information

31D(1A) False or misleading information
type: Concept
source: therapeutic-goods-act-1989.pdf, p.255
note: Giving false or misleading information after receiving a notice is an offence.
asserts: therapeutic-goods-act-1989-sec-31d-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-31d-ss-1a-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-31d-ss-1a
schema version: 2
part of: 31D False or misleading information

therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-1
type: LogicApplication
conclusion text: The person commits an offence if the information is false or misleading.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits giving false or misleading information after receiving a notice.
modality: Deontic
operator: Prohibition
premise text: The person gives information to the Secretary in compliance or purported compliance with the notice.

therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation on the person to give accurate information after receiving a notice.
modality: Deontic
operator: Obligation
premise text: The person is required to give information in compliance with the notice.

therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits omitting any matter or thing without which the information is misleading.
modality: Deontic
operator: Prohibition
premise text: The information omits any matter or thing without which it is misleading.

therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation on the person to provide accurate information that includes all necessary matters and things.
modality: Deontic
operator: Obligation
premise text: The information must include all matter and thing without which it is misleading.

therapeutic-goods-act-1989-sec-31d-ss-1a-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Specifies the temporal interval for giving false or misleading information as after receiving a notice.
modality: LTL
operator: TemporalInterval
premise text: The person gives information to the Secretary in compliance or purported compliance with the notice.

therapeutic-goods-act-1989-sec-31d-ss-1a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31D(1A) False or misleading information

31E False or misleading documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.256
curation status: Proposed
has part: 31E(1) False or misleading documents
has part: 31E(1A) False or misleading documents
has part: 31E(1B) False or misleading documents
has part: 31E(2) False or misleading documents
has part: 31E(3) False or misleading documents
proposed by: legis2cml
realized by: sec-31e
schema version: 2

31E(1) False or misleading documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.256
note: Producing false or misleading documents is an offence.
asserts: therapeutic-goods-act-1989-sec-31e-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-31e-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-31e-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-31e-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-31e-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-31e-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-31e-ss-1
schema version: 2
part of: 31E False or misleading documents

therapeutic-goods-act-1989-sec-31e-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: The temporal interval for producing documents starts at (1)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines a temporal interval for producing documents.
modality: AllenInterval
operator: Temporal Interval
premise text: (1) A person commits an offence if: (a) the person produces a document to the Secretary; and (b) the person does so knowing that the document is false or misleading; and (c) the document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA.

therapeutic-goods-act-1989-sec-31e-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: The document is classified as true or false/misleading using AI.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Classifies the document as true or false/misleading using AI.
modality: CogAI
operator: Classify
premise text: (1) A person commits an offence if: (a) the person produces a document to the Secretary; and (b) the person does so knowing that the document is false or misleading; and (c) the document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA.

therapeutic-goods-act-1989-sec-31e-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The person commits an offence if the document is produced knowing that it is false or misleading.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits producing false or misleading documents.
modality: Deontic
operator: Prohibit
premise text: The document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA.

therapeutic-goods-act-1989-sec-31e-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: The prohibition diffuses to all agents who produce documents.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses the prohibition to all agents.
modality: Diffusion
operator: Diffuse
premise text: (1) A person commits an offence if: (a) the person produces a document to the Secretary; and (b) the person does so knowing that the document is false or misleading; and (c) the document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA.

therapeutic-goods-act-1989-sec-31e-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: The recurring trace of document production starts at (1)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines a recurring trace of document production.
modality: LTL
operator: Recurring Trace
premise text: (1) A person commits an offence if: (a) the person produces a document to the Secretary; and (b) the person does so knowing that the document is false or misleading; and (c) the document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA.

therapeutic-goods-act-1989-sec-31e-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31E(1) False or misleading documents

31E(1A) False or misleading documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.256
note: Producing false or misleading documents in compliance with a notice is an offence.
asserts: therapeutic-goods-act-1989-sec-31e-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-31e-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-31e-ss-1a
schema version: 2
part of: 31E False or misleading documents

therapeutic-goods-act-1989-sec-31e-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits producing false or misleading documents in compliance with a notice.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-31e-ss-1a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31E(1A) False or misleading documents

31E(1B) False or misleading documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.256
note: Offence of strict liability for false or misleading documents
asserts: therapeutic-goods-act-1989-sec-31e-ss-1b-norm
asserts: therapeutic-goods-act-1989-sec-31e-ss-1b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-31e-ss-1b
schema version: 2
part of: 31E False or misleading documents

therapeutic-goods-act-1989-sec-31e-ss-1b-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits offence of strict liability
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-31e-ss-1b-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31E(1B) False or misleading documents

31E(2) False or misleading documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.256
note: Defendant bears evidential burden in relation to the matter.
asserts: therapeutic-goods-act-1989-sec-31e-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-31e-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-31e-ss-2-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-31e-ss-2
schema version: 2
part of: 31E False or misleading documents

therapeutic-goods-act-1989-sec-31e-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-31e-ss-2-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Defendant has a duty to provide evidence.
modality: Epistemic
operator: evidential burden

therapeutic-goods-act-1989-sec-31e-ss-2-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 31E(2) False or misleading documents

31E(3) False or misleading documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.256
note: Exemption from subsection (1) or (1A) for documents accompanied by a written statement
asserts: therapeutic-goods-act-1989-sec-31e-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-31e-ss-3
schema version: 2
part of: 31E False or misleading documents

31F Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.257
curation status: Proposed
has part: 31F(1) Self-incrimination
has part: 31F(2) Self-incrimination
proposed by: legis2cml
realized by: sec-31f
schema version: 2

31F(1) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.257
note: No excuse for giving information under certain notices
asserts: therapeutic-goods-act-1989-sec-31f-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-31f-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-31f-ss-1
schema version: 2
part of: 31F Self-incrimination

therapeutic-goods-act-1989-sec-31f-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

therapeutic-goods-act-1989-sec-31f-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31F(1) Self-incrimination

31F(2) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.257
note: Protection against self-incrimination in certain cases
asserts: therapeutic-goods-act-1989-sec-31f-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-31f-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-31f-ss-2
schema version: 2
part of: 31F Self-incrimination

therapeutic-goods-act-1989-sec-31f-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-31f-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 31F(2) Self-incrimination

32 What this Part is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.259
note: Regulates biologicals by providing a process for inclusion in the Register and enforcement through criminal offences and civil penalties.
asserts: therapeutic-goods-act-1989-sec-32-norm
asserts: therapeutic-goods-act-1989-sec-32-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32-logic-linearlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32
schema version: 2

therapeutic-goods-act-1989-sec-32-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Establishes a regulatory framework for biologicals.
modality: Deontic
operator: regulates

therapeutic-goods-act-1989-sec-32-logic-linearlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Establishes administrative processes for regulating biologicals.
modality: LinearLogic
operator: provides

therapeutic-goods-act-1989-sec-32-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32 What this Part is about

32A Meaning of biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.259
note: Defines what constitutes a biological.
asserts: therapeutic-goods-act-1989-sec-32a-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32a
schema version: 2

32AA Biological classes
type: Concept
source: therapeutic-goods-act-1989.pdf, p.260
note: Regulations may prescribe different classes of biologicals.
asserts: therapeutic-goods-act-1989-sec-32aa-norm
asserts: therapeutic-goods-act-1989-sec-32aa-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32aa-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32aa
schema version: 2

therapeutic-goods-act-1989-sec-32aa-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: May prescribe different classes of biologicals.
modality: Deontic
operator: mayPrescribe

therapeutic-goods-act-1989-sec-32aa-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classify biologicals into different classes.
modality: DescriptionLogic
operator: classify

therapeutic-goods-act-1989-sec-32aa-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32AA Biological classes

32AB When biologicals are separate and distinct from other
type: Concept
source: therapeutic-goods-act-1989.pdf, p.260
curation status: Proposed
has part: 32AB(1) When biologicals are separate and distinct from other
has part: 32AB(2) When biologicals are separate and distinct from other
proposed by: legis2cml
realized by: sec-32ab
schema version: 2

32AB(1) When biologicals are separate and distinct from other
type: Concept
source: therapeutic-goods-act-1989.pdf, p.260
note: Regulations may prescribe circumstances for separate and distinct biologicals.
asserts: therapeutic-goods-act-1989-sec-32ab-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32ab-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ab-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ab-ss-1
schema version: 2
part of: 32AB When biologicals are separate and distinct from other

therapeutic-goods-act-1989-sec-32ab-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations may prescribe circumstances.
modality: Deontic
operator: mayPrescribe

therapeutic-goods-act-1989-sec-32ab-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classify biologicals by specified class.
modality: DescriptionLogic
operator: classify

therapeutic-goods-act-1989-sec-32ab-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32AB(1) When biologicals are separate and distinct from other

32AB(2) When biologicals are separate and distinct from other
type: Concept
source: therapeutic-goods-act-1989.pdf, p.260
note: Different provision for different classes of biologicals
asserts: therapeutic-goods-act-1989-sec-32ab-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ab-ss-2
schema version: 2
part of: 32AB When biologicals are separate and distinct from other

therapeutic-goods-act-1989-sec-32ab-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32AB(2) When biologicals are separate and distinct from other

32B What this Division is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.262
note: Defines criminal offences and civil penalties relating to biologicals.
asserts: therapeutic-goods-act-1989-sec-32b-norm
asserts: therapeutic-goods-act-1989-sec-32b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32b
schema version: 2

therapeutic-goods-act-1989-sec-32b-logic-deontic-1
type: LogicApplication
conclusion text: State
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Identifies the subject of the obligation.
modality: Deontic
operator: is

therapeutic-goods-act-1989-sec-32b-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32B What this Division is about

32BA Criminal offences for importing a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.262
curation status: Proposed
has part: 32BA(1) Criminal offences for importing a biological
has part: 32BA(4) Criminal offences for importing a biological
has part: 32BA(4A) Criminal offences for importing a biological
proposed by: legis2cml
realized by: sec-32ba
schema version: 2

32BA(1) Criminal offences for importing a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.262
note: Importing a biological for use in humans is prohibited unless certain exemptions apply.
asserts: therapeutic-goods-act-1989-sec-32ba-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32ba-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ba-ss-1
schema version: 2
part of: 32BA Criminal offences for importing a biological

therapeutic-goods-act-1989-sec-32ba-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-32ba-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BA(1) Criminal offences for importing a biological

32BA(4) Criminal offences for importing a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.262
note: Importing a biological for use in humans is prohibited.
asserts: therapeutic-goods-act-1989-sec-32ba-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32ba-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ba-ss-4
schema version: 2
part of: 32BA Criminal offences for importing a biological

therapeutic-goods-act-1989-sec-32ba-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the importation of a biological for use in humans.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-32ba-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BA(4) Criminal offences for importing a biological

32BA(4A) Criminal offences for importing a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.262
note: Importing a biological for use in humans without registration is an offence.
asserts: therapeutic-goods-act-1989-sec-32ba-ss-4a-norm
asserts: therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-cogai-4
asserts: therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-shacl-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ba-ss-4a
schema version: 2
part of: 32BA Criminal offences for importing a biological

therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines the temporal interval during which importing a biological for use in humans without registration is an offence.
modality: AllenInterval
operator: Temporal Interval
premise text: (4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:

therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-cogai-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Represents importing a biological for use in humans without registration as an offence using knowledge representation.
modality: CogAI
operator: Knowledge Representation
premise text: (4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:

therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits importing a biological for use in humans without registration.
modality: Deontic
operator: Prohibit
premise text: (4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:

therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines a recurring trace of importing a biological for use in humans without registration as an offence.
modality: LTL
operator: Recurring Trace
premise text: (4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:

therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-shacl-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::shacl
logic summary: Defines a schema definition for importing a biological for use in humans without registration as an offence.
modality: SHACL
operator: Schema Definition
premise text: (4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:

therapeutic-goods-act-1989-sec-32ba-ss-4a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BA(4A) Criminal offences for importing a biological

32BB Criminal offences for exporting a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.265
curation status: Proposed
has part: 32BB(1) Criminal offences for exporting a biological
has part: 32BB(4) Criminal offences for exporting a biological
proposed by: legis2cml
realized by: sec-32bb
schema version: 2

32BB(1) Criminal offences for exporting a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.265
note: Exporting a biological for use in humans is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32bb-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bb-ss-1
schema version: 2
part of: 32BB Criminal offences for exporting a biological

therapeutic-goods-act-1989-sec-32bb-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the export of a biological for use in humans.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-32bb-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BB(1) Criminal offences for exporting a biological

32BB(4) Criminal offences for exporting a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.265
note: Exporting a biological for use in humans is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bb-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32bb-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32bb-ss-4-logic-linearlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bb-ss-4
schema version: 2
part of: 32BB Criminal offences for exporting a biological

therapeutic-goods-act-1989-sec-32bb-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits exporting a biological for use in humans.
modality: Deontic
operator: Prohibit
premise text: (4) A person commits an offence if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:

therapeutic-goods-act-1989-sec-32bb-ss-4-logic-linearlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Prohibits exporting a biological for use in humans.
modality: LinearLogic
operator: Prohibit
premise text: (4) A person commits an offence if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:

therapeutic-goods-act-1989-sec-32bb-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BB(4) Criminal offences for exporting a biological

32BC Criminal offences for manufacturing a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.267
note: Manufacturing a biological without proper authorization is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bc-norm
asserts: therapeutic-goods-act-1989-sec-32bc-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bc
schema version: 2

therapeutic-goods-act-1989-sec-32bc-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the manufacture of biologicals without authorization.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-32bc-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BC Criminal offences for manufacturing a biological

32BD Criminal offences for supplying a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.270
curation status: Proposed
has part: 32BD(1) Criminal offences for supplying a biological
has part: 32BD(4) Criminal offences for supplying a biological
has part: 32BD(4A) Criminal offences for supplying a biological
proposed by: legis2cml
realized by: sec-32bd
schema version: 2

32BD(1) Criminal offences for supplying a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.270
note: Supplying a biological for use in humans is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bd-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32bd-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bd-ss-1
schema version: 2
part of: 32BD Criminal offences for supplying a biological

therapeutic-goods-act-1989-sec-32bd-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying a biological for use in humans.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-32bd-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BD(1) Criminal offences for supplying a biological

32BD(4) Criminal offences for supplying a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.270
note: Supplying a biological for use in humans is an offence.
asserts: therapeutic-goods-act-1989-sec-32bd-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32bd-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bd-ss-4
schema version: 2
part of: 32BD Criminal offences for supplying a biological

therapeutic-goods-act-1989-sec-32bd-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: The supply of a biological for use in humans is prohibited.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying a biological for use in humans.
modality: Deontic
operator: Prohibit
premise text: (4) A person commits an offence if...

therapeutic-goods-act-1989-sec-32bd-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BD(4) Criminal offences for supplying a biological

32BD(4A) Criminal offences for supplying a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.270
note: Supplying a biological for use in humans is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bd-ss-4a-norm
asserts: therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-ltl-2
asserts: therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-diffusion-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bd-ss-4a
schema version: 2
part of: 32BD Criminal offences for supplying a biological

therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-alleninterval-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Places supplying a biological for use in humans between committing an offence.
modality: AllenInterval
operator: Between
premise text: (4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;

therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying a biological for use in humans.
modality: Deontic
operator: Prohibit
premise text: (4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;

therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-diffusion-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses the prohibition of supplying a biological for use in humans.
modality: Diffusion
operator: Diffuse
premise text: (4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;

therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-ltl-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Traces supplying a biological for use in humans to an offence.
modality: LTL
operator: Trace
premise text: (4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;

therapeutic-goods-act-1989-sec-32bd-ss-4a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BD(4A) Criminal offences for supplying a biological

32BE Notice required to adduce evidence in support of exception to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.273
curation status: Proposed
has part: 32BE(1) Notice required to adduce evidence in support of exception to
has part: 32BE(2) Notice required to adduce evidence in support of exception to
has part: 32BE(3) Notice required to adduce evidence in support of exception to
proposed by: legis2cml
realized by: sec-32be
schema version: 2

32BE(1) Notice required to adduce evidence in support of exception to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.273
note: Defendant must be informed of requirements and given a copy of the section.
asserts: therapeutic-goods-act-1989-sec-32be-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32be-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32be-ss-1
schema version: 2
part of: 32BE Notice required to adduce evidence in support of exception to

therapeutic-goods-act-1989-sec-32be-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Defendant must be informed.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32be-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BE(1) Notice required to adduce evidence in support of exception to

32BE(2) Notice required to adduce evidence in support of exception to
type: Concept
description: Notice of particulars of the exception
source: therapeutic-goods-act-1989.pdf, p.273
note: No evidence can be adduced without notice of particulars of the exception.
asserts: therapeutic-goods-act-1989-sec-32be-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32be-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32be-ss-2
schema version: 2
part of: 32BE Notice required to adduce evidence in support of exception to

therapeutic-goods-act-1989-sec-32be-ss-2-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-32be-ss-2-norm
type: Prohibition
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 32BE(2) Notice required to adduce evidence in support of exception to

32BE(3) Notice required to adduce evidence in support of exception to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.273
note: Defendant cannot call another person to give evidence without leave of the court.
asserts: therapeutic-goods-act-1989-sec-32be-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32be-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32be-ss-3-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-32be-ss-3-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-32be-ss-3-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-32be-ss-3-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-32be-ss-3-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-32be-ss-3
schema version: 2
part of: 32BE Notice required to adduce evidence in support of exception to

therapeutic-goods-act-1989-sec-32be-ss-3-logic-alleninterval-3
type: LogicApplication
conclusion text: ...the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between notice and address information.
modality: AllenInterval
operator: Temporal relation
premise text: (b) if the name or the address is not included in the notice—the court is satisfied that...

therapeutic-goods-act-1989-sec-32be-ss-3-logic-cogai-6
type: LogicApplication
conclusion text: ...the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address;
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Knowledge representation of defendant's actions.
modality: CogAI
operator: Knowledge representation
premise text: (a) the notice under subsection (2) includes the name and address of the person or...

therapeutic-goods-act-1989-sec-32be-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: ...call any other person to give evidence in support of the exception unless...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on calling another person to give evidence.
modality: Deontic
operator: Prohibit
premise text: (3) A defendant must not, without leave of the court...

therapeutic-goods-act-1989-sec-32be-ss-3-logic-descriptionlogic-2
type: LogicApplication
conclusion text: ...the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of individuals based on notice and address information.
modality: DescriptionLogic
operator: Classify
premise text: (a) the notice under subsection (2) includes the name and address of the person or...

therapeutic-goods-act-1989-sec-32be-ss-3-logic-diffusion-5
type: LogicApplication
conclusion text: ...to ascertain the name or address;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Dissemination of information about defendant's actions.
modality: Diffusion
operator: Information dissemination
premise text: ...the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps...

therapeutic-goods-act-1989-sec-32be-ss-3-logic-ltl-4
type: LogicApplication
conclusion text: ...the name or address; and
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of defendant's actions.
modality: LTL
operator: Recurring trace
premise text: ...the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps...

therapeutic-goods-act-1989-sec-32be-ss-3-norm
type: Prohibition
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 32BE(3) Notice required to adduce evidence in support of exception to

32BF Civil penalties for importing, exporting, manufacturing or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.275
curation status: Proposed
has part: 32BF(1) Civil penalties for importing, exporting, manufacturing or
has part: 32BF(2) Civil penalties for importing, exporting, manufacturing or
proposed by: legis2cml
realized by: sec-32bf
schema version: 2

32BF(1) Civil penalties for importing, exporting, manufacturing or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.275
note: Importing, exporting, manufacturing biologicals for use in humans without approval is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bf-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32bf-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bf-ss-1
schema version: 2
part of: 32BF Civil penalties for importing, exporting, manufacturing or

therapeutic-goods-act-1989-sec-32bf-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of importing, exporting, manufacturing biologicals for use in humans.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-32bf-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BF(1) Civil penalties for importing, exporting, manufacturing or

32BF(2) Civil penalties for importing, exporting, manufacturing or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.275
note: Exporting biologicals for human use without registration is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bf-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32bf-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32bf-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32bf-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32bf-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-32bf-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bf-ss-2
schema version: 2
part of: 32BF Civil penalties for importing, exporting, manufacturing or

therapeutic-goods-act-1989-sec-32bf-ss-2-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval between export and registration.
modality: AllenInterval
operator: Temporal Interval
premise text: (2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:

therapeutic-goods-act-1989-sec-32bf-ss-2-logic-cogai-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Knowledge graph representation of prohibited knowledge.
modality: CogAI
operator: Knowledge Graph
premise text: (2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:

therapeutic-goods-act-1989-sec-32bf-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of exporting biologicals for human use without registration.
modality: Deontic
operator: Prohibit
premise text: (2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:

therapeutic-goods-act-1989-sec-32bf-ss-2-logic-diffusion-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusion of prohibited knowledge.
modality: Diffusion
operator: Diffusion
premise text: (2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:

therapeutic-goods-act-1989-sec-32bf-ss-2-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of unregistered exports.
modality: LTL
operator: Recurring Trace
premise text: (2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:

therapeutic-goods-act-1989-sec-32bf-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BF(2) Civil penalties for importing, exporting, manufacturing or

32BG Criminal offences and civil penalty relating to a failure to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.279
curation status: Proposed
has part: 32BG(1) Criminal offences and civil penalty relating to a failure to
has part: 32BG(1A) Criminal offences and civil penalty relating to a failure to
proposed by: legis2cml
realized by: sec-32bg
schema version: 2

32BG(1) Criminal offences and civil penalty relating to a failure to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.279
note: Importing, exporting, manufacturing, or supplying a biological for use in humans without proper notification is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bg-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32bg-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bg-ss-1
schema version: 2
part of: 32BG Criminal offences and civil penalty relating to a failure to

therapeutic-goods-act-1989-sec-32bg-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-32bg-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BG(1) Criminal offences and civil penalty relating to a failure to

32BG(1A) Criminal offences and civil penalty relating to a failure to
type: Concept
source: therapeutic-goods-act-1989.pdf, p.279
note: Importing or exporting biologicals for use in humans is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bg-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-32bg-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bg-ss-1a
schema version: 2
part of: 32BG Criminal offences and civil penalty relating to a failure to

therapeutic-goods-act-1989-sec-32bg-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the action.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-32bg-ss-1a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BG(1A) Criminal offences and civil penalty relating to a failure to

32BH Criminal offence relating to wholesale supply
type: Concept
source: therapeutic-goods-act-1989.pdf, p.281
note: Supplying biologicals for use in humans without proper exemption or approval is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bh-norm
asserts: therapeutic-goods-act-1989-sec-32bh-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bh
schema version: 2

therapeutic-goods-act-1989-sec-32bh-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying biologicals for use in humans without proper exemption or approval.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-32bh-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BH Criminal offence relating to wholesale supply

32BI Criminal offence for using a biological not included in the
type: Concept
source: therapeutic-goods-act-1989.pdf, p.282
curation status: Proposed
has part: 32BI(1) Criminal offence for using a biological not included in the
has part: 32BI(4) Criminal offence for using a biological not included in the
proposed by: legis2cml
realized by: sec-32bi
schema version: 2

32BI(1) Criminal offence for using a biological not included in the
type: Concept
source: therapeutic-goods-act-1989.pdf, p.282
note: Using a biological without proper authorization is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bi-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32bi-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bi-ss-1
schema version: 2
part of: 32BI Criminal offence for using a biological not included in the

therapeutic-goods-act-1989-sec-32bi-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-32bi-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BI(1) Criminal offence for using a biological not included in the

32BI(4) Criminal offence for using a biological not included in the
type: Concept
source: therapeutic-goods-act-1989.pdf, p.282
note: Using a biological not included in the Register for certain purposes is an offence.
asserts: therapeutic-goods-act-1989-sec-32bi-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32bi-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bi-ss-4
schema version: 2
part of: 32BI Criminal offence for using a biological not included in the

therapeutic-goods-act-1989-sec-32bi-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: An offence has been committed.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition
modality: Deontic
operator: Prohibit
premise text: The biological is used in the treatment of another person or solely for experimental purposes in humans.

therapeutic-goods-act-1989-sec-32bi-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BI(4) Criminal offence for using a biological not included in the

32BJ General criminal offences relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.284
curation status: Proposed
has part: 32BJ(1) General criminal offences relating to this Part
has part: 32BJ(2) General criminal offences relating to this Part
has part: 32BJ(2A) General criminal offences relating to this Part
has part: 32BJ(2B) General criminal offences relating to this Part
proposed by: legis2cml
realized by: sec-32bj
schema version: 2

32BJ(1) General criminal offences relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.284
note: Setting out false biological numbers on containers or labels is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bj-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32bj-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bj-ss-1
schema version: 2
part of: 32BJ General criminal offences relating to this Part

therapeutic-goods-act-1989-sec-32bj-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of false biological numbers
modality: Deontic
operator: Prohibit

32BJ(2) General criminal offences relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.284
note: Defines what constitutes a number for the purposes of subsection (1)
asserts: therapeutic-goods-act-1989-sec-32bj-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bj-ss-2
schema version: 2
part of: 32BJ General criminal offences relating to this Part

therapeutic-goods-act-1989-sec-32bj-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BJ(2) General criminal offences relating to this Part

32BJ(2A) General criminal offences relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.284
note: Advertising a biological for an indication that is not accepted in relation to its inclusion in the Register is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bj-ss-2a-norm
asserts: therapeutic-goods-act-1989-sec-32bj-ss-2a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32bj-ss-2a-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bj-ss-2a
schema version: 2
part of: 32BJ General criminal offences relating to this Part

therapeutic-goods-act-1989-sec-32bj-ss-2a-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 a biological for an indication that is not accepted in relation to its inclusion in the Register.
modality: Deontic
operator: Prohibit
premise text: (2A) A person commits an offence if: (a) the person, by any means, advertises a biological for an indication; and (b) the biological is included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion; and

therapeutic-goods-act-1989-sec-32bj-ss-2a-logic-descriptionlogic-2
type: LogicApplication
conclusion text: (d) either: (i) the use of the biological for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the biological for the advertised indication, if the biological were so used, would result in, or would be likely to result in, harm or injury to any person.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of the advertisement as a prohibited act.
modality: DescriptionLogic
operator: Classify
premise text: (2A) A person commits an offence if: (a) the person, by any means, advertises a biological for an indication; and (b) the biological is included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion; and

therapeutic-goods-act-1989-sec-32bj-ss-2a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BJ(2A) General criminal offences relating to this Part

32BJ(2B) General criminal offences relating to this Part
type: Concept
source: therapeutic-goods-act-1989.pdf, p.284
note: Advertising a biological for an indication without proper inclusion in the Register is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bj-ss-2b-norm
asserts: therapeutic-goods-act-1989-sec-32bj-ss-2b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bj-ss-2b
schema version: 2
part of: 32BJ General criminal offences relating to this Part

therapeutic-goods-act-1989-sec-32bj-ss-2b-logic-deontic-1
type: LogicApplication
conclusion text: (2B) A person commits an offence if: (a) the person, by any means, advertises a biological for an indication; and (b) the biological is included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of advertising a biological for an indication without proper inclusion in the Register.
modality: Deontic
operator: Prohibit
premise text: (2B) A person commits an offence if: (a) the person, by any means, advertises a biological for an indication; and (b) the biological is included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.

therapeutic-goods-act-1989-sec-32bj-ss-2b-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BJ(2B) General criminal offences relating to this Part

32BK Civil penalty for making misrepresentations about biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.286
curation status: Proposed
has part: 32BK(1) Civil penalty for making misrepresentations about biologicals
has part: 32BK(2) Civil penalty for making misrepresentations about biologicals
proposed by: legis2cml
realized by: sec-32bk
schema version: 2

32BK(1) Civil penalty for making misrepresentations about biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.286
note: Making false or misleading representations about biologicals is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bk-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32bk-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32bk-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32bk-ss-1-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bk-ss-1
schema version: 2
part of: 32BK Civil penalty for making misrepresentations about biologicals

therapeutic-goods-act-1989-sec-32bk-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: ...and (b) for an individual—5,000 penalty units; and
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines a temporal interval for the prohibition.
modality: AllenInterval
operator: Temporal Interval
premise text: (1) A person contravenes this section if:

therapeutic-goods-act-1989-sec-32bk-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: (1) A person contravenes this section if:...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making false or misleading representations about biologicals.
modality: Deontic
operator: Prohibit
premise text: (a) the person makes a representation of a kind referred to in subsection (2); and (b) the representation is false or misleading.

therapeutic-goods-act-1989-sec-32bk-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: ...and (b) for a body corporate—50,000 penalty units.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines a temporal interval for the prohibition.
modality: LTL
operator: Temporal Interval
premise text: (1) A person contravenes this section if:

therapeutic-goods-act-1989-sec-32bk-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BK(1) Civil penalty for making misrepresentations about biologicals

32BK(2) Civil penalty for making misrepresentations about biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.286
note: Making misrepresentations about biologicals is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bk-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32bk-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bk-ss-2
schema version: 2
part of: 32BK Civil penalty for making misrepresentations about biologicals

therapeutic-goods-act-1989-sec-32bk-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of making misrepresentations about biologicals.
modality: Deontic
operator: Prohibit
premise text: Subsection (1) applies to the following representations:

therapeutic-goods-act-1989-sec-32bk-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BK(2) Civil penalty for making misrepresentations about biologicals

32BL Civil penalty for advertising biological for an indication
type: Concept
source: therapeutic-goods-act-1989.pdf, p.287
note: Advertising biological for an indication without proper registration is prohibited.
asserts: therapeutic-goods-act-1989-sec-32bl-norm
asserts: therapeutic-goods-act-1989-sec-32bl-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32bl-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32bl
schema version: 2

therapeutic-goods-act-1989-sec-32bl-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits advertising biological for an indication without proper registration.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-32bl-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classifies advertisements as prohibited if they include unregistered biologicals.
modality: DescriptionLogic
operator: Classify

therapeutic-goods-act-1989-sec-32bl-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32BL Civil penalty for advertising biological for an indication

32C What this Division is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.288
note: Exemptions of biologicals under regulations, emergencies, special and experimental uses, and substitutes unavailable.
asserts: therapeutic-goods-act-1989-sec-32c-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32c
schema version: 2

32CA Exempt biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.288
curation status: Proposed
has part: 32CA(1) Exempt biologicals
has part: 32CA(2) Exempt biologicals
has part: 32CA(3) Exempt biologicals
has part: 32CA(5) Exempt biologicals
proposed by: legis2cml
realized by: sec-32ca
schema version: 2

32CA(1) Exempt biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.288
note: Exempts specified persons from Division 4 operation in relation to specified biologicals.
asserts: therapeutic-goods-act-1989-sec-32ca-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32ca-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ca-ss-1
schema version: 2
part of: 32CA Exempt biologicals

therapeutic-goods-act-1989-sec-32ca-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exempts
modality: Deontic
operator: exemption

therapeutic-goods-act-1989-sec-32ca-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CA(1) Exempt biologicals

32CA(2) Exempt biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.288
note: Exempt biologicals from Division 4 operation.
asserts: therapeutic-goods-act-1989-sec-32ca-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32ca-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ca-ss-2
schema version: 2
part of: 32CA Exempt biologicals

therapeutic-goods-act-1989-sec-32ca-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations may exempt specified biologicals.
modality: Deontic
operator: exemption

therapeutic-goods-act-1989-sec-32ca-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CA(2) Exempt biologicals

32CA(3) Exempt biologicals
type: Concept
references: sec-32CP
references: sec-32CQ
source: therapeutic-goods-act-1989.pdf, p.288
note: Exemptions may be subject to conditions prescribed in regulations.
asserts: therapeutic-goods-act-1989-sec-32ca-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32ca-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ca-ss-3
schema version: 2
part of: 32CA Exempt biologicals

therapeutic-goods-act-1989-sec-32ca-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to exempt biologicals with conditions.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-32ca-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CA(3) Exempt biologicals

32CA(5) Exempt biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.288
note: Revocation of exemption takes effect after specified day
asserts: therapeutic-goods-act-1989-sec-32ca-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32ca-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ca-ss-5-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32ca-ss-5-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32ca-ss-5-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-32ca-ss-5-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ca-ss-5
schema version: 2
part of: 32CA Exempt biologicals

therapeutic-goods-act-1989-sec-32ca-ss-5-logic-alleninterval-2
type: LogicApplication
conclusion text: ...than 28 days after the day on which the regulations revoking the exemption take effect.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relationship between revocation and commencement of revocation
modality: AllenInterval
operator: meetsBefore
premise text: (5) If the regulations revoke an exemption, the revocation takes effect...

therapeutic-goods-act-1989-sec-32ca-ss-5-logic-cogai-5
type: LogicApplication
conclusion text: ...than 28 days after the day on which the regulations revoking the exemption take effect.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Revocation of exemption recognized by regulatory agency
modality: CogAI
operator: recognizes
premise text: (5) If the regulations revoke an exemption, the revocation takes effect...

therapeutic-goods-act-1989-sec-32ca-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: ...than 28 days after the day on which the regulations revoking the exemption take effect.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to revoke exemption on specified day
modality: Deontic
operator: takesEffect
premise text: (5) If the regulations revoke an exemption, the revocation takes effect...

therapeutic-goods-act-1989-sec-32ca-ss-5-logic-diffusion-4
type: LogicApplication
conclusion text: ...than 28 days after the day on which the regulations revoking the exemption take effect.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Revocation of exemption diffuses to affected parties
modality: Diffusion
operator: diffusesTo
premise text: (5) If the regulations revoke an exemption, the revocation takes effect...

therapeutic-goods-act-1989-sec-32ca-ss-5-logic-ltl-3
type: LogicApplication
conclusion text: ...than 28 days after the day on which the regulations revoking the exemption take effect.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal relationship between revocation and commencement of revocation
modality: LTL
operator: holdsForAll
premise text: (5) If the regulations revoke an exemption, the revocation takes effect...

therapeutic-goods-act-1989-sec-32ca-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CA(5) Exempt biologicals

32CB Minister may make exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.289
curation status: Proposed
has part: 32CB(1) Minister may make exemptions
has part: 32CB(1A) Minister may make exemptions
has part: 32CB(2) Minister may make exemptions
has part: 32CB(2A) Minister may make exemptions
proposed by: legis2cml
realized by: sec-32cb
schema version: 2

32CB(1) Minister may make exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.289
note: Minister may exempt specified biologicals from Division 4 operation.
asserts: therapeutic-goods-act-1989-sec-32cb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32cb-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cb-ss-1
schema version: 2
part of: 32CB Minister may make exemptions

therapeutic-goods-act-1989-sec-32cb-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

32CB(1A) Minister may make exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.289
note: Minister must make exemption under certain conditions.
asserts: therapeutic-goods-act-1989-sec-32cb-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-32cb-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cb-ss-1a
schema version: 2
part of: 32CB Minister may make exemptions

therapeutic-goods-act-1989-sec-32cb-ss-1a-logic-deontic-1
type: LogicApplication
conclusion text: Exemption must be made
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to make exemption
modality: Deontic
operator: MUST
premise text: Minister is satisfied of the matter in subsection (2) or (2A)

32CB(2) Minister may make exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.289
note: Minister may make exemptions in national interest.
asserts: therapeutic-goods-act-1989-sec-32cb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32cb-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cb-ss-2
schema version: 2
part of: 32CB Minister may make exemptions

therapeutic-goods-act-1989-sec-32cb-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to make exemptions.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-32cb-ss-2-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CB(2) Minister may make exemptions

32CB(2A) Minister may make exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.289
note: Minister may make exemptions under certain conditions.
asserts: therapeutic-goods-act-1989-sec-32cb-ss-2a-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cb-ss-2a
schema version: 2
part of: 32CB Minister may make exemptions

therapeutic-goods-act-1989-sec-32cb-ss-2a-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CB(2A) Minister may make exemptions

32CC Conditions of exemptions
type: Concept
source: therapeutic-goods-act-1989.pdf, p.290
note: Conditions for exemptions under section 32CB
asserts: therapeutic-goods-act-1989-sec-32cc-norm
asserts: therapeutic-goods-act-1989-sec-32cc-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32cc-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cc
schema version: 2

therapeutic-goods-act-1989-sec-32cc-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Conditions for exemptions
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-32cc-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Exemptions under section 32CB are subject to conditions
modality: DescriptionLogic
operator: ClassHierarchy

therapeutic-goods-act-1989-sec-32cc-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CC Conditions of exemptions

32CD Variation or revocation of exemption
type: Concept
source: therapeutic-goods-act-1989.pdf, p.291
curation status: Proposed
has part: 32CD(1) Variation or revocation of exemption
has part: 32CD(2) Variation or revocation of exemption
has part: 32CD(3) Variation or revocation of exemption
proposed by: legis2cml
realized by: sec-32cd
schema version: 2

32CD(1) Variation or revocation of exemption
type: Concept
source: therapeutic-goods-act-1989.pdf, p.291
note: Variation of exemption by Minister
asserts: therapeutic-goods-act-1989-sec-32cd-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32cd-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cd-ss-1
schema version: 2
part of: 32CD Variation or revocation of exemption

therapeutic-goods-act-1989-sec-32cd-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Granting permission
modality: Deontic
operator: may

32CD(2) Variation or revocation of exemption
type: Concept
source: therapeutic-goods-act-1989.pdf, p.291
note: Revocation of exemption by Minister
asserts: therapeutic-goods-act-1989-sec-32cd-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32cd-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cd-ss-2
schema version: 2
part of: 32CD Variation or revocation of exemption

therapeutic-goods-act-1989-sec-32cd-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to revoke exemption
modality: Deontic
operator: may

32CD(3) Variation or revocation of exemption
type: Concept
source: therapeutic-goods-act-1989.pdf, p.291
note: The Minister may vary or revoke the conditions of an exemption made under section 32CB.
asserts: therapeutic-goods-act-1989-sec-32cd-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32cd-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cd-ss-3
schema version: 2
part of: 32CD Variation or revocation of exemption

therapeutic-goods-act-1989-sec-32cd-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Expresses permission or obligation.
modality: Deontic
operator: may

32CE Informing persons of exemption etc.
type: Concept
description: copy of exemption and variation/revocation
source: therapeutic-goods-act-1989.pdf, p.292
note: Must inform persons of exemption under section 32CB
asserts: therapeutic-goods-act-1989-sec-32ce-norm
asserts: therapeutic-goods-act-1989-sec-32ce-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ce
schema version: 2

therapeutic-goods-act-1989-sec-32ce-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to inform
modality: Deontic
operator: MUST

32CF Notification and tabling
type: Concept
source: therapeutic-goods-act-1989.pdf, p.292
curation status: Proposed
has part: 32CF(1) Notification and tabling
has part: 32CF(2) Notification and tabling
proposed by: legis2cml
realized by: sec-32cf
schema version: 2

32CF(1) Notification and tabling
type: Concept
description: Notice setting out particulars of exemption, variation or revocation
source: therapeutic-goods-act-1989.pdf, p.292
note: Publish notice in Gazette within 7 days after exemption, variation or revocation is made.
asserts: therapeutic-goods-act-1989-sec-32cf-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32cf-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cf-ss-1
schema version: 2
part of: 32CF Notification and tabling

therapeutic-goods-act-1989-sec-32cf-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 within 7 days
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32cf-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CF(1) Notification and tabling

32CF(2) Notification and tabling
type: Concept
description: document setting out particulars
source: therapeutic-goods-act-1989.pdf, p.292
note: Notification and tabling of exemptions, variations, or revocations made under section 32CB.
asserts: therapeutic-goods-act-1989-sec-32cf-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32cf-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cf-ss-2
schema version: 2
part of: 32CF Notification and tabling

therapeutic-goods-act-1989-sec-32cf-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to notify and table
modality: Deontic
operator: MUST

32CG Disposal of unused biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.293
note: This section applies to a biological if an exemption under section 32CB ceases to have effect.
asserts: therapeutic-goods-act-1989-sec-32cg-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cg
schema version: 2

32CJ Criminal offences and civil penalty for biologicals not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.294
curation status: Proposed
has part: 32CJ(1) Criminal offences and civil penalty for biologicals not
has part: 32CJ(2) Criminal offences and civil penalty for biologicals not
has part: 32CJ(3) Criminal offences and civil penalty for biologicals not
has part: 32CJ(4) Criminal offences and civil penalty for biologicals not
has part: 32CJ(5) Criminal offences and civil penalty for biologicals not
has part: 32CJ(6) Criminal offences and civil penalty for biologicals not
has part: 32CJ(7) Criminal offences and civil penalty for biologicals not
has part: 32CJ(9) Criminal offences and civil penalty for biologicals not
has part: 32CJ(10) Criminal offences and civil penalty for biologicals not
proposed by: legis2cml
realized by: sec-32cj
schema version: 2

32CJ(1) Criminal offences and civil penalty for biologicals not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.294
note: Supplying non-conforming biologicals is prohibited.
asserts: therapeutic-goods-act-1989-sec-32cj-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32cj-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32cj-ss-1-logic-linearlogic-2
asserts: therapeutic-goods-act-1989-sec-32cj-ss-1-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-32cj-ss-1-logic-diffusion-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cj-ss-1
schema version: 2
part of: 32CJ Criminal offences and civil penalty for biologicals not

therapeutic-goods-act-1989-sec-32cj-ss-1-logic-alleninterval-3
type: LogicApplication
conclusion text: Supply period includes non-conforming biologicals.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval within supply period
modality: AllenInterval
operator: Within
premise text: (c) the Secretary is satisfied that the biologicals included in that batch: (i) do not conform to a standard applicable to the biologicals; or (ii) are otherwise not fit to be used for their intended purposes.

therapeutic-goods-act-1989-sec-32cj-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Supplying non-conforming biologicals is prohibited.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition
modality: Deontic
operator: Prohibit
premise text: (a) a biological is exempt under section 32CB; and (b) a person supplies a batch of the biologicals;

therapeutic-goods-act-1989-sec-32cj-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: Non-compliance implies supply.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Implication from supply and non-compliance
modality: Diffusion
operator: Imply
premise text: (c) the Secretary is satisfied that the biologicals included in that batch: (i) do not conform to a standard applicable to the biologicals; or (ii) are otherwise not fit to be used for their intended purposes.

therapeutic-goods-act-1989-sec-32cj-ss-1-logic-linearlogic-2
type: LogicApplication
conclusion text: Supplying non-conforming biologicals implies violation of exemption.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Implication from exemption and supply
modality: LinearLogic
operator: Imply
premise text: (a) a biological is exempt under section 32CB; and (b) a person supplies a batch of the biologicals;

therapeutic-goods-act-1989-sec-32cj-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CJ(1) Criminal offences and civil penalty for biologicals not

32CJ(10) Criminal offences and civil penalty for biologicals not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.294
note: An offence against subsection (9) is an offence of strict liability.
asserts: therapeutic-goods-act-1989-sec-32cj-ss-10-norm
asserts: therapeutic-goods-act-1989-sec-32cj-ss-10-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cj-ss-10
schema version: 2
part of: 32CJ Criminal offences and civil penalty for biologicals not

therapeutic-goods-act-1989-sec-32cj-ss-10-logic-deontic-1
type: LogicApplication
conclusion text: (10)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Strict liability
modality: Deontic
operator: is
premise text: (9)

32CJ(2) Criminal offences and civil penalty for biologicals not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.294
note: Require person to take steps to recall biologicals
asserts: therapeutic-goods-act-1989-sec-32cj-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32cj-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cj-ss-2
schema version: 2
part of: 32CJ Criminal offences and civil penalty for biologicals not

therapeutic-goods-act-1989-sec-32cj-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
modality: Deontic
operator: require

therapeutic-goods-act-1989-sec-32cj-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CJ(2) Criminal offences and civil penalty for biologicals not

32CJ(3) Criminal offences and civil penalty for biologicals not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.294
note: Requirements for recalling biologicals
asserts: therapeutic-goods-act-1989-sec-32cj-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32cj-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32cj-ss-3-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cj-ss-3
schema version: 2
part of: 32CJ Criminal offences and civil penalty for biologicals not

therapeutic-goods-act-1989-sec-32cj-ss-3-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Steps must be taken within a reasonable period
modality: AllenInterval
operator: within
premise text: c) a reasonable period within which the steps are to be taken.

therapeutic-goods-act-1989-sec-32cj-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires steps to be taken
modality: Deontic
operator: requires
premise text: (3) The notice may specify one or more of the following requirements:

therapeutic-goods-act-1989-sec-32cj-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CJ(3) Criminal offences and civil penalty for biologicals not

32CJ(4) Criminal offences and civil penalty for biologicals not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.294
note: Publish notice in Gazette or Department's website
asserts: therapeutic-goods-act-1989-sec-32cj-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32cj-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cj-ss-4
schema version: 2
part of: 32CJ Criminal offences and civil penalty for biologicals not

therapeutic-goods-act-1989-sec-32cj-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must publish notice
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32cj-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CJ(4) Criminal offences and civil penalty for biologicals not

32CJ(5) Criminal offences and civil penalty for biologicals not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.294
note: Notice given under subsection (2) is not a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-32cj-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32cj-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cj-ss-5
schema version: 2
part of: 32CJ Criminal offences and civil penalty for biologicals not

therapeutic-goods-act-1989-sec-32cj-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits notice given under subsection (2) from being a legislative instrument.
modality: Deontic
operator: Prohibition

32CJ(6) Criminal offences and civil penalty for biologicals not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.294
note: Failure to comply with notice requirement results in harm or injury.
asserts: therapeutic-goods-act-1989-sec-32cj-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-32cj-ss-6-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cj-ss-6
schema version: 2
part of: 32CJ Criminal offences and civil penalty for biologicals not

therapeutic-goods-act-1989-sec-32cj-ss-6-logic-alleninterval-3
type: LogicApplication
conclusion text: Notice requirement overlaps with potential harm/injury.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal overlap between notice and harm/injury.
modality: AllenInterval
operator: Overlaps
premise text: The use of any of the biologicals has resulted in, will result in, or is likely to result in, harm or injury to any person.

therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: Harm or injury results.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of non-compliance with notice requirement.
modality: Deontic
operator: Prohibition
premise text: The person fails to comply with the specified requirement.

therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-2
type: LogicApplication
conclusion text: Compliance with notice requirement is required.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Notice requirement is a duty.
modality: Deontic
operator: Obligation
premise text: The Secretary gives a notice to the person under subsection (2).

therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-4
type: LogicApplication
conclusion text: Harm or injury results from non-compliance.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Non-compliance with notice requirement is prohibited.
modality: Deontic
operator: Prohibition
premise text: (c) the person fails to comply with that requirement; and

therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-5
type: LogicApplication
conclusion text: Compliance with notice requirement is required.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Compliance with notice requirement is a duty.
modality: Deontic
operator: Obligation
premise text: (a) the Secretary gives a notice to the person under subsection (2); and

therapeutic-goods-act-1989-sec-32cj-ss-6-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CJ(6) Criminal offences and civil penalty for biologicals not

32CJ(7) Criminal offences and civil penalty for biologicals not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.294
note: Failure to comply with notice requirement is an offence.
asserts: therapeutic-goods-act-1989-sec-32cj-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-32cj-ss-7-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32cj-ss-7-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32cj-ss-7-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32cj-ss-7-logic-argumentation-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cj-ss-7
schema version: 2
part of: 32CJ Criminal offences and civil penalty for biologicals not

therapeutic-goods-act-1989-sec-32cj-ss-7-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The provision has an overlapping temporal interval.
modality: AllenInterval
operator: Overlaps
premise text: (7) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement.

therapeutic-goods-act-1989-sec-32cj-ss-7-logic-argumentation-4
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::argumentation
logic summary: The provision implies a consequence if the person fails to comply.
modality: Argumentation
operator: Implication
premise text: (7) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement.

therapeutic-goods-act-1989-sec-32cj-ss-7-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: Obligation to comply with notice requirement.
modality: Deontic
operator: Obligation
premise text: (7) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement.

therapeutic-goods-act-1989-sec-32cj-ss-7-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The provision has a recurring trace.
modality: LTL
operator: Recurrently
premise text: (7) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement.

therapeutic-goods-act-1989-sec-32cj-ss-7-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CJ(7) Criminal offences and civil penalty for biologicals not

32CJ(9) Criminal offences and civil penalty for biologicals not
type: Concept
source: therapeutic-goods-act-1989.pdf, p.294
note: Failure to comply with notice requirement is an offence.
asserts: therapeutic-goods-act-1989-sec-32cj-ss-9-norm
asserts: therapeutic-goods-act-1989-sec-32cj-ss-9-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32cj-ss-9-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-32cj-ss-9-logic-linearlogic-3
asserts: therapeutic-goods-act-1989-sec-32cj-ss-9-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cj-ss-9
schema version: 2
part of: 32CJ Criminal offences and civil penalty for biologicals not

therapeutic-goods-act-1989-sec-32cj-ss-9-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: Obligation to comply with notice requirement.
modality: Deontic
operator: obligation
premise text: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement.

therapeutic-goods-act-1989-sec-32cj-ss-9-logic-deontic-2
type: LogicApplication
conclusion text: Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on non-compliance with notice requirement.
modality: Deontic
operator: prohibition
premise text: (9) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement.

therapeutic-goods-act-1989-sec-32cj-ss-9-logic-deontic-4
type: LogicApplication
conclusion text: The person has a right to receive notice from the Secretary.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Right to receive notice from Secretary.
modality: Deontic
operator: right
premise text: (9) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement.

therapeutic-goods-act-1989-sec-32cj-ss-9-logic-linearlogic-3
type: LogicApplication
conclusion text: Penalty: 100 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Implies penalty for non-compliance.
modality: LinearLogic
operator: implies
premise text: (9) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement.

therapeutic-goods-act-1989-sec-32cj-ss-9-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CJ(9) Criminal offences and civil penalty for biologicals not

32CK Approvals for importing, exporting or supplying a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.296
curation status: Proposed
has part: 32CK(1) Approvals for importing, exporting or supplying a biological
has part: 32CK(1A) Approvals for importing, exporting or supplying a biological
has part: 32CK(2) Approvals for importing, exporting or supplying a biological
has part: 32CK(3) Approvals for importing, exporting or supplying a biological
has part: 32CK(4) Approvals for importing, exporting or supplying a biological
has part: 32CK(5) Approvals for importing, exporting or supplying a biological
proposed by: legis2cml
realized by: sec-32ck
schema version: 2

32CK(1) Approvals for importing, exporting or supplying a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.296
note: Approval for importing, exporting or supplying a biological
asserts: therapeutic-goods-act-1989-sec-32ck-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ck-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32ck-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ck-ss-1
schema version: 2
part of: 32CK Approvals for importing, exporting or supplying a biological

therapeutic-goods-act-1989-sec-32ck-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: ...for variation of an approval...
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation for approval
modality: AllenInterval
operator: during
premise text: (1)(e) for use solely for experimental purposes in humans.

therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...a person for one or more of the following:
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Granting approval
modality: Deontic
operator: grant
premise text: (1) The Secretary may, by notice in writing...

therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: ...or for use in the treatment of another person;
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on experimental use
modality: Deontic
operator: forbid
premise text: (e) for use solely for experimental purposes in humans.

therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-5
type: LogicApplication
conclusion text: ...or for use solely for experimental purposes in humans.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on unauthorized use
modality: Deontic
operator: forbid
premise text: (d) for use in the treatment of another person.

therapeutic-goods-act-1989-sec-32ck-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: ...see subsection (9A).
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Conditional commencement
modality: LTL
operator: until
premise text: For variation of an approval...

therapeutic-goods-act-1989-sec-32ck-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CK(1) Approvals for importing, exporting or supplying a biological

32CK(1A) Approvals for importing, exporting or supplying a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.296
note: Approval for use of a biological must be granted only to a health practitioner.
asserts: therapeutic-goods-act-1989-sec-32ck-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ck-ss-1a
schema version: 2
part of: 32CK Approvals for importing, exporting or supplying a biological

therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-alleninterval-3
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Restricts the approval to only those who are health practitioners at the time of granting.
modality: AllenInterval
operator: Temporal Restriction
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-32ck-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits granting approval unless the person is a health practitioner.
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-32ck-ss-1a-logic-deontic-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Restricts the approval to only those who are health practitioners.
modality: Deontic
operator: Restrict
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-32ck-ss-1a-logic-deontic-4
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Ensures that only health practitioners are granted approval.
modality: Deontic
operator: Enforce
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-32ck-ss-1a-logic-deontic-5
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Justifies the restriction on approval to only those who are health practitioners.
modality: Deontic
operator: Justify
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-32ck-ss-1a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CK(1A) Approvals for importing, exporting or supplying a biological

32CK(2) Approvals for importing, exporting or supplying a biological
type: Concept
source: therapeutic-goods-act-1989.pdf, p.296
note: Exemption from subsection 32CA(1) for biologicals in the Register or under subsection 32CA(2)
asserts: therapeutic-goods-act-1989-sec-32ck-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ck-ss-2
schema version: 2
part of: 32CK Approvals for importing, exporting or supplying a biological

32CK(3) Approvals for importing, exporting or supplying a biological
type: Concept
description: Information relating to the biological subject of the application
source: therapeutic-goods-act-1989.pdf, p.296
note: Application for approval must be made to the Secretary and accompanied by required information.
asserts: therapeutic-goods-act-1989-sec-32ck-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32ck-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ck-ss-3
schema version: 2
part of: 32CK Approvals for importing, exporting or supplying a biological

therapeutic-goods-act-1989-sec-32ck-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application must be made
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32ck-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CK(3) Approvals for importing, exporting or supplying a biological

32CK(4) Approvals for importing, exporting or supplying a biological
type: Concept
description: Information relating to the biological subject of the application, prescribed evaluation fee
source: therapeutic-goods-act-1989.pdf, p.296
note: Application for approval must be made to the Secretary and meet certain requirements.
asserts: therapeutic-goods-act-1989-sec-32ck-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32ck-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ck-ss-4
schema version: 2
part of: 32CK Approvals for importing, exporting or supplying a biological

therapeutic-goods-act-1989-sec-32ck-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application must be made
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32ck-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CK(4) Approvals for importing, exporting or supplying a biological

32CK(5) Approvals for importing, exporting or supplying a biological
type: Concept
description: Reasons for decision if not granting approval
source: therapeutic-goods-act-1989.pdf, p.296
note: Secretary must notify applicant of decision on application as soon as practicable.
asserts: therapeutic-goods-act-1989-sec-32ck-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32ck-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ck-ss-5
schema version: 2
part of: 32CK Approvals for importing, exporting or supplying a biological

therapeutic-goods-act-1989-sec-32ck-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must notify applicant
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32ck-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CK(5) Approvals for importing, exporting or supplying a biological

32CL Conditions of use of biological for experimental purposes in
type: Concept
source: therapeutic-goods-act-1989.pdf, p.299
note: Use of biological for experimental purposes in humans subject to conditions specified in regulations.
asserts: therapeutic-goods-act-1989-sec-32cl-norm
asserts: therapeutic-goods-act-1989-sec-32cl-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32cl-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32cl-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-32cl-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-32cl-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cl
schema version: 2

therapeutic-goods-act-1989-sec-32cl-logic-alleninterval-2
type: LogicApplication
conclusion text: occurs during the period specified in the regulations.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Describes the temporal relationship between the regulation and its application.
modality: AllenInterval
operator: Overlaps
premise text: The use by a person (the experimenter) for experimental purposes...

therapeutic-goods-act-1989-sec-32cl-logic-argumentation-3
type: LogicApplication
conclusion text: must comply with the conditions specified in the regulations.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Describes the relationship between the regulation and its consequences.
modality: Argumentation
operator: Implication
premise text: The use by a person (the experimenter) for experimental purposes...

therapeutic-goods-act-1989-sec-32cl-logic-cogai-5
type: LogicApplication
conclusion text: can be inferred from the regulations.
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Describes the process of reasoning about the regulation.
modality: CogAI
operator: Inference
premise text: The use by a person (the experimenter) for experimental purposes...

therapeutic-goods-act-1989-sec-32cl-logic-deontic-1
type: LogicApplication
conclusion text: is subject to the conditions specified in the regulations.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a duty on the experimenter.
modality: Deontic
operator: Obligation
premise text: The use by a person (the experimenter) for experimental purposes in humans of a biological...

therapeutic-goods-act-1989-sec-32cl-logic-diffusion-4
type: LogicApplication
conclusion text: is disseminated through the regulations.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Describes the spread of information about the regulation.
modality: Diffusion
operator: Propagation
premise text: The use by a person (the experimenter) for experimental purposes...

therapeutic-goods-act-1989-sec-32cl-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CL Conditions of use of biological for experimental purposes in

32CM Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.300
curation status: Proposed
has part: 32CM(1) Authorities for health practitioners
has part: 32CM(1A) Authorities for health practitioners
has part: 32CM(2) Authorities for health practitioners
has part: 32CM(3) Authorities for health practitioners
has part: 32CM(4) Authorities for health practitioners
has part: 32CM(5) Authorities for health practitioners
has part: 32CM(6) Authorities for health practitioners
has part: 32CM(7) Authorities for health practitioners
has part: 32CM(7A) Authorities for health practitioners
has part: 32CM(7B) Authorities for health practitioners
has part: 32CM(7C) Authorities for health practitioners
has part: 32CM(7D) Authorities for health practitioners
has part: 32CM(7E) Authorities for health practitioners
proposed by: legis2cml
realized by: sec-32cm
schema version: 2

32CM(1) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.300
note: The Secretary may authorise a medical practitioner to supply biologicals.
asserts: therapeutic-goods-act-1989-sec-32cm-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cm-ss-1
schema version: 2
part of: 32CM Authorities for health practitioners

therapeutic-goods-act-1989-sec-32cm-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authorisation is an obligation.
modality: Deontic
operator: authorise

therapeutic-goods-act-1989-sec-32cm-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CM(1) Authorities for health practitioners

32CM(1A) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.300
note: Application for authority must be in approved form
asserts: therapeutic-goods-act-1989-sec-32cm-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cm-ss-1a
schema version: 2
part of: 32CM Authorities for health practitioners

therapeutic-goods-act-1989-sec-32cm-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

32CM(2) Authorities for health practitioners
type: Concept
references: sec-32cp
references: sec-32cq
source: therapeutic-goods-act-1989.pdf, p.300
note: The Secretary may give an authority under subsection (1) subject to conditions.
asserts: therapeutic-goods-act-1989-sec-32cm-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cm-ss-2
schema version: 2
part of: 32CM Authorities for health practitioners

therapeutic-goods-act-1989-sec-32cm-ss-2-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authority may be given subject to conditions.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-32cm-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CM(2) Authorities for health practitioners

32CM(3) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.300
note: Secretary may impose conditions on an authority
asserts: therapeutic-goods-act-1989-sec-32cm-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cm-ss-3
schema version: 2
part of: 32CM Authorities for health practitioners

therapeutic-goods-act-1989-sec-32cm-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-32cm-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CM(3) Authorities for health practitioners

32CM(4) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.300
note: Authority for medical practitioners to supply specified biologicals.
asserts: therapeutic-goods-act-1989-sec-32cm-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32cm-ss-4-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-32cm-ss-4-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-32cm-ss-4-logic-alleninterval-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cm-ss-4
schema version: 2
part of: 32CM Authorities for health practitioners

therapeutic-goods-act-1989-sec-32cm-ss-4-logic-alleninterval-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval relation
modality: AllenInterval
operator: prescribed by
premise text: for the purposes of this subsection

therapeutic-goods-act-1989-sec-32cm-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: to a medical practitioner
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authority restriction
modality: Deontic
operator: may only be given
premise text: (4) An authority under subsection (1)

therapeutic-goods-act-1989-sec-32cm-ss-4-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Approval requirement for supply
modality: Deontic
operator: has approval
premise text: (b) who has the approval of an ethics committee to supply the specified biological

therapeutic-goods-act-1989-sec-32cm-ss-4-logic-descriptionlogic-2
type: LogicApplication
conclusion text: for the purposes of this paragraph
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Class of medical practitioners
modality: DescriptionLogic
operator: includes
premise text: (a) who is included in a class of medical practitioners prescribed by the regulations

therapeutic-goods-act-1989-sec-32cm-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CM(4) Authorities for health practitioners

32CM(5) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.300
note: Authority for health practitioners limited to prescribed classes of recipients.
asserts: therapeutic-goods-act-1989-sec-32cm-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cm-ss-5
schema version: 2
part of: 32CM Authorities for health practitioners

therapeutic-goods-act-1989-sec-32cm-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: may only be given in relation to a class or classes of recipients prescribed by the regulations
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Limited authority
modality: Deontic
operator: only
premise text: (5) An authority under subsection (1)

therapeutic-goods-act-1989-sec-32cm-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CM(5) Authorities for health practitioners

32CM(6) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.300
note: Regulations may prescribe circumstances for supplying biologicals under authority.
asserts: therapeutic-goods-act-1989-sec-32cm-ss-6-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cm-ss-6
schema version: 2
part of: 32CM Authorities for health practitioners

therapeutic-goods-act-1989-sec-32cm-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CM(6) Authorities for health practitioners

32CM(7) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.300
note: An authority under subsection (1) is not a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cm-ss-7
schema version: 2
part of: 32CM Authorities for health practitioners

therapeutic-goods-act-1989-sec-32cm-ss-7-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CM(7) Authorities for health practitioners

32CM(7A) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.300
note: The Minister may make rules authorising health practitioners to supply biologicals.
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7a-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7a-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cm-ss-7a
schema version: 2
part of: 32CM Authorities for health practitioners

therapeutic-goods-act-1989-sec-32cm-ss-7a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to supply biologicals
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-32cm-ss-7a-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Rules specify class of health practitioners and recipients
modality: DescriptionLogic
operator: Class inclusion

therapeutic-goods-act-1989-sec-32cm-ss-7a-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CM(7A) Authorities for health practitioners

32CM(7B) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.300
note: Comply with regulations when making rules under subsection (7A)
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7b-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cm-ss-7b
schema version: 2
part of: 32CM Authorities for health practitioners

therapeutic-goods-act-1989-sec-32cm-ss-7b-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: (7B) In making rules under subsection (7A), the Minister...

32CM(7C) Authorities for health practitioners
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.300
note: Notify supply to Secretary within 28 days after supply.
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7c-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7c-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cm-ss-7c
schema version: 2
part of: 32CM Authorities for health practitioners

therapeutic-goods-act-1989-sec-32cm-ss-7c-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

32CM(7D) Authorities for health practitioners
type: Concept
description: Information as prescribed by regulations
source: therapeutic-goods-act-1989.pdf, p.300
note: Notification requirements for health practitioners
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7d-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7d-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cm-ss-7d
schema version: 2
part of: 32CM Authorities for health practitioners

therapeutic-goods-act-1989-sec-32cm-ss-7d-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-32cm-ss-7d-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CM(7D) Authorities for health practitioners

32CM(7E) Authorities for health practitioners
type: Concept
source: therapeutic-goods-act-1989.pdf, p.300
note: Approval of a form may require or permit information to be given in accordance with specified software requirements.
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7e-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cm-ss-7e
schema version: 2
part of: 32CM Authorities for health practitioners

32CN Criminal offences relating to the giving of an authority to a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.302
curation status: Proposed
has part: 32CN(1) Criminal offences relating to the giving of an authority to a
has part: 32CN(4) Criminal offences relating to the giving of an authority to a
has part: 32CN(4A) Criminal offences relating to the giving of an authority to a
proposed by: legis2cml
realized by: sec-32cn
schema version: 2

32CN(1) Criminal offences relating to the giving of an authority to a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.302
note: Supplying a biological without proper authority is prohibited.
asserts: therapeutic-goods-act-1989-sec-32cn-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-32cn-ss-1-logic-linearlogic-3
asserts: therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cn-ss-1
schema version: 2
part of: 32CN Criminal offences relating to the giving of an authority to a

therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The supply is not in accordance with the authority.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying a biological without proper authority.
modality: Deontic
operator: Prohibit
premise text: (a) the Secretary has authorised, under subsection 32CM(1), the person to supply a biological; and (b) the person supplies the biological;

therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: The supply is not in accordance with the authority.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying a biological that would result in harm or injury to any person.
modality: Deontic
operator: Prohibit
premise text: (d) either: (i) the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the biological, if the biological were used, would result in, or would be likely to result in, harm or injury to any person;

therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: The supply is not in accordance with the authority.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying a biological that would not result in harm or injury to any person.
modality: Deontic
operator: Prohibit
premise text: (e) the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because: (i) the supply is not in accordance with the authority; or (ii) the supply is not in accordance with regulations made for the purpose of subsection 32CM(6).

therapeutic-goods-act-1989-sec-32cn-ss-1-logic-linearlogic-3
type: LogicApplication
conclusion text: The supply is prohibited.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: If supplying a biological without proper authority would result in harm or injury, then it is prohibited.
modality: LinearLogic
operator: Implication
premise text: (d) either: (i) the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the biological, if the biological were used, would result in, or would be likely to result in, harm or injury to any person;

therapeutic-goods-act-1989-sec-32cn-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CN(1) Criminal offences relating to the giving of an authority to a

32CN(4) Criminal offences relating to the giving of an authority to a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.302
note: Supplying a biological without proper authority is prohibited.
asserts: therapeutic-goods-act-1989-sec-32cn-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32cn-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32cn-ss-4-logic-ltl-2
asserts: therapeutic-goods-act-1989-sec-32cn-ss-4-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cn-ss-4
schema version: 2
part of: 32CN Criminal offences relating to the giving of an authority to a

therapeutic-goods-act-1989-sec-32cn-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: ...the supply is not in accordance with the authority;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying a biological without proper authority.
modality: Deontic
operator: Prohibit
premise text: (4) A person commits an offence if...

therapeutic-goods-act-1989-sec-32cn-ss-4-logic-deontic-3
type: LogicApplication
conclusion text: ...the supply is not in accordance with the regulations;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying a biological without proper authority.
modality: Deontic
operator: Prohibit
premise text: (4) A person commits an offence if...

therapeutic-goods-act-1989-sec-32cn-ss-4-logic-ltl-2
type: LogicApplication
conclusion text: ...the supply is not in accordance with the authority;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Requires recurring trace of supplying a biological.
modality: LTL
operator: Recurring Trace
premise text: (4) A person commits an offence if...

therapeutic-goods-act-1989-sec-32cn-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CN(4) Criminal offences relating to the giving of an authority to a

32CN(4A) Criminal offences relating to the giving of an authority to a
type: Concept
source: therapeutic-goods-act-1989.pdf, p.302
note: Supplying a biological without authorization is prohibited.
asserts: therapeutic-goods-act-1989-sec-32cn-ss-4a-norm
asserts: therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cn-ss-4a
schema version: 2
part of: 32CN Criminal offences relating to the giving of an authority to a

therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-alleninterval-2
type: LogicApplication
conclusion text: ...and (b) the person supplies the biological;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines temporal interval for supply of a biological.
modality: AllenInterval
operator: Temporal Interval
premise text: (4A) A person commits an offence if...

therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-cogai-5
type: LogicApplication
conclusion text: ...and (c) either of the following applies:
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Recognizes prohibition in supply of a biological.
modality: CogAI
operator: Recognize
premise text: (4A) A person commits an offence if...

therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-deontic-1
type: LogicApplication
conclusion text: ...and (b) the person supplies the biological;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits supplying a biological.
modality: Deontic
operator: Prohibit
premise text: (4A) A person commits an offence if...

therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-diffusion-4
type: LogicApplication
conclusion text: ...and (b) the person supplies the biological;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffuses prohibition to related provisions.
modality: Diffusion
operator: Diffuse
premise text: (4A) A person commits an offence if...

therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-ltl-3
type: LogicApplication
conclusion text: ...and (c) either of the following applies:
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines temporal trace for supply of a biological.
modality: LTL
operator: Temporal Trace
premise text: (4A) A person commits an offence if...

therapeutic-goods-act-1989-sec-32cn-ss-4a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CN(4A) Criminal offences relating to the giving of an authority to a

32CO Approvals where substitutes for biologicals are unavailable
type: Concept
source: therapeutic-goods-act-1989.pdf, p.305
note: Secretary may grant approval for importation of specified biologicals
asserts: therapeutic-goods-act-1989-sec-32co-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32co
schema version: 2

therapeutic-goods-act-1989-sec-32co-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CO Approvals where substitutes for biologicals are unavailable

32CP Offences for breaching a condition of an exemption, approval
type: Concept
source: therapeutic-goods-act-1989.pdf, p.309
note: Offence for breaching a condition of an exemption, approval
asserts: therapeutic-goods-act-1989-sec-32cp-norm
asserts: therapeutic-goods-act-1989-sec-32cp-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cp
schema version: 2

therapeutic-goods-act-1989-sec-32cp-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 breaching a condition of an exemption, approval
modality: Deontic
operator: Prohibit
premise text: The person does an act or omits to do an act

therapeutic-goods-act-1989-sec-32cp-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CP Offences for breaching a condition of an exemption, approval

32CQ Civil penalty for breaching a condition of an exemption,
type: Concept
source: therapeutic-goods-act-1989.pdf, p.311
note: Civil penalty for breaching a condition of an exemption
asserts: therapeutic-goods-act-1989-sec-32cq-norm
asserts: therapeutic-goods-act-1989-sec-32cq-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32cq
schema version: 2

therapeutic-goods-act-1989-sec-32cq-logic-deontic-1
type: LogicApplication
conclusion text: Civil penalty for breaching a condition of an exemption
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits breach of conditions
modality: Deontic
operator: Prohibit
premise text: Section 32CQ

therapeutic-goods-act-1989-sec-32cq-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32CQ Civil penalty for breaching a condition of an exemption,

32D Simplified outline of this Division
type: Concept
source: therapeutic-goods-act-1989.pdf, p.313
note: Application requirements for inclusion in the Register
asserts: therapeutic-goods-act-1989-sec-32d-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32d
schema version: 2

therapeutic-goods-act-1989-sec-32d-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32D Simplified outline of this Division

32DA Application for inclusion in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.313
curation status: Proposed
has part: 32DA(1) Application for inclusion in the Register
has part: 32DA(2) Application for inclusion in the Register
proposed by: legis2cml
realized by: sec-32da
schema version: 2

32DA(1) Application for inclusion in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.313
note: Application for inclusion in the Register
asserts: therapeutic-goods-act-1989-sec-32da-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32da-ss-1
schema version: 2
part of: 32DA Application for inclusion in the Register

therapeutic-goods-act-1989-sec-32da-ss-1-norm
type: Permission
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 32DA(1) Application for inclusion in the Register

32DA(2) Application for inclusion in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.313
note: Application must be made in accordance with a form approved by the Secretary and accompanied by a statement certifying matters.
asserts: therapeutic-goods-act-1989-sec-32da-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32da-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32da-ss-2
schema version: 2
part of: 32DA Application for inclusion in the Register

therapeutic-goods-act-1989-sec-32da-ss-2-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-32da-ss-2-norm
type: Obligation
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 32DA(2) Application for inclusion in the Register

32DB Inclusion of Class 1 biological in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.315
curation status: Proposed
has part: 32DB(1) Inclusion of Class 1 biological in the Register
has part: 32DB(2) Inclusion of Class 1 biological in the Register
has part: 32DB(3) Inclusion of Class 1 biological in the Register
has part: 32DB(4) Inclusion of Class 1 biological in the Register
proposed by: legis2cml
realized by: sec-32db
schema version: 2

32DB(1) Inclusion of Class 1 biological in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.315
note: Secretary must include biological in Register if application is made.
asserts: therapeutic-goods-act-1989-sec-32db-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32db-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32db-ss-1
schema version: 2
part of: 32DB Inclusion of Class 1 biological in the Register

therapeutic-goods-act-1989-sec-32db-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Biological included in Register
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must include biological
modality: Deontic
operator: MUST
premise text: Application made for inclusion

therapeutic-goods-act-1989-sec-32db-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DB(1) Inclusion of Class 1 biological in the Register

32DB(2) Inclusion of Class 1 biological in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.315
note: Secretary must assign a unique number to the biological if included in the Register.
asserts: therapeutic-goods-act-1989-sec-32db-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32db-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32db-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32db-ss-2
schema version: 2
part of: 32DB Inclusion of Class 1 biological in the Register

therapeutic-goods-act-1989-sec-32db-ss-2-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-32db-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of biological in Register
modality: DescriptionLogic
operator: CLASSIFICATION

therapeutic-goods-act-1989-sec-32db-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DB(2) Inclusion of Class 1 biological in the Register

32DB(3) Inclusion of Class 1 biological in the Register
type: Concept
description: Certificate of inclusion
source: therapeutic-goods-act-1989.pdf, p.315
note: Secretary must provide certificate upon inclusion in Register
asserts: therapeutic-goods-act-1989-sec-32db-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32db-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32db-ss-3
schema version: 2
part of: 32DB Inclusion of Class 1 biological in the Register

therapeutic-goods-act-1989-sec-32db-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: The Secretary must give to the applicant a certificate of the inclusion of the biological in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide certificate
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32db-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DB(3) Inclusion of Class 1 biological in the Register

32DB(4) Inclusion of Class 1 biological in the Register
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.315
note: Specify biological number and commencement day for inclusion in Register
asserts: therapeutic-goods-act-1989-sec-32db-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32db-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32db-ss-4
schema version: 2
part of: 32DB Inclusion of Class 1 biological in the Register

therapeutic-goods-act-1989-sec-32db-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Specify biological number and commencement day
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32db-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DB(4) Inclusion of Class 1 biological in the Register

32DC Refusal to include Class 1 biological in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.316
curation status: Proposed
has part: 32DC(1) Refusal to include Class 1 biological in the Register
has part: 32DC(2) Refusal to include Class 1 biological in the Register
has part: 32DC(3) Refusal to include Class 1 biological in the Register
has part: 32DC(4) Refusal to include Class 1 biological in the Register
proposed by: legis2cml
realized by: sec-32dc
schema version: 2

32DC(1) Refusal to include Class 1 biological in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.316
note: Application for inclusion of export only biological in the Register
asserts: therapeutic-goods-act-1989-sec-32dc-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dc-ss-1
schema version: 2
part of: 32DC Refusal to include Class 1 biological in the Register

therapeutic-goods-act-1989-sec-32dc-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DC(1) Refusal to include Class 1 biological in the Register

32DC(2) Refusal to include Class 1 biological in the Register
type: Concept
description: Form, statement, and fee
source: therapeutic-goods-act-1989.pdf, p.316
note: Application must be made in accordance with a form approved by the Secretary and accompanied by a statement certifying certain matters.
asserts: therapeutic-goods-act-1989-sec-32dc-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32dc-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dc-ss-2
schema version: 2
part of: 32DC Refusal to include Class 1 biological in the Register

therapeutic-goods-act-1989-sec-32dc-ss-2-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-32dc-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DC(2) Refusal to include Class 1 biological in the Register

32DC(3) Refusal to include Class 1 biological in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.316
note: Application may be required for approval of a form
asserts: therapeutic-goods-act-1989-sec-32dc-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dc-ss-3
schema version: 2
part of: 32DC Refusal to include Class 1 biological in the Register

32DC(4) Refusal to include Class 1 biological in the Register
type: Concept
description: Certification of safety, presentation, and compliance with standards
source: therapeutic-goods-act-1989.pdf, p.316
note: Certification requirements for export only biologicals
asserts: therapeutic-goods-act-1989-sec-32dc-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32dc-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dc-ss-4
schema version: 2
part of: 32DC Refusal to include Class 1 biological in the Register

therapeutic-goods-act-1989-sec-32dc-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Certification is required
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32dc-ss-4-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 32DC(4) Refusal to include Class 1 biological in the Register

32DD Application for inclusion in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.321
curation status: Proposed
has part: 32DD(1) Application for inclusion in the Register
has part: 32DD(2) Application for inclusion in the Register
proposed by: legis2cml
realized by: sec-32dd
schema version: 2

32DD(1) Application for inclusion in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.321
note: Secretary must carry out assessment of application requirements
asserts: therapeutic-goods-act-1989-sec-32dd-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32dd-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dd-ss-1
schema version: 2
part of: 32DD Application for inclusion in the Register

therapeutic-goods-act-1989-sec-32dd-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must perform assessment
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32dd-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DD(1) Application for inclusion in the Register

32DD(2) Application for inclusion in the Register
type: Concept
description: Information of a kind determined under subsection (9) and in a form determined under subsection (10)
source: therapeutic-goods-act-1989.pdf, p.321
note: Application requirements for inclusion in the Register
asserts: therapeutic-goods-act-1989-sec-32dd-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32dd-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32dd-ss-2-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-32dd-ss-2-logic-descriptionlogic-3
asserts: therapeutic-goods-act-1989-sec-32dd-ss-2-logic-alleninterval-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dd-ss-2
schema version: 2
part of: 32DD Application for inclusion in the Register

therapeutic-goods-act-1989-sec-32dd-ss-2-logic-alleninterval-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Application must be delivered to an office of the Department within a reasonable time frame
modality: AllenInterval
operator: >=

therapeutic-goods-act-1989-sec-32dd-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Information of a kind determined under subsection (9) and in a form determined under subsection (10)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application requirements for inclusion in the Register
modality: Deontic
operator: Obligate

therapeutic-goods-act-1989-sec-32dd-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Application must be made in accordance with the approved form
modality: DescriptionLogic
operator: hasClass

therapeutic-goods-act-1989-sec-32dd-ss-2-logic-descriptionlogic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Prescribed application fee must be paid
modality: DescriptionLogic
operator: hasValue

therapeutic-goods-act-1989-sec-32dd-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DD(2) Application for inclusion in the Register

32DE Evaluation of biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.324
curation status: Proposed
has part: 32DE(1) Evaluation of biologicals
has part: 32DE(2) Evaluation of biologicals
has part: 32DE(3) Evaluation of biologicals
proposed by: legis2cml
realized by: sec-32de
schema version: 2

32DE(1) Evaluation of biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.324
note: The Secretary must evaluate a biological for inclusion in the Register, considering various factors. The regulations may empower the Secretary to make biologicals (priority applicant) determinations.
asserts: therapeutic-goods-act-1989-sec-32de-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32de-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32de-ss-1
schema version: 2
part of: 32DE Evaluation of biologicals

therapeutic-goods-act-1989-sec-32de-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must evaluate a biological.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32de-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DE(1) Evaluation of biologicals

32DE(2) Evaluation of biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.324
note: Determination of priority applicant for section 32DD applications Corresponding application of subsections for paragraph (1)(g)
asserts: therapeutic-goods-act-1989-sec-32de-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32de-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32de-ss-2-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32de-ss-2
schema version: 2
part of: 32DE Evaluation of biologicals

therapeutic-goods-act-1989-sec-32de-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Priority applicant designation
modality: Deontic
operator: has

therapeutic-goods-act-1989-sec-32de-ss-2-logic-deontic-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Corresponding application of subsections for paragraph (1)(g)
modality: Deontic
operator: Obligate

therapeutic-goods-act-1989-sec-32de-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DE(2) Evaluation of biologicals

32DE(3) Evaluation of biologicals
type: Concept
description: information that must accompany an application
source: therapeutic-goods-act-1989.pdf, p.324
note: Regulations for applications of biologicals
asserts: therapeutic-goods-act-1989-sec-32de-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32de-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32de-ss-3
schema version: 2
part of: 32DE Evaluation of biologicals

therapeutic-goods-act-1989-sec-32de-ss-3-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations require information to be provided
modality: Deontic
operator: MUST PROVIDE

therapeutic-goods-act-1989-sec-32de-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DE(3) Evaluation of biologicals

32DF Inclusion of biological in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.327
curation status: Proposed
has part: 32DF(1) Inclusion of biological in the Register
has part: 32DF(2) Inclusion of biological in the Register
has part: 32DF(3) Inclusion of biological in the Register
has part: 32DF(4) Inclusion of biological in the Register
proposed by: legis2cml
realized by: sec-32df
schema version: 2

32DF(1) Inclusion of biological in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.327
note: Secretary must include biological in Register if certain conditions met.
asserts: therapeutic-goods-act-1989-sec-32df-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32df-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32df-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32df-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32df-ss-1-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-32df-ss-1
schema version: 2
part of: 32DF Inclusion of biological in the Register

therapeutic-goods-act-1989-sec-32df-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: the evaluation must occur before inclusion.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Evaluation must occur before inclusion
modality: AllenInterval
operator: >=
premise text: (b) the Secretary decides that it is appropriate to include the biological in the Register after an evaluation under section 32DE;

therapeutic-goods-act-1989-sec-32df-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: the Secretary must include the biological in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide
modality: Deontic
operator: MUST
premise text: (1) If...

therapeutic-goods-act-1989-sec-32df-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: no exceptions are allowed.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: No exceptions allowed
modality: Deontic
operator: MUST
premise text: (1) If...

therapeutic-goods-act-1989-sec-32df-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: the evaluation fee must be paid before inclusion.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Evaluation fee must be paid before inclusion
modality: LTL
operator: <=
premise text: (c) no part of an evaluation fee under section 32DI that is due and payable by the person remains unpaid;

therapeutic-goods-act-1989-sec-32df-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DF(1) Inclusion of biological in the Register

32DF(2) Inclusion of biological in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.327
note: Secretary must assign a unique number to the biological if included in the Register.
asserts: therapeutic-goods-act-1989-sec-32df-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32df-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32df-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32df-ss-2
schema version: 2
part of: 32DF Inclusion of biological in the Register

therapeutic-goods-act-1989-sec-32df-ss-2-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-32df-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of biological in the Register
modality: DescriptionLogic
operator: CLASSIFICATION

therapeutic-goods-act-1989-sec-32df-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DF(2) Inclusion of biological in the Register

32DF(3) Inclusion of biological in the Register
type: Concept
description: Certificate of inclusion
source: therapeutic-goods-act-1989.pdf, p.327
note: Secretary must provide certificate upon inclusion in Register
asserts: therapeutic-goods-act-1989-sec-32df-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32df-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32df-ss-3
schema version: 2
part of: 32DF Inclusion of biological in the Register

therapeutic-goods-act-1989-sec-32df-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: The Secretary must give to the applicant a certificate of the inclusion of the biological in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide certificate
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32df-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DF(3) Inclusion of biological in the Register

32DF(4) Inclusion of biological in the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.327
note: Specifies requirements for a certificate's content regarding biological inclusion in the Register.
asserts: therapeutic-goods-act-1989-sec-32df-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32df-ss-4
schema version: 2
part of: 32DF Inclusion of biological in the Register

32DG Refusal to include biological in the Register
type: Concept
description: Notice of refusal and reasons for refusal
source: therapeutic-goods-act-1989.pdf, p.328
note: Secretary must provide notice after refusing application to include biological in the Register.
asserts: therapeutic-goods-act-1989-sec-32dg-norm
asserts: therapeutic-goods-act-1989-sec-32dg-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dg
schema version: 2

therapeutic-goods-act-1989-sec-32dg-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must provide notice
modality: Deontic
operator: Must

therapeutic-goods-act-1989-sec-32dg-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DG Refusal to include biological in the Register

32DH Lapsing of application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.328
curation status: Proposed
has part: 32DH(1) Lapsing of application
has part: 32DH(2) Lapsing of application
proposed by: legis2cml
realized by: sec-32dh
schema version: 2

32DH(1) Lapsing of application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.328
note: Application lapse due to unpaid fee, false information, or non-compliance with patient data requirements.
asserts: therapeutic-goods-act-1989-sec-32dh-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dh-ss-1
schema version: 2
part of: 32DH Lapsing of application

therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Application lapse.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of application lapse due to unpaid fee.
modality: Deontic
operator: Prohibit
premise text: Unpaid fee

therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: Application lapse.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of application lapse due to false information.
modality: Deontic
operator: Prohibit
premise text: False information

therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-3
type: LogicApplication
conclusion text: Application lapse.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of application lapse due to non-compliance with patient data requirements.
modality: Deontic
operator: Prohibit
premise text: Non-compliance with patient data requirements

therapeutic-goods-act-1989-sec-32dh-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DH(1) Lapsing of application

32DH(2) Lapsing of application
type: Concept
source: therapeutic-goods-act-1989.pdf, p.328
note: Defines patient data in relation to a biological.
asserts: therapeutic-goods-act-1989-sec-32dh-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32dh-ss-2-logic-descriptionlogic-1
asserts: therapeutic-goods-act-1989-sec-32dh-ss-2-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dh-ss-2
schema version: 2
part of: 32DH Lapsing of application

therapeutic-goods-act-1989-sec-32dh-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: clinical trials
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Describes temporal relationship
modality: AllenInterval
operator: during
premise text: before, during and after

therapeutic-goods-act-1989-sec-32dh-ss-2-logic-descriptionlogic-1
type: LogicApplication
conclusion text: information derived from clinical trials
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Identifies specific information types
modality: DescriptionLogic
operator: =
premise text: patient data, in relation to a biological

therapeutic-goods-act-1989-sec-32dh-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DH(2) Lapsing of application

32DI Evaluation fee
type: Concept
source: therapeutic-goods-act-1989.pdf, p.329
curation status: Proposed
has part: 32DI(1) Evaluation fee
has part: 32DI(2) Evaluation fee
proposed by: legis2cml
realized by: sec-32di
schema version: 2

32DI(1) Evaluation fee
type: Concept
source: therapeutic-goods-act-1989.pdf, p.329
note: Pay evaluation fee for biological inclusion in Register
asserts: therapeutic-goods-act-1989-sec-32di-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32di-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32di-ss-1
schema version: 2
part of: 32DI Evaluation fee

therapeutic-goods-act-1989-sec-32di-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Duty to pay evaluation fee
modality: Deontic
operator: Obligation

32DI(2) Evaluation fee
type: Concept
description: yes
source: therapeutic-goods-act-1989.pdf, p.329
note: The Secretary must notify the applicant in writing of the evaluation fee.
asserts: therapeutic-goods-act-1989-sec-32di-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32di-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32di-ss-2
schema version: 2
part of: 32DI Evaluation fee

therapeutic-goods-act-1989-sec-32di-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must notify the applicant in writing of the evaluation fee.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32di-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DI(2) Evaluation fee

32DJ When evaluation fee due for payment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.329
curation status: Proposed
has part: 32DJ(1) When evaluation fee due for payment
has part: 32DJ(2) When evaluation fee due for payment
proposed by: legis2cml
realized by: sec-32dj
schema version: 2

32DJ(1) When evaluation fee due for payment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.329
note: Evaluation fee due on notification of amount
asserts: therapeutic-goods-act-1989-sec-32dj-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32dj-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32dj-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32dj-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32dj-ss-1-logic-diffusion-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dj-ss-1
schema version: 2
part of: 32DJ When evaluation fee due for payment

therapeutic-goods-act-1989-sec-32dj-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between notification and payment
modality: AllenInterval
operator: on
premise text: (1) Subject to sections 32DK and 32DM, an evaluation fee payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee.

therapeutic-goods-act-1989-sec-32dj-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to pay evaluation fee
modality: Deontic
operator: due
premise text: (1) Subject to sections 32DK and 32DM, an evaluation fee payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee.

therapeutic-goods-act-1989-sec-32dj-ss-1-logic-diffusion-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Spread of obligation to pay evaluation fee
modality: Diffusion
operator: on
premise text: (1) Subject to sections 32DK and 32DM, an evaluation fee payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee.

therapeutic-goods-act-1989-sec-32dj-ss-1-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal trace between notification and payment
modality: LTL
operator: on
premise text: (1) Subject to sections 32DK and 32DM, an evaluation fee payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee.

therapeutic-goods-act-1989-sec-32dj-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DJ(1) When evaluation fee due for payment

32DJ(2) When evaluation fee due for payment
type: Concept
source: therapeutic-goods-act-1989.pdf, p.329
note: Evaluation fee must be paid in the manner prescribed by regulations.
asserts: therapeutic-goods-act-1989-sec-32dj-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32dj-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dj-ss-2
schema version: 2
part of: 32DJ When evaluation fee due for payment

therapeutic-goods-act-1989-sec-32dj-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to pay evaluation fee
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32dj-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DJ(2) When evaluation fee due for payment

32DK Payment of evaluation fee by instalments
type: Concept
source: therapeutic-goods-act-1989.pdf, p.329
curation status: Proposed
has part: 32DK(1) Payment of evaluation fee by instalments
has part: 32DK(2) Payment of evaluation fee by instalments
has part: 32DK(3) Payment of evaluation fee by instalments
proposed by: legis2cml
realized by: sec-32dk
schema version: 2

32DK(1) Payment of evaluation fee by instalments
type: Concept
source: therapeutic-goods-act-1989.pdf, p.329
note: Payment of evaluation fee by instalments is obligatory.
asserts: therapeutic-goods-act-1989-sec-32dk-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32dk-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dk-ss-1
schema version: 2
part of: 32DK Payment of evaluation fee by instalments

therapeutic-goods-act-1989-sec-32dk-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Payment of evaluation fee by instalments is obligatory.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-32dk-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DK(1) Payment of evaluation fee by instalments

32DK(2) Payment of evaluation fee by instalments
type: Concept
source: therapeutic-goods-act-1989.pdf, p.329
note: Payment of evaluation fee by instalments is not allowed if any part of an instalment was unpaid immediately after it became due for payment.
asserts: therapeutic-goods-act-1989-sec-32dk-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32dk-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32dk-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32dk-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32dk-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-32dk-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dk-ss-2
schema version: 2
part of: 32DK Payment of evaluation fee by instalments

therapeutic-goods-act-1989-sec-32dk-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: ...if any part of an instalment of that or any other evaluation fee payable by the person 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: Payment of evaluation fee by instalments overlaps with the condition that any part of an instalment was unpaid immediately after it became due.
modality: AllenInterval
operator: Overlaps
premise text: (2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments...

therapeutic-goods-act-1989-sec-32dk-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: ...if any part of an instalment of that or any other evaluation fee payable by the person was unpaid immediately after the time when it became due for payment.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Payment of evaluation fee by instalments is recognized as a prohibited action if any part was unpaid immediately after it became due.
modality: CogAI
operator: Recognizes
premise text: (2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments...

therapeutic-goods-act-1989-sec-32dk-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: ...if any part of an instalment of that or any other evaluation fee payable by the person was unpaid immediately after the time when it became due for payment.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits payment of evaluation fee by instalments if any part was unpaid immediately after it became due.
modality: Deontic
operator: Prohibit
premise text: (2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments...

therapeutic-goods-act-1989-sec-32dk-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: ...if any part of an instalment of that or any other evaluation fee payable by the person was unpaid immediately after the time when it became due for payment.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Payment of evaluation fee by instalments diffuses to all persons who are not allowed to pay an evaluation fee by instalments if any part was unpaid immediately after it became due.
modality: Diffusion
operator: Diffuses
premise text: (2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments...

therapeutic-goods-act-1989-sec-32dk-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: ...if any part of an instalment of that or any other evaluation fee payable by the person 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: Payment of evaluation fee by instalments contains the condition that any part of an instalment was unpaid immediately after it became due.
modality: LTL
operator: Contains
premise text: (2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments...

therapeutic-goods-act-1989-sec-32dk-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DK(2) Payment of evaluation fee by instalments

32DK(3) Payment of evaluation fee by instalments
type: Concept
source: therapeutic-goods-act-1989.pdf, p.329
note: Payment of evaluation fee by instalments
asserts: therapeutic-goods-act-1989-sec-32dk-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32dk-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dk-ss-3
schema version: 2
part of: 32DK Payment of evaluation fee by instalments

therapeutic-goods-act-1989-sec-32dk-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must pay evaluation fee
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32dk-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DK(3) Payment of evaluation fee by instalments

32DL Recovery of evaluation fee
type: Concept
source: therapeutic-goods-act-1989.pdf, p.330
note: The Commonwealth may recover an evaluation fee as a debt.
asserts: therapeutic-goods-act-1989-sec-32dl-norm
asserts: therapeutic-goods-act-1989-sec-32dl-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dl
schema version: 2

therapeutic-goods-act-1989-sec-32dl-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Implies obligation
modality: Deontic
operator: may

32DM Reduction of evaluation fee where evaluation not completed
type: Concept
source: therapeutic-goods-act-1989.pdf, p.330
curation status: Proposed
has part: 32DM(1) Reduction of evaluation fee where evaluation not completed
has part: 32DM(2) Reduction of evaluation fee where evaluation not completed
has part: 32DM(3) Reduction of evaluation fee where evaluation not completed
has part: 32DM(4) Reduction of evaluation fee where evaluation not completed
has part: 32DM(5) Reduction of evaluation fee where evaluation not completed
has part: 32DM(6) Reduction of evaluation fee where evaluation not completed
proposed by: legis2cml
realized by: sec-32dm
schema version: 2

32DM(1) Reduction of evaluation fee where evaluation not completed
type: Concept
source: therapeutic-goods-act-1989.pdf, p.330
note: No payment of more than 3/4 evaluation fee before completion if a period is prescribed for completing the evaluation.
asserts: therapeutic-goods-act-1989-sec-32dm-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32dm-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dm-ss-1
schema version: 2
part of: 32DM Reduction of evaluation fee where evaluation not completed

therapeutic-goods-act-1989-sec-32dm-ss-1-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-32dm-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DM(1) Reduction of evaluation fee where evaluation not completed

32DM(2) Reduction of evaluation fee where evaluation not completed
type: Concept
source: therapeutic-goods-act-1989.pdf, p.330
note: Secretary must notify applicant of evaluation completion date
asserts: therapeutic-goods-act-1989-sec-32dm-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32dm-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dm-ss-2
schema version: 2
part of: 32DM Reduction of evaluation fee where evaluation not completed

therapeutic-goods-act-1989-sec-32dm-ss-2-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-32dm-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DM(2) Reduction of evaluation fee where evaluation not completed

32DM(3) Reduction of evaluation fee where evaluation not completed
type: Concept
source: therapeutic-goods-act-1989.pdf, p.330
note: Reduction of evaluation fee if evaluation not completed within period
asserts: therapeutic-goods-act-1989-sec-32dm-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32dm-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dm-ss-3
schema version: 2
part of: 32DM Reduction of evaluation fee where evaluation not completed

therapeutic-goods-act-1989-sec-32dm-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: (evaluation fee is reduced)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Conditional obligation
modality: Deontic
operator: if
premise text: (evaluation not completed within period)

therapeutic-goods-act-1989-sec-32dm-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DM(3) Reduction of evaluation fee where evaluation not completed

32DM(4) Reduction of evaluation fee where evaluation not completed
type: Concept
source: therapeutic-goods-act-1989.pdf, p.330
note: Payment of unpaid evaluation fee upon completion of evaluation.
asserts: therapeutic-goods-act-1989-sec-32dm-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32dm-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dm-ss-4
schema version: 2
part of: 32DM Reduction of evaluation fee where evaluation not completed

therapeutic-goods-act-1989-sec-32dm-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-32dm-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DM(4) Reduction of evaluation fee where evaluation not completed

32DM(5) Reduction of evaluation fee where evaluation not completed
type: Concept
source: therapeutic-goods-act-1989.pdf, p.330
note: Evaluation fee reduction where report is given to applicant or committee.
asserts: therapeutic-goods-act-1989-sec-32dm-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32dm-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32dm-ss-5-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32dm-ss-5-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32dm-ss-5-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-32dm-ss-5-logic-argumentation-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dm-ss-5
schema version: 2
part of: 32DM Reduction of evaluation fee where evaluation not completed

therapeutic-goods-act-1989-sec-32dm-ss-5-logic-alleninterval-2
type: LogicApplication
conclusion text: then the evaluation is taken to be completed immediately before the first copy or summary is so given.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Evaluation fee reduction applies when report is given within a specified period.
modality: AllenInterval
operator: Overlaps
premise text: (5) For the purposes of this section, if a copy of the evaluation report...

therapeutic-goods-act-1989-sec-32dm-ss-5-logic-argumentation-5
type: LogicApplication
conclusion text: then the evaluation is taken to be completed immediately before the first copy or summary is so given.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Withdrawal after report being given implies obligation to pay full evaluation fee.
modality: Argumentation
operator: Implication
premise text: (5) For the purposes of this section, if a copy of the evaluation report...

therapeutic-goods-act-1989-sec-32dm-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: then the evaluation is taken to be completed immediately before the first copy or summary is so given.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Duty to pay full evaluation fee if applicant withdraws after report is given.
modality: Deontic
operator: Obligation
premise text: (5) For the purposes of this section, if a copy of the evaluation report...

therapeutic-goods-act-1989-sec-32dm-ss-5-logic-diffusion-4
type: LogicApplication
conclusion text: then the evaluation is taken to be completed immediately before the first copy or summary is so given.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Report being given to applicant or committee diffuses the obligation to pay full evaluation fee.
modality: Diffusion
operator: Diffuses
premise text: (5) For the purposes of this section, if a copy of the evaluation report...

therapeutic-goods-act-1989-sec-32dm-ss-5-logic-ltl-3
type: LogicApplication
conclusion text: then the evaluation is taken to be completed immediately before the first copy or summary is so given.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Evaluation fee reduction applies until report is given to applicant or committee.
modality: LTL
operator: Until
premise text: (5) For the purposes of this section, if a copy of the evaluation report...

therapeutic-goods-act-1989-sec-32dm-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DM(5) Reduction of evaluation fee where evaluation not completed

32DM(6) Reduction of evaluation fee where evaluation not completed
type: Concept
source: therapeutic-goods-act-1989.pdf, p.330
note: Notification under subsection (2) is not a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-32dm-ss-6-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dm-ss-6
schema version: 2
part of: 32DM Reduction of evaluation fee where evaluation not completed

therapeutic-goods-act-1989-sec-32dm-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DM(6) Reduction of evaluation fee where evaluation not completed

32DN Transitional provisions for existing biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.331
note: Secretary must cancel inclusion of goods in part and include biological in Register under Part
asserts: therapeutic-goods-act-1989-sec-32dn-norm
asserts: therapeutic-goods-act-1989-sec-32dn-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dn
schema version: 2

therapeutic-goods-act-1989-sec-32dn-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-32dn-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DN Transitional provisions for existing biologicals

32DO Criminal offences for false statements in applications for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.334
curation status: Proposed
has part: 32DO(1) Criminal offences for false statements in applications for
has part: 32DO(4) Criminal offences for false statements in applications for
has part: 32DO(5) Criminal offences for false statements in applications for
has part: 32DO(6) Criminal offences for false statements in applications for
proposed by: legis2cml
realized by: sec-32do
schema version: 2

32DO(1) Criminal offences for false statements in applications for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.334
note: Making false statements in applications for biological inclusion is a criminal offence.
asserts: therapeutic-goods-act-1989-sec-32do-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32do-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32do-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-32do-ss-1-logic-linearlogic-3
asserts: therapeutic-goods-act-1989-sec-32do-ss-1-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-32do-ss-1
schema version: 2
part of: 32DO Criminal offences for false statements in applications for

therapeutic-goods-act-1989-sec-32do-ss-1-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: Prohibits making false statements in applications for biological inclusion.
modality: Deontic
operator: Prohibit
premise text: The statement is made in, or in connection with, an application for inclusion of a biological in the Register.

therapeutic-goods-act-1989-sec-32do-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: or (ii) the use of the biological, if the biological were used, would result in, or would be likely to result in, harm or injury to any person.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits harm or injury to any person resulting from the use of the biological.
modality: Deontic
operator: Prohibit
premise text: (i) the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person;

therapeutic-goods-act-1989-sec-32do-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: and (b) the statement is made in, or in connection with, an application for inclusion of a biological in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making false statements in applications for biological inclusion.
modality: Deontic
operator: Prohibit
premise text: (a) the person makes a statement;

therapeutic-goods-act-1989-sec-32do-ss-1-logic-linearlogic-3
type: LogicApplication
conclusion text: or (ii) the use of the biological, if the biological were used, would result in, or would be likely to result in, harm or injury to any person.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Implies that the provision is related to harm or injury.
modality: LinearLogic
operator: Imply
premise text: (i) the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person;

therapeutic-goods-act-1989-sec-32do-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DO(1) Criminal offences for false statements in applications for

32DO(4) Criminal offences for false statements in applications for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.334
note: Making false statements in applications for inclusion of biologicals in the Register is an offence.
asserts: therapeutic-goods-act-1989-sec-32do-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32do-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32do-ss-4
schema version: 2
part of: 32DO Criminal offences for false statements in applications for

therapeutic-goods-act-1989-sec-32do-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of false statements
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-32do-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DO(4) Criminal offences for false statements in applications for

32DO(5) Criminal offences for false statements in applications for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.334
note: Making false statements in applications for inclusion of a biological in the Register is an offence.
asserts: therapeutic-goods-act-1989-sec-32do-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32do-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32do-ss-5
schema version: 2
part of: 32DO Criminal offences for false statements in applications for

therapeutic-goods-act-1989-sec-32do-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making false statements in applications.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-32do-ss-5-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DO(5) Criminal offences for false statements in applications for

32DO(6) Criminal offences for false statements in applications for
type: Concept
source: therapeutic-goods-act-1989.pdf, p.334
note: An offence against subsection (5) is an offence of strict liability.
asserts: therapeutic-goods-act-1989-sec-32do-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-32do-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32do-ss-6
schema version: 2
part of: 32DO Criminal offences for false statements in applications for

therapeutic-goods-act-1989-sec-32do-ss-6-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-32do-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DO(6) Criminal offences for false statements in applications for

32DP Civil penalty for false statements in applications for including
type: Concept
source: therapeutic-goods-act-1989.pdf, p.335
note: False statements in applications for inclusion of biologicals in the Register
asserts: therapeutic-goods-act-1989-sec-32dp-norm
asserts: therapeutic-goods-act-1989-sec-32dp-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dp
schema version: 2

therapeutic-goods-act-1989-sec-32dp-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on false statements
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-32dp-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DP Civil penalty for false statements in applications for including

32DQ Criminal offence and civil penalty for failing to notify adverse
type: Concept
source: therapeutic-goods-act-1989.pdf, p.335
note: Failure to notify adverse effects of a biological included in the Register is an offence.
asserts: therapeutic-goods-act-1989-sec-32dq-norm
asserts: therapeutic-goods-act-1989-sec-32dq-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dq
schema version: 2

therapeutic-goods-act-1989-sec-32dq-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to notify adverse effects of a biological included in the Register.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-32dq-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DQ Criminal offence and civil penalty for failing to notify adverse

32DR Criminal offences and civil penalties for failing to notify
type: Concept
source: therapeutic-goods-act-1989.pdf, p.337
curation status: Proposed
has part: 32DR(1) Criminal offences and civil penalties for failing to notify
has part: 32DR(2) Criminal offences and civil penalties for failing to notify
has part: 32DR(3) Criminal offences and civil penalties for failing to notify
proposed by: legis2cml
realized by: sec-32dr
schema version: 2

32DR(1) Criminal offences and civil penalties for failing to notify
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.337
note: Notify the Secretary of known information within 14 days after application withdrawal or lapse.
asserts: therapeutic-goods-act-1989-sec-32dr-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32dr-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dr-ss-1
schema version: 2
part of: 32DR Criminal offences and civil penalties for failing to notify

therapeutic-goods-act-1989-sec-32dr-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must notify the Secretary.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32dr-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DR(1) Criminal offences and civil penalties for failing to notify

32DR(2) Criminal offences and civil penalties for failing to notify
type: Concept
source: therapeutic-goods-act-1989.pdf, p.337
note: Failing to notify of certain information may result in criminal offences or civil penalties.
asserts: therapeutic-goods-act-1989-sec-32dr-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32dr-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dr-ss-2
schema version: 2
part of: 32DR Criminal offences and civil penalties for failing to notify

therapeutic-goods-act-1989-sec-32dr-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Failing to notify is prohibited
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of failing to notify
modality: Deontic
operator: Prohibit
premise text: Notification is required

therapeutic-goods-act-1989-sec-32dr-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DR(2) Criminal offences and civil penalties for failing to notify

32DR(3) Criminal offences and civil penalties for failing to notify
type: Concept
source: therapeutic-goods-act-1989.pdf, p.337
note: Failure to comply with notice within 30 days results in imprisonment or penalty units.
asserts: therapeutic-goods-act-1989-sec-32dr-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32dr-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dr-ss-3
schema version: 2
part of: 32DR Criminal offences and civil penalties for failing to notify

therapeutic-goods-act-1989-sec-32dr-ss-3-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: Obligation to comply with notice.
modality: Deontic
operator: obligation
premise text: Secretary gives notice.

therapeutic-goods-act-1989-sec-32dr-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DR(3) Criminal offences and civil penalties for failing to notify

32DS Consultation with Gene Technology Regulator
type: Concept
source: therapeutic-goods-act-1989.pdf, p.339
curation status: Proposed
has part: 32DS(1) Consultation with Gene Technology Regulator
has part: 32DS(2) Consultation with Gene Technology Regulator
has part: 32DS(3) Consultation with Gene Technology Regulator
has part: 32DS(4) Consultation with Gene Technology Regulator
has part: 32DS(5) Consultation with Gene Technology Regulator
has part: 32DS(6) Consultation with Gene Technology Regulator
proposed by: legis2cml
realized by: sec-32ds
schema version: 2

32DS(1) Consultation with Gene Technology Regulator
type: Concept
source: therapeutic-goods-act-1989.pdf, p.339
note: Application for inclusion of a biological in the Register must consult with the Gene Technology Regulator.
asserts: therapeutic-goods-act-1989-sec-32ds-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32ds-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ds-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32ds-ss-1-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-32ds-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-32ds-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ds-ss-1
schema version: 2
part of: 32DS Consultation with Gene Technology Regulator

therapeutic-goods-act-1989-sec-32ds-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: ...must consult with the Gene Technology Regulator.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Consultation must occur before the application is processed.
modality: AllenInterval
operator: >=
premise text: The application for inclusion of a biological in the Register...

therapeutic-goods-act-1989-sec-32ds-ss-1-logic-argumentation-3
type: LogicApplication
conclusion text: ...must consult with the Gene Technology Regulator.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Consultation implies that the application is not exempt from regulation.
modality: Argumentation
operator: IMPLIES
premise text: The application for inclusion of a biological in the Register...

therapeutic-goods-act-1989-sec-32ds-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: ...must consult with the Gene Technology Regulator.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Consultation is an artificial intelligence-powered regulation mechanism.
modality: CogAI
operator: IS_A
premise text: The application for inclusion of a biological in the Register...

therapeutic-goods-act-1989-sec-32ds-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...must consult with the Gene Technology Regulator.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application must comply with consultation requirement.
modality: Deontic
operator: MUST
premise text: The application for inclusion of a biological in the Register...

therapeutic-goods-act-1989-sec-32ds-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: ...must consult with the Gene Technology Regulator.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Consultation is a necessary step for the regulation of genetic modification.
modality: Diffusion
operator: IS_A
premise text: The application for inclusion of a biological in the Register...

therapeutic-goods-act-1989-sec-32ds-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DS(1) Consultation with Gene Technology Regulator

32DS(2) Consultation with Gene Technology Regulator
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.339
note: The Secretary must give written notice to the Gene Technology Regulator.
asserts: therapeutic-goods-act-1989-sec-32ds-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32ds-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ds-ss-2
schema version: 2
part of: 32DS Consultation with Gene Technology Regulator

therapeutic-goods-act-1989-sec-32ds-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must give written notice.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32ds-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DS(2) Consultation with Gene Technology Regulator

32DS(3) Consultation with Gene Technology Regulator
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.339
note: The Gene Technology Regulator must provide written advice to the Secretary about a gene technology application.
asserts: therapeutic-goods-act-1989-sec-32ds-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32ds-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ds-ss-3
schema version: 2
part of: 32DS Consultation with Gene Technology Regulator

therapeutic-goods-act-1989-sec-32ds-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Gene Technology Regulator must provide written advice.
modality: Deontic
operator: MUST

32DS(4) Consultation with Gene Technology Regulator
type: Concept
source: therapeutic-goods-act-1989.pdf, p.339
note: Consultation with Gene Technology Regulator within specified period.
asserts: therapeutic-goods-act-1989-sec-32ds-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32ds-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ds-ss-4
schema version: 2
part of: 32DS Consultation with Gene Technology Regulator

therapeutic-goods-act-1989-sec-32ds-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: Consultation with Gene Technology Regulator within specified period.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide consultation
modality: Deontic
operator: MUST
premise text: The advice is to be given within the period specified in the notice.

32DS(5) Consultation with Gene Technology Regulator
type: Concept
source: therapeutic-goods-act-1989.pdf, p.339
note: No notification required for applications within a class of biologicals subject to Gene Technology Regulator advice.
asserts: therapeutic-goods-act-1989-sec-32ds-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32ds-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ds-ss-5-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-32ds-ss-5-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-32ds-ss-5-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-32ds-ss-5-logic-diffusion-5
asserts: therapeutic-goods-act-1989-sec-32ds-ss-5-logic-cogai-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ds-ss-5
schema version: 2
part of: 32DS Consultation with Gene Technology Regulator

therapeutic-goods-act-1989-sec-32ds-ss-5-logic-alleninterval-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT.
modality: AllenInterval
operator: Temporal Exemption
premise text: (5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class.

therapeutic-goods-act-1989-sec-32ds-ss-5-logic-cogai-6
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT.
modality: CogAI
operator: Knowledge Representation
premise text: (5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class.

therapeutic-goods-act-1989-sec-32ds-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: No notification required for applications within a class of biologicals subject to Gene Technology Regulator advice.
modality: Deontic
operator: Exemption
premise text: (5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class.

therapeutic-goods-act-1989-sec-32ds-ss-5-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: The Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class.
modality: DescriptionLogic
operator: Class Inclusion
premise text: (5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class.

therapeutic-goods-act-1989-sec-32ds-ss-5-logic-diffusion-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT.
modality: Diffusion
operator: Information Dissemination
premise text: (5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class.

therapeutic-goods-act-1989-sec-32ds-ss-5-logic-ltl-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT.
modality: LTL
operator: Temporal Exemption
premise text: (5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class.

therapeutic-goods-act-1989-sec-32ds-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DS(5) Consultation with Gene Technology Regulator

32DS(6) Consultation with Gene Technology Regulator
type: Concept
source: therapeutic-goods-act-1989.pdf, p.339
note: Notice under subsection (2) is not a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-32ds-ss-6-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ds-ss-6
schema version: 2
part of: 32DS Consultation with Gene Technology Regulator

32DT Secretary may seek advice about classes of GM products or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.339
note: The Secretary may request advice from the Gene Technology Regulator about specific GM products or organisms.
asserts: therapeutic-goods-act-1989-sec-32dt-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32dt
schema version: 2

32DU Secretary to take advice into account
type: Concept
source: therapeutic-goods-act-1989.pdf, p.340
note: Secretary must take advice into account when making a decision on an application.
asserts: therapeutic-goods-act-1989-sec-32du-norm
asserts: therapeutic-goods-act-1989-sec-32du-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32du-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32du
schema version: 2

therapeutic-goods-act-1989-sec-32du-logic-deontic-1
type: LogicApplication
conclusion text: The Secretary must ensure that the advice is taken into account in making a decision on the application.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must take advice into account.
modality: Deontic
operator: MUST
premise text: The Secretary receives advice from the Gene Technology Regulator.

therapeutic-goods-act-1989-sec-32du-logic-deontic-2
type: LogicApplication
conclusion text: The Secretary must inform the Gene Technology Regulator of the decision on the application.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary informs the Gene Technology Regulator of the decision on the application.
modality: Deontic
operator: MUST
premise text: The Secretary must inform the Gene Technology Regulator of the decision on the application.

therapeutic-goods-act-1989-sec-32du-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32DU Secretary to take advice into account

32E What this Division is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.341
note: Exemptions from automatic conditions for inclusions of biologicals in the Register
asserts: therapeutic-goods-act-1989-sec-32e-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32e
schema version: 2

32EA Conditions applying automatically
type: Concept
source: therapeutic-goods-act-1989.pdf, p.341
note: Allow entry and inspection of premises for authorized persons.
asserts: therapeutic-goods-act-1989-sec-32ea-norm
asserts: therapeutic-goods-act-1989-sec-32ea-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ea-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ea
schema version: 2

therapeutic-goods-act-1989-sec-32ea-logic-alleninterval-2
type: LogicApplication
conclusion text: ...to enter, inspect, and examine at any reasonable time.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Entry is allowed during reasonable hours.
modality: AllenInterval
operator: During
premise text: at any reasonable time

therapeutic-goods-act-1989-sec-32ea-logic-deontic-1
type: LogicApplication
conclusion text: ...to allow an authorised person to enter, inspect, and examine.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Grant permission for entry and inspection.
modality: Deontic
operator: Allow
premise text: The person in relation to whom the biological is included in the Register...

therapeutic-goods-act-1989-sec-32ea-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32EA Conditions applying automatically

32EB Certification of manufacturing steps outside Australia
type: Concept
source: therapeutic-goods-act-1989.pdf, p.345
curation status: Proposed
has part: 32EB(1) Certification of manufacturing steps outside Australia
has part: 32EB(2) Certification of manufacturing steps outside Australia
has part: 32EB(3) Certification of manufacturing steps outside Australia
proposed by: legis2cml
realized by: sec-32eb
schema version: 2

32EB(1) Certification of manufacturing steps outside Australia
type: Concept
source: therapeutic-goods-act-1989.pdf, p.345
note: Application for certification of manufacturing steps outside Australia
asserts: therapeutic-goods-act-1989-sec-32eb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32eb-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32eb-ss-1
schema version: 2
part of: 32EB Certification of manufacturing steps outside Australia

therapeutic-goods-act-1989-sec-32eb-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to apply for certification
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-32eb-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32EB(1) Certification of manufacturing steps outside Australia

32EB(2) Certification of manufacturing steps outside Australia
type: Concept
description: written notice
source: therapeutic-goods-act-1989.pdf, p.345
note: Secretary must certify manufacturing procedures upon request.
asserts: therapeutic-goods-act-1989-sec-32eb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32eb-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32eb-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32eb-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32eb-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-32eb-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32eb-ss-2
schema version: 2
part of: 32EB Certification of manufacturing steps outside Australia

therapeutic-goods-act-1989-sec-32eb-ss-2-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Certification is within a specific time frame
modality: AllenInterval
operator: BETWEEN
premise text: (2) If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable.

therapeutic-goods-act-1989-sec-32eb-ss-2-logic-cogai-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Certification is a form of artificial intelligence
modality: CogAI
operator: IS_A
premise text: (2) If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable.

therapeutic-goods-act-1989-sec-32eb-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: The Secretary must give the person written notice of the certification.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide written notice
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32eb-ss-2-logic-diffusion-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Certification is a form of diffusion
modality: Diffusion
operator: IS_A
premise text: (2) If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable.

therapeutic-goods-act-1989-sec-32eb-ss-2-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Certification is within a specific time frame
modality: LTL
operator: BETWEEN
premise text: (2) If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable.

therapeutic-goods-act-1989-sec-32eb-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32EB(2) Certification of manufacturing steps outside Australia

32EB(3) Certification of manufacturing steps outside Australia
type: Concept
source: therapeutic-goods-act-1989.pdf, p.345
note: Applying subsections for certification decision
asserts: therapeutic-goods-act-1989-sec-32eb-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32eb-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32eb-ss-3
schema version: 2
part of: 32EB Certification of manufacturing steps outside Australia

therapeutic-goods-act-1989-sec-32eb-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Decision made under subsections
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Applying relevant rules
modality: Deontic
operator: apply
premise text: Subsections apply for certification decision

therapeutic-goods-act-1989-sec-32eb-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32EB(3) Certification of manufacturing steps outside Australia

32EC Imposition of conditions by legislative instrument
type: Concept
source: therapeutic-goods-act-1989.pdf, p.345
curation status: Proposed
has part: 32EC(1) Imposition of conditions by legislative instrument
has part: 32EC(2) Imposition of conditions by legislative instrument
has part: 32EC(3) Imposition of conditions by legislative instrument
proposed by: legis2cml
realized by: sec-32ec
schema version: 2

32EC(1) Imposition of conditions by legislative instrument
type: Concept
source: therapeutic-goods-act-1989.pdf, p.345
note: Conditions for inclusion of a biological in the Register
asserts: therapeutic-goods-act-1989-sec-32ec-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32ec-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ec-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32ec-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32ec-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-32ec-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ec-ss-1
schema version: 2
part of: 32EC Imposition of conditions by legislative instrument

therapeutic-goods-act-1989-sec-32ec-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Conditions apply during the process of inclusion
modality: AllenInterval
operator: during
premise text: (1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2).

therapeutic-goods-act-1989-sec-32ec-ss-1-logic-cogai-5
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Applies to the process of inclusion
modality: CogAI
operator: appliesTo
premise text: (1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2).

therapeutic-goods-act-1989-sec-32ec-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes conditions on inclusion of a biological in the Register
modality: Deontic
operator: imposes
premise text: (1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2).

therapeutic-goods-act-1989-sec-32ec-ss-1-logic-diffusion-4
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Applies to the process of inclusion
modality: Diffusion
operator: appliesTo
premise text: (1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2).

therapeutic-goods-act-1989-sec-32ec-ss-1-logic-ltl-3
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Conditions apply during the process of inclusion
modality: LTL
operator: during
premise text: (1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2).

therapeutic-goods-act-1989-sec-32ec-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32EC(1) Imposition of conditions by legislative instrument

32EC(2) Imposition of conditions by legislative instrument
type: Concept
source: therapeutic-goods-act-1989.pdf, p.345
note: Minister may impose conditions on the manufacture, custody, use, supply, disposal or destruction of a biological.
asserts: therapeutic-goods-act-1989-sec-32ec-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ec-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32ec-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ec-ss-2
schema version: 2
part of: 32EC Imposition of conditions by legislative instrument

therapeutic-goods-act-1989-sec-32ec-ss-2-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal intervals for conditions
modality: AllenInterval
operator: between
premise text: (2) The Minister may, by legislative instrument, make a determination setting out conditions for the purposes of subsection (1);

therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposition of conditions
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Conditions for the biological
modality: Deontic
operator: must be met
premise text: (a) the manufacture of the biological; or (b) the custody, use, supply, disposal or destruction of the biological;

therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Reporting requirements for the biological
modality: Deontic
operator: must be met
premise text: (ca) reporting requirements relating to the biological;

therapeutic-goods-act-1989-sec-32ec-ss-2-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal scope of conditions
modality: LTL
operator: for all
premise text: (2) The Minister may, by legislative instrument, make a determination setting out conditions for the purposes of subsection (1);

therapeutic-goods-act-1989-sec-32ec-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32EC(2) Imposition of conditions by legislative instrument

32EC(3) Imposition of conditions by legislative instrument
type: Concept
source: therapeutic-goods-act-1989.pdf, p.345
note: Different conditions may be specified for different classes of biologicals.
asserts: therapeutic-goods-act-1989-sec-32ec-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ec-ss-3
schema version: 2
part of: 32EC Imposition of conditions by legislative instrument

therapeutic-goods-act-1989-sec-32ec-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32EC(3) Imposition of conditions by legislative instrument

32ED Imposition of conditions at time biological included in the
type: Concept
source: therapeutic-goods-act-1989.pdf, p.346
curation status: Proposed
has part: 32ED(1) Imposition of conditions at time biological included in the
has part: 32ED(2) Imposition of conditions at time biological included in the
proposed by: legis2cml
realized by: sec-32ed
schema version: 2

32ED(1) Imposition of conditions at time biological included in the
type: Concept
source: therapeutic-goods-act-1989.pdf, p.346
note: Secretary may impose conditions on inclusion of biological in Register
asserts: therapeutic-goods-act-1989-sec-32ed-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32ed-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ed-ss-1-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ed-ss-1
schema version: 2
part of: 32ED Imposition of conditions at time biological included in the

therapeutic-goods-act-1989-sec-32ed-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-32ed-ss-1-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Includes biological in Register
modality: DescriptionLogic
operator: includes

therapeutic-goods-act-1989-sec-32ed-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32ED(1) Imposition of conditions at time biological included in the

32ED(2) Imposition of conditions at time biological included in the
type: Concept
source: therapeutic-goods-act-1989.pdf, p.346
note: A notice under subsection (1) is not a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-32ed-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32ed-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ed-ss-2
schema version: 2
part of: 32ED Imposition of conditions at time biological included in the

therapeutic-goods-act-1989-sec-32ed-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: A notice under subsection (1) is not a legislative instrument.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Negative obligation
modality: Deontic
operator: not
premise text: A notice under subsection (1) is a legislative instrument.

32EE Imposition or variation or removal of conditions after
type: Concept
source: therapeutic-goods-act-1989.pdf, p.346
curation status: Proposed
has part: 32EE(1) Imposition or variation or removal of conditions after
has part: 32EE(2) Imposition or variation or removal of conditions after
has part: 32EE(3) Imposition or variation or removal of conditions after
has part: 32EE(3A) Imposition or variation or removal of conditions after
has part: 32EE(4) Imposition or variation or removal of conditions after
proposed by: legis2cml
realized by: sec-32ee
schema version: 2

32EE(1) Imposition or variation or removal of conditions after
type: Concept
source: therapeutic-goods-act-1989.pdf, p.346
note: Secretary may impose new conditions on biological inclusion
asserts: therapeutic-goods-act-1989-sec-32ee-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32ee-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ee-ss-1
schema version: 2
part of: 32EE Imposition or variation or removal of conditions after

therapeutic-goods-act-1989-sec-32ee-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-32ee-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32EE(1) Imposition or variation or removal of conditions after

32EE(2) Imposition or variation or removal of conditions after
type: Concept
description: fee
source: therapeutic-goods-act-1989.pdf, p.346
note: Request must be accompanied by prescribed fee.
asserts: therapeutic-goods-act-1989-sec-32ee-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32ee-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ee-ss-2
schema version: 2
part of: 32EE Imposition or variation or removal of conditions after

therapeutic-goods-act-1989-sec-32ee-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: fee must be provided
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide fee
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32ee-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32EE(2) Imposition or variation or removal of conditions after

32EE(3) Imposition or variation or removal of conditions after
type: Concept
source: therapeutic-goods-act-1989.pdf, p.346
note: Conditions for imposition or variation of conditions after notice is given to the person.
asserts: therapeutic-goods-act-1989-sec-32ee-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32ee-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ee-ss-3-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32ee-ss-3-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32ee-ss-3-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ee-ss-3
schema version: 2
part of: 32EE Imposition or variation or removal of conditions after

therapeutic-goods-act-1989-sec-32ee-ss-3-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Notice specifies start date for imposition or variation.
modality: AllenInterval
operator: within interval
premise text: (aa) in the case of an imposition or variation requested by the person, and to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 28 days after the notice is given to the person;

therapeutic-goods-act-1989-sec-32ee-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposition or variation takes effect on specified day.
modality: Deontic
operator: takes effect
premise text: (3) The imposition or variation or removal of a condition under subsection (1) takes effect:

therapeutic-goods-act-1989-sec-32ee-ss-3-logic-deontic-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Person must agree to earlier start date for imposition or variation.
modality: Deontic
operator: must provide
premise text: unless the person has agreed to an earlier day;

therapeutic-goods-act-1989-sec-32ee-ss-3-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Notice specifies recurring pattern for imposition or variation.
modality: LTL
operator: recurring trace
premise text: (ab) in the case of a removal to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person has agreed to an earlier day;

32EE(3A) Imposition or variation or removal of conditions after
type: Concept
source: therapeutic-goods-act-1989.pdf, p.346
note: The earlier day must not be earlier than the day the notice is given to the person.
asserts: therapeutic-goods-act-1989-sec-32ee-ss-3a-norm
asserts: therapeutic-goods-act-1989-sec-32ee-ss-3a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ee-ss-3a-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ee-ss-3a
schema version: 2
part of: 32EE Imposition or variation or removal of conditions after

therapeutic-goods-act-1989-sec-32ee-ss-3a-logic-alleninterval-2
type: LogicApplication
conclusion text: The notice must be given on or after the day before the given day.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation
modality: AllenInterval
operator: =
premise text: The earlier day is a temporal interval before the given day.

therapeutic-goods-act-1989-sec-32ee-ss-3a-logic-deontic-1
type: LogicApplication
conclusion text: The notice must be given on or after the given day.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Temporal constraint
modality: Deontic
operator: >=
premise text: The earlier day must not be earlier than the given day.

therapeutic-goods-act-1989-sec-32ee-ss-3a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32EE(3A) Imposition or variation or removal of conditions after

32EE(4) Imposition or variation or removal of conditions after
type: Concept
source: therapeutic-goods-act-1989.pdf, p.346
note: Legislative instrument notice is not a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-32ee-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32ee-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ee-ss-4
schema version: 2
part of: 32EE Imposition or variation or removal of conditions after

therapeutic-goods-act-1989-sec-32ee-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits notices from being legislative instruments.
modality: Deontic
operator: Prohibition

32EF Criminal offences for breach of condition
type: Concept
source: therapeutic-goods-act-1989.pdf, p.347
curation status: Proposed
has part: 32EF(1) Criminal offences for breach of condition
has part: 32EF(4) Criminal offences for breach of condition
has part: 32EF(5) Criminal offences for breach of condition
proposed by: legis2cml
realized by: sec-32ef
schema version: 2

32EF(1) Criminal offences for breach of condition
type: Concept
source: therapeutic-goods-act-1989.pdf, p.347
note: Breach of condition results in harm or injury to any person.
asserts: therapeutic-goods-act-1989-sec-32ef-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32ef-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ef-ss-1
schema version: 2
part of: 32EF Criminal offences for breach of condition

therapeutic-goods-act-1989-sec-32ef-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: Prohibits breach of condition.
modality: Deontic
operator: Prohibition
premise text: (1) A person commits an offence if: (a) a biological is included in the Register in relation to the person; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the inclusion of the biological in the Register; and (d) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.

32EF(4) Criminal offences for breach of condition
type: Concept
source: therapeutic-goods-act-1989.pdf, p.347
note: Breach of condition results in criminal offence
asserts: therapeutic-goods-act-1989-sec-32ef-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32ef-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ef-ss-4-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-32ef-ss-4-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-32ef-ss-4-logic-ltl-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ef-ss-4
schema version: 2
part of: 32EF Criminal offences for breach of condition

therapeutic-goods-act-1989-sec-32ef-ss-4-logic-alleninterval-3
type: LogicApplication
conclusion text: The person commits an offence if...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for breach of conditions
modality: AllenInterval
operator: Between
premise text: (c) the act or omission breaches a condition of the inclusion of the biological in the Register.

therapeutic-goods-act-1989-sec-32ef-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: Obligation to comply with conditions
modality: Deontic
operator: Obligation
premise text: (a) a biological is included in the Register in relation to the person; and (b) the person does an act or omits to do an act;

therapeutic-goods-act-1989-sec-32ef-ss-4-logic-deontic-2
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: Prohibition on breach of conditions
modality: Deontic
operator: Prohibition
premise text: (c) the act or omission breaches a condition of the inclusion of the biological in the Register.

therapeutic-goods-act-1989-sec-32ef-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: Temporal constraint on breach of conditions
modality: LTL
operator: Until
premise text: (c) the act or omission breaches a condition of the inclusion of the biological in the Register.

therapeutic-goods-act-1989-sec-32ef-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32EF(4) Criminal offences for breach of condition

32EF(5) Criminal offences for breach of condition
type: Concept
source: therapeutic-goods-act-1989.pdf, p.347
note: Breach of condition results in criminal offence
asserts: therapeutic-goods-act-1989-sec-32ef-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32ef-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ef-ss-5
schema version: 2
part of: 32EF Criminal offences for breach of condition

therapeutic-goods-act-1989-sec-32ef-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits breach of condition
modality: Deontic
operator: Prohibition

32EG Civil penalty for breach of condition
type: Concept
source: therapeutic-goods-act-1989.pdf, p.348
note: Civil penalty for breach of condition
asserts: therapeutic-goods-act-1989-sec-32eg-norm
asserts: therapeutic-goods-act-1989-sec-32eg-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32eg-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-32eg-logic-linearlogic-3
asserts: therapeutic-goods-act-1989-sec-32eg-logic-alleninterval-4
asserts: therapeutic-goods-act-1989-sec-32eg-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32eg
schema version: 2

therapeutic-goods-act-1989-sec-32eg-logic-alleninterval-4
type: LogicApplication
conclusion text: ...breaches a condition...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Indicates temporal interval for breach of condition
modality: AllenInterval
operator: Within
premise text: (a) a biological is included in the Register in relation to the person; and (b) the person does an act or omits to do an act;

therapeutic-goods-act-1989-sec-32eg-logic-deontic-1
type: LogicApplication
conclusion text: ...breaches a condition of the inclusion of the biological in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits breach of condition
modality: Deontic
operator: Prohibit
premise text: A person contravenes this section if...

therapeutic-goods-act-1989-sec-32eg-logic-deontic-2
type: LogicApplication
conclusion text: ...for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits breach of condition for individuals and bodies corporate
modality: Deontic
operator: Prohibit
premise text: Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units.

therapeutic-goods-act-1989-sec-32eg-logic-deontic-5
type: LogicApplication
conclusion text: ...for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits breach of condition for individuals and bodies corporate
modality: Deontic
operator: Prohibit
premise text: (a) for an individual—5,000 penalty units; (b) for a body corporate—50,000 penalty units.

therapeutic-goods-act-1989-sec-32eg-logic-linearlogic-3
type: LogicApplication
conclusion text: ...breaches a condition...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Implicates breach of condition on inclusion in Register
modality: LinearLogic
operator: Imply
premise text: (a) a biological is included in the Register in relation to the person; and (b) the person does an act or omits to do an act;

therapeutic-goods-act-1989-sec-32eg-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32EG Civil penalty for breach of condition

32F What this Division is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.349
note: The Secretary may suspend biologicals from the Register in certain circumstances.
asserts: therapeutic-goods-act-1989-sec-32f-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32f
schema version: 2

therapeutic-goods-act-1989-sec-32f-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32F What this Division is about

32FA Suspension of biological from the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.349
curation status: Proposed
has part: 32FA(1) Suspension of biological from the Register
has part: 32FA(2) Suspension of biological from the Register
proposed by: legis2cml
realized by: sec-32fa
schema version: 2

32FA(1) Suspension of biological from the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.349
note: Suspension of biological from the Register is allowed under certain conditions.
asserts: therapeutic-goods-act-1989-sec-32fa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32fa-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32fa-ss-1
schema version: 2
part of: 32FA Suspension of biological from the Register

therapeutic-goods-act-1989-sec-32fa-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits suspension of biological from the Register.
modality: Deontic
operator: Prohibit
premise text: (1) The Secretary may, by written notice given to a person in relation to whom a biological is included in the Register...

therapeutic-goods-act-1989-sec-32fa-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32FA(1) Suspension of biological from the Register

32FA(2) Suspension of biological from the Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.349
note: Secretary must suspend biological from Register before cancelling entry under section 32GC
asserts: therapeutic-goods-act-1989-sec-32fa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32fa-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32fa-ss-2
schema version: 2
part of: 32FA Suspension of biological from the Register

therapeutic-goods-act-1989-sec-32fa-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Duty to suspend biological from Register
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32fa-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32FA(2) Suspension of biological from the Register

32FB When suspension takes effect etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.350
curation status: Proposed
has part: 32FB(1) When suspension takes effect etc.
has part: 32FB(2) When suspension takes effect etc.
has part: 32FB(3) When suspension takes effect etc.
has part: 32FB(4) When suspension takes effect etc.
has part: 32FB(5) When suspension takes effect etc.
proposed by: legis2cml
realized by: sec-32fb
schema version: 2

32FB(1) When suspension takes effect etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.350
note: Suspension of therapeutic goods takes effect under certain conditions.
asserts: therapeutic-goods-act-1989-sec-32fb-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32fb-ss-1
schema version: 2
part of: 32FB When suspension takes effect etc.

32FB(2) When suspension takes effect etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.350
note: Suspension duration
asserts: therapeutic-goods-act-1989-sec-32fb-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32fb-ss-2
schema version: 2
part of: 32FB When suspension takes effect etc.

32FB(3) When suspension takes effect etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.350
note: Secretary may extend period specified under subsection 32FA(4) by a further specified period not exceeding 6 months.
asserts: therapeutic-goods-act-1989-sec-32fb-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32fb-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32fb-ss-3
schema version: 2
part of: 32FB When suspension takes effect etc.

therapeutic-goods-act-1989-sec-32fb-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to extend period
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-32fb-ss-3-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32FB(3) When suspension takes effect etc.

32FB(4) When suspension takes effect etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.350
note: Publish notice of extension particulars
asserts: therapeutic-goods-act-1989-sec-32fb-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32fb-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32fb-ss-4
schema version: 2
part of: 32FB When suspension takes effect etc.

therapeutic-goods-act-1989-sec-32fb-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must publish notice
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32fb-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32FB(4) When suspension takes effect etc.

32FB(5) When suspension takes effect etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.350
note: Notice under subsection (3) is not a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-32fb-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32fb-ss-5
schema version: 2
part of: 32FB When suspension takes effect etc.

therapeutic-goods-act-1989-sec-32fb-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32FB(5) When suspension takes effect etc.

32FC Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.351
curation status: Proposed
has part: 32FC(1) Revocation of suspension
has part: 32FC(2) Revocation of suspension
proposed by: legis2cml
realized by: sec-32fc
schema version: 2

32FC(1) Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.351
note: Secretary must revoke suspension under certain conditions.
asserts: therapeutic-goods-act-1989-sec-32fc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32fc-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32fc-ss-1
schema version: 2
part of: 32FC Revocation of suspension

therapeutic-goods-act-1989-sec-32fc-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Revocation required
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must revoke suspension
modality: Deontic
operator: Must
premise text: Ground on which biological was suspended no longer applies

therapeutic-goods-act-1989-sec-32fc-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32FC(1) Revocation of suspension

32FC(2) Revocation of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.351
note: Exercise of power by Secretary
asserts: therapeutic-goods-act-1989-sec-32fc-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32fc-ss-2
schema version: 2
part of: 32FC Revocation of suspension

therapeutic-goods-act-1989-sec-32fc-ss-2-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32FC(2) Revocation of suspension

32FD Effect of suspension
type: Concept
source: therapeutic-goods-act-1989.pdf, p.352
note: Dealing in a biological not included in the Register may be a criminal offence or contravene a civil penalty provision.
asserts: therapeutic-goods-act-1989-sec-32fd-norm
asserts: therapeutic-goods-act-1989-sec-32fd-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32fd
schema version: 2

therapeutic-goods-act-1989-sec-32fd-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits dealing in a biological not included in the Register.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-32fd-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32FD Effect of suspension

32G What this Division is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.353
note: Secretary may cancel inclusions of biologicals in the Register under certain circumstances.
asserts: therapeutic-goods-act-1989-sec-32g-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32g
schema version: 2

32GA Immediate cancellation of biological from the Register in
type: Concept
source: therapeutic-goods-act-1989.pdf, p.353
note: Cancellation of biological entry from Register under specified circumstances.
asserts: therapeutic-goods-act-1989-sec-32ga-norm
asserts: therapeutic-goods-act-1989-sec-32ga-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ga-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ga
schema version: 2

therapeutic-goods-act-1989-sec-32ga-logic-alleninterval-2
type: LogicApplication
conclusion text: The cancellation is effective from the date of notice.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for cancellation
modality: AllenInterval
operator: Temporal Interval
premise text: The cancellation is effective immediately.

therapeutic-goods-act-1989-sec-32ga-logic-deontic-1
type: LogicApplication
conclusion text: The entry must be cancelled.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on biological entry
modality: Deontic
operator: Prohibit
premise text: The Secretary may cancel the entry of a biological from the Register.

therapeutic-goods-act-1989-sec-32ga-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32GA Immediate cancellation of biological from the Register in

32GB Immediate cancellation of biological from the Register after
type: Concept
source: therapeutic-goods-act-1989.pdf, p.355
curation status: Proposed
has part: 32GB(1) Immediate cancellation of biological from the Register after
has part: 32GB(2) Immediate cancellation of biological from the Register after
proposed by: legis2cml
realized by: sec-32gb
schema version: 2

32GB(1) Immediate cancellation of biological from the Register after
type: Concept
source: therapeutic-goods-act-1989.pdf, p.355
note: The Secretary may cancel a biological entry from the Register if the person fails to comply with a notice.
asserts: therapeutic-goods-act-1989-sec-32gb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32gb-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32gb-ss-1
schema version: 2
part of: 32GB Immediate cancellation of biological from the Register after

therapeutic-goods-act-1989-sec-32gb-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary has an obligation to cancel the biological entry.
modality: Deontic
operator: obligation

therapeutic-goods-act-1989-sec-32gb-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32GB(1) Immediate cancellation of biological from the Register after

32GB(2) Immediate cancellation of biological from the Register after
type: Concept
description: Notice under section 32JA
source: therapeutic-goods-act-1989.pdf, p.355
note: Secretary must provide notice to person before cancelling biological entry from Register.
asserts: therapeutic-goods-act-1989-sec-32gb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32gb-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32gb-ss-2
schema version: 2
part of: 32GB Immediate cancellation of biological from the Register after

therapeutic-goods-act-1989-sec-32gb-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must provide notice
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32gb-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32GB(2) Immediate cancellation of biological from the Register after

32GC Cancellation of biological from the Register after notice of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.356
curation status: Proposed
has part: 32GC(1) Cancellation of biological from the Register after notice of
has part: 32GC(2) Cancellation of biological from the Register after notice of
has part: 32GC(3) Cancellation of biological from the Register after notice of
has part: 32GC(4) Cancellation of biological from the Register after notice of
proposed by: legis2cml
realized by: sec-32gc
schema version: 2

32GC(1) Cancellation of biological from the Register after notice of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.356
note: Cancellation of biological from the Register after notice of unacceptable quality, safety or efficacy.
asserts: therapeutic-goods-act-1989-sec-32gc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32gc-ss-1
schema version: 2
part of: 32GC Cancellation of biological from the Register after notice of

therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The person must not include the biological in the Register.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition
modality: Deontic
operator: Prohibit
premise text: The Secretary may cancel the entry of the biological from the Register.

therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: The person must not advertise the biological.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of advertising
modality: Deontic
operator: Prohibit
premise text: The person contravenes subsection 32DQ(1) or (2) in relation to the biological.

therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-3
type: LogicApplication
conclusion text: The related body corporate must not advertise the biological.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of advertising by related body corporate
modality: Deontic
operator: Prohibit
premise text: If the person is a body corporate, a related body corporate contravenes a direction or condition given to the related body corporate under subsection 42DV(1) in relation to the advertising of the biological.

therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: The person must comply with the Therapeutic Goods Advertising Code.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of non-compliance with Therapeutic Goods Advertising Code
modality: Deontic
operator: Prohibit
premise text: Either of the following has not been complied with in relation to the biological: an applicable provision of the Therapeutic Goods Advertising Code; any other requirement relating to advertising applicable under Part 5-1 or under the regulations.

therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-5
type: LogicApplication
conclusion text: The person must comply with regulatory requirements.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of non-compliance with regulatory requirements
modality: Deontic
operator: Prohibit
premise text: The person contravenes subsection 32DQ(1) or (2) in relation to the biological.

therapeutic-goods-act-1989-sec-32gc-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32GC(1) Cancellation of biological from the Register after notice of

32GC(2) Cancellation of biological from the Register after notice of
type: Concept
description: written notice, written submissions
source: therapeutic-goods-act-1989.pdf, p.356
note: Secretary must inform person of proposed cancellation and invite written submissions.
asserts: therapeutic-goods-act-1989-sec-32gc-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32gc-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32gc-ss-2-logic-epistemic-2
asserts: therapeutic-goods-act-1989-sec-32gc-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32gc-ss-2-logic-argumentation-4
asserts: therapeutic-goods-act-1989-sec-32gc-ss-2-logic-alleninterval-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32gc-ss-2
schema version: 2
part of: 32GC Cancellation of biological from the Register after notice of

therapeutic-goods-act-1989-sec-32gc-ss-2-logic-alleninterval-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Cancellation period is specified as a duration after notice.
modality: AllenInterval
operator: DURING
premise text: 28 days after day notice is given.

therapeutic-goods-act-1989-sec-32gc-ss-2-logic-argumentation-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Person must provide written submissions in response to notice.
modality: Argumentation
operator: REQUIRES

therapeutic-goods-act-1989-sec-32gc-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must inform person of proposed cancellation.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32gc-ss-2-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Secretary is obligated to inform person of proposed cancellation.
modality: Epistemic
operator: OBLIGES

therapeutic-goods-act-1989-sec-32gc-ss-2-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Cancellation must be made within a specified period after notice.
modality: LTL
operator: CONTAINS
premise text: 28 days after day notice is given.

therapeutic-goods-act-1989-sec-32gc-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32GC(2) Cancellation of biological from the Register after notice of

32GC(3) Cancellation of biological from the Register after notice of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.356
note: Secretary must consider submissions before making a decision on cancellation.
asserts: therapeutic-goods-act-1989-sec-32gc-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32gc-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32gc-ss-3
schema version: 2
part of: 32GC Cancellation of biological from the Register after notice of

therapeutic-goods-act-1989-sec-32gc-ss-3-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-32gc-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32GC(3) Cancellation of biological from the Register after notice of

32GC(4) Cancellation of biological from the Register after notice of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.356
note: A notice under subsection (1) must not be a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-32gc-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32gc-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32gc-ss-4
schema version: 2
part of: 32GC Cancellation of biological from the Register after notice of

therapeutic-goods-act-1989-sec-32gc-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of notice being a legislative instrument.
modality: Deontic
operator: MustNot

therapeutic-goods-act-1989-sec-32gc-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32GC(4) Cancellation of biological from the Register after notice of

32GD Revocation of cancellation of biological upon request
type: Concept
description: Application fee
source: therapeutic-goods-act-1989.pdf, p.357
note: Request for revocation of cancellation of biological upon request
asserts: therapeutic-goods-act-1989-sec-32gd-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32gd
schema version: 2

therapeutic-goods-act-1989-sec-32gd-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32GD Revocation of cancellation of biological upon request

32GE Publication of cancellation of entry from Register
type: Concept
description: Notice with particulars of cancellation
source: therapeutic-goods-act-1989.pdf, p.358
note: Publish notice of cancellation from Register
asserts: therapeutic-goods-act-1989-sec-32ge-norm
asserts: therapeutic-goods-act-1989-sec-32ge-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ge
schema version: 2

therapeutic-goods-act-1989-sec-32ge-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Publish notice
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32ge-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32GE Publication of cancellation of entry from Register

32GF Date of effect of cancellation of entries from Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.359
note: Date of effect of cancellation of entries from Register
asserts: therapeutic-goods-act-1989-sec-32gf-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32gf
schema version: 2

32H What this Division is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.360
note: The Secretary may require a person to recall biologicals or inform the public about non-compliant biologicals.
asserts: therapeutic-goods-act-1989-sec-32h-norm
asserts: therapeutic-goods-act-1989-sec-32h-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32h
schema version: 2

therapeutic-goods-act-1989-sec-32h-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes a duty on the Secretary to require recall or notification.
modality: Deontic
operator: require

therapeutic-goods-act-1989-sec-32h-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32H What this Division is about

32HA Public notification, and recall, of biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.360
note: The Secretary may impose requirements on a person supplying a biological if certain circumstances occur.
asserts: therapeutic-goods-act-1989-sec-32ha-norm
asserts: therapeutic-goods-act-1989-sec-32ha-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ha
schema version: 2

therapeutic-goods-act-1989-sec-32ha-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposition of requirements is an obligation.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-32ha-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32HA Public notification, and recall, of biologicals

32HB Publication of requirements
type: Concept
description: Notice setting out particulars of the requirement
source: therapeutic-goods-act-1989.pdf, p.364
note: Secretary must publish notice after imposing requirement.
asserts: therapeutic-goods-act-1989-sec-32hb-norm
asserts: therapeutic-goods-act-1989-sec-32hb-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32hb
schema version: 2

therapeutic-goods-act-1989-sec-32hb-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-32hb-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32HB Publication of requirements

32HC Criminal offences for non-compliance with requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
curation status: Proposed
has part: 32HC(1) Criminal offences for non-compliance with requirements
has part: 32HC(4) Criminal offences for non-compliance with requirements
has part: 32HC(5) Criminal offences for non-compliance with requirements
has part: 32HC(6) Criminal offences for non-compliance with requirements
proposed by: legis2cml
realized by: sec-32hc
schema version: 2

32HC(1) Criminal offences for non-compliance with requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Non-compliance with requirements is a criminal offence.
asserts: therapeutic-goods-act-1989-sec-32hc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32hc-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32hc-ss-1
schema version: 2
part of: 32HC Criminal offences for non-compliance with requirements

therapeutic-goods-act-1989-sec-32hc-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits non-compliance with requirements.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-32hc-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32HC(1) Criminal offences for non-compliance with requirements

32HC(4) Criminal offences for non-compliance with requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Non-compliance with section 32HA requirements is an offence.
asserts: therapeutic-goods-act-1989-sec-32hc-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32hc-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32hc-ss-4
schema version: 2
part of: 32HC Criminal offences for non-compliance with requirements

therapeutic-goods-act-1989-sec-32hc-ss-4-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: Definition of obligation
modality: Deontic
operator: is

therapeutic-goods-act-1989-sec-32hc-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32HC(4) Criminal offences for non-compliance with requirements

32HC(5) Criminal offences for non-compliance with requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Offence for non-compliance with requirements
asserts: therapeutic-goods-act-1989-sec-32hc-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32hc-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32hc-ss-5
schema version: 2
part of: 32HC Criminal offences for non-compliance with requirements

therapeutic-goods-act-1989-sec-32hc-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits non-compliance with requirements
modality: Deontic
operator: Prohibition

32HC(6) Criminal offences for non-compliance with requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.364
note: Offence of strict liability for non-compliance with requirements
asserts: therapeutic-goods-act-1989-sec-32hc-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-32hc-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32hc-ss-6
schema version: 2
part of: 32HC Criminal offences for non-compliance with requirements

therapeutic-goods-act-1989-sec-32hc-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: An offence of strict liability
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Definition of strict liability
modality: Deontic
operator: is
premise text: (6) An offence against subsection (5)

therapeutic-goods-act-1989-sec-32hc-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32HC(6) Criminal offences for non-compliance with requirements

32HD Civil penalty for non-compliance with requirements
type: Concept
source: therapeutic-goods-act-1989.pdf, p.365
note: Civil penalty for non-compliance with requirements
asserts: therapeutic-goods-act-1989-sec-32hd-norm
asserts: therapeutic-goods-act-1989-sec-32hd-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32hd
schema version: 2

therapeutic-goods-act-1989-sec-32hd-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits civil penalty for non-compliance
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-32hd-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32HD Civil penalty for non-compliance with requirements

32HE Powers of suspension and cancellation unaffected
type: Concept
source: therapeutic-goods-act-1989.pdf, p.365
note: Powers of suspension and cancellation unaffected
asserts: therapeutic-goods-act-1989-sec-32he-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32he
schema version: 2

32HF Saving of other laws
type: Concept
source: therapeutic-goods-act-1989.pdf, p.365
note: No exclusion or limitation of other laws
asserts: therapeutic-goods-act-1989-sec-32hf-norm
asserts: therapeutic-goods-act-1989-sec-32hf-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32hf
schema version: 2

therapeutic-goods-act-1989-sec-32hf-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibiting exclusion
modality: Deontic
operator: prohibition

32J What this Division is about
type: Concept
source: therapeutic-goods-act-1989.pdf, p.366
note: The Secretary may seek information or documents from applicants, biologicals included in the Register, and suppliers of exempted biologicals.
asserts: therapeutic-goods-act-1989-sec-32j-norm
asserts: therapeutic-goods-act-1989-sec-32j-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32j-logic-epistemic-2
asserts: therapeutic-goods-act-1989-sec-32j-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32j-logic-argumentation-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-32j
schema version: 2

therapeutic-goods-act-1989-sec-32j-logic-argumentation-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: There are criminal offences for failing to comply with a notice and civil penalties for giving false or misleading information or documents.
modality: Argumentation
operator: for

therapeutic-goods-act-1989-sec-32j-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary may seek information or documents.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-32j-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: There are penalties for failing to comply with a notice.
modality: Epistemic
operator: must provide

therapeutic-goods-act-1989-sec-32j-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The Secretary may seek information or documents from applicants, biologicals included in the Register, and suppliers of exempted biologicals.
modality: LTL
operator: for

therapeutic-goods-act-1989-sec-32j-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32J What this Division is about

32JA Secretary may require information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.366
note: The Secretary may require information or documents from a person.
asserts: therapeutic-goods-act-1989-sec-32ja-norm
asserts: therapeutic-goods-act-1989-sec-32ja-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ja
schema version: 2

therapeutic-goods-act-1989-sec-32ja-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: May require
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-32ja-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JA Secretary may require information or documents

32JB Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.368
curation status: Proposed
has part: 32JB(1) Criminal offences for failing to comply with a notice etc.
has part: 32JB(1A) Criminal offences for failing to comply with a notice etc.
has part: 32JB(1B) Criminal offences for failing to comply with a notice etc.
has part: 32JB(1C) Criminal offences for failing to comply with a notice etc.
has part: 32JB(1D) Criminal offences for failing to comply with a notice etc.
has part: 32JB(2) Criminal offences for failing to comply with a notice etc.
proposed by: legis2cml
realized by: sec-32jb
schema version: 2

32JB(1) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.368
note: Failure to comply with a notice results in an offence.
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jb-ss-1
schema version: 2
part of: 32JB Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-32jb-ss-1-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: Prohibit

therapeutic-goods-act-1989-sec-32jb-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JB(1) Criminal offences for failing to comply with a notice etc.

32JB(1A) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.368
note: Defendant bears evidential burden for reasonable excuse
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1a-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jb-ss-1a
schema version: 2
part of: 32JB Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-32jb-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Defendant has an obligation to provide a reasonable excuse
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-32jb-ss-1a-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Defendant bears the burden of proof for their excuse
modality: Epistemic
operator: Burden of Proof

therapeutic-goods-act-1989-sec-32jb-ss-1a-norm
type: Obligation
scope note: borne by: NaturalPerson
curation status: Proposed
modality: Deontic
borne by: NaturalPerson
deontic status: HeuristicDerived
part of: 32JB(1A) Criminal offences for failing to comply with a notice etc.

32JB(1B) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.368
note: Failure to comply with a notice results in an offence.
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1b-norm
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1b-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1b-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1b-logic-alleninterval-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jb-ss-1b
schema version: 2
part of: 32JB Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-32jb-ss-1b-logic-alleninterval-3
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines the temporal interval during which the obligation to comply applies.
modality: AllenInterval
operator: Overlaps

therapeutic-goods-act-1989-sec-32jb-ss-1b-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 failing to comply with a notice.
modality: Deontic
operator: Prohibition
premise text: (a) the person is given a notice under section 32JA; and (b) the person is covered by paragraph 32JA(1)(b) or (c); and (c) the person fails to comply with the notice.

therapeutic-goods-act-1989-sec-32jb-ss-1b-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 an obligation to comply with a notice.
modality: Deontic
operator: Obligation
premise text: (c) the person fails to comply with the notice.

therapeutic-goods-act-1989-sec-32jb-ss-1b-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JB(1B) Criminal offences for failing to comply with a notice etc.

32JB(1C) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.368
note: Offence of strict liability for failing to comply with a notice.
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1c-norm
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1c-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jb-ss-1c
schema version: 2
part of: 32JB Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-32jb-ss-1c-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-32jb-ss-1c-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JB(1C) Criminal offences for failing to comply with a notice etc.

32JB(1D) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.368
note: Defendant bears evidential burden for reasonable excuse
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1d-norm
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1d-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1d-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jb-ss-1d
schema version: 2
part of: 32JB Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-32jb-ss-1d-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Bearing of evidential burden
modality: Deontic
operator: has

therapeutic-goods-act-1989-sec-32jb-ss-1d-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Reasonable excuse justification
modality: Epistemic
operator: justification

therapeutic-goods-act-1989-sec-32jb-ss-1d-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 32JB(1D) Criminal offences for failing to comply with a notice etc.

32JB(2) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.368
note: Failure to comply with a notice results in an offence.
asserts: therapeutic-goods-act-1989-sec-32jb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32jb-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jb-ss-2
schema version: 2
part of: 32JB Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-32jb-ss-2-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

32JC Civil penalty for giving false or misleading information or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.370
note: Giving false or misleading information in compliance with a notice is prohibited.
asserts: therapeutic-goods-act-1989-sec-32jc-norm
asserts: therapeutic-goods-act-1989-sec-32jc-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jc
schema version: 2

therapeutic-goods-act-1989-sec-32jc-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 32JA.

therapeutic-goods-act-1989-sec-32jc-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JC Civil penalty for giving false or misleading information or

32JD Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.371
curation status: Proposed
has part: 32JD(1) Self-incrimination
has part: 32JD(2) Self-incrimination
proposed by: legis2cml
realized by: sec-32jd
schema version: 2

32JD(1) Self-incrimination
type: Concept
description: Information or document
source: therapeutic-goods-act-1989.pdf, p.371
note: No excuse for self-incrimination
asserts: therapeutic-goods-act-1989-sec-32jd-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32jd-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jd-ss-1
schema version: 2
part of: 32JD Self-incrimination

therapeutic-goods-act-1989-sec-32jd-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-32jd-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JD(1) Self-incrimination

32JD(2) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.371
note: Exemptions from self-incrimination in certain cases
asserts: therapeutic-goods-act-1989-sec-32jd-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32jd-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jd-ss-2
schema version: 2
part of: 32JD Self-incrimination

therapeutic-goods-act-1989-sec-32jd-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exemptions from self-incrimination
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-32jd-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JD(2) Self-incrimination

32JE Secretary may require information etc. about biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.371
note: Secretary may require information about biologicals from exempt persons.
asserts: therapeutic-goods-act-1989-sec-32je-norm
asserts: therapeutic-goods-act-1989-sec-32je-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32je
schema version: 2

therapeutic-goods-act-1989-sec-32je-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Implies an obligation.
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-32je-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JE Secretary may require information etc. about biologicals

32JF Secretary may require information etc. about biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.373
curation status: Proposed
has part: 32JF(1) Secretary may require information etc. about biologicals
has part: 32JF(2) Secretary may require information etc. about biologicals
has part: 32JF(3) Secretary may require information etc. about biologicals
has part: 32JF(4) Secretary may require information etc. about biologicals
proposed by: legis2cml
realized by: sec-32jf
schema version: 2

32JF(1) Secretary may require information etc. about biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.373
note: Secretary may require information about biologicals
asserts: therapeutic-goods-act-1989-sec-32jf-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32jf-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jf-ss-1
schema version: 2
part of: 32JF Secretary may require information etc. about biologicals

therapeutic-goods-act-1989-sec-32jf-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Requires information from a person
modality: Deontic
operator: requires

therapeutic-goods-act-1989-sec-32jf-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JF(1) Secretary may require information etc. about biologicals

32JF(2) Secretary may require information etc. about biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.373
note: The Secretary may require information or documents from a person.
asserts: therapeutic-goods-act-1989-sec-32jf-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32jf-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jf-ss-2
schema version: 2
part of: 32JF Secretary may require information etc. about biologicals

therapeutic-goods-act-1989-sec-32jf-ss-2-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-32jf-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JF(2) Secretary may require information etc. about biologicals

32JF(3) Secretary may require information etc. about biologicals
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.373
note: Must provide information within a specified period and in a specified form.
asserts: therapeutic-goods-act-1989-sec-32jf-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32jf-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jf-ss-3
schema version: 2
part of: 32JF Secretary may require information etc. about biologicals

therapeutic-goods-act-1989-sec-32jf-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide information within a specified period and in a specified form.
modality: Deontic
operator: MUST PROVIDE

therapeutic-goods-act-1989-sec-32jf-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JF(3) Secretary may require information etc. about biologicals

32JF(4) Secretary may require information etc. about biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.373
note: The form may require or permit the information to be given, or the documents to be produced, in accordance with specified software requirements.
asserts: therapeutic-goods-act-1989-sec-32jf-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jf-ss-4
schema version: 2
part of: 32JF Secretary may require information etc. about biologicals

therapeutic-goods-act-1989-sec-32jf-ss-4-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JF(4) Secretary may require information etc. about biologicals

32JG Secretary may require information etc. about biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.374
curation status: Proposed
has part: 32JG(1) Secretary may require information etc. about biologicals
has part: 32JG(2) Secretary may require information etc. about biologicals
has part: 32JG(3) Secretary may require information etc. about biologicals
has part: 32JG(3A) Secretary may require information etc. about biologicals
has part: 32JG(4) Secretary may require information etc. about biologicals
proposed by: legis2cml
realized by: sec-32jg
schema version: 2

32JG(1) Secretary may require information etc. about biologicals
type: Concept
description: specified information or documents relating to the supply, handling, monitoring of the supply, and results of the supply of the biological
source: therapeutic-goods-act-1989.pdf, p.374
note: The Secretary may require information from a person granted an approval under subsection 32CK(1) in relation to a biological.
asserts: therapeutic-goods-act-1989-sec-32jg-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jg-ss-1
schema version: 2
part of: 32JG Secretary may require information etc. about biologicals

therapeutic-goods-act-1989-sec-32jg-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JG(1) Secretary may require information etc. about biologicals

32JG(2) Secretary may require information etc. about biologicals
type: Concept
description: specified information or documents relating to the use of the biological
source: therapeutic-goods-act-1989.pdf, p.374
note: The Secretary may require information etc. about biologicals.
asserts: therapeutic-goods-act-1989-sec-32jg-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32jg-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jg-ss-2
schema version: 2
part of: 32JG Secretary may require information etc. about biologicals

therapeutic-goods-act-1989-sec-32jg-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary may require information etc.
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-32jg-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JG(2) Secretary may require information etc. about biologicals

32JG(3) Secretary may require information etc. about biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.374
note: The Secretary may require specified information or documents from a person granted an authority under subsection 32CM(1) in relation to a biological.
asserts: therapeutic-goods-act-1989-sec-32jg-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32jg-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jg-ss-3
schema version: 2
part of: 32JG Secretary may require information etc. about biologicals

therapeutic-goods-act-1989-sec-32jg-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary may require specified information or documents.
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-32jg-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JG(3) Secretary may require information etc. about biologicals

32JG(3A) Secretary may require information etc. about biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.374
note: Secretary may require specified information or documents from a person authorized to supply a biological.
asserts: therapeutic-goods-act-1989-sec-32jg-ss-3a-norm
asserts: therapeutic-goods-act-1989-sec-32jg-ss-3a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jg-ss-3a
schema version: 2
part of: 32JG Secretary may require information etc. about biologicals

therapeutic-goods-act-1989-sec-32jg-ss-3a-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-32jg-ss-3a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JG(3A) Secretary may require information etc. about biologicals

32JG(4) Secretary may require information etc. about biologicals
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.374
note: Must provide information or documents within a specified period and in a specified form.
asserts: therapeutic-goods-act-1989-sec-32jg-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32jg-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jg-ss-4
schema version: 2
part of: 32JG Secretary may require information etc. about biologicals

therapeutic-goods-act-1989-sec-32jg-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 within a specified period and in a specified form.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-32jg-ss-4-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 32JG(4) Secretary may require information etc. about biologicals

32JH Secretary may require information etc. about biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.376
curation status: Proposed
has part: 32JH(1) Secretary may require information etc. about biologicals
has part: 32JH(2) Secretary may require information etc. about biologicals
has part: 32JH(3) Secretary may require information etc. about biologicals
proposed by: legis2cml
realized by: sec-32jh
schema version: 2

32JH(1) Secretary may require information etc. about biologicals
type: Concept
description: (a) the supply of the biological; (b) the handling of the biological; (c) the monitoring of the supply of the biological; (d) the results of the supply of the biological; (e) any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.
source: therapeutic-goods-act-1989.pdf, p.376
note: The Secretary may require information about a biological.
asserts: therapeutic-goods-act-1989-sec-32jh-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32jh-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jh-ss-1
schema version: 2
part of: 32JH Secretary may require information etc. about biologicals

therapeutic-goods-act-1989-sec-32jh-ss-1-logic-deontic-1
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-32jh-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JH(1) Secretary may require information etc. about biologicals

32JH(2) Secretary may require information etc. about biologicals
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.376
note: Must provide information or documents within a specified period and in the form specified by the notice.
asserts: therapeutic-goods-act-1989-sec-32jh-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32jh-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jh-ss-2
schema version: 2
part of: 32JH Secretary may require information etc. about biologicals

therapeutic-goods-act-1989-sec-32jh-ss-2-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-32jh-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JH(2) Secretary may require information etc. about biologicals

32JH(3) Secretary may require information etc. about biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.376
note: The form may require or permit the information to be given, or the documents to be produced in accordance with specified software requirements.
asserts: therapeutic-goods-act-1989-sec-32jh-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jh-ss-3
schema version: 2
part of: 32JH Secretary may require information etc. about biologicals

therapeutic-goods-act-1989-sec-32jh-ss-3-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JH(3) Secretary may require information etc. about biologicals

32JI Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.377
curation status: Proposed
has part: 32JI(1) Criminal offences for failing to comply with a notice etc.
has part: 32JI(1A) Criminal offences for failing to comply with a notice etc.
has part: 32JI(1B) Criminal offences for failing to comply with a notice etc.
has part: 32JI(2) Criminal offences for failing to comply with a notice etc.
has part: 32JI(3) Criminal offences for failing to comply with a notice etc.
proposed by: legis2cml
realized by: sec-32ji
schema version: 2

32JI(1) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.377
note: Failure to comply with a notice results in an offence.
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1-logic-argumentation-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ji-ss-1
schema version: 2
part of: 32JI Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-32ji-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: ...and penalty: 500 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines a temporal interval during which failing to comply with a notice results in an offence.
modality: AllenInterval
operator: Overlaps
premise text: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice.

therapeutic-goods-act-1989-sec-32ji-ss-1-logic-argumentation-5
type: LogicApplication
conclusion text: ...and penalty: 500 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Justifies the imposition of a penalty for failing to comply with notices.
modality: Argumentation
operator: Implication
premise text: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice.

therapeutic-goods-act-1989-sec-32ji-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Penalty: 500 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits failing to comply with a notice.
modality: Deontic
operator: Prohibition
premise text: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice.

therapeutic-goods-act-1989-sec-32ji-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: ...and penalty: 500 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation on persons to comply with notices.
modality: Deontic
operator: Obligation
premise text: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice.

therapeutic-goods-act-1989-sec-32ji-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: ...and penalty: 500 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines a recurring obligation to comply with notices.
modality: LTL
operator: Recurrently
premise text: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice.

therapeutic-goods-act-1989-sec-32ji-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JI(1) Criminal offences for failing to comply with a notice etc.

32JI(1A) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.377
note: Failure to comply with a notice results in an offence.
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ji-ss-1a
schema version: 2
part of: 32JI Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-alleninterval-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Notices issued under sections 32JE, 32JF, 32JG or 32JH overlap with the offence.
modality: AllenInterval
operator: Overlaps
premise text: (1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and

therapeutic-goods-act-1989-sec-32ji-ss-1a-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 failing to comply with a notice.
modality: Deontic
operator: Prohibition
premise text: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice.

therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-deontic-4
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation to comply with the notice.
modality: Deontic
operator: Obligation
premise text: (1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and

therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-deontic-5
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits failure to comply with the notice.
modality: Deontic
operator: Prohibition
premise text: (1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and

therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-ltl-3
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Notice must be repeated for each failure to comply.
modality: LTL
operator: Repeats
premise text: (1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and

therapeutic-goods-act-1989-sec-32ji-ss-1a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JI(1A) Criminal offences for failing to comply with a notice etc.

32JI(1B) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.377
note: Offence of strict liability for failing to comply with a notice
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1b-norm
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ji-ss-1b
schema version: 2
part of: 32JI Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-32ji-ss-1b-logic-deontic-1
type: LogicApplication
conclusion text: An offence of strict liability
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits an offence of strict liability
modality: Deontic
operator: Prohibition
premise text: (1B) An offence against subsection (1A)

therapeutic-goods-act-1989-sec-32ji-ss-1b-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JI(1B) Criminal offences for failing to comply with a notice etc.

32JI(2) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.377
note: Failing to comply with a notice results in an offence.
asserts: therapeutic-goods-act-1989-sec-32ji-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32ji-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ji-ss-2
schema version: 2
part of: 32JI Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-32ji-ss-2-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

32JI(3) Criminal offences for failing to comply with a notice etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.377
note: Offence for failing to comply with a notice
asserts: therapeutic-goods-act-1989-sec-32ji-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32ji-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32ji-ss-3
schema version: 2
part of: 32JI Criminal offences for failing to comply with a notice etc.

therapeutic-goods-act-1989-sec-32ji-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits failure to comply with a notice
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-32ji-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JI(3) Criminal offences for failing to comply with a notice etc.

32JJ Civil penalty for giving false or misleading information or
type: Concept
source: therapeutic-goods-act-1989.pdf, p.378
note: Giving false or misleading information in compliance with a notice is prohibited.
asserts: therapeutic-goods-act-1989-sec-32jj-norm
asserts: therapeutic-goods-act-1989-sec-32jj-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jj
schema version: 2

therapeutic-goods-act-1989-sec-32jj-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits giving false or misleading information in compliance with a notice.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-32jj-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JJ Civil penalty for giving false or misleading information or

32JK Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.378
curation status: Proposed
has part: 32JK(1) Self-incrimination
has part: 32JK(2) Self-incrimination
proposed by: legis2cml
realized by: sec-32jk
schema version: 2

32JK(1) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.378
note: No excuse for self-incrimination
asserts: therapeutic-goods-act-1989-sec-32jk-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32jk-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jk-ss-1
schema version: 2
part of: 32JK Self-incrimination

therapeutic-goods-act-1989-sec-32jk-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

therapeutic-goods-act-1989-sec-32jk-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JK(1) Self-incrimination

32JK(2) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.378
note: Exemptions from self-incrimination in certain circumstances
asserts: therapeutic-goods-act-1989-sec-32jk-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32jk-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jk-ss-2
schema version: 2
part of: 32JK Self-incrimination

therapeutic-goods-act-1989-sec-32jk-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: None
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exemptions from self-incrimination
modality: Deontic
operator: Obligation
premise text: None

therapeutic-goods-act-1989-sec-32jk-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JK(2) Self-incrimination

32JL Secretary may inspect and copy documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.379
note: Inspect and copy documents produced under certain sections.
asserts: therapeutic-goods-act-1989-sec-32jl-norm
asserts: therapeutic-goods-act-1989-sec-32jl-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jl
schema version: 2

therapeutic-goods-act-1989-sec-32jl-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits inspection and copying.
modality: Deontic
operator: can

32JM Secretary may retain documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.379
curation status: Proposed
has part: 32JM(1) Secretary may retain documents
has part: 32JM(2) Secretary may retain documents
has part: 32JM(3) Secretary may retain documents
has part: 32JM(4) Secretary may retain documents
proposed by: legis2cml
realized by: sec-32jm
schema version: 2

32JM(1) Secretary may retain documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.379
note: The Secretary may retain documents for a reasonable period.
asserts: therapeutic-goods-act-1989-sec-32jm-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32jm-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-32jm-ss-1-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jm-ss-1
schema version: 2
part of: 32JM Secretary may retain documents

therapeutic-goods-act-1989-sec-32jm-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation to document retention
modality: AllenInterval
operator: during

therapeutic-goods-act-1989-sec-32jm-ss-1-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to retain documents
modality: Deontic
operator: may

32JM(2) Secretary may retain documents
type: Concept
description: true
source: therapeutic-goods-act-1989.pdf, p.379
note: Secretary must provide a copy of the document upon request.
asserts: therapeutic-goods-act-1989-sec-32jm-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32jm-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jm-ss-2
schema version: 2
part of: 32JM Secretary may retain documents

therapeutic-goods-act-1989-sec-32jm-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary has an obligation to provide a copy of the document.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-32jm-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JM(2) Secretary may retain documents

32JM(3) Secretary may retain documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.379
note: The certified copy must be received as evidence.
asserts: therapeutic-goods-act-1989-sec-32jm-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32jm-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jm-ss-3
schema version: 2
part of: 32JM Secretary may retain documents

therapeutic-goods-act-1989-sec-32jm-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to receive certified copy
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-32jm-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 32JM(3) Secretary may retain documents

32JM(4) Secretary may retain documents
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.379
note: Must provide access to documents for inspection and copying.
asserts: therapeutic-goods-act-1989-sec-32jm-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32jm-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-32jm-ss-4
schema version: 2
part of: 32JM Secretary may retain documents

therapeutic-goods-act-1989-sec-32jm-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

33A Part does not apply to a medical device
type: Concept
source: therapeutic-goods-act-1989.pdf, p.380
note: Part does not apply to medical devices.
asserts: therapeutic-goods-act-1989-sec-33a-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-33a
schema version: 2

33B Application of this Part to biologicals
type: Concept
source: therapeutic-goods-act-1989.pdf, p.380
note: This Part does not apply to a Class 1 biological.
asserts: therapeutic-goods-act-1989-sec-33b-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-33b
schema version: 2

34 Exempt goods and exempt persons
type: Concept
source: therapeutic-goods-act-1989.pdf, p.380
curation status: Proposed
has part: 34(1) Exempt goods and exempt persons
has part: 34(2) Exempt goods and exempt persons
has part: 34(3) Exempt goods and exempt persons
proposed by: legis2cml
realized by: sec-34
schema version: 2

34(1) Exempt goods and exempt persons
type: Concept
source: therapeutic-goods-act-1989.pdf, p.380
note: Therapeutic goods may be exempt from the operation of this Part.
asserts: therapeutic-goods-act-1989-sec-34-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-34-ss-1
schema version: 2
part of: 34 Exempt goods and exempt persons

therapeutic-goods-act-1989-sec-34-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 34(1) Exempt goods and exempt persons

34(2) Exempt goods and exempt persons
type: Concept
source: therapeutic-goods-act-1989.pdf, p.380
note: Exempts a person from the operation of this Part in relation to the manufacture or a step in the manufacture of therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-34-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-34-ss-2
schema version: 2
part of: 34 Exempt goods and exempt persons

34(3) Exempt goods and exempt persons
type: Concept
source: therapeutic-goods-act-1989.pdf, p.380
note: Revocation of exemption takes effect after 28 days
asserts: therapeutic-goods-act-1989-sec-34-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-34-ss-3
schema version: 2
part of: 34 Exempt goods and exempt persons

35 Criminal offences relating to manufacturing therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.380
curation status: Proposed
has part: 35(1) Criminal offences relating to manufacturing therapeutic goods
has part: 35(4) Criminal offences relating to manufacturing therapeutic goods
proposed by: legis2cml
realized by: sec-35
schema version: 2

35(1) Criminal offences relating to manufacturing therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.380
note: Manufacturing therapeutic goods without proper authorization is prohibited.
asserts: therapeutic-goods-act-1989-sec-35-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-35-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-35-ss-1
schema version: 2
part of: 35 Criminal offences relating to manufacturing therapeutic goods

therapeutic-goods-act-1989-sec-35-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the manufacture of therapeutic goods without proper authorization.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-35-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 35(1) Criminal offences relating to manufacturing therapeutic goods

35(4) Criminal offences relating to manufacturing therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.380
note: Manufacturing therapeutic goods without proper license
asserts: therapeutic-goods-act-1989-sec-35-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-35-ss-4
schema version: 2
part of: 35 Criminal offences relating to manufacturing therapeutic goods

therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: ...and none of the following applies: (i) the goods are exempt goods;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits manufacturing therapeutic goods without license
modality: Deontic
operator: Prohibit
premise text: (a) the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods...

therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-2
type: LogicApplication
conclusion text: ...and none of the following applies: (i) the goods are exempt goods;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits manufacturing therapeutic goods without proper license
modality: Deontic
operator: Prohibit
premise text: (b) the goods are for supply for use in humans;

therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-3
type: LogicApplication
conclusion text: ...and none of the following applies: (i) the goods are exempt goods;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits manufacturing therapeutic goods without proper license
modality: Deontic
operator: Prohibit
premise text: (c) none of the following applies:

therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-4
type: LogicApplication
conclusion text: ...and none of the following applies: (i) the goods are exempt goods;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits manufacturing therapeutic goods without proper license
modality: Deontic
operator: Prohibit
premise text: (iii) the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises.

therapeutic-goods-act-1989-sec-35-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 35(4) Criminal offences relating to manufacturing therapeutic goods

35A Civil penalties relating to manufacturing therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.383
note: Carrying out steps in manufacturing therapeutic goods at Australian premises is prohibited.
asserts: therapeutic-goods-act-1989-sec-35a-norm
asserts: therapeutic-goods-act-1989-sec-35a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-35a
schema version: 2

therapeutic-goods-act-1989-sec-35a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of manufacturing therapeutic goods at Australian premises.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-35a-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 35A Civil penalties relating to manufacturing therapeutic goods

35B Criminal offences relating to breaching a condition of a licence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.384
curation status: Proposed
has part: 35B(1) Criminal offences relating to breaching a condition of a licence
has part: 35B(4) Criminal offences relating to breaching a condition of a licence
has part: 35B(5) Criminal offences relating to breaching a condition of a licence
has part: 35B(6) Criminal offences relating to breaching a condition of a licence
proposed by: legis2cml
realized by: sec-35b
schema version: 2

35B(1) Criminal offences relating to breaching a condition of a licence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.384
note: A person commits an offence if they hold a licence and breach a condition of the licence.
asserts: therapeutic-goods-act-1989-sec-35b-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-35b-ss-1
schema version: 2
part of: 35B Criminal offences relating to breaching a condition of a licence

therapeutic-goods-act-1989-sec-35b-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: Licence is a necessary condition for committing an offence.
modality: Deontic
operator: has
premise text: The person holds a licence.

therapeutic-goods-act-1989-sec-35b-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: Breach of the licence's condition is a necessary condition for committing an offence.
modality: Deontic
operator: has
premise text: 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-35b-ss-1-logic-deontic-3
type: LogicApplication
conclusion text: The penalty for committing an offence is imprisonment for 5 years or 4,000 penalty units.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imprisonment for 5 years or 4,000 penalty units is a possible consequence of committing an offence.
modality: Deontic
operator: has
premise text: A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence; and (d) 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-35b-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: The court has discretion to acquit or convict a person of an offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead.
modality: Deontic
operator: has
premise text: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

therapeutic-goods-act-1989-sec-35b-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 35B(1) Criminal offences relating to breaching a condition of a licence

35B(4) Criminal offences relating to breaching a condition of a licence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.384
note: Breach of licence condition is an offence.
asserts: therapeutic-goods-act-1989-sec-35b-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-35b-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-35b-ss-4
schema version: 2
part of: 35B Criminal offences relating to breaching a condition of a licence

therapeutic-goods-act-1989-sec-35b-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Licence breach is a duty.
modality: Deontic
operator: is

therapeutic-goods-act-1989-sec-35b-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 35B(4) Criminal offences relating to breaching a condition of a licence

35B(5) Criminal offences relating to breaching a condition of a licence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.384
note: Breach of licence condition is an offence.
asserts: therapeutic-goods-act-1989-sec-35b-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-35b-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-35b-ss-5-logic-linearlogic-2
asserts: therapeutic-goods-act-1989-sec-35b-ss-5-logic-alleninterval-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-35b-ss-5
schema version: 2
part of: 35B Criminal offences relating to breaching a condition of a licence

therapeutic-goods-act-1989-sec-35b-ss-5-logic-alleninterval-3
type: LogicApplication
conclusion text: The licence breach occurs during the licence period.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Licence breach occurs during licence period.
modality: AllenInterval
operator: during
premise text: (5) A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence.

therapeutic-goods-act-1989-sec-35b-ss-5-logic-deontic-1
type: LogicApplication
conclusion text: The person is obligated to comply with the licence conditions.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Licence breach is a duty.
modality: Deontic
operator: is
premise text: (5) A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence.

therapeutic-goods-act-1989-sec-35b-ss-5-logic-linearlogic-2
type: LogicApplication
conclusion text: The person is obligated to comply with the licence conditions.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Licence breach implies obligation to comply.
modality: LinearLogic
operator: =>
premise text: (5) A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence.

therapeutic-goods-act-1989-sec-35b-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 35B(5) Criminal offences relating to breaching a condition of a licence

35B(6) Criminal offences relating to breaching a condition of a licence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.384
note: An offence against subsection (5) is an offence of strict liability.
asserts: therapeutic-goods-act-1989-sec-35b-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-35b-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-35b-ss-6
schema version: 2
part of: 35B Criminal offences relating to breaching a condition of a licence

therapeutic-goods-act-1989-sec-35b-ss-6-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-35b-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 35B(6) Criminal offences relating to breaching a condition of a licence

35C Civil penalty relating to breaching a condition of a licence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.385
note: Breach of licence condition results in civil penalty
asserts: therapeutic-goods-act-1989-sec-35c-norm
asserts: therapeutic-goods-act-1989-sec-35c-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-35c
schema version: 2

therapeutic-goods-act-1989-sec-35c-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits breaching a licence condition
modality: Deontic
operator: forbid

therapeutic-goods-act-1989-sec-35c-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 35C Civil penalty relating to breaching a condition of a licence

36 Manufacturing principles
type: Concept
source: therapeutic-goods-act-1989.pdf, p.385
note: The Minister may determine written principles for the manufacture of therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-36-norm
asserts: therapeutic-goods-act-1989-sec-36-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-36
schema version: 2

therapeutic-goods-act-1989-sec-36-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to determine principles
modality: Deontic
operator: may

37 Application for licence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.386
curation status: Proposed
has part: 37(1) Application for licence
has part: 37(1A) Application for licence
has part: 37(1B) Application for licence
proposed by: legis2cml
realized by: sec-37
schema version: 2

37(1) Application for licence
type: Concept
description: a form approved by the Secretary, identification of therapeutic goods or classes of therapeutic goods, manufacturing sites, steps in manufacture, and control measures
source: therapeutic-goods-act-1989.pdf, p.386
note: Application for licence must be made in accordance with a form approved by the Secretary.
asserts: therapeutic-goods-act-1989-sec-37-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-37-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-37-ss-1
schema version: 2
part of: 37 Application for licence

therapeutic-goods-act-1989-sec-37-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-37-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 37(1) Application for licence

37(1A) Application for licence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.386
note: Application must relate to one manufacturing site only.
asserts: therapeutic-goods-act-1989-sec-37-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-37-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-37-ss-1a-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-37-ss-1a
schema version: 2
part of: 37 Application for licence

therapeutic-goods-act-1989-sec-37-ss-1a-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between manufacturing sites
modality: AllenInterval
operator: during

therapeutic-goods-act-1989-sec-37-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application must relate to one manufacturing site only.
modality: Deontic
operator: Obligate

therapeutic-goods-act-1989-sec-37-ss-1a-norm
type: Obligation
scope note: borne by: LegalPerson
curation status: Proposed
modality: Deontic
borne by: LegalPerson
deontic status: HeuristicDerived
part of: 37(1A) Application for licence

37(1B) Application for licence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.386
note: Applicant may identify multiple manufacturing sites in application.
asserts: therapeutic-goods-act-1989-sec-37-ss-1b-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-37-ss-1b
schema version: 2
part of: 37 Application for licence

therapeutic-goods-act-1989-sec-37-ss-1b-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 37(1B) Application for licence

38 Grant of licence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.388
note: Grant of licence for manufacturing therapeutic goods
asserts: therapeutic-goods-act-1989-sec-38-norm
asserts: therapeutic-goods-act-1989-sec-38-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-38
schema version: 2

therapeutic-goods-act-1989-sec-38-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Grant of licence for manufacturing therapeutic goods
modality: Deontic
operator: Obligate

therapeutic-goods-act-1989-sec-38-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 38 Grant of licence

38A Guidelines for multi-site licences
type: Concept
source: therapeutic-goods-act-1989.pdf, p.391
note: The Secretary must make guidelines for multi-site licences.
asserts: therapeutic-goods-act-1989-sec-38a-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-38a
schema version: 2

38B Splitting multi-site licences
type: Concept
source: therapeutic-goods-act-1989.pdf, p.391
note: This section applies if a licence (the old licence):
asserts: therapeutic-goods-act-1989-sec-38b-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-38b
schema version: 2

39 Term of licence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.394
curation status: Proposed
has part: 39(1) Term of licence
has part: 39(2) Term of licence
has part: 39(3) Term of licence
proposed by: legis2cml
realized by: sec-39
schema version: 2

39(1) Term of licence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.394
note: Licence commencement and duration
asserts: therapeutic-goods-act-1989-sec-39-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-39-ss-1-logic-alleninterval-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-39-ss-1
schema version: 2
part of: 39 Term of licence

therapeutic-goods-act-1989-sec-39-ss-1-logic-alleninterval-1
type: LogicApplication
conclusion text: Licence commences on specified day
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines temporal interval for licence commencement
modality: AllenInterval
operator: Applicable
premise text: Commencement day is specified

39(2) Term of licence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.394
note: Licence ceases to be in force if goods cease to be exempt under section 18A.
asserts: therapeutic-goods-act-1989-sec-39-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-39-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-39-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-39-ss-2-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-39-ss-2
schema version: 2
part of: 39 Term of licence

therapeutic-goods-act-1989-sec-39-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: when those goods cease to be exempt under that section.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between exemption and licence revocation
modality: AllenInterval
operator: during
premise text: (b) those goods cease to be exempt under that section before the licence is revoked;

therapeutic-goods-act-1989-sec-39-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: the licence ceases to be in force in relation to those goods when those goods cease to be exempt under that section.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Ceases to be in force
modality: Deontic
operator: cease
premise text: (2) If the licence covers therapeutic goods that are exempt under section 18A; and those goods cease to be exempt under that section before the licence is revoked;

therapeutic-goods-act-1989-sec-39-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: when those goods cease to be exempt under that section.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Temporal relation between exemption and licence revocation
modality: LTL
operator: during
premise text: (b) those goods cease to be exempt under that section before the licence is revoked;

39(3) Term of licence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.394
note: Licence ceases in force if biological ceases to be exempt under section 32CB.
asserts: therapeutic-goods-act-1989-sec-39-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-39-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-39-ss-3-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-39-ss-3-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-39-ss-3-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-39-ss-3-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-39-ss-3
schema version: 2
part of: 39 Term of licence

therapeutic-goods-act-1989-sec-39-ss-3-logic-alleninterval-2
type: LogicApplication
confidence: 0.8000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Biological ceases to be exempt under section 32CB before licence is revoked
modality: AllenInterval
operator: MEETS
premise text: (b) the biological ceases to be exempt under that section before the licence is revoked;

therapeutic-goods-act-1989-sec-39-ss-3-logic-cogai-5
type: LogicApplication
confidence: 0.8000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Licence ceases in force when biological ceases to be exempt under section 32CB
modality: CogAI
operator: MEETS
premise text: (a) the licence covers a biological that is exempt under section 32CB; and (b) the biological ceases to be exempt under that section before the licence is revoked;

therapeutic-goods-act-1989-sec-39-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: the licence ceases to be in force in relation to the biological when the biological ceases to be exempt under that section.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Ceases in force
modality: Deontic
operator: CEASES
premise text: (a) the licence covers a biological that is exempt under section 32CB; and (b) the biological ceases to be exempt under that section before the licence is revoked;

therapeutic-goods-act-1989-sec-39-ss-3-logic-diffusion-4
type: LogicApplication
confidence: 0.8000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Licence ceases in force when biological ceases to be exempt under section 32CB
modality: Diffusion
operator: MEETS
premise text: (a) the licence covers a biological that is exempt under section 32CB; and (b) the biological ceases to be exempt under that section before the licence is revoked;

therapeutic-goods-act-1989-sec-39-ss-3-logic-ltl-3
type: LogicApplication
confidence: 0.8000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Biological ceases to be exempt under section 32CB at some point in time
modality: LTL
operator: MEETS
premise text: (b) the biological ceases to be exempt under that section before the licence is revoked;

3A Declaration—member of European Community
type: Concept
source: therapeutic-goods-act-1989.pdf, p.42
curation status: Proposed
has part: 3A(1) Declaration—member of European Community
has part: 3A(2) Declaration—member of European Community
proposed by: legis2cml
realized by: sec-3a
schema version: 2

3A(1) Declaration—member of European Community
type: Concept
source: therapeutic-goods-act-1989.pdf, p.42
note: Declaration of membership in European Community or EFTA
asserts: therapeutic-goods-act-1989-sec-3a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-3a-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3a-ss-1
schema version: 2
part of: 3A Declaration—member of European Community

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

3A(2) Declaration—member of European Community
type: Concept
source: therapeutic-goods-act-1989.pdf, p.42
note: Declaration must be published in Gazette or on Department's website.
asserts: therapeutic-goods-act-1989-sec-3a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-3a-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3a-ss-2
schema version: 2
part of: 3A Declaration—member of European Community

therapeutic-goods-act-1989-sec-3a-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must publish declaration
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-3a-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 3A(2) Declaration—member of European Community

3AA Homoeopathic preparations and homoeopathic standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.39
curation status: Proposed
has part: 3AA(1) Homoeopathic preparations and homoeopathic standards
has part: 3AA(2) Homoeopathic preparations and homoeopathic standards
has part: 3AA(3) Homoeopathic preparations and homoeopathic standards
has part: 3AA(4) Homoeopathic preparations and homoeopathic standards
has part: 3AA(5) Homoeopathic preparations and homoeopathic standards
proposed by: legis2cml
realized by: sec-3aa
schema version: 2

3AA(1) Homoeopathic preparations and homoeopathic standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.39
note: Definition of homoeopathic preparation and standard.
asserts: therapeutic-goods-act-1989-sec-3aa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-3aa-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-3aa-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-3aa-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-3aa-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-3aa-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-3aa-ss-1
schema version: 2
part of: 3AA Homoeopathic preparations and homoeopathic standards

therapeutic-goods-act-1989-sec-3aa-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Defines a temporal interval.
modality: AllenInterval
operator: =
premise text: (1) For the purposes of this Act, a homoeopathic preparation is a...

therapeutic-goods-act-1989-sec-3aa-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Defines a concept that can be processed by AI.
modality: CogAI
operator: =
premise text: (1) For the purposes of this Act, a homoeopathic preparation is a...

therapeutic-goods-act-1989-sec-3aa-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: a homoeopathic standard
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Defines a term with a clear obligation.
modality: Deontic
operator: =
premise text: (1) For the purposes of this Act, a homoeopathic preparation is a...

therapeutic-goods-act-1989-sec-3aa-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Defines a concept that can be shared.
modality: Diffusion
operator: =
premise text: (1) For the purposes of this Act, a homoeopathic preparation is a...

therapeutic-goods-act-1989-sec-3aa-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Defines a temporal interval.
modality: LTL
operator: =
premise text: (1) For the purposes of this Act, a homoeopathic preparation is a...

therapeutic-goods-act-1989-sec-3aa-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 3AA(1) Homoeopathic preparations and homoeopathic standards

3AA(2) Homoeopathic preparations and homoeopathic standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.39
note: A homoeopathic standard is constituted by the statements in monographs describing manufacturing procedures.
asserts: therapeutic-goods-act-1989-sec-3aa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-3aa-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3aa-ss-2
schema version: 2
part of: 3AA Homoeopathic preparations and homoeopathic standards

therapeutic-goods-act-1989-sec-3aa-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: then there is a homoeopathic standard
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Establishes a homoeopathic standard
modality: Deontic
operator: constitutes
premise text: (a) and (b)

therapeutic-goods-act-1989-sec-3aa-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 3AA(2) Homoeopathic preparations and homoeopathic standards

3AA(3) Homoeopathic preparations and homoeopathic standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.39
note: Specify publications and/or parts of publications for homoeopathic pharmacopoeia definition
asserts: therapeutic-goods-act-1989-sec-3aa-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-3aa-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3aa-ss-3
schema version: 2
part of: 3AA Homoeopathic preparations and homoeopathic standards

therapeutic-goods-act-1989-sec-3aa-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Specify
modality: Deontic
operator: May

3AA(4) Homoeopathic preparations and homoeopathic standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.39
note: Minister may exempt specified monographs from certain requirements.
asserts: therapeutic-goods-act-1989-sec-3aa-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-3aa-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3aa-ss-4
schema version: 2
part of: 3AA Homoeopathic preparations and homoeopathic standards

therapeutic-goods-act-1989-sec-3aa-ss-4-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

3AA(5) Homoeopathic preparations and homoeopathic standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.39
note: The Minister may determine exemptions for specified statements in monographs.
asserts: therapeutic-goods-act-1989-sec-3aa-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-3aa-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3aa-ss-5
schema version: 2
part of: 3AA Homoeopathic preparations and homoeopathic standards

therapeutic-goods-act-1989-sec-3aa-ss-5-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

3AB Anthroposophic preparations and anthroposophic standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.41
curation status: Proposed
has part: 3AB(1) Anthroposophic preparations and anthroposophic standards
has part: 3AB(2) Anthroposophic preparations and anthroposophic standards
has part: 3AB(3) Anthroposophic preparations and anthroposophic standards
has part: 3AB(4) Anthroposophic preparations and anthroposophic standards
has part: 3AB(5) Anthroposophic preparations and anthroposophic standards
proposed by: legis2cml
realized by: sec-3ab
schema version: 2

3AB(1) Anthroposophic preparations and anthroposophic standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.41
note: Definition of anthroposophic preparation
asserts: therapeutic-goods-act-1989-sec-3ab-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-3ab-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-3ab-ss-1-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-3ab-ss-1
schema version: 2
part of: 3AB Anthroposophic preparations and anthroposophic standards

therapeutic-goods-act-1989-sec-3ab-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: anthroposophic standard
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation definition
modality: AllenInterval
operator: =
premise text: (1) For the purposes of this Act, an anthroposophic preparation is a...

therapeutic-goods-act-1989-sec-3ab-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: anthroposophic standard
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Definition of term
modality: Deontic
operator: =
premise text: (1) For the purposes of this Act, an anthroposophic preparation is a...

therapeutic-goods-act-1989-sec-3ab-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 3AB(1) Anthroposophic preparations and anthroposophic standards

3AB(2) Anthroposophic preparations and anthroposophic standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.41
note: An anthroposophic standard is constituted by the statements in monographs describing manufacturing procedures.
asserts: therapeutic-goods-act-1989-sec-3ab-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-3ab-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3ab-ss-2
schema version: 2
part of: 3AB Anthroposophic preparations and anthroposophic standards

therapeutic-goods-act-1989-sec-3ab-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Anthroposophic standard is constituted by statements in monographs
modality: Deontic
operator: constitutes

therapeutic-goods-act-1989-sec-3ab-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 3AB(2) Anthroposophic preparations and anthroposophic standards

3AB(3) Anthroposophic preparations and anthroposophic standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.41
note: Specify publications and/or parts of publications for the definition of anthroposophic pharmacopoeia.
asserts: therapeutic-goods-act-1989-sec-3ab-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-3ab-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3ab-ss-3
schema version: 2
part of: 3AB Anthroposophic preparations and anthroposophic standards

therapeutic-goods-act-1989-sec-3ab-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Specify publications and/or parts of publications.
modality: Deontic
operator: Specify

therapeutic-goods-act-1989-sec-3ab-ss-3-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 3AB(3) Anthroposophic preparations and anthroposophic standards

3AB(4) Anthroposophic preparations and anthroposophic standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.41
note: Minister may exempt specified monographs from paragraph (2)(b) purposes.
asserts: therapeutic-goods-act-1989-sec-3ab-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-3ab-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3ab-ss-4
schema version: 2
part of: 3AB Anthroposophic preparations and anthroposophic standards

therapeutic-goods-act-1989-sec-3ab-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to exempt monographs
modality: Deontic
operator: may

3AB(5) Anthroposophic preparations and anthroposophic standards
type: Concept
source: therapeutic-goods-act-1989.pdf, p.41
note: Minister may exempt specified statements from subsection (2)
asserts: therapeutic-goods-act-1989-sec-3ab-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-3ab-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3ab-ss-5
schema version: 2
part of: 3AB Anthroposophic preparations and anthroposophic standards

therapeutic-goods-act-1989-sec-3ab-ss-5-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to exempt
modality: Deontic
operator: may

3B Declaration—country covered by non-EC/EFTA MRA
type: Concept
source: therapeutic-goods-act-1989.pdf, p.42
curation status: Proposed
has part: 3B(1) Declaration—country covered by non-EC/EFTA MRA
has part: 3B(2) Declaration—country covered by non-EC/EFTA MRA
proposed by: legis2cml
realized by: sec-3b
schema version: 2

3B(1) Declaration—country covered by non-EC/EFTA MRA
type: Concept
source: therapeutic-goods-act-1989.pdf, p.42
note: Minister may declare a country covered by non-EC/EFTA MRA.
asserts: therapeutic-goods-act-1989-sec-3b-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-3b-ss-1
schema version: 2
part of: 3B Declaration—country covered by non-EC/EFTA MRA

therapeutic-goods-act-1989-sec-3b-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 3B(1) Declaration—country covered by non-EC/EFTA MRA

3B(2) Declaration—country covered by non-EC/EFTA MRA
type: Concept
source: therapeutic-goods-act-1989.pdf, p.42
note: Declaration must be published in Gazette or on Department's website.
asserts: therapeutic-goods-act-1989-sec-3b-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-3b-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3b-ss-2
schema version: 2
part of: 3B Declaration—country covered by non-EC/EFTA MRA

therapeutic-goods-act-1989-sec-3b-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Declaration is mandatory.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-3b-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 3B(2) Declaration—country covered by non-EC/EFTA MRA

3C Exempting monographs in pharmacopoeias
type: Concept
source: therapeutic-goods-act-1989.pdf, p.43
curation status: Proposed
has part: 3C(1) Exempting monographs in pharmacopoeias
has part: 3C(2) Exempting monographs in pharmacopoeias
has part: 3C(3) Exempting monographs in pharmacopoeias
proposed by: legis2cml
realized by: sec-3c
schema version: 2

3C(1) Exempting monographs in pharmacopoeias
type: Concept
source: therapeutic-goods-act-1989.pdf, p.43
note: The Minister may determine exemptions for specified monographs in relation to therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-3c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-3c-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3c-ss-1
schema version: 2
part of: 3C Exempting monographs in pharmacopoeias

therapeutic-goods-act-1989-sec-3c-ss-1-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-3c-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 3C(1) Exempting monographs in pharmacopoeias

3C(2) Exempting monographs in pharmacopoeias
type: Concept
source: therapeutic-goods-act-1989.pdf, p.43
note: Determination of exemptions for therapeutic goods
asserts: therapeutic-goods-act-1989-sec-3c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-3c-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3c-ss-2
schema version: 2
part of: 3C Exempting monographs in pharmacopoeias

therapeutic-goods-act-1989-sec-3c-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to determine exemptions
modality: Deontic
operator: may

3C(3) Exempting monographs in pharmacopoeias
type: Concept
source: therapeutic-goods-act-1989.pdf, p.43
note: Exempts monographs in pharmacopoeias from certain legislation
asserts: therapeutic-goods-act-1989-sec-3c-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-3c-ss-3-logic-alleninterval-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-3c-ss-3
schema version: 2
part of: 3C Exempting monographs in pharmacopoeias

therapeutic-goods-act-1989-sec-3c-ss-3-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 instrument and writing
modality: AllenInterval
operator: Applicable
premise text: Temporal intervals mentioned

4 Objects of Act
type: Concept
source: therapeutic-goods-act-1989.pdf, p.43
curation status: Proposed
has part: 4(1) Objects of Act
has part: 4(1A) Objects of Act
has part: 4(2) Objects of Act
proposed by: legis2cml
realized by: sec-4
schema version: 2

4(1) Objects of Act
type: Concept
source: therapeutic-goods-act-1989.pdf, p.43
note: List therapeutic goods for national system of controls
asserts: therapeutic-goods-act-1989-sec-4-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-4-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-4-ss-1
schema version: 2
part of: 4 Objects of Act

therapeutic-goods-act-1989-sec-4-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 State
modality: Deontic
operator: shall

therapeutic-goods-act-1989-sec-4-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 4(1) Objects of Act

4(1A) Objects of Act
type: Concept
source: therapeutic-goods-act-1989.pdf, p.43
note: Manufacturer's intent for medical devices
asserts: therapeutic-goods-act-1989-sec-4-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-4-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-4-ss-1a
schema version: 2
part of: 4 Objects of Act

therapeutic-goods-act-1989-sec-4-ss-1a-logic-deontic-1
type: LogicApplication
conclusion text: The efficacy of therapeutic goods is a reference to the performance of devices as the manufacturer intended.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Performance of devices as intended
modality: Deontic
operator: performance
premise text: (1A) The reference in paragraph (1)(a)

therapeutic-goods-act-1989-sec-4-ss-1a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 4(1A) Objects of Act

4(2) Objects of Act
type: Concept
source: therapeutic-goods-act-1989.pdf, p.43
note: Act does not exclude concurrent operation with other laws.
asserts: therapeutic-goods-act-1989-sec-4-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-4-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-4-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-4-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-4-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-4-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-4-ss-2
schema version: 2
part of: 4 Objects of Act

therapeutic-goods-act-1989-sec-4-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: to the extent that the law is capable of operating concurrently with this Act.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Simultaneous operation allowed
modality: AllenInterval
operator: simultaneity
premise text: (2) This Act is therefore not intended to apply...

therapeutic-goods-act-1989-sec-4-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Cognitive framework for concurrent operation
modality: CogAI
operator: cognitive framework
premise text: (2) This Act is therefore not intended to apply...

therapeutic-goods-act-1989-sec-4-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: to the extent that the law is capable of operating concurrently with this Act.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Exclusion of concurrent operation
modality: Deontic
operator: exclusion
premise text: (2) This Act is therefore not intended to apply...

therapeutic-goods-act-1989-sec-4-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: to the extent that the law is capable of operating concurrently with this Act.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Diffusing concurrent operation
modality: Diffusion
operator: diffusion
premise text: (2) This Act is therefore not intended to apply...

therapeutic-goods-act-1989-sec-4-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Tracing concurrent operation
modality: LTL
operator: trace
premise text: (2) This Act is therefore not intended to apply...

40 Conditions of licences
type: Concept
source: therapeutic-goods-act-1989.pdf, p.394
curation status: Proposed
has part: 40(1) Conditions of licences
has part: 40(2) Conditions of licences
has part: 40(3) Conditions of licences
has part: 40(3A) Conditions of licences
has part: 40(4) Conditions of licences
proposed by: legis2cml
realized by: sec-40
schema version: 2

40(1) Conditions of licences
type: Concept
source: therapeutic-goods-act-1989.pdf, p.394
note: Conditions for granting a licence
asserts: therapeutic-goods-act-1989-sec-40-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-40-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-40-ss-1
schema version: 2
part of: 40 Conditions of licences

therapeutic-goods-act-1989-sec-40-ss-1-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: shall

therapeutic-goods-act-1989-sec-40-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 40(1) Conditions of licences

40(2) Conditions of licences
type: Concept
source: therapeutic-goods-act-1989.pdf, p.394
note: Secretary may impose new conditions on a licence.
asserts: therapeutic-goods-act-1989-sec-40-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-40-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-40-ss-2
schema version: 2
part of: 40 Conditions of licences

therapeutic-goods-act-1989-sec-40-ss-2-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-40-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 40(2) Conditions of licences

40(3) Conditions of licences
type: Concept
source: therapeutic-goods-act-1989.pdf, p.394
note: Conditions for imposing, varying or removing conditions on licences.
asserts: therapeutic-goods-act-1989-sec-40-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-40-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-40-ss-3
schema version: 2
part of: 40 Conditions of licences

therapeutic-goods-act-1989-sec-40-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposition of obligations.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-40-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 40(3) Conditions of licences

40(3A) Conditions of licences
type: Concept
source: therapeutic-goods-act-1989.pdf, p.394
note: The earlier day must not be earlier than the day the notice is given to the person.
asserts: therapeutic-goods-act-1989-sec-40-ss-3a-norm
asserts: therapeutic-goods-act-1989-sec-40-ss-3a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-40-ss-3a-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-40-ss-3a-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-40-ss-3a-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-40-ss-3a-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-40-ss-3a
schema version: 2
part of: 40 Conditions of licences

therapeutic-goods-act-1989-sec-40-ss-3a-logic-alleninterval-2
type: LogicApplication
conclusion text: (3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The earlier day meets the notice day.
modality: AllenInterval
operator: Meets
premise text: (3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person.

therapeutic-goods-act-1989-sec-40-ss-3a-logic-cogai-5
type: LogicApplication
conclusion text: (3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: The earlier day meets the notice day.
modality: CogAI
operator: Meets
premise text: (3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person.

therapeutic-goods-act-1989-sec-40-ss-3a-logic-deontic-1
type: LogicApplication
conclusion text: (3A) For the purposes of paragraph (3)(b), the earlier day must be on or after the notice day.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The earlier day must be on or after the notice day.
modality: Deontic
operator: Necessity
premise text: (3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person.

therapeutic-goods-act-1989-sec-40-ss-3a-logic-diffusion-4
type: LogicApplication
conclusion text: (3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: The earlier day meets the notice day.
modality: Diffusion
operator: Meets
premise text: (3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person.

therapeutic-goods-act-1989-sec-40-ss-3a-logic-ltl-3
type: LogicApplication
conclusion text: (3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The earlier day meets the notice day.
modality: LTL
operator: Meets
premise text: (3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person.

therapeutic-goods-act-1989-sec-40-ss-3a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 40(3A) Conditions of licences

40(4) Conditions of licences
type: Concept
source: therapeutic-goods-act-1989.pdf, p.394
note: Ensure goods conform to standards and follow manufacturing principles.
asserts: therapeutic-goods-act-1989-sec-40-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-40-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-40-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-40-ss-4-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-40-ss-4-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-40-ss-4-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-40-ss-4
schema version: 2
part of: 40 Conditions of licences

therapeutic-goods-act-1989-sec-40-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: ...the goods conform to any standard applicable to the goods; and...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Manufacturing principles apply during the manufacture of goods.
modality: AllenInterval
operator: during
premise text: The holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence;

therapeutic-goods-act-1989-sec-40-ss-4-logic-cogai-5
type: LogicApplication
conclusion text: ...the goods are a biological and are for supply after the circumstances prescribed by the regulations...
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Goods have a certain property if they conform to standards.
modality: CogAI
operator: has
premise text: (i) the goods conform to any standard applicable to the goods;

therapeutic-goods-act-1989-sec-40-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: ...the goods conform to any standard applicable to the goods; and the holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Ensure compliance with standards and principles.
modality: Deontic
operator: must
premise text: The holder of the licence must ensure that...

therapeutic-goods-act-1989-sec-40-ss-4-logic-diffusion-4
type: LogicApplication
conclusion text: ...the goods conform to any standard applicable to the goods; and...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Manufacturing principles apply if certain conditions are met.
modality: Diffusion
operator: if
premise text: The holder of the licence will: (a) ensure that:...

therapeutic-goods-act-1989-sec-40-ss-4-logic-ltl-3
type: LogicApplication
conclusion text: ...the goods are a biological and are for supply after the circumstances prescribed by the regulations...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Manufacturing principles apply until the circumstances prescribed by the regulations have occurred.
modality: LTL
operator: until
premise text: The holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence;

therapeutic-goods-act-1989-sec-40-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 40(4) Conditions of licences

40A Variation of manufacturing site authorisations—Secretary’s
type: Concept
source: therapeutic-goods-act-1989.pdf, p.397
curation status: Proposed
has part: 40A(1) Variation of manufacturing site authorisations—Secretary’s
has part: 40A(2) Variation of manufacturing site authorisations—Secretary’s
proposed by: legis2cml
realized by: sec-40a
schema version: 2

40A(1) Variation of manufacturing site authorisations—Secretary’s
type: Concept
source: therapeutic-goods-act-1989.pdf, p.397
note: The Secretary may vary a manufacturing site authorisation on their own initiative.
asserts: therapeutic-goods-act-1989-sec-40a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-40a-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-40a-ss-1
schema version: 2
part of: 40A Variation of manufacturing site authorisations—Secretary’s

therapeutic-goods-act-1989-sec-40a-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary has the power to vary a manufacturing site authorisation.
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-40a-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 40A(1) Variation of manufacturing site authorisations—Secretary’s

40A(2) Variation of manufacturing site authorisations—Secretary’s
type: Concept
source: therapeutic-goods-act-1989.pdf, p.397
note: Variation of manufacturing site authorisations—Secretary’s
asserts: therapeutic-goods-act-1989-sec-40a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-40a-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-40a-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-40a-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-40a-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-40a-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-40a-ss-2
schema version: 2
part of: 40A Variation of manufacturing site authorisations—Secretary’s

therapeutic-goods-act-1989-sec-40a-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: Chapter 3 Medicines and other therapeutic goods that are not medical devices
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relationship of variation effectiveness
modality: AllenInterval
operator: begins at
premise text: (2) A variation under subsection (1)

therapeutic-goods-act-1989-sec-40a-ss-2-logic-cogai-5
type: LogicApplication
conclusion text: Chapter 3 Medicines and other therapeutic goods that are not medical devices
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Artificial intelligence application for variation effectiveness
modality: CogAI
operator: is a capability of
premise text: (2) A variation under subsection (1)

therapeutic-goods-act-1989-sec-40a-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Chapter 3 Medicines and other therapeutic goods that are not medical devices
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Effectiveness of variation
modality: Deontic
operator: takes effect
premise text: (2) A variation under subsection (1)

therapeutic-goods-act-1989-sec-40a-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: Chapter 3 Medicines and other therapeutic goods that are not medical devices
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Spread of variation effectiveness
modality: Diffusion
operator: diffuses to
premise text: (2) A variation under subsection (1)

therapeutic-goods-act-1989-sec-40a-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: Chapter 3 Medicines and other therapeutic goods that are not medical devices
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring relationship of variation effectiveness
modality: LTL
operator: is a trace of
premise text: (2) A variation under subsection (1)

therapeutic-goods-act-1989-sec-40a-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 40A(2) Variation of manufacturing site authorisations—Secretary’s

40B Variation of licences—application by licence holder
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
curation status: Proposed
has part: 40B(1) Variation of licences—application by licence holder
has part: 40B(2) Variation of licences—application by licence holder
has part: 40B(3) Variation of licences—application by licence holder
has part: 40B(4) Variation of licences—application by licence holder
has part: 40B(5) Variation of licences—application by licence holder
has part: 40B(6) Variation of licences—application by licence holder
has part: 40B(7) Variation of licences—application by licence holder
has part: 40B(8) Variation of licences—application by licence holder
has part: 40B(9) Variation of licences—application by licence holder
proposed by: legis2cml
realized by: sec-40b
schema version: 2

40B(1) Variation of licences—application by licence holder
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: Licence holder may apply for variation of licence to cover additional manufacturing sites.
asserts: therapeutic-goods-act-1989-sec-40b-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-40b-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-40b-ss-1
schema version: 2
part of: 40B Variation of licences—application by licence holder

therapeutic-goods-act-1989-sec-40b-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission granted by the holder.
modality: Deontic
operator: May

40B(2) Variation of licences—application by licence holder
type: Concept
description: information relating to manufacturing steps, quality control measures, and personnel
source: therapeutic-goods-act-1989.pdf, p.398
note: Application requirements for variation of licences
asserts: therapeutic-goods-act-1989-sec-40b-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-40b-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-40b-ss-2
schema version: 2
part of: 40B Variation of licences—application by licence holder

therapeutic-goods-act-1989-sec-40b-ss-2-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

40B(3) Variation of licences—application by licence holder
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: Variation of licences—application by licence holder
asserts: therapeutic-goods-act-1989-sec-40b-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-40b-ss-3
schema version: 2
part of: 40B Variation of licences—application by licence holder

therapeutic-goods-act-1989-sec-40b-ss-3-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 40B(3) Variation of licences—application by licence holder

40B(4) Variation of licences—application by licence holder
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: The Secretary must vary the licence to authorise the holder of the licence to carry out specified steps in the manufacture of specified therapeutic goods at that manufacturing site.
asserts: therapeutic-goods-act-1989-sec-40b-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-40b-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-40b-ss-4-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-40b-ss-4
schema version: 2
part of: 40B Variation of licences—application by licence holder

therapeutic-goods-act-1989-sec-40b-ss-4-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The variation is specified for each manufacturing site.
modality: AllenInterval
operator: AT A SPECIFIED MANUFACTURING SITE

therapeutic-goods-act-1989-sec-40b-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must vary the licence.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-40b-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 40B(4) Variation of licences—application by licence holder

40B(5) Variation of licences—application by licence holder
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: Variation of manufacturing site authorisations takes effect on the day notice is given to the holder.
asserts: therapeutic-goods-act-1989-sec-40b-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-40b-ss-5
schema version: 2
part of: 40B Variation of licences—application by licence holder

40B(6) Variation of licences—application by licence holder
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: Holder of a licence may apply for variation of manufacturing site authorisation.
asserts: therapeutic-goods-act-1989-sec-40b-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-40b-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-40b-ss-6
schema version: 2
part of: 40B Variation of licences—application by licence holder

therapeutic-goods-act-1989-sec-40b-ss-6-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to apply for variation
modality: Deontic
operator: May

40B(7) Variation of licences—application by licence holder
type: Concept
description: Form, application fee
source: therapeutic-goods-act-1989.pdf, p.398
note: Application for variation of licence must be made in accordance with a form approved by the Secretary.
asserts: therapeutic-goods-act-1989-sec-40b-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-40b-ss-7-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-40b-ss-7
schema version: 2
part of: 40B Variation of licences—application by licence holder

therapeutic-goods-act-1989-sec-40b-ss-7-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-40b-ss-7-norm
type: Obligation
scope note: borne by: LegalPerson
curation status: Proposed
modality: Deontic
borne by: LegalPerson
deontic status: HeuristicDerived
part of: 40B(7) Variation of licences—application by licence holder

40B(8) Variation of licences—application by licence holder
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: Secretary may vary manufacturing site authorisation upon application and payment of inspection fees.
asserts: therapeutic-goods-act-1989-sec-40b-ss-8-norm
asserts: therapeutic-goods-act-1989-sec-40b-ss-8-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-40b-ss-8
schema version: 2
part of: 40B Variation of licences—application by licence holder

therapeutic-goods-act-1989-sec-40b-ss-8-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits variation of manufacturing site authorisation.
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-40b-ss-8-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 40B(8) Variation of licences—application by licence holder

40B(9) Variation of licences—application by licence holder
type: Concept
source: therapeutic-goods-act-1989.pdf, p.398
note: Variation of licences—application by licence holder
asserts: therapeutic-goods-act-1989-sec-40b-ss-9-norm
asserts: therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-40b-ss-9-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-40b-ss-9-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-40b-ss-9
schema version: 2
part of: 40B Variation of licences—application by licence holder

therapeutic-goods-act-1989-sec-40b-ss-9-logic-alleninterval-2
type: LogicApplication
conclusion text: The variation's effectiveness is tied to a specific date.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal specification of variation
modality: AllenInterval
operator: specifies temporal interval
premise text: (9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder.

therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-1
type: LogicApplication
conclusion text: The variation takes effect on the specified day.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Effectiveness of variation
modality: Deontic
operator: takes effect
premise text: (9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder.

therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-4
type: LogicApplication
conclusion text: The licence holder must comply with the variation's terms.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Application of variation obligation
modality: Deontic
operator: applies to licence holder
premise text: (9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder.

therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-5
type: LogicApplication
conclusion text: The variation's application is subject to specific rules.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Variation type specification
modality: Deontic
operator: specifies variation type
premise text: (9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder.

therapeutic-goods-act-1989-sec-40b-ss-9-logic-ltl-3
type: LogicApplication
conclusion text: The variation's application can be traced back to its notification date.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Tracing variation application
modality: LTL
operator: specifies trace
premise text: (9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder.

41 Revocation and suspension of licences
type: Concept
source: therapeutic-goods-act-1989.pdf, p.401
note: Revocation or suspension of a licence for specified reasons
asserts: therapeutic-goods-act-1989-sec-41-norm
asserts: therapeutic-goods-act-1989-sec-41-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41
schema version: 2

therapeutic-goods-act-1989-sec-41-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits revocation or suspension of a licence for specified reasons
modality: Deontic
operator: Prohibit
premise text: (1) Subject to subsection (2), the Secretary may, by notice in writing...

therapeutic-goods-act-1989-sec-41-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits breach of a condition of a manufacturing licence
modality: Deontic
operator: Prohibit
premise text: (viii) breached a condition of a manufacturing licence;

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

41A Publication of list of manufacturers etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.410
note: The Secretary must publish a list of licensed persons and goods.
asserts: therapeutic-goods-act-1989-sec-41a-norm
asserts: therapeutic-goods-act-1989-sec-41a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41a
schema version: 2

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

therapeutic-goods-act-1989-sec-41a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41A Publication of list of manufacturers etc.

41AA Spent convictions scheme
type: Concept
source: therapeutic-goods-act-1989.pdf, p.404
note: Relieves persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them.
asserts: therapeutic-goods-act-1989-sec-41aa-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41aa
schema version: 2

41AB Secretary may require information or documents
type: Concept
source: therapeutic-goods-act-1989.pdf, p.404
note: The Secretary may require a person to provide information or documents.
asserts: therapeutic-goods-act-1989-sec-41ab-norm
asserts: therapeutic-goods-act-1989-sec-41ab-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ab
schema version: 2

therapeutic-goods-act-1989-sec-41ab-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 or documents.
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-41ab-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41AB Secretary may require information or documents

41AC Criminal offence for contravening a requirement in a notice
type: Concept
source: therapeutic-goods-act-1989.pdf, p.406
note: Failure to comply with a notice results in an offence.
asserts: therapeutic-goods-act-1989-sec-41ac-norm
asserts: therapeutic-goods-act-1989-sec-41ac-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ac
schema version: 2

therapeutic-goods-act-1989-sec-41ac-logic-deontic-1
type: LogicApplication
conclusion text: Failure to do so results in 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: Given a notice under section 41AB, the person must do an act.

therapeutic-goods-act-1989-sec-41ac-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41AC Criminal offence for contravening a requirement in a notice

41AD False or misleading information—offence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.406
curation status: Proposed
has part: 41AD(1) False or misleading information—offence
has part: 41AD(2) False or misleading information—offence
has part: 41AD(3) False or misleading information—offence
proposed by: legis2cml
realized by: sec-41ad
schema version: 2

41AD(1) False or misleading information—offence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.406
note: Providing false or misleading information to the Secretary is an offence.
asserts: therapeutic-goods-act-1989-sec-41ad-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ad-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ad-ss-1
schema version: 2
part of: 41AD False or misleading information—offence

therapeutic-goods-act-1989-sec-41ad-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Providing false or misleading information is an offence.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition of providing false or misleading information.
modality: Deontic
operator: Prohibit
premise text: The person gives information to the Secretary in compliance, or purported compliance, with the notice.

therapeutic-goods-act-1989-sec-41ad-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41AD(1) False or misleading information—offence

41AD(2) False or misleading information—offence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.406
note: Defendant bears evidential burden in relation to the matter.
asserts: therapeutic-goods-act-1989-sec-41ad-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41ad-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ad-ss-2
schema version: 2
part of: 41AD False or misleading information—offence

therapeutic-goods-act-1989-sec-41ad-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-41ad-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41AD(2) False or misleading information—offence

41AD(3) False or misleading information—offence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.406
note: Defendant bears evidential burden in relation to matter in subsection (3)
asserts: therapeutic-goods-act-1989-sec-41ad-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41ad-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ad-ss-3
schema version: 2
part of: 41AD False or misleading information—offence

therapeutic-goods-act-1989-sec-41ad-ss-3-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-41ad-ss-3-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 41AD(3) False or misleading information—offence

41AE False or misleading documents—offence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.407
curation status: Proposed
has part: 41AE(1) False or misleading documents—offence
has part: 41AE(2) False or misleading documents—offence
proposed by: legis2cml
realized by: sec-41ae
schema version: 2

41AE(1) False or misleading documents—offence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.407
note: Producing false or misleading documents is an offence.
asserts: therapeutic-goods-act-1989-sec-41ae-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ae-ss-1
schema version: 2
part of: 41AE False or misleading documents—offence

therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...the document is produced in compliance, or purported compliance, with a notice given under section 41AB.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits producing false or misleading documents.
modality: Deontic
operator: Prohibition
premise text: (1) A person commits an offence if...

therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-2
type: LogicApplication
conclusion text: ...the document is produced in compliance, or purported compliance, with a notice given under section 41AB.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation to not produce false or misleading documents.
modality: Deontic
operator: Obligation
premise text: (1) A person commits an offence if...

therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-3
type: LogicApplication
conclusion text: ...the person does so knowing that the document is false or misleading;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits knowing that the document is false or misleading.
modality: Deontic
operator: Prohibition
premise text: (a) the person produces a document to the Secretary; and

therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-4
type: LogicApplication
conclusion text: ...the document is produced in compliance, or purported compliance, with a notice given under section 41AB.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits producing in compliance with a notice given under section 41AB.
modality: Deontic
operator: Prohibition
premise text: (c) the document is produced in compliance, or purported compliance, with a notice given under section 41AB.

therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-5
type: LogicApplication
conclusion text: ...the document is produced in compliance, or purported compliance, with a notice given under section 41AB.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation to not produce false or misleading documents.
modality: Deontic
operator: Prohibition
premise text: (b) the person does so knowing that the document is false or misleading;

therapeutic-goods-act-1989-sec-41ae-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41AE(1) False or misleading documents—offence

41AE(2) False or misleading documents—offence
type: Concept
source: therapeutic-goods-act-1989.pdf, p.407
note: Defendant bears evidential burden in relation to the matter.
asserts: therapeutic-goods-act-1989-sec-41ae-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41ae-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ae-ss-2-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ae-ss-2
schema version: 2
part of: 41AE False or misleading documents—offence

therapeutic-goods-act-1989-sec-41ae-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-41ae-ss-2-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: Defendant must provide evidence.
modality: Epistemic
operator: evidential burden

therapeutic-goods-act-1989-sec-41ae-ss-2-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 41AE(2) False or misleading documents—offence

41AF False or misleading information or documents—civil penalty
type: Concept
source: therapeutic-goods-act-1989.pdf, p.408
curation status: Proposed
has part: 41AF(1) False or misleading information or documents—civil penalty
has part: 41AF(2) False or misleading information or documents—civil penalty
proposed by: legis2cml
realized by: sec-41af
schema version: 2

41AF(1) False or misleading information or documents—civil penalty
type: Concept
source: therapeutic-goods-act-1989.pdf, p.408
note: Giving false or misleading information in compliance with a notice is prohibited.
asserts: therapeutic-goods-act-1989-sec-41af-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41af-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41af-ss-1
schema version: 2
part of: 41AF False or misleading information or documents—civil penalty

therapeutic-goods-act-1989-sec-41af-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Civil penalty for contravention
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: Notice under section 41AB

therapeutic-goods-act-1989-sec-41af-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41AF(1) False or misleading information or documents—civil penalty

41AF(2) False or misleading information or documents—civil penalty
type: Concept
source: therapeutic-goods-act-1989.pdf, p.408
note: Exemption from subsection (1) for documents accompanied by a written statement
asserts: therapeutic-goods-act-1989-sec-41af-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-41af-ss-2
schema version: 2
part of: 41AF False or misleading information or documents—civil penalty

41AG Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.409
curation status: Proposed
has part: 41AG(1) Self-incrimination
has part: 41AG(2) Self-incrimination
has part: 41AG(3) Self-incrimination
proposed by: legis2cml
realized by: sec-41ag
schema version: 2

41AG(1) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.409
note: Regulations may make provision for the transfer of licences. No excuse for giving information or producing a document under a section 41AB notice
asserts: therapeutic-goods-act-1989-sec-41ag-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ag-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ag-ss-1
schema version: 2
part of: 41AG Self-incrimination

therapeutic-goods-act-1989-sec-41ag-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-41ag-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41AG(1) Self-incrimination

41AG(2) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.409
note: Self-incrimination protection for individuals in criminal proceedings. Regulations may make provision for and in relation to the making of an application, payment of a fee, assessment of an application, conditions of a licence upon transfer, and review of decisions.
asserts: therapeutic-goods-act-1989-sec-41ag-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-5
asserts: therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-6
asserts: therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-7
asserts: therapeutic-goods-act-1989-sec-41ag-ss-2-logic-alleninterval-8
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ag-ss-2
schema version: 2
part of: 41AG Self-incrimination

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-alleninterval-8
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval
modality: AllenInterval
operator: during

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: is not admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits admissibility of self-incrimination evidence in criminal proceedings.
modality: Deontic
operator: Prohibition
premise text: (2) However, in the case of an individual:

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-2
type: LogicApplication
conclusion text: is not admissible in evidence in: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits admissibility of self-incrimination evidence in pecuniary penalty order proceedings.
modality: Deontic
operator: Prohibition
premise text: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision.

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-3
type: LogicApplication
conclusion text: is admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits admissibility of self-incrimination evidence in certain proceedings.
modality: Deontic
operator: Permission
premise text: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-4
type: LogicApplication
conclusion text: is admissible in evidence in: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits admissibility of self-incrimination evidence in certain proceedings.
modality: Deontic
operator: Permission
premise text: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision.

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-5
type: LogicApplication
conclusion text: the information given or the document produced; or the giving of the information or the production of the document; or any information, document or thing obtained as a direct or indirect consequence of giving the information or producing the document; is not admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Establishes right to self-incrimination protection.
modality: Deontic
operator: Right
premise text: (2) However, in the case of an individual:

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-6
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Establishes undertaking to protect self-incrimination.
modality: Deontic
operator: Undertaking
premise text: (2) However, in the case of an individual:

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-7
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations may make provision for and in relation to the making of an application, payment of a fee, assessment of an application, conditions of a licence upon transfer, and review of decisions.
modality: Deontic
operator: Permit

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

41AG(3) Self-incrimination
type: Concept
source: therapeutic-goods-act-1989.pdf, p.409
note: No self-incrimination for subsection (1) beyond what is limited by subsection (2)
asserts: therapeutic-goods-act-1989-sec-41ag-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-41ag-ss-3
schema version: 2
part of: 41AG Self-incrimination

therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: State must not incriminate under subsection (1)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation on the state
modality: Deontic
operator: Obligation
premise text: Subsection (2) does not limit subsection (1)

therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-2
type: LogicApplication
conclusion text: State may incriminate under subsection (1)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits self-incrimination under subsection (1)
modality: Deontic
operator: Permission
premise text: Subsection (2) does not limit subsection (1)

therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-3
type: LogicApplication
conclusion text: State must limit self-incrimination under subsection (1)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation on the state to limit self-incrimination under subsection (1)
modality: Deontic
operator: Obligation
premise text: Subsection (2) does not limit subsection (1)

therapeutic-goods-act-1989-sec-41ag-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 41AG(3) Self-incrimination

5 September 2025
type: Concept
source: therapeutic-goods-act-1989.pdf, p.1
note: Compilation information and notes on amendments.
asserts: therapeutic-goods-act-1989-sec-5-norm
asserts: therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-5
schema version: 2

5 Act to bind Crown
type: Concept
source: therapeutic-goods-act-1989.pdf, p.44
note: The Crown is bound by this Act.
asserts: therapeutic-goods-act-1989-sec-5-2-norm
asserts: therapeutic-goods-act-1989-sec-5-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-5-2
schema version: 2

therapeutic-goods-act-1989-sec-5-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Crown is obligated to comply with the Act.
modality: Deontic
operator: Binding

therapeutic-goods-act-1989-sec-5-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 5 Act to bind Crown

therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-1
type: LogicApplication
conclusion text: The compilation date is 05/09/2025.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Identifies the compilation date.
modality: DescriptionLogic
operator: =
premise text: Compilation date: 05/09/2025

5A Application of the Criminal Code—extended geographical
type: Concept
source: therapeutic-goods-act-1989.pdf, p.45
note: Jurisdiction applies to specific offences
asserts: therapeutic-goods-act-1989-sec-5a-norm
asserts: therapeutic-goods-act-1989-sec-5a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-5a
schema version: 2

therapeutic-goods-act-1989-sec-5a-logic-deontic-1
type: LogicApplication
conclusion text: to offences against specified subsections
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Jurisdiction is applied
modality: Deontic
operator: applies
premise text: Section 15.2 of the Criminal Code

therapeutic-goods-act-1989-sec-5a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 5A Application of the Criminal Code—extended geographical

6 Operation of Act
type: Concept
source: therapeutic-goods-act-1989.pdf, p.45
note: Applicable to corporations and natural persons/corporations in certain trade/commerce contexts.
asserts: therapeutic-goods-act-1989-sec-6-norm
asserts: therapeutic-goods-act-1989-sec-6-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-6-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-6-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-6
schema version: 2

therapeutic-goods-act-1989-sec-6-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Applicable to corporations and natural persons/corporations.
modality: Deontic
operator: appliesTo
premise text: (1) This Act (other than Part 4-8A or Part 6-1A)

therapeutic-goods-act-1989-sec-6-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Applicable to corporations and natural persons/corporations.
modality: Deontic
operator: appliesTo
premise text: (a) things done by corporations; (b) things done by natural persons or corporations in so far as those things are done:

therapeutic-goods-act-1989-sec-6-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Applicable to trade/commerce between Australia and a place outside Australia, among the States, between a State and a Territory or between 2 Territories.
modality: Deontic
operator: appliesTo
premise text: (i) in the course of, or in preparation for, trade or commerce between Australia and a place outside Australia, among the States, between a State and a Territory or between 2 Territories;

therapeutic-goods-act-1989-sec-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 6 Operation of Act

6B Review of certain decisions under State laws
type: Concept
source: therapeutic-goods-act-1989.pdf, p.50
curation status: Proposed
has part: 6B(1) Review of certain decisions under State laws
has part: 6B(2) Review of certain decisions under State laws
has part: 6B(3) Review of certain decisions under State laws
proposed by: legis2cml
realized by: sec-6b
schema version: 2

6B(1) Review of certain decisions under State laws
type: Concept
source: therapeutic-goods-act-1989.pdf, p.50
note: Application for review of a State decision may be made.
asserts: therapeutic-goods-act-1989-sec-6b-ss-1-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-6b-ss-1
schema version: 2
part of: 6B Review of certain decisions under State laws

6B(2) Review of certain decisions under State laws
type: Concept
source: therapeutic-goods-act-1989.pdf, p.50
note: A decision made by the Secretary is reviewable if it meets certain conditions.
asserts: therapeutic-goods-act-1989-sec-6b-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-6b-ss-2
schema version: 2
part of: 6B Review of certain decisions under State laws

therapeutic-goods-act-1989-sec-6b-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 6B(2) Review of certain decisions under State laws

6B(3) Review of certain decisions under State laws
type: Concept
source: therapeutic-goods-act-1989.pdf, p.50
note: Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act.
asserts: therapeutic-goods-act-1989-sec-6b-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-6b-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-6b-ss-3-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-6b-ss-3-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-6b-ss-3-logic-cogai-4
asserts: therapeutic-goods-act-1989-sec-6b-ss-3-logic-shacl-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-6b-ss-3
schema version: 2
part of: 6B Review of certain decisions under State laws

therapeutic-goods-act-1989-sec-6b-ss-3-logic-alleninterval-2
type: LogicApplication
conclusion text: Administrative Review Tribunal Act 2024
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The Administrative Review Tribunal Act 2024 has effect during the period of a corresponding State law.
modality: AllenInterval
operator: during
premise text: State law

therapeutic-goods-act-1989-sec-6b-ss-3-logic-cogai-4
type: LogicApplication
conclusion text: Administrative Review Tribunal Act 2024
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: The Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act.
modality: CogAI
operator: hasEffectAsIf
premise text: State law

therapeutic-goods-act-1989-sec-6b-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Legal effect of the Administrative Review Tribunal Act 2024 on State laws.
modality: Deontic
operator: hasEffectAsIf
premise text: State law

therapeutic-goods-act-1989-sec-6b-ss-3-logic-ltl-3
type: LogicApplication
conclusion text: Administrative Review Tribunal Act 2024
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: The Administrative Review Tribunal Act 2024 has effect during the period of a corresponding State law.
modality: LTL
operator: during
premise text: State law

therapeutic-goods-act-1989-sec-6b-ss-3-logic-shacl-5
type: LogicApplication
conclusion text: Administrative Review Tribunal Act 2024
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::shacl
logic summary: The Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act.
modality: SHACL
operator: hasEffectAsIf
premise text: State law

therapeutic-goods-act-1989-sec-6b-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 6B(3) Review of certain decisions under State laws

6C Fees payable to Commonwealth under State laws
type: Concept
source: therapeutic-goods-act-1989.pdf, p.51
curation status: Proposed
has part: 6C(1) Fees payable to Commonwealth under State laws
has part: 6C(2) Fees payable to Commonwealth under State laws
proposed by: legis2cml
realized by: sec-6c
schema version: 2

6C(1) Fees payable to Commonwealth under State laws
type: Concept
source: therapeutic-goods-act-1989.pdf, p.51
note: Fees payable to Commonwealth under State laws
asserts: therapeutic-goods-act-1989-sec-6c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-6c-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-6c-ss-1
schema version: 2
part of: 6C Fees payable to Commonwealth under State laws

therapeutic-goods-act-1989-sec-6c-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes an obligation on States to pay fees to the Commonwealth
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-6c-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 6C(1) Fees payable to Commonwealth under State laws

6C(2) Fees payable to Commonwealth under State laws
type: Concept
source: therapeutic-goods-act-1989.pdf, p.51
note: Arrangements for Commonwealth fees under State laws
asserts: therapeutic-goods-act-1989-sec-6c-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-6c-ss-2
schema version: 2
part of: 6C Fees payable to Commonwealth under State laws

7 Declaration that goods are/are not therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.51
curation status: Proposed
has part: 7(1) Declaration that goods are/are not therapeutic goods
has part: 7(1A) Declaration that goods are/are not therapeutic goods
has part: 7(4) Declaration that goods are/are not therapeutic goods
has part: 7(2) Declaration that goods are/are not therapeutic goods
proposed by: legis2cml
realized by: sec-7
schema version: 2

7(1) Declaration that goods are/are not therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.51
note: The Secretary may make an order declaring classes of goods are or are not therapeutic goods. Minister may determine goods are therapeutic for Act purposes
asserts: therapeutic-goods-act-1989-sec-7-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-7-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-7-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-7-ss-1-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-7-ss-1
schema version: 2
part of: 7 Declaration that goods are/are not therapeutic goods

therapeutic-goods-act-1989-sec-7-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The Secretary may make an order at any time
modality: AllenInterval
operator: Temporal interval
premise text: (1) Where the Secretary is satisfied that classes of goods:

therapeutic-goods-act-1989-sec-7-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary may make an order
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-7-ss-1-logic-deontic-3
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to determine goods
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-7-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 7(1) Declaration that goods are/are not therapeutic goods

7(1A) Declaration that goods are/are not therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.51
note: Secretary must disregard certain paragraphs when deciding if goods are therapeutic.
asserts: therapeutic-goods-act-1989-sec-7-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-7-ss-1a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-7-ss-1a
schema version: 2
part of: 7 Declaration that goods are/are not therapeutic goods

therapeutic-goods-act-1989-sec-7-ss-1a-logic-deontic-1
type: LogicApplication
conclusion text: ...must disregard paragraphs (e) and (f)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must disregard certain paragraphs.
modality: Deontic
operator: Must Disregard
premise text: (1A) In deciding...

therapeutic-goods-act-1989-sec-7-ss-1a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 7(1A) Declaration that goods are/are not therapeutic goods

7(2) Declaration that goods are/are not therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.51
note: Goods are not therapeutic goods under certain conditions. Minister must consider certain matters before making a determination about regulating goods.
asserts: therapeutic-goods-act-1989-sec-7-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-7-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-7-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-7-ss-2-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-7-ss-2
schema version: 2
part of: 7 Declaration that goods are/are not therapeutic goods

therapeutic-goods-act-1989-sec-7-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: when used, advertised, or presented for supply in a particular way
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relationship between conditions
modality: AllenInterval
operator: before
premise text: (2)

therapeutic-goods-act-1989-sec-7-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: (a) are not therapeutic goods; or (b) when used, advertised, or presented for supply in a particular way, are not therapeutic goods.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Negative assertion of a property
modality: Deontic
operator: not
premise text: (2) (excluded goods)

therapeutic-goods-act-1989-sec-7-ss-2-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Minister must consider certain matters.
modality: Deontic
operator: MUST
premise text: (2) Before making a determination under subsection (1), the Minister:

therapeutic-goods-act-1989-sec-7-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 7(2) Declaration that goods are/are not therapeutic goods

7(4) Declaration that goods are/are not therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.51
note: Goods are not therapeutic goods if declaration applies wholly or partly to goods that would be medical devices.
asserts: therapeutic-goods-act-1989-sec-7-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-7-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-7-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-7-ss-4-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-7-ss-4-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-7-ss-4-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-7-ss-4
schema version: 2
part of: 7 Declaration that goods are/are not therapeutic goods

therapeutic-goods-act-1989-sec-7-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: Goods are not therapeutic goods during use, advertisement, or presentation for supply.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Declaration applies during use, advertisement, or presentation for supply.
modality: AllenInterval
operator: During
premise text: Declaration applies wholly or partly to goods that would be medical devices.

therapeutic-goods-act-1989-sec-7-ss-4-logic-cogai-5
type: LogicApplication
conclusion text: Goods are classified as non-therapeutic goods by AI.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Declaration classifies goods using AI.
modality: CogAI
operator: Classification
premise text: Declaration is a declaration that classes of goods are not therapeutic goods.

therapeutic-goods-act-1989-sec-7-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: Goods are not therapeutic goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Declaration applies implies goods are not therapeutic goods.
modality: Deontic
operator: Implies
premise text: Declaration applies wholly or partly to goods that would be medical devices.

therapeutic-goods-act-1989-sec-7-ss-4-logic-diffusion-4
type: LogicApplication
conclusion text: Goods are diffused as non-therapeutic goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Declaration implies diffusion of goods being non-therapeutic goods.
modality: Diffusion
operator: Implication
premise text: Declaration applies wholly or partly to goods that would be medical devices.

therapeutic-goods-act-1989-sec-7-ss-4-logic-ltl-3
type: LogicApplication
conclusion text: Goods are not therapeutic goods due to recurring declaration.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Declaration is recurring in its application to goods.
modality: LTL
operator: Recurring
premise text: Declaration applies wholly or partly to goods that would be medical devices.

therapeutic-goods-act-1989-sec-7-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 7(4) Declaration that goods are/are not therapeutic goods

7A Authorised persons
type: Concept
source: therapeutic-goods-act-1989.pdf, p.53
curation status: Proposed
has part: 7A(1) Authorised persons
has part: 7A(2) Authorised persons
proposed by: legis2cml
realized by: sec-7a
schema version: 2

7A(1) Authorised persons
type: Concept
source: therapeutic-goods-act-1989.pdf, p.53
note: Authorises Secretary to authorise persons to exercise powers under specified provisions of the Act.
asserts: therapeutic-goods-act-1989-sec-7a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-7a-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-7a-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-7a-ss-1-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-7a-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-7a-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-7a-ss-1
schema version: 2
part of: 7A Authorised persons

therapeutic-goods-act-1989-sec-7a-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: Authority is granted during the term of the Secretary's office.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The authority is granted during the term of the Secretary's office.
modality: AllenInterval
operator: during
premise text: Authority is granted by the Secretary.

therapeutic-goods-act-1989-sec-7a-ss-1-logic-argumentation-3
type: LogicApplication
conclusion text: Authority implies that the person exercising powers has a specified role.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: The authority implies that the person exercising powers has a specified role.
modality: Argumentation
operator: entails
premise text: Person exercising powers has a specified role.

therapeutic-goods-act-1989-sec-7a-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: Authority implies that the person exercising powers has a specified function.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: The authority implies that the person exercising powers has a specified function.
modality: CogAI
operator: implies
premise text: Person exercising powers has a specified function.

therapeutic-goods-act-1989-sec-7a-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: Persons are authorised to exercise powers.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Authorisation is granted.
modality: Deontic
operator: authorise
premise text: Secretary may authorise persons to exercise powers under specified provisions of the Act.

therapeutic-goods-act-1989-sec-7a-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: Authority implies that the Secretary's office is responsible for enforcing health matters or law enforcement matters.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: The authority implies that the Secretary's office is responsible for enforcing health matters or law enforcement matters.
modality: Diffusion
operator: implies
premise text: Secretary's office is responsible for enforcing health matters or law enforcement matters.

therapeutic-goods-act-1989-sec-7a-ss-1-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 7A(1) Authorised persons

7A(2) Authorised persons
type: Concept
source: therapeutic-goods-act-1989.pdf, p.53
note: Authorised person must comply with directions of the Secretary.
asserts: therapeutic-goods-act-1989-sec-7a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-7a-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-7a-ss-2-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-7a-ss-2
schema version: 2
part of: 7A Authorised persons

therapeutic-goods-act-1989-sec-7a-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: Action must occur after directions are given.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between directions and actions
modality: AllenInterval
operator: CONTAINS
premise text: Directions are given at some point in time.

therapeutic-goods-act-1989-sec-7a-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Comply with directions of the Secretary.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must comply
modality: Deontic
operator: MUST
premise text: Authorised person has power under a provision of this Act.

therapeutic-goods-act-1989-sec-7a-ss-2-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 7A(2) Authorised persons

7AA Excluded goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.52
curation status: Proposed
has part: 7AA(1) Excluded goods
has part: 7AA(2) Excluded goods
has part: 7AA(3) Excluded goods
has part: 7AA(4) Excluded goods
proposed by: legis2cml
realized by: sec-7aa
schema version: 2

7AA(1) Excluded goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.52
note: The Minister may determine that specified goods are excluded goods.
asserts: therapeutic-goods-act-1989-sec-7aa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-7aa-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-7aa-ss-1
schema version: 2
part of: 7AA Excluded goods

therapeutic-goods-act-1989-sec-7aa-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to exclude goods
modality: Deontic
operator: may

7AA(2) Excluded goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.52
note: Determination of excluded goods
asserts: therapeutic-goods-act-1989-sec-7aa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-7aa-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-7aa-ss-2
schema version: 2
part of: 7AA Excluded goods

therapeutic-goods-act-1989-sec-7aa-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to determine excluded goods
modality: Deontic
operator: may

7AA(3) Excluded goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.52
note: Minister must consider certain matters before making a determination under this section.
asserts: therapeutic-goods-act-1989-sec-7aa-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-7aa-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-7aa-ss-3
schema version: 2
part of: 7AA Excluded goods

therapeutic-goods-act-1989-sec-7aa-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Minister must consider certain matters.
modality: Deontic
operator: MUST
premise text: (3) Before making a determination under this section, the Minister...

therapeutic-goods-act-1989-sec-7aa-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 7AA(3) Excluded goods

7AA(4) Excluded goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.52
note: Consideration of relevant matters by the Minister
asserts: therapeutic-goods-act-1989-sec-7aa-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-7aa-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-7aa-ss-4-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-7aa-ss-4-logic-argumentation-3
asserts: therapeutic-goods-act-1989-sec-7aa-ss-4-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-7aa-ss-4-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-7aa-ss-4
schema version: 2
part of: 7AA Excluded goods

therapeutic-goods-act-1989-sec-7aa-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: Consideration of relevant matters by the Minister
confidence: 0.5000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal relation between consideration and action
modality: AllenInterval
operator: during
premise text: The Minister may have regard to any other matter he or she considers relevant.

therapeutic-goods-act-1989-sec-7aa-ss-4-logic-argumentation-3
type: LogicApplication
conclusion text: Consideration of relevant matters by the Minister
confidence: 0.5000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: Relevance consideration in decision-making
modality: Argumentation
operator: may
premise text: The Minister may have regard to any other matter he or she considers relevant.

therapeutic-goods-act-1989-sec-7aa-ss-4-logic-cogai-5
type: LogicApplication
conclusion text: Consideration of relevant matters by the Minister
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Relevance consideration in decision-making
modality: CogAI
operator: may
premise text: The Minister may have regard to any other matter he or she considers relevant.

therapeutic-goods-act-1989-sec-7aa-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: Consideration of relevant matters by the Minister
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to consider other matters
modality: Deontic
operator: may
premise text: The Minister may have regard to...

therapeutic-goods-act-1989-sec-7aa-ss-4-logic-diffusion-4
type: LogicApplication
conclusion text: Consideration of relevant matters by the Minister
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Relevance consideration in decision-making
modality: Diffusion
operator: may
premise text: The Minister may have regard to any other matter he or she considers relevant.

7B Kits
type: Concept
source: therapeutic-goods-act-1989.pdf, p.54
curation status: Proposed
has part: 7B(1) Kits
has part: 7B(2) Kits
has part: 7B(3) Kits
proposed by: legis2cml
realized by: sec-7b
schema version: 2

7B(1) Kits
type: Concept
source: therapeutic-goods-act-1989.pdf, p.54
note: A package and its goods constitute a kit if they meet certain conditions.
asserts: therapeutic-goods-act-1989-sec-7b-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-7b-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-7b-ss-1
schema version: 2
part of: 7B Kits

therapeutic-goods-act-1989-sec-7b-ss-1-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Kit definition
modality: Deontic
operator: must-be

therapeutic-goods-act-1989-sec-7b-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 7B(1) Kits

7B(2) Kits
type: Concept
source: therapeutic-goods-act-1989.pdf, p.54
note: Therapeutic goods must be combined before administration or in a particular sequence.
asserts: therapeutic-goods-act-1989-sec-7b-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-7b-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-7b-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-7b-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-7b-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-7b-ss-2-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-7b-ss-2
schema version: 2
part of: 7B Kits

therapeutic-goods-act-1989-sec-7b-ss-2-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Combining therapeutic goods is necessary before administration.
modality: AllenInterval
operator: Requires
premise text: it is necessary that the therapeutic goods be combined before administration or that they be administered in a particular sequence.

therapeutic-goods-act-1989-sec-7b-ss-2-logic-cogai-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Therapeutic goods are for administration as a single treatment or course of treatment.
modality: CogAI
operator: Classifies
premise text: (c) the therapeutic goods are for administration as a single treatment or as a single course of treatment; and

therapeutic-goods-act-1989-sec-7b-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Therapeutic goods must be combined before administration or in a particular sequence.
modality: Deontic
operator: Must
premise text: (2) A package and therapeutic goods in the package together constitute a composite pack if:...

therapeutic-goods-act-1989-sec-7b-ss-2-logic-diffusion-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Combining therapeutic goods must happen in a particular order.
modality: Diffusion
operator: Requires
premise text: the package does not contain any medical devices; and

therapeutic-goods-act-1989-sec-7b-ss-2-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Combining therapeutic goods must happen before administration.
modality: LTL
operator: Requires
premise text: it is necessary that the therapeutic goods be combined before administration or that they be administered in a particular sequence.

therapeutic-goods-act-1989-sec-7b-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 7B(2) Kits

7B(3) Kits
type: Concept
source: therapeutic-goods-act-1989.pdf, p.54
note: A kit constitutes therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-7b-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-7b-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-7b-ss-3
schema version: 2
part of: 7B Kits

therapeutic-goods-act-1989-sec-7b-ss-3-logic-deontic-1
type: LogicApplication
conclusion text: It is declared that...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Definition of a kit
modality: Deontic
operator: is
premise text: A kit is defined as...

therapeutic-goods-act-1989-sec-7b-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 7B(3) Kits

7C Secretary may arrange for use of computer programs to make
type: Concept
source: therapeutic-goods-act-1989.pdf, p.55
curation status: Proposed
has part: 7C(1) Secretary may arrange for use of computer programs to make
has part: 7C(2) Secretary may arrange for use of computer programs to make
has part: 7C(3) Secretary may arrange for use of computer programs to make
has part: 7C(4) Secretary may arrange for use of computer programs to make
proposed by: legis2cml
realized by: sec-7c
schema version: 2

7C(1) Secretary may arrange for use of computer programs to make
type: Concept
source: therapeutic-goods-act-1989.pdf, p.55
note: The Secretary may arrange for the use of computer programs under their control.
asserts: therapeutic-goods-act-1989-sec-7c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-7c-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-7c-ss-1
schema version: 2
part of: 7C Secretary may arrange for use of computer programs to make

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

7C(2) Secretary may arrange for use of computer programs to make
type: Concept
source: therapeutic-goods-act-1989.pdf, p.55
note: Decision made by computer program is taken to be Secretary's decision.
asserts: therapeutic-goods-act-1989-sec-7c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-7c-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-7c-ss-2
schema version: 2
part of: 7C Secretary may arrange for use of computer programs to make

therapeutic-goods-act-1989-sec-7c-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Secretary's decision
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Decision making
modality: Deontic
operator: =
premise text: Computer program makes a decision

7C(3) Secretary may arrange for use of computer programs to make
type: Concept
source: therapeutic-goods-act-1989.pdf, p.55
note: Secretary may correct initial decision made by computer program.
asserts: therapeutic-goods-act-1989-sec-7c-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-7c-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-7c-ss-3
schema version: 2
part of: 7C Secretary may arrange for use of computer programs to make

therapeutic-goods-act-1989-sec-7c-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: May correct initial decision
modality: Deontic
operator: MAY

7C(4) Secretary may arrange for use of computer programs to make
type: Concept
source: therapeutic-goods-act-1989.pdf, p.55
note: Secretary must make substituted decision within 60 days of initial decision.
asserts: therapeutic-goods-act-1989-sec-7c-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-7c-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-7c-ss-4
schema version: 2
part of: 7C Secretary may arrange for use of computer programs to make

therapeutic-goods-act-1989-sec-7c-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide a substituted decision within the specified timeframe.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-7c-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 7C(4) Secretary may arrange for use of computer programs to make

7D Form for product information for medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.55
curation status: Proposed
has part: 7D(1) Form for product information for medicine
has part: 7D(2) Form for product information for medicine
proposed by: legis2cml
realized by: sec-7d
schema version: 2

7D(1) Form for product information for medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.55
note: The Secretary may approve a form for product information in relation to medicine.
asserts: therapeutic-goods-act-1989-sec-7d-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-7d-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-7d-ss-1
schema version: 2
part of: 7D Form for product information for medicine

therapeutic-goods-act-1989-sec-7d-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary may approve a form.
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-7d-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 7D(1) Form for product information for medicine

7D(2) Form for product information for medicine
type: Concept
source: therapeutic-goods-act-1989.pdf, p.55
note: Secretary may approve different forms for different medicines or classes of medicine.
asserts: therapeutic-goods-act-1989-sec-7d-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-7d-ss-2
schema version: 2
part of: 7D Form for product information for medicine

therapeutic-goods-act-1989-sec-7d-ss-2-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 7D(2) Form for product information for medicine

8 Power to obtain information with respect to therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.55
curation status: Proposed
has part: 8(1) Power to obtain information with respect to therapeutic goods
has part: 8(1A) Power to obtain information with respect to therapeutic goods
has part: 8(2) Power to obtain information with respect to therapeutic goods
has part: 8(3) Power to obtain information with respect to therapeutic goods
has part: 8(4) Power to obtain information with respect to therapeutic goods
proposed by: legis2cml
realized by: sec-8
schema version: 2

8(1) Power to obtain information with respect to therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.55
note: Request for information about therapeutic goods
asserts: therapeutic-goods-act-1989-sec-8-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-8-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-8-ss-1-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-8-ss-1
schema version: 2
part of: 8 Power to obtain information with respect to therapeutic goods

therapeutic-goods-act-1989-sec-8-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Within a reasonable period
modality: AllenInterval
operator: WITHIN
premise text: within such reasonable period as is specified in the notice

therapeutic-goods-act-1989-sec-8-ss-1-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-8-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 8(1) Power to obtain information with respect to therapeutic goods

8(1A) Power to obtain information with respect to therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.55
note: Notice may require information to be given in writing or according to specified software requirements.
asserts: therapeutic-goods-act-1989-sec-8-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-8-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-8-ss-1a-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-8-ss-1a
schema version: 2
part of: 8 Power to obtain information with respect to therapeutic goods

therapeutic-goods-act-1989-sec-8-ss-1a-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-8-ss-1a-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of software requirements
modality: DescriptionLogic
operator: Classifies
premise text: (a) in writing; or (b) in accordance with specified software requirements:

8(2) Power to obtain information with respect to therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.55
note: Must comply with notice given under section.
asserts: therapeutic-goods-act-1989-sec-8-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-8-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-8-ss-2
schema version: 2
part of: 8 Power to obtain information with respect to therapeutic goods

therapeutic-goods-act-1989-sec-8-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Must comply
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to comply
modality: Deontic
operator: MUST
premise text: Notice given under section.

therapeutic-goods-act-1989-sec-8-ss-2-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 8(2) Power to obtain information with respect to therapeutic goods

8(3) Power to obtain information with respect to therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.55
note: A reasonable excuse is a valid reason for not applying subsection (2).
asserts: therapeutic-goods-act-1989-sec-8-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-8-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-8-ss-3-logic-epistemic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-8-ss-3
schema version: 2
part of: 8 Power to obtain information with respect to therapeutic goods

therapeutic-goods-act-1989-sec-8-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to provide a reasonable excuse.
modality: Deontic
operator: Obligation

therapeutic-goods-act-1989-sec-8-ss-3-logic-epistemic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::epistemic
logic summary: The defendant believes they have a reasonable excuse.
modality: Epistemic
operator: Belief

therapeutic-goods-act-1989-sec-8-ss-3-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 8(3) Power to obtain information with respect to therapeutic goods

8(4) Power to obtain information with respect to therapeutic goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.55
note: An offence under subsection (2) is an obligation.
asserts: therapeutic-goods-act-1989-sec-8-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-8-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-8-ss-4
schema version: 2
part of: 8 Power to obtain information with respect to therapeutic goods

therapeutic-goods-act-1989-sec-8-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: An obligation
modality: Deontic
operator: Obligation

9 Arrangements with States etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.56
curation status: Proposed
has part: 9(1) Arrangements with States etc.
has part: 9(2) Arrangements with States etc.
proposed by: legis2cml
realized by: sec-9
schema version: 2

9(1) Arrangements with States etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.56
note: The Minister may make arrangements with a State for the carrying out of certain functions on behalf of the Commonwealth.
asserts: therapeutic-goods-act-1989-sec-9-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-9-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9-ss-1-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-9-ss-1
schema version: 2
part of: 9 Arrangements with States etc.

therapeutic-goods-act-1989-sec-9-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to make arrangements
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-9-ss-1-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to make arrangements
modality: Deontic
operator: must

therapeutic-goods-act-1989-sec-9-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9(1) Arrangements with States etc.

9(2) Arrangements with States etc.
type: Concept
source: therapeutic-goods-act-1989.pdf, p.56
note: Payment of amounts to a State or Territory for performance of functions under an arrangement.
asserts: therapeutic-goods-act-1989-sec-9-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-9-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9-ss-2
schema version: 2
part of: 9 Arrangements with States etc.

therapeutic-goods-act-1989-sec-9-ss-2-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-9-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9(2) Arrangements with States etc.

9A Australian Register of Therapeutic Goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.58
curation status: Proposed
has part: 9A(1) Australian Register of Therapeutic Goods
has part: 9A(2) Australian Register of Therapeutic Goods
has part: 9A(3) Australian Register of Therapeutic Goods
proposed by: legis2cml
realized by: sec-9a
schema version: 2

9A(1) Australian Register of Therapeutic Goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.58
note: Maintain a register of therapeutic goods.
asserts: therapeutic-goods-act-1989-sec-9a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-9a-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9a-ss-1
schema version: 2
part of: 9A Australian Register of Therapeutic Goods

therapeutic-goods-act-1989-sec-9a-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to maintain a register.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-9a-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9A(1) Australian Register of Therapeutic Goods

9A(2) Australian Register of Therapeutic Goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.58
note: The Register is to be kept in such form as the Secretary determines.
asserts: therapeutic-goods-act-1989-sec-9a-ss-2-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-9a-ss-2
schema version: 2
part of: 9A Australian Register of Therapeutic Goods

9A(3) Australian Register of Therapeutic Goods
type: Concept
source: therapeutic-goods-act-1989.pdf, p.58
note: Classification of goods in the Australian Register of Therapeutic Goods
asserts: therapeutic-goods-act-1989-sec-9a-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-9a-ss-3
schema version: 2
part of: 9A Australian Register of Therapeutic Goods

9C Inspection of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
curation status: Proposed
has part: 9C(1) Inspection of entries in Register
has part: 9C(2) Inspection of entries in Register
has part: 9C(3) Inspection of entries in Register
proposed by: legis2cml
realized by: sec-9c
schema version: 2

9C(1) Inspection of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Request for copy of entry in Register
asserts: therapeutic-goods-act-1989-sec-9c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-9c-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9c-ss-1
schema version: 2
part of: 9C Inspection of entries in Register

therapeutic-goods-act-1989-sec-9c-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Therapeutic goods entry request
modality: Deontic
operator: hasObligation

therapeutic-goods-act-1989-sec-9c-ss-1-norm
type: Obligation
scope note: borne by: Agent
curation status: Proposed
modality: Deontic
borne by: Agent
deontic status: HeuristicDerived
part of: 9C(1) Inspection of entries in Register

9C(2) Inspection of entries in Register
type: Concept
description: Yes
source: therapeutic-goods-act-1989.pdf, p.59
note: Must provide a copy of requested entry from computer database
asserts: therapeutic-goods-act-1989-sec-9c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-9c-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9c-ss-2
schema version: 2
part of: 9C Inspection of entries in Register

therapeutic-goods-act-1989-sec-9c-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

9C(3) Inspection of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Secretary may provide information in electronic format upon request.
asserts: therapeutic-goods-act-1989-sec-9c-ss-3-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-9c-ss-3
schema version: 2
part of: 9C Inspection of entries in Register

9D Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
curation status: Proposed
has part: 9D(1) Variation of entries in Register
has part: 9D(1A) Variation of entries in Register
has part: 9D(1B) Variation of entries in Register
has part: 9D(1C) Variation of entries in Register
has part: 9D(1D) Variation of entries in Register
has part: 9D(2) Variation of entries in Register
has part: 9D(2A) Variation of entries in Register
has part: 9D(2C) Variation of entries in Register
has part: 9D(2D) Variation of entries in Register
has part: 9D(3) Variation of entries in Register
has part: 9D(3A) Variation of entries in Register
has part: 9D(3B) Variation of entries in Register
has part: 9D(3C) Variation of entries in Register
has part: 9D(3D) Variation of entries in Register
has part: 9D(4) Variation of entries in Register
has part: 9D(6) Variation of entries in Register
has part: 9D(7) Variation of entries in Register
has part: 9D(8) Variation of entries in Register
proposed by: legis2cml
realized by: sec-9d
schema version: 2

9D(1) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Secretary may vary entry in Register under certain conditions.
asserts: therapeutic-goods-act-1989-sec-9d-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-1
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-1-logic-deontic-1
type: LogicApplication
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permissive obligation
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-9d-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(1) Variation of entries in Register

9D(1A) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Secretary may vary entry in Register under certain conditions.
asserts: therapeutic-goods-act-1989-sec-9d-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-1a-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9d-ss-1a-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-1a
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-1a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits Secretary to take action.
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-9d-ss-1a-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Variation of entries in Register is a class inclusion.
modality: DescriptionLogic
operator: ClassInclusion

therapeutic-goods-act-1989-sec-9d-ss-1a-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(1A) Variation of entries in Register

9D(1B) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: The Secretary may vary the entry in the Register on their own initiative.
asserts: therapeutic-goods-act-1989-sec-9d-ss-1b-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-1b-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9d-ss-1b-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-1b
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-1b-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permission to vary the entry in the Register.
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-9d-ss-1b-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Varying the entry in the Register.
modality: DescriptionLogic
operator: Variation of entries
premise text: (1B) If...

therapeutic-goods-act-1989-sec-9d-ss-1b-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(1B) Variation of entries in Register

9D(1C) Variation of entries in Register
type: Concept
description: written notice, submission
source: therapeutic-goods-act-1989.pdf, p.59
note: Secretary must give notice and opportunity to submit before making variation.
asserts: therapeutic-goods-act-1989-sec-9d-ss-1c-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-1c-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9d-ss-1c-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-1c
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-1c-logic-alleninterval-2
type: LogicApplication
conclusion text: Notice given at least this far in advance
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Secretary must give notice before making variation
modality: AllenInterval
operator: >=
premise text: Date of proposed variation

therapeutic-goods-act-1989-sec-9d-ss-1c-logic-deontic-1
type: LogicApplication
conclusion text: Decision to make variation
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must take submission into account
modality: Deontic
operator: MUST
premise text: Submission made in accordance with paragraph (b)

therapeutic-goods-act-1989-sec-9d-ss-1c-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(1C) Variation of entries in Register

9D(1D) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Subsections (1A) and (1B) apply despite subsection 16(1).
asserts: therapeutic-goods-act-1989-sec-9d-ss-1d-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-9d-ss-1d-logic-linearlogic-3
asserts: therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-1d
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-1
type: LogicApplication
conclusion text: Subsections (1A) and (1B) apply despite subsection 16(1).
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Continues the obligation despite a condition.
modality: Deontic
operator: Continuation
premise text: (1D) Subsections (1A) and (1B)

therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-2
type: LogicApplication
conclusion text: Subsections (1A) and (1B) apply despite subsection 16(1).
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Overrides the condition.
modality: Deontic
operator: Overriding Condition
premise text: (1D)

therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-4
type: LogicApplication
conclusion text: Subsections (1A) and (1B) do not apply despite subsection 16(1).
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Negates the condition.
modality: Deontic
operator: Negation
premise text: (1D)

therapeutic-goods-act-1989-sec-9d-ss-1d-logic-linearlogic-3
type: LogicApplication
conclusion text: Subsections (1A) and (1B) apply despite subsection 16(1).
confidence: 0.5000
curation status: Proposed
execution surface: modalities::linear
logic summary: Continues the linear logic application.
modality: LinearLogic
operator: Continuation
premise text: (1D)

therapeutic-goods-act-1989-sec-9d-ss-1d-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(1D) Variation of entries in Register

9D(2) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Variation of entries in Register upon request
asserts: therapeutic-goods-act-1989-sec-9d-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9d-ss-2-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-2
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide variation upon request
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-9d-ss-2-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Classification of therapeutic goods
modality: DescriptionLogic
operator: CLASSIFICATION

therapeutic-goods-act-1989-sec-9d-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(2) Variation of entries in Register

9D(2A) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Subsection (2) of section 16(1) applies despite subsection (2A)
asserts: therapeutic-goods-act-1989-sec-9d-ss-2a-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-2a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-2a
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-2a-logic-deontic-1
type: LogicApplication
conclusion text: (2)
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Subsection (2) applies despite subsection (2A)
modality: Deontic
operator: applies
premise text: (2A)

therapeutic-goods-act-1989-sec-9d-ss-2a-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(2A) Variation of entries in Register

9D(2C) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Secretary must vary entry in Register upon request.
asserts: therapeutic-goods-act-1989-sec-9d-ss-2c-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-9d-ss-2c-logic-alleninterval-3
asserts: therapeutic-goods-act-1989-sec-9d-ss-2c-logic-ltl-4
asserts: therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-2c
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-2c-logic-alleninterval-3
type: LogicApplication
conclusion text: the request was made at some point in time.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Request must be made within unspecified time frame.
modality: AllenInterval
operator: BETWEEN
premise text: (a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary the entry in the Register that relates to the goods;

therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-1
type: LogicApplication
conclusion text: the Secretary must vary the entry in accordance with the request.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must provide variation upon request.
modality: Deontic
operator: MUST
premise text: (a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary the entry in the Register that relates to the goods;

therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-2
type: LogicApplication
conclusion text: the conditions (if any) specified in the regulations are satisfied;
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must satisfy conditions specified in regulations.
modality: Deontic
operator: MUST
premise text: (b) the variation is of a kind specified in the regulations;

therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-5
type: LogicApplication
conclusion text: the request was made by a person who has registered or listed therapeutic goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Request must be made by person with registered or listed therapeutic goods.
modality: Deontic
operator: MUST
premise text: (a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary the entry in the Register that relates to the goods;

therapeutic-goods-act-1989-sec-9d-ss-2c-logic-ltl-4
type: LogicApplication
conclusion text: the request was made at some point in time.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Request must be made within unspecified time frame.
modality: LTL
operator: BETWEEN
premise text: (a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary the entry in the Register that relates to the goods;

therapeutic-goods-act-1989-sec-9d-ss-2c-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(2C) Variation of entries in Register

9D(2D) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Subsection (2C) applies despite subsection 16(1).
asserts: therapeutic-goods-act-1989-sec-9d-ss-2d-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-2d-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-2d
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-2d-logic-deontic-1
type: LogicApplication
conclusion text: (2C)
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Subsection (2C) implies subsection 16(1).
modality: Deontic
operator: Implies
premise text: (2D)

therapeutic-goods-act-1989-sec-9d-ss-2d-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(2D) Variation of entries in Register

9D(3) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Secretary may vary entry in Register upon request.
asserts: therapeutic-goods-act-1989-sec-9d-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9d-ss-3-logic-descriptionlogic-2
asserts: therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-9d-ss-3-logic-linearlogic-4
asserts: therapeutic-goods-act-1989-sec-9d-ss-3-logic-descriptionlogic-5
asserts: therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-3
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits variation of entries in Register.
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must vary entry in Register upon request.
modality: Deontic
operator: Must
premise text: (3AA) If: ...; (3AC) If: ...;

therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-6
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must vary entry in Register upon request.
modality: Deontic
operator: Must
premise text: (3) If: ...; (3AA) If: ...; (3AC) If: ...;

therapeutic-goods-act-1989-sec-9d-ss-3-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Specifies conditions for variation of entries in Register.
modality: DescriptionLogic
operator: Variation
premise text: (3) If: ...; (3AA) If: ...; (3AC) If: ...;

therapeutic-goods-act-1989-sec-9d-ss-3-logic-descriptionlogic-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Specifies conditions for variation of entries in Register.
modality: DescriptionLogic
operator: Satisfies
premise text: (c) the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used;

therapeutic-goods-act-1989-sec-9d-ss-3-logic-linearlogic-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::linear
logic summary: Combines conditions for variation of entries in Register.
modality: LinearLogic
operator: And
premise text: (3) If: ... And (3AA) If: ... And (3AC) If: ...;

therapeutic-goods-act-1989-sec-9d-ss-3-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(3) Variation of entries in Register

9D(3A) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Secretary may vary entry in Register upon request.
asserts: therapeutic-goods-act-1989-sec-9d-ss-3a-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-3a-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-3a
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-3a-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits variation of entries in Register.
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-9d-ss-3a-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(3A) Variation of entries in Register

9D(3B) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Secretary must move entry from part of Register for biologicals to applicable part.
asserts: therapeutic-goods-act-1989-sec-9d-ss-3b-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-3b-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-3b
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-3b-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to move entry
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-9d-ss-3b-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(3B) Variation of entries in Register

9D(3C) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Variation of entries in Register upon request
asserts: therapeutic-goods-act-1989-sec-9d-ss-3c-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-9d-ss-3c-logic-descriptionlogic-3
asserts: therapeutic-goods-act-1989-sec-9d-ss-3c-logic-alleninterval-4
asserts: therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-5
asserts: therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-6
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-3c
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-3c-logic-alleninterval-4
type: LogicApplication
conclusion text: ...the Secretary must vary the entry in accordance with the request.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Variation of entries is contained within variation upon request
modality: AllenInterval
operator: CONTAINS
premise text: (3C) If...

therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-1
type: LogicApplication
conclusion text: ...the Secretary must vary the entry in accordance with the request.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must vary entry
modality: Deontic
operator: MUST
premise text: (a) the person in relation to whom a kind of medical device is included in the Register has requested...

therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-2
type: LogicApplication
conclusion text: ...the Secretary must vary the entry in accordance with the request.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must satisfy conditions
modality: Deontic
operator: MUST
premise text: (c) the conditions (if any) specified in the regulations are satisfied;

therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-5
type: LogicApplication
conclusion text: ...the Secretary must vary the entry in accordance with the request.
confidence: 0.5000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: May vary entry without conditions
modality: Deontic
operator: MAY
premise text: (3CB) If...(a) the person in relation to whom a kind of medical device is included in the Register has requested...

therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-6
type: LogicApplication
conclusion text: ...the Secretary must vary the entry in accordance with the request.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Must add warning, restriction or precaution
modality: Deontic
operator: MUST
premise text: (b) the only effect of the variation would be...(ii) to add a warning, restriction or precaution...

therapeutic-goods-act-1989-sec-9d-ss-3c-logic-descriptionlogic-3
type: LogicApplication
conclusion text: ...the Secretary must vary the entry in accordance with the request.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Variation of entries is a subclass of variation upon request
modality: DescriptionLogic
operator: SUBCLASS_OF
premise text: (3C) If...

therapeutic-goods-act-1989-sec-9d-ss-3c-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(3C) Variation of entries in Register

9D(3D) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Secretary may vary entry in Register upon request.
asserts: therapeutic-goods-act-1989-sec-9d-ss-3d-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-3d-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9d-ss-3d-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-3d
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-3d-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits variation of entries in Register.
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-9d-ss-3d-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Allows for variation of entries in Register.
modality: DescriptionLogic
operator: Variation

therapeutic-goods-act-1989-sec-9d-ss-3d-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(3D) Variation of entries in Register

9D(4) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Must move entry from medical devices part to applicable part of Register
asserts: therapeutic-goods-act-1989-sec-9d-ss-4-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-4
schema version: 2
part of: 9D Variation of entries in Register

9D(6) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: Secretary may approve forms and manners for requests under this section.
asserts: therapeutic-goods-act-1989-sec-9d-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-6-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9d-ss-6-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-6
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-6-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Limits the scope to specific temporal intervals.
modality: AllenInterval
operator: Within
premise text: (6) The Secretary may, by writing:

therapeutic-goods-act-1989-sec-9d-ss-6-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Permits the Secretary to approve forms and manners.
modality: Deontic
operator: May

therapeutic-goods-act-1989-sec-9d-ss-6-norm
type: Permission
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(6) Variation of entries in Register

9D(7) Variation of entries in Register
type: Concept
description: Form, information, application fee, and prescribed documentation
source: therapeutic-goods-act-1989.pdf, p.59
note: Request for variation of entries in Register must comply with approved form and contain required information.
asserts: therapeutic-goods-act-1989-sec-9d-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-7-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9d-ss-7-logic-descriptionlogic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-7
schema version: 2
part of: 9D Variation of entries in Register

therapeutic-goods-act-1989-sec-9d-ss-7-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Request must comply with approved form
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-9d-ss-7-logic-descriptionlogic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::dl
logic summary: Form and information are of a kind determined under subsection (8)
modality: DescriptionLogic
operator: IS_A

therapeutic-goods-act-1989-sec-9d-ss-7-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9D(7) Variation of entries in Register

9D(8) Variation of entries in Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.59
note: The Secretary may determine a kind of information for the purposes of subparagraph (7)(g)(i).
asserts: therapeutic-goods-act-1989-sec-9d-ss-8-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-9d-ss-8
schema version: 2
part of: 9D Variation of entries in Register

9E Publication of list of goods on Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.65
note: The Secretary must publish a list of therapeutic goods on the Register at least once every 12 months.
asserts: therapeutic-goods-act-1989-sec-9e-norm
asserts: therapeutic-goods-act-1989-sec-9e-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9e
schema version: 2

therapeutic-goods-act-1989-sec-9e-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: The Secretary must publish a list of therapeutic goods on the Register.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-9e-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9E Publication of list of goods on Register

9F Removal of entries from Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.65
curation status: Proposed
has part: 9F(1) Removal of entries from Register
has part: 9F(2) Removal of entries from Register
has part: 9F(3) Removal of entries from Register
has part: 9F(4) Removal of entries from Register
has part: 9F(5) Removal of entries from Register
has part: 9F(6) Removal of entries from Register
has part: 9F(7) Removal of entries from Register
proposed by: legis2cml
realized by: sec-9f
schema version: 2

9F(1) Removal of entries from Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.65
note: Prohibition on removal of entries from Register if goods are therapeutic
asserts: therapeutic-goods-act-1989-sec-9f-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-9f-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9f-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-9f-ss-1-logic-ltl-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-9f-ss-1
schema version: 2
part of: 9F Removal of entries from Register

therapeutic-goods-act-1989-sec-9f-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: The provision applies during the existence of an entry on the Register related to goods that are not therapeutic goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Describes the temporal relationship between the provision and its application
modality: AllenInterval
operator: during
premise text: (1) This section applies if: (a) there is an entry on the Register in relation to goods; and (b) the Secretary is satisfied that the goods are not therapeutic goods.

therapeutic-goods-act-1989-sec-9f-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: The removal of entries from the Register is prohibited.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits removal of entries from Register
modality: Deontic
operator: forbid
premise text: (1) This section applies if: (a) there is an entry on the Register in relation to goods; and (b) the Secretary is satisfied that the goods are not therapeutic goods.

therapeutic-goods-act-1989-sec-9f-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: The provision applies everywhere where there is an entry on the Register related to goods that are not therapeutic goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Describes the spatial relationship between the provision and its application
modality: LTL
operator: everywhere
premise text: (a) there is an entry on the Register in relation to goods; and (b) the Secretary is satisfied that the goods are not therapeutic goods.

therapeutic-goods-act-1989-sec-9f-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9F(1) Removal of entries from Register

9F(2) Removal of entries from Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.65
note: Secretary may remove entry from Register
asserts: therapeutic-goods-act-1989-sec-9f-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-9f-ss-2-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9f-ss-2
schema version: 2
part of: 9F Removal of entries from Register

therapeutic-goods-act-1989-sec-9f-ss-2-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Obligation to remove entry
modality: Deontic
operator: may

therapeutic-goods-act-1989-sec-9f-ss-2-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9F(2) Removal of entries from Register

9F(3) Removal of entries from Register
type: Concept
description: written submissions
source: therapeutic-goods-act-1989.pdf, p.65
note: Secretary must inform person of proposed removal and invite written submissions.
asserts: therapeutic-goods-act-1989-sec-9f-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-9f-ss-3-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9f-ss-3-logic-deontic-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-9f-ss-3
schema version: 2
part of: 9F Removal of entries from Register

therapeutic-goods-act-1989-sec-9f-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Secretary must inform person of proposed removal.
modality: Deontic
operator: MUST

therapeutic-goods-act-1989-sec-9f-ss-3-logic-deontic-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Person may make written submissions to Secretary.
modality: Deontic
operator: MAY

therapeutic-goods-act-1989-sec-9f-ss-3-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9F(3) Removal of entries from Register

9F(4) Removal of entries from Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.65
note: Secretary must consider submissions before giving notice.
asserts: therapeutic-goods-act-1989-sec-9f-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-9f-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9f-ss-4
schema version: 2
part of: 9F Removal of entries from Register

therapeutic-goods-act-1989-sec-9f-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: ...until the Secretary has had regard to...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Mandatory action
modality: Deontic
operator: Must
premise text: The Secretary must not...

therapeutic-goods-act-1989-sec-9f-ss-4-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9F(4) Removal of entries from Register

9F(5) Removal of entries from Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.65
note: Notice under subsection (2) is not a legislative instrument.
asserts: therapeutic-goods-act-1989-sec-9f-ss-5-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-9f-ss-5
schema version: 2
part of: 9F Removal of entries from Register

therapeutic-goods-act-1989-sec-9f-ss-5-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9F(5) Removal of entries from Register

9F(6) Removal of entries from Register
type: Concept
source: therapeutic-goods-act-1989.pdf, p.65
note: Removal of entries from Register has effect on specified day
asserts: therapeutic-goods-act-1989-sec-9f-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-9f-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9f-ss-6
schema version: 2
part of: 9F Removal of entries from Register

therapeutic-goods-act-1989-sec-9f-ss-6-logic-deontic-1
type: LogicApplication
conclusion text: The removal has effect...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Imposes obligation
modality: Deontic
operator: hasEffect

therapeutic-goods-act-1989-sec-9f-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9F(6) Removal of entries from Register

9F(7) Removal of entries from Register
type: Concept
description: Notice setting out particulars of removal
source: therapeutic-goods-act-1989.pdf, p.65
note: Secretary must publish notice after removing entry from Register.
asserts: therapeutic-goods-act-1989-sec-9f-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-9f-ss-7-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9f-ss-7
schema version: 2
part of: 9F Removal of entries from Register

therapeutic-goods-act-1989-sec-9f-ss-7-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-9f-ss-7-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9F(7) Removal of entries from Register

9G Criminal offences for false statements in requests for variation of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.66
curation status: Proposed
has part: 9G(1) Criminal offences for false statements in requests for variation of
has part: 9G(4) Criminal offences for false statements in requests for variation of
has part: 9G(5) Criminal offences for false statements in requests for variation of
has part: 9G(6) Criminal offences for false statements in requests for variation of
proposed by: legis2cml
realized by: sec-9g
schema version: 2

9G(1) Criminal offences for false statements in requests for variation of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.66
note: Making false statements in requests for variation of therapeutic goods entries is prohibited.
asserts: therapeutic-goods-act-1989-sec-9g-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-9g-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9g-ss-1
schema version: 2
part of: 9G Criminal offences for false statements in requests for variation of

therapeutic-goods-act-1989-sec-9g-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-9g-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9G(1) Criminal offences for false statements in requests for variation of

9G(4) Criminal offences for false statements in requests for variation of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.66
note: Making false statements in requests for variation of therapeutic goods entries is prohibited.
asserts: therapeutic-goods-act-1989-sec-9g-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-9g-ss-4-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9g-ss-4
schema version: 2
part of: 9G Criminal offences for false statements in requests for variation of

therapeutic-goods-act-1989-sec-9g-ss-4-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making false statements in requests for variation of therapeutic goods entries.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-9g-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9G(4) Criminal offences for false statements in requests for variation of

9G(5) Criminal offences for false statements in requests for variation of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.66
note: Making false statements in requests for variation of therapeutic goods entries is an offence.
asserts: therapeutic-goods-act-1989-sec-9g-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-9g-ss-5-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9g-ss-5
schema version: 2
part of: 9G Criminal offences for false statements in requests for variation of

therapeutic-goods-act-1989-sec-9g-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making false statements in requests for variation of therapeutic goods entries.
modality: Deontic
operator: Prohibition

therapeutic-goods-act-1989-sec-9g-ss-5-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9G(5) Criminal offences for false statements in requests for variation of

9G(6) Criminal offences for false statements in requests for variation of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.66
note: An offence against subsection (5) is an offence of strict liability.
asserts: therapeutic-goods-act-1989-sec-9g-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-9g-ss-6-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9g-ss-6
schema version: 2
part of: 9G Criminal offences for false statements in requests for variation of

therapeutic-goods-act-1989-sec-9g-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-9g-ss-6-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9G(6) Criminal offences for false statements in requests for variation of

9H Civil penalty for false statements in requests for variation of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.68
note: False statements in requests for variation of entries in Register
asserts: therapeutic-goods-act-1989-sec-9h-norm
asserts: therapeutic-goods-act-1989-sec-9h-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9h
schema version: 2

therapeutic-goods-act-1989-sec-9h-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits making false statements
modality: Deontic
operator: Prohibition

9J Simplified outline of this Chapter
type: Concept
source: therapeutic-goods-act-1989.pdf, p.69
note: Regulations may prohibit imports, exports, manufacture, and supplies of certain goods.
asserts: therapeutic-goods-act-1989-sec-9j-norm
asserts: therapeutic-goods-act-1989-sec-9j-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9j-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-9j
schema version: 2

therapeutic-goods-act-1989-sec-9j-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Regulations apply to imports, exports, manufacture, and supplies within a specific temporal interval.
modality: AllenInterval
operator: Temporal Interval

therapeutic-goods-act-1989-sec-9j-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations prohibit imports, exports, manufacture, and supplies of certain goods.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-9j-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9J Simplified outline of this Chapter

9K Prohibition on import, export, manufacture or supply of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.69
curation status: Proposed
has part: 9K(1) Prohibition on import, export, manufacture or supply of
has part: 9K(2) Prohibition on import, export, manufacture or supply of
has part: 9K(3) Prohibition on import, export, manufacture or supply of
has part: 9K(4) Prohibition on import, export, manufacture or supply of
has part: 9K(5) Prohibition on import, export, manufacture or supply of
has part: 9K(6) Prohibition on import, export, manufacture or supply of
has part: 9K(7) Prohibition on import, export, manufacture or supply of
has part: 9K(8) Prohibition on import, export, manufacture or supply of
proposed by: legis2cml
realized by: sec-9k
schema version: 2

9K(1) Prohibition on import, export, manufacture or supply of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.69
note: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods
asserts: therapeutic-goods-act-1989-sec-9k-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-9k-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9k-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-9k-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-9k-ss-1-logic-deontic-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-9k-ss-1
schema version: 2
part of: 9K Prohibition on import, export, manufacture or supply of

therapeutic-goods-act-1989-sec-9k-ss-1-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Prohibition applies during international agreements
modality: AllenInterval
operator: During
premise text: If therapeutic goods or vaping goods are the subject of an international agreement prescribed for the purposes of this subsection, the regulations may prohibit one or more of the following:

therapeutic-goods-act-1989-sec-9k-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the specified actions
modality: Deontic
operator: Prohibit
premise text: (1) If therapeutic goods or vaping goods are the subject of an international agreement prescribed for the purposes of this subsection, the regulations may prohibit one or more of the following:

therapeutic-goods-act-1989-sec-9k-ss-1-logic-deontic-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the specified actions
modality: Deontic
operator: Prohibit
premise text: (b) the export from Australia of the therapeutic goods or vaping goods;

therapeutic-goods-act-1989-sec-9k-ss-1-logic-ltl-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Prohibition ends when international agreements expire
modality: LTL
operator: Until
premise text: (1) If therapeutic goods or vaping goods are the subject of an international agreement prescribed for the purposes of this subsection, the regulations may prohibit one or more of the following:

therapeutic-goods-act-1989-sec-9k-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9K(1) Prohibition on import, export, manufacture or supply of

9K(2) Prohibition on import, export, manufacture or supply of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.69
note: Regulations must prohibit or restrict import, export, manufacture and supply of certain goods before an international agreement is made.
asserts: therapeutic-goods-act-1989-sec-9k-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-9k-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9k-ss-2-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-9k-ss-2-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-9k-ss-2-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-9k-ss-2-logic-argumentation-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-9k-ss-2
schema version: 2
part of: 9K Prohibition on import, export, manufacture or supply of

therapeutic-goods-act-1989-sec-9k-ss-2-logic-alleninterval-2
type: LogicApplication
conclusion text: Regulations must be made before an international agreement is made.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Regulations must be made before an international agreement is made.
modality: AllenInterval
operator: Temporal Interval
premise text: Before regulations are made prescribing an international agreement for the purposes of subsection (1), the Minister must be satisfied that the agreement requires parties to the agreement to take steps to prohibit or restrict one or more of the import, export, manufacture and supply of certain goods.

therapeutic-goods-act-1989-sec-9k-ss-2-logic-argumentation-5
type: LogicApplication
conclusion text: International agreements imply regulations that prohibit or restrict import, export, manufacture and supply of certain goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::argumentation
logic summary: International agreements imply regulations that prohibit or restrict import, export, manufacture and supply of certain goods.
modality: Argumentation
operator: Implication
premise text: The Minister must be satisfied that the agreement requires parties to the agreement to take steps to prohibit or restrict one or more of the import, export, manufacture and supply of certain goods.

therapeutic-goods-act-1989-sec-9k-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Regulations must prohibit or restrict import, export, manufacture and supply of certain goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations must prohibit or restrict certain goods.
modality: Deontic
operator: Prohibit
premise text: International agreement requires parties to take steps to prohibit or restrict import, export, manufacture and supply of certain goods.

therapeutic-goods-act-1989-sec-9k-ss-2-logic-diffusion-4
type: LogicApplication
conclusion text: Regulations must diffuse to all parties to the agreement.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Regulations must diffuse to all parties to the agreement.
modality: Diffusion
operator: Diffuse
premise text: The Minister must be satisfied that the agreement requires parties to the agreement to take steps to prohibit or restrict one or more of the import, export, manufacture and supply of certain goods.

therapeutic-goods-act-1989-sec-9k-ss-2-logic-ltl-3
type: LogicApplication
conclusion text: International agreements require parties to take steps to prohibit or restrict import, export, manufacture and supply of certain goods.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: International agreements require parties to take steps to prohibit or restrict import, export, manufacture and supply of certain goods.
modality: LTL
operator: Recurring Trace
premise text: The Minister must be satisfied that the agreement requires parties to the agreement to take steps to prohibit or restrict one or more of the import, export, manufacture and supply of certain goods.

therapeutic-goods-act-1989-sec-9k-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9K(2) Prohibition on import, export, manufacture or supply of

9K(3) Prohibition on import, export, manufacture or supply of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.69
note: Regulations may prohibit import, export, manufacture or supply of therapeutic goods or vaping goods containing a specified ingredient or component.
asserts: therapeutic-goods-act-1989-sec-9k-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-9k-ss-3-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9k-ss-3
schema version: 2
part of: 9K Prohibition on import, export, manufacture or supply of

therapeutic-goods-act-1989-sec-9k-ss-3-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations prohibit certain actions.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-9k-ss-3-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9K(3) Prohibition on import, export, manufacture or supply of

9K(4) Prohibition on import, export, manufacture or supply of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.69
note: Regulations must prohibit or restrict import, export, manufacture and supply of goods containing a specific ingredient or component.
asserts: therapeutic-goods-act-1989-sec-9k-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-9k-ss-4-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9k-ss-4-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-9k-ss-4
schema version: 2
part of: 9K Prohibition on import, export, manufacture or supply of

therapeutic-goods-act-1989-sec-9k-ss-4-logic-alleninterval-2
type: LogicApplication
conclusion text: ...the Minister must be satisfied...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: The regulation must be made before a specific temporal interval.
modality: AllenInterval
operator: Temporal Interval
premise text: (4) Before regulations are made...

therapeutic-goods-act-1989-sec-9k-ss-4-logic-deontic-1
type: LogicApplication
conclusion text: ...the Minister must be satisfied...
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations must prohibit the specified activity.
modality: Deontic
operator: Prohibit
premise text: (4) Before regulations are made...

therapeutic-goods-act-1989-sec-9k-ss-4-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9K(4) Prohibition on import, export, manufacture or supply of

9K(5) Prohibition on import, export, manufacture or supply of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.69
note: Absolute or conditionally prescribed prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods.
asserts: therapeutic-goods-act-1989-sec-9k-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-9k-ss-5-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9k-ss-5-logic-alleninterval-2
curation status: Proposed
proposed by: legis2cml
realized by: sec-9k-ss-5
schema version: 2
part of: 9K Prohibition on import, export, manufacture or supply of

therapeutic-goods-act-1989-sec-9k-ss-5-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval for prohibition
modality: AllenInterval
operator: Temporal Interval
premise text: (5) A prohibition referred to in subsection (1) or (3) may be absolute

therapeutic-goods-act-1989-sec-9k-ss-5-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Absolute prohibition
modality: Deontic
operator: Prohibit
premise text: (5) A prohibition referred to in subsection (1) or (3) may be absolute

therapeutic-goods-act-1989-sec-9k-ss-5-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9K(5) Prohibition on import, export, manufacture or supply of

9K(6) Prohibition on import, export, manufacture or supply of
type: Concept
description: (i) the international agreement; (ii) the Minister’s satisfaction; (iii) the proposed prohibition
source: therapeutic-goods-act-1989.pdf, p.69
note: Regulations containing a prohibition must be published and wait 30 days before implementation.
asserts: therapeutic-goods-act-1989-sec-9k-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9k-ss-6-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-4
asserts: therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-9k-ss-6
schema version: 2
part of: 9K Prohibition on import, export, manufacture or supply of

therapeutic-goods-act-1989-sec-9k-ss-6-logic-alleninterval-2
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Notice must be published for at least 30 days before implementation
modality: AllenInterval
operator: Temporal Interval
premise text: (b) a period of 30 days has passed since the notice was published

therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations containing a prohibition
modality: Deontic
operator: Prohibition
premise text: (6) Regulations containing a prohibition referred to in subsection (1) or (3)

therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-3
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations must be published for public review
modality: Deontic
operator: Permission
premise text: (a) the Minister causes to be published on the Department’s website a notice setting out details of: (i) the international agreement; and (ii) the Minister’s satisfaction

therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-4
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Minister must cause publication of notice
modality: Deontic
operator: Obligation
premise text: (a) the Minister causes to be published on the Department’s website a notice setting out details of: (i) the international agreement; and (ii) the Minister’s satisfaction

therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-5
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations containing prohibition must be implemented after publication
modality: Deontic
operator: Prohibition
premise text: (b) a period of 30 days has passed since the notice was published

therapeutic-goods-act-1989-sec-9k-ss-6-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9K(6) Prohibition on import, export, manufacture or supply of

9K(7) Prohibition on import, export, manufacture or supply of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.69
note: Regulations with prohibition must not start before the international agreement enters into force.
asserts: therapeutic-goods-act-1989-sec-9k-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-9k-ss-7-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9k-ss-7-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-9k-ss-7-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-9k-ss-7-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-9k-ss-7-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-9k-ss-7
schema version: 2
part of: 9K Prohibition on import, export, manufacture or supply of

therapeutic-goods-act-1989-sec-9k-ss-7-logic-alleninterval-2
type: LogicApplication
conclusion text: the day the international agreement enters into force for Australia.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Regulations with prohibition overlap with the international agreement.
modality: AllenInterval
operator: Overlaps
premise text: (7) Regulations containing a prohibition referred to in subsection (1) or (3)

therapeutic-goods-act-1989-sec-9k-ss-7-logic-cogai-5
type: LogicApplication
conclusion text: must not be expressed to commence on a day earlier than the day the international agreement enters into force for Australia.
confidence: 1.0000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: Regulations with prohibition infer the international agreement.
modality: CogAI
operator: Infer
premise text: (7) Regulations containing a prohibition referred to in subsection (1) or (3)

therapeutic-goods-act-1989-sec-9k-ss-7-logic-deontic-1
type: LogicApplication
conclusion text: must not be expressed to commence on a day earlier than the day the international agreement enters into force for Australia.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Regulations with prohibition cannot start before the international agreement enters into force.
modality: Deontic
operator: Cannot
premise text: (7) Regulations containing a prohibition referred to in subsection (1) or (3)

therapeutic-goods-act-1989-sec-9k-ss-7-logic-diffusion-4
type: LogicApplication
conclusion text: the day the international agreement enters into force for Australia.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: Regulations with prohibition diffuse to the international agreement.
modality: Diffusion
operator: Diffuses
premise text: (7) Regulations containing a prohibition referred to in subsection (1) or (3)

therapeutic-goods-act-1989-sec-9k-ss-7-logic-ltl-3
type: LogicApplication
conclusion text: must not be expressed to commence on a day earlier than the day the international agreement enters into force for Australia.
confidence: 1.0000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Regulations with prohibition are until the international agreement enters into force.
modality: LTL
operator: Until
premise text: (7) Regulations containing a prohibition referred to in subsection (1) or (3)

therapeutic-goods-act-1989-sec-9k-ss-7-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9K(7) Prohibition on import, export, manufacture or supply of

9K(8) Prohibition on import, export, manufacture or supply of
type: Concept
source: therapeutic-goods-act-1989.pdf, p.69
note: Regulations may confer power on Minister or Secretary to make administrative decisions.
asserts: therapeutic-goods-act-1989-sec-9k-ss-8-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-9k-ss-8
schema version: 2
part of: 9K Prohibition on import, export, manufacture or supply of

9L Offence and civil penalty
type: Concept
source: therapeutic-goods-act-1989.pdf, p.71
curation status: Proposed
has part: 9L(1) Offence and civil penalty
has part: 9L(2) Offence and civil penalty
proposed by: legis2cml
realized by: sec-9l
schema version: 2

9L(1) Offence and civil penalty
type: Concept
source: therapeutic-goods-act-1989.pdf, p.71
note: Import, export, manufacture or supply of therapeutic goods or vaping goods is prohibited.
asserts: therapeutic-goods-act-1989-sec-9l-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-9l-ss-1-logic-deontic-1
curation status: Proposed
proposed by: legis2cml
realized by: sec-9l-ss-1
schema version: 2
part of: 9L Offence and civil penalty

therapeutic-goods-act-1989-sec-9l-ss-1-logic-deontic-1
type: LogicApplication
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibits the import, export, manufacture or supply of therapeutic goods or vaping goods.
modality: Deontic
operator: Prohibit

therapeutic-goods-act-1989-sec-9l-ss-1-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9L(1) Offence and civil penalty

9L(2) Offence and civil penalty
type: Concept
source: therapeutic-goods-act-1989.pdf, p.71
note: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
asserts: therapeutic-goods-act-1989-sec-9l-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-3
asserts: therapeutic-goods-act-1989-sec-9l-ss-2-logic-alleninterval-4
curation status: Proposed
proposed by: legis2cml
realized by: sec-9l-ss-2
schema version: 2
part of: 9L Offence and civil penalty

therapeutic-goods-act-1989-sec-9l-ss-2-logic-alleninterval-4
type: LogicApplication
conclusion text: Maximum civil penalty: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Temporal interval: Maximum civil penalty
modality: AllenInterval
operator: =
premise text: (a) for an individual—300 penalty units; and (b) for a body corporate—3,000 penalty units.

therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Absolute prohibition
modality: Deontic
operator: =
premise text: (i) an absolute prohibition in force for the purposes of subsection 9K(1) or (3);

therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-2
type: LogicApplication
conclusion text: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
modality: Deontic
operator: =
premise text: (ii) one or more conditions of a prohibition in force for the purposes of subsection 9K(1) or (3).

therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-3
type: LogicApplication
conclusion text: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Maximum civil penalty: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
modality: Deontic
operator: =
premise text: (a) for an individual—300 penalty units; and (b) for a body corporate—3,000 penalty units.

therapeutic-goods-act-1989-sec-9l-ss-2-norm
type: Prohibition
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9L(2) Offence and civil penalty

9M Application of Customs Act 1901
type: Concept
source: therapeutic-goods-act-1989.pdf, p.73
note: Customs Act 1901 applies to prohibited imports or exports if notified by Secretary.
asserts: therapeutic-goods-act-1989-sec-9m-norm
curation status: Proposed
proposed by: legis2cml
realized by: sec-9m
schema version: 2

therapeutic-goods-act-1989-sec-9m-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9M Application of Customs Act 1901

9N Constitutional basis
type: Concept
source: therapeutic-goods-act-1989.pdf, p.73
curation status: Proposed
has part: 9N(1) Constitutional basis
has part: 9N(2) Constitutional basis
proposed by: legis2cml
realized by: sec-9n
schema version: 2

9N(1) Constitutional basis
type: Concept
source: therapeutic-goods-act-1989.pdf, p.73
note: Relies on Commonwealth's legislative power under paragraph 51(xxix) of the Constitution.
asserts: therapeutic-goods-act-1989-sec-9n-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-9n-ss-1-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9n-ss-1-logic-alleninterval-2
asserts: therapeutic-goods-act-1989-sec-9n-ss-1-logic-ltl-3
asserts: therapeutic-goods-act-1989-sec-9n-ss-1-logic-diffusion-4
asserts: therapeutic-goods-act-1989-sec-9n-ss-1-logic-cogai-5
curation status: Proposed
proposed by: legis2cml
realized by: sec-9n-ss-1
schema version: 2
part of: 9N Constitutional basis

therapeutic-goods-act-1989-sec-9n-ss-1-logic-alleninterval-2
type: LogicApplication
conclusion text: ...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::interval_reasoning
logic summary: Prescribed for the purposes of subsection 9K(1) or (3)
modality: AllenInterval
operator: PrescribedFor
premise text: ...prescribed for the purposes of subsection 9K(1) or (3).

therapeutic-goods-act-1989-sec-9n-ss-1-logic-cogai-5
type: LogicApplication
conclusion text: ...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3).
confidence: 0.5000
curation status: Proposed
execution surface: sparql_library::parsers::chk_parser
logic summary: SHACL validation
modality: CogAI
operator: SHACL
premise text: ...prescribed for the purposes of subsection 9K(1) or (3).

therapeutic-goods-act-1989-sec-9n-ss-1-logic-deontic-1
type: LogicApplication
conclusion text: ...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3).
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Relies on Commonwealth's legislative power
modality: Deontic
operator: ReliesOn
premise text: (1) This Chapter, and any other provision of this Act to the extent it relates to this Chapter, relies...

therapeutic-goods-act-1989-sec-9n-ss-1-logic-diffusion-4
type: LogicApplication
conclusion text: ...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3).
confidence: 0.5000
curation status: Proposed
execution surface: modalities::diffusion
logic summary: International agreement
modality: Diffusion
operator: InternationalAgreement
premise text: ...prescribed for the purposes of subsection 9K(1) or (3).

therapeutic-goods-act-1989-sec-9n-ss-1-logic-ltl-3
type: LogicApplication
conclusion text: ...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3).
confidence: 0.5000
curation status: Proposed
execution surface: modalities::temporal_ltl
logic summary: Recurring trace of subsection 9K(1) or (3)
modality: LTL
operator: RecurringTrace
premise text: ...prescribed for the purposes of subsection 9K(1) or (3).

therapeutic-goods-act-1989-sec-9n-ss-1-norm
type: Obligation
scope note: borne by: State
curation status: Proposed
modality: Deontic
borne by: State
deontic status: HeuristicDerived
part of: 9N(1) Constitutional basis

9N(2) Constitutional basis
type: Concept
source: therapeutic-goods-act-1989.pdf, p.73
note: Does not limit section 6
asserts: therapeutic-goods-act-1989-sec-9n-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-1
asserts: therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-2
asserts: therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-3
curation status: Proposed
proposed by: legis2cml
realized by: sec-9n-ss-2
schema version: 2
part of: 9N Constitutional basis

therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-1
type: LogicApplication
conclusion text: Section 6 is unaffected
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Limits the scope of section 6
modality: Deontic
operator: does not imply
premise text: Section 9N(2)

therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-2
type: LogicApplication
conclusion text: Conduct related to section 6 is permitted
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Does not ban conduct related to section 6
modality: Deontic
operator: does not prohibit
premise text: Section 9N(2) does not limit section 6

therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-3
type: LogicApplication
conclusion text: Conduct related to section 6 is permitted but not a right
confidence: 1.0000
curation status: Proposed
execution surface: modalities::logic::deontic
logic summary: Does not grant a right to conduct related to section 6
modality: Deontic
operator: does not create right
premise text: Section 9N(2) does not limit section 6

Therapeutic Goods Act 1989
type: Document
date: 5 September 2025
identifier: No. 21 of 1990
curation status: Proposed
proposed by: legis2cml
category: AU