Therapeutic Goods Act 1989
type: Document
category: AU
identifier: No. 21 of 1990
date: 5 September 2025
proposed by: legis2cml
curation status: Proposed

5 September 2025
type: Concept
realized by: sec-5
note: Compilation information and notes on amendments.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.1
asserts: therapeutic-goods-act-1989-sec-5-norm
asserts: therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-1

therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-1
type: LogicApplication
modality: DescriptionLogic
operator: =
logic summary: Identifies the compilation date.
premise text: Compilation date: 05/09/2025
conclusion text: The compilation date is 05/09/2025.
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

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

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

3 Interpretation
type: Concept
realized by: sec-3
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.17

3(1) Interpretation
type: Concept
realized by: sec-3-ss-1
part of: 3 Interpretation
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.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.17
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

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

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

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

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-4
type: LogicApplication
modality: DescriptionLogic
operator: =
logic summary: Classifies terms into categories
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.
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.
execution surface: modalities::dl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-5
type: LogicApplication
modality: DescriptionLogic
operator: =
logic summary: Classifies terms into categories
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.
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.
execution surface: modalities::dl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-6
type: LogicApplication
modality: DescriptionLogic
operator: =
logic summary: Classifies terms into categories
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.
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.
execution surface: modalities::dl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-7
type: LogicApplication
modality: DescriptionLogic
operator: =
logic summary: Classifies terms into categories
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.
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.
execution surface: modalities::dl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-8
type: LogicApplication
modality: DescriptionLogic
operator: =
logic summary: Classifies terms into categories
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).
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).
execution surface: modalities::dl
confidence: 0.5000
curation status: Proposed

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

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

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-11
type: LogicApplication
modality: DescriptionLogic
operator: =
logic summary: Class hierarchy for therapeutic goods
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...
conclusion text: product information, in relation to therapeutic goods, means information relating to the safe and effective use of the goods
execution surface: modalities::dl
confidence: 0.5000
curation status: Proposed

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

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-13
type: LogicApplication
modality: DescriptionLogic
operator: =
logic summary: Class hierarchy for reportable medicine
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)
conclusion text: reportable medicine has the meaning given by section 30EH
execution surface: modalities::dl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-14
type: LogicApplication
modality: DescriptionLogic
operator: =
logic summary: Class hierarchy for therapeutic goods
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...
conclusion text: biologicals, medical devices and goods declared to be therapeutic goods under an order in force under section 7 but do not include...
execution surface: modalities::dl
confidence: 0.5000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

3(4) Interpretation
type: Concept
realized by: sec-3-ss-4
part of: 3 Interpretation
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.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.17
asserts: therapeutic-goods-act-1989-sec-3-ss-4-norm

therapeutic-goods-act-1989-sec-3-ss-4-norm
type: Obligation
modality: Deontic
part of: 3(4) Interpretation
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

3(5) Interpretation
type: Concept
realized by: sec-3-ss-5
part of: 3 Interpretation
note: Presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.17
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

therapeutic-goods-act-1989-sec-3-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits the presentation of therapeutic goods that is misleading or confusing.
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
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-5-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: Classify
logic summary: Classifies presentation of therapeutic goods as unacceptable if it is misleading or confusing.
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
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-5-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Defines a temporal interval for when presentation of therapeutic goods is unacceptable.
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
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-5-logic-ltl-4
type: LogicApplication
modality: LTL
operator: Recurring Trace
logic summary: Defines a recurring trace for when presentation of therapeutic goods is unacceptable.
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
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-5-logic-diffusion-5
type: LogicApplication
modality: Diffusion
operator: Diffuse
logic summary: Diffuses the prohibition on presentation of therapeutic goods that is misleading or confusing.
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
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-5-logic-cogai-6
type: LogicApplication
modality: CogAI
operator: Recognize
logic summary: Recognizes the presentation of therapeutic goods that is misleading or confusing.
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
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

3(5A) Interpretation
type: Concept
realized by: sec-3-ss-5a
part of: 3 Interpretation
note: Specify advisory statements in relation to medicine
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.17
asserts: therapeutic-goods-act-1989-sec-3-ss-5a-norm
asserts: therapeutic-goods-act-1989-sec-3-ss-5a-logic-deontic-1

therapeutic-goods-act-1989-sec-3-ss-5a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permission to specify advisory statements
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

3(5B) Interpretation
type: Concept
realized by: sec-3-ss-5b
part of: 3 Interpretation
note: Specify different advisory statements for medicines or classes of medicine.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.17
asserts: therapeutic-goods-act-1989-sec-3-ss-5b-norm
asserts: therapeutic-goods-act-1989-sec-3-ss-5b-logic-deontic-1

therapeutic-goods-act-1989-sec-3-ss-5b-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permission to specify advisory statements
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

3(6) Interpretation
type: Concept
realized by: sec-3-ss-6
part of: 3 Interpretation
note: References charges under Therapeutic Goods (Charges) Act 1989.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.17
asserts: therapeutic-goods-act-1989-sec-3-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-3-ss-6-logic-deontic-1

therapeutic-goods-act-1989-sec-3-ss-6-norm
type: Obligation
modality: Deontic
part of: 3(6) Interpretation
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-6-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: =
logic summary: Definition of charge reference
premise text: Annual charges under Therapeutic Goods (Charges) Act 1989
conclusion text: Charge reference defined as such a charge imposed under the Act
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

3(7) Interpretation
type: Concept
realized by: sec-3-ss-7
part of: 3 Interpretation
note: References an offence against this Act to related offences under other laws.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.17
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

therapeutic-goods-act-1989-sec-3-ss-7-norm
type: Obligation
modality: Deontic
part of: 3(7) Interpretation
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-1
type: LogicApplication
modality: DescriptionLogic
operator: =
logic summary: Classifies the subject of the reference
premise text: A reference to an offence against this Act includes a reference to...
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
execution surface: modalities::dl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: =
logic summary: Classifies the subject of the reference
premise text: A reference to an offence against this Act includes a reference to...
conclusion text: an offence against section 136.1, 137.1 or 137.2 of the Criminal Code
execution surface: modalities::dl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-3
type: LogicApplication
modality: DescriptionLogic
operator: =
logic summary: Classifies the subject of the reference
premise text: A reference to an offence against this Act includes a reference to...
conclusion text: an offence against the regulations
execution surface: modalities::dl
confidence: 0.5000
curation status: Proposed

3(7A) Interpretation
type: Concept
realized by: sec-3-ss-7a
part of: 3 Interpretation
note: Imposes a duty on Commonwealth authorities if corresponding State law confers function or power and gives rise to obligation.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.17
asserts: therapeutic-goods-act-1989-sec-3-ss-7a-norm
asserts: therapeutic-goods-act-1989-sec-3-ss-7a-logic-deontic-1

therapeutic-goods-act-1989-sec-3-ss-7a-norm
type: Obligation
modality: Deontic
part of: 3(7A) Interpretation
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-3-ss-7a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Imposes
logic summary: States a duty
premise text: (7A) For the purposes of this Act, a corresponding State law imposes a duty...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

3(8) Interpretation
type: Concept
realized by: sec-3-ss-8
part of: 3 Interpretation
note: Clarifies interpretation of registered therapeutic goods and provisional registration.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.17
asserts: therapeutic-goods-act-1989-sec-3-ss-8-norm

3AA Homoeopathic preparations and homoeopathic standards
type: Concept
realized by: sec-3aa
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.39

3AA(1) Homoeopathic preparations and homoeopathic standards
type: Concept
realized by: sec-3aa-ss-1
part of: 3AA Homoeopathic preparations and homoeopathic standards
note: Definition of homoeopathic preparation and standard.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.39
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

therapeutic-goods-act-1989-sec-3aa-ss-1-norm
type: Obligation
modality: Deontic
part of: 3AA(1) Homoeopathic preparations and homoeopathic standards
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-3aa-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: =
logic summary: Defines a term with a clear obligation.
premise text: (1) For the purposes of this Act, a homoeopathic preparation is a...
conclusion text: a homoeopathic standard
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-3aa-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: =
logic summary: Defines a temporal interval.
premise text: (1) For the purposes of this Act, a homoeopathic preparation is a...
conclusion text: a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-3aa-ss-1-logic-ltl-3
type: LogicApplication
modality: LTL
operator: =
logic summary: Defines a temporal interval.
premise text: (1) For the purposes of this Act, a homoeopathic preparation is a...
conclusion text: a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia
execution surface: modalities::temporal_ltl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-3aa-ss-1-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: =
logic summary: Defines a concept that can be shared.
premise text: (1) For the purposes of this Act, a homoeopathic preparation is a...
conclusion text: a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia
execution surface: modalities::diffusion
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-3aa-ss-1-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: =
logic summary: Defines a concept that can be processed by AI.
premise text: (1) For the purposes of this Act, a homoeopathic preparation is a...
conclusion text: a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia
execution surface: sparql_library::parsers::chk_parser
confidence: 0.5000
curation status: Proposed

3AA(2) Homoeopathic preparations and homoeopathic standards
type: Concept
realized by: sec-3aa-ss-2
part of: 3AA Homoeopathic preparations and homoeopathic standards
note: A homoeopathic standard is constituted by the statements in monographs describing manufacturing procedures.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.39
asserts: therapeutic-goods-act-1989-sec-3aa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-3aa-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-3aa-ss-2-norm
type: Obligation
modality: Deontic
part of: 3AA(2) Homoeopathic preparations and homoeopathic standards
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-3aa-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: constitutes
logic summary: Establishes a homoeopathic standard
premise text: (a) and (b)
conclusion text: then there is a homoeopathic standard
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

3AA(3) Homoeopathic preparations and homoeopathic standards
type: Concept
realized by: sec-3aa-ss-3
part of: 3AA Homoeopathic preparations and homoeopathic standards
note: Specify publications and/or parts of publications for homoeopathic pharmacopoeia definition
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.39
asserts: therapeutic-goods-act-1989-sec-3aa-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-3aa-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-3aa-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Specify
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

3AA(4) Homoeopathic preparations and homoeopathic standards
type: Concept
realized by: sec-3aa-ss-4
part of: 3AA Homoeopathic preparations and homoeopathic standards
note: Minister may exempt specified monographs from certain requirements.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.39
asserts: therapeutic-goods-act-1989-sec-3aa-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-3aa-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-3aa-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permission to exempt
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

3AA(5) Homoeopathic preparations and homoeopathic standards
type: Concept
realized by: sec-3aa-ss-5
part of: 3AA Homoeopathic preparations and homoeopathic standards
note: The Minister may determine exemptions for specified statements in monographs.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.39
asserts: therapeutic-goods-act-1989-sec-3aa-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-3aa-ss-5-logic-deontic-1

therapeutic-goods-act-1989-sec-3aa-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to exempt
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

3AB Anthroposophic preparations and anthroposophic standards
type: Concept
realized by: sec-3ab
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.41

3AB(1) Anthroposophic preparations and anthroposophic standards
type: Concept
realized by: sec-3ab-ss-1
part of: 3AB Anthroposophic preparations and anthroposophic standards
note: Definition of anthroposophic preparation
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.41
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

therapeutic-goods-act-1989-sec-3ab-ss-1-norm
type: Obligation
modality: Deontic
part of: 3AB(1) Anthroposophic preparations and anthroposophic standards
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-3ab-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: =
logic summary: Definition of term
premise text: (1) For the purposes of this Act, an anthroposophic preparation is a...
conclusion text: anthroposophic standard
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-3ab-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: =
logic summary: Temporal relation definition
premise text: (1) For the purposes of this Act, an anthroposophic preparation is a...
conclusion text: anthroposophic standard
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

3AB(2) Anthroposophic preparations and anthroposophic standards
type: Concept
realized by: sec-3ab-ss-2
part of: 3AB Anthroposophic preparations and anthroposophic standards
note: An anthroposophic standard is constituted by the statements in monographs describing manufacturing procedures.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.41
asserts: therapeutic-goods-act-1989-sec-3ab-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-3ab-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-3ab-ss-2-norm
type: Obligation
modality: Deontic
part of: 3AB(2) Anthroposophic preparations and anthroposophic standards
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-3ab-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: constitutes
logic summary: Anthroposophic standard is constituted by statements in monographs
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

3AB(3) Anthroposophic preparations and anthroposophic standards
type: Concept
realized by: sec-3ab-ss-3
part of: 3AB Anthroposophic preparations and anthroposophic standards
note: Specify publications and/or parts of publications for the definition of anthroposophic pharmacopoeia.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.41
asserts: therapeutic-goods-act-1989-sec-3ab-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-3ab-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-3ab-ss-3-norm
type: Permission
modality: Deontic
part of: 3AB(3) Anthroposophic preparations and anthroposophic standards
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-3ab-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Specify
logic summary: Specify publications and/or parts of publications.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

3AB(4) Anthroposophic preparations and anthroposophic standards
type: Concept
realized by: sec-3ab-ss-4
part of: 3AB Anthroposophic preparations and anthroposophic standards
note: Minister may exempt specified monographs from paragraph (2)(b) purposes.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.41
asserts: therapeutic-goods-act-1989-sec-3ab-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-3ab-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-3ab-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to exempt monographs
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

3AB(5) Anthroposophic preparations and anthroposophic standards
type: Concept
realized by: sec-3ab-ss-5
part of: 3AB Anthroposophic preparations and anthroposophic standards
note: Minister may exempt specified statements from subsection (2)
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.41
asserts: therapeutic-goods-act-1989-sec-3ab-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-3ab-ss-5-logic-deontic-1

therapeutic-goods-act-1989-sec-3ab-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to exempt
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

3A Declaration—member of European Community
type: Concept
realized by: sec-3a
has part: 3A(1) Declaration—member of European Community
has part: 3A(2) Declaration—member of European Community
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.42

3A(1) Declaration—member of European Community
type: Concept
realized by: sec-3a-ss-1
part of: 3A Declaration—member of European Community
note: Declaration of membership in European Community or EFTA
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.42
asserts: therapeutic-goods-act-1989-sec-3a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-3a-ss-1-logic-deontic-1

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

3A(2) Declaration—member of European Community
type: Concept
realized by: sec-3a-ss-2
part of: 3A Declaration—member of European Community
note: Declaration must be published in Gazette or on Department's website.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.42
asserts: therapeutic-goods-act-1989-sec-3a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-3a-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-3a-ss-2-norm
type: Obligation
modality: Deontic
part of: 3A(2) Declaration—member of European Community
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

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

3B Declaration—country covered by non-EC/EFTA MRA
type: Concept
realized by: sec-3b
has part: 3B(1) Declaration—country covered by non-EC/EFTA MRA
has part: 3B(2) Declaration—country covered by non-EC/EFTA MRA
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.42

3B(1) Declaration—country covered by non-EC/EFTA MRA
type: Concept
realized by: sec-3b-ss-1
part of: 3B Declaration—country covered by non-EC/EFTA MRA
note: Minister may declare a country covered by non-EC/EFTA MRA.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.42
asserts: therapeutic-goods-act-1989-sec-3b-ss-1-norm

therapeutic-goods-act-1989-sec-3b-ss-1-norm
type: Obligation
modality: Deontic
part of: 3B(1) Declaration—country covered by non-EC/EFTA MRA
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

3B(2) Declaration—country covered by non-EC/EFTA MRA
type: Concept
realized by: sec-3b-ss-2
part of: 3B Declaration—country covered by non-EC/EFTA MRA
note: Declaration must be published in Gazette or on Department's website.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.42
asserts: therapeutic-goods-act-1989-sec-3b-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-3b-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-3b-ss-2-norm
type: Obligation
modality: Deontic
part of: 3B(2) Declaration—country covered by non-EC/EFTA MRA
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

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

3C Exempting monographs in pharmacopoeias
type: Concept
realized by: sec-3c
has part: 3C(1) Exempting monographs in pharmacopoeias
has part: 3C(2) Exempting monographs in pharmacopoeias
has part: 3C(3) Exempting monographs in pharmacopoeias
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.43

3C(1) Exempting monographs in pharmacopoeias
type: Concept
realized by: sec-3c-ss-1
part of: 3C Exempting monographs in pharmacopoeias
note: The Minister may determine exemptions for specified monographs in relation to therapeutic goods.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.43
asserts: therapeutic-goods-act-1989-sec-3c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-3c-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-3c-ss-1-norm
type: Permission
modality: Deontic
part of: 3C(1) Exempting monographs in pharmacopoeias
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-3c-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permission granted by the Minister.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

3C(2) Exempting monographs in pharmacopoeias
type: Concept
realized by: sec-3c-ss-2
part of: 3C Exempting monographs in pharmacopoeias
note: Determination of exemptions for therapeutic goods
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.43
asserts: therapeutic-goods-act-1989-sec-3c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-3c-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-3c-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to determine exemptions
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

3C(3) Exempting monographs in pharmacopoeias
type: Concept
realized by: sec-3c-ss-3
part of: 3C Exempting monographs in pharmacopoeias
note: Exempts monographs in pharmacopoeias from certain legislation
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.43
asserts: therapeutic-goods-act-1989-sec-3c-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-3c-ss-3-logic-alleninterval-1

therapeutic-goods-act-1989-sec-3c-ss-3-logic-alleninterval-1
type: LogicApplication
modality: AllenInterval
operator: Applicable
logic summary: Requires temporal relation between instrument and writing
premise text: Temporal intervals mentioned
conclusion text: Undertaking
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

4 Objects of Act
type: Concept
realized by: sec-4
has part: 4(1) Objects of Act
has part: 4(1A) Objects of Act
has part: 4(2) Objects of Act
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.43

4(1) Objects of Act
type: Concept
realized by: sec-4-ss-1
part of: 4 Objects of Act
note: List therapeutic goods for national system of controls
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.43
asserts: therapeutic-goods-act-1989-sec-4-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-4-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-4-ss-1-norm
type: Obligation
modality: Deontic
part of: 4(1) Objects of Act
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-4-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: shall
logic summary: Imposes a duty on the State
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

4(1A) Objects of Act
type: Concept
realized by: sec-4-ss-1a
part of: 4 Objects of Act
note: Manufacturer's intent for medical devices
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.43
asserts: therapeutic-goods-act-1989-sec-4-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-4-ss-1a-logic-deontic-1

therapeutic-goods-act-1989-sec-4-ss-1a-norm
type: Obligation
modality: Deontic
part of: 4(1A) Objects of Act
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-4-ss-1a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: performance
logic summary: Performance of devices as intended
premise text: (1A) The reference in paragraph (1)(a)
conclusion text: The efficacy of therapeutic goods is a reference to the performance of devices as the manufacturer intended.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

4(2) Objects of Act
type: Concept
realized by: sec-4-ss-2
part of: 4 Objects of Act
note: Act does not exclude concurrent operation with other laws.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.43
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

therapeutic-goods-act-1989-sec-4-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: exclusion
logic summary: Exclusion of concurrent operation
premise text: (2) This Act is therefore not intended to apply...
conclusion text: to the extent that the law is capable of operating concurrently with this Act.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-4-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: simultaneity
logic summary: Simultaneous operation allowed
premise text: (2) This Act is therefore not intended to apply...
conclusion text: to the extent that the law is capable of operating concurrently with this Act.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-4-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: trace
logic summary: Tracing concurrent operation
premise text: (2) This Act is therefore not intended to apply...
conclusion text: to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-4-ss-2-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: diffusion
logic summary: Diffusing concurrent operation
premise text: (2) This Act is therefore not intended to apply...
conclusion text: to the extent that the law is capable of operating concurrently with this Act.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-4-ss-2-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: cognitive framework
logic summary: Cognitive framework for concurrent operation
premise text: (2) This Act is therefore not intended to apply...
conclusion text: to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

5 Act to bind Crown
type: Concept
realized by: sec-5-2
note: The Crown is bound by this Act.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.44
asserts: therapeutic-goods-act-1989-sec-5-2-norm
asserts: therapeutic-goods-act-1989-sec-5-2-logic-deontic-1

therapeutic-goods-act-1989-sec-5-2-norm
type: Obligation
modality: Deontic
part of: 5 Act to bind Crown
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-5-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Binding
logic summary: The Crown is obligated to comply with the Act.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

5A Application of the Criminal Code—extended geographical
type: Concept
realized by: sec-5a
note: Jurisdiction applies to specific offences
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.45
asserts: therapeutic-goods-act-1989-sec-5a-norm
asserts: therapeutic-goods-act-1989-sec-5a-logic-deontic-1

therapeutic-goods-act-1989-sec-5a-norm
type: Obligation
modality: Deontic
part of: 5A Application of the Criminal Code—extended geographical
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-5a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: applies
logic summary: Jurisdiction is applied
premise text: Section 15.2 of the Criminal Code
conclusion text: to offences against specified subsections
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

6 Operation of Act
type: Concept
realized by: sec-6
note: Applicable to corporations and natural persons/corporations in certain trade/commerce contexts.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.45
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

therapeutic-goods-act-1989-sec-6-norm
type: Obligation
modality: Deontic
part of: 6 Operation of Act
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-6-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: appliesTo
logic summary: Applicable to corporations and natural persons/corporations.
premise text: (1) This Act (other than Part 4-8A or Part 6-1A)
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-6-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: appliesTo
logic summary: Applicable to corporations and natural persons/corporations.
premise text: (a) things done by corporations; (b) things done by natural persons or corporations in so far as those things are done:
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-6-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: appliesTo
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.
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;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

6B Review of certain decisions under State laws
type: Concept
realized by: sec-6b
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.50

6B(1) Review of certain decisions under State laws
type: Concept
realized by: sec-6b-ss-1
part of: 6B Review of certain decisions under State laws
note: Application for review of a State decision may be made.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.50
asserts: therapeutic-goods-act-1989-sec-6b-ss-1-norm

6B(2) Review of certain decisions under State laws
type: Concept
realized by: sec-6b-ss-2
part of: 6B Review of certain decisions under State laws
note: A decision made by the Secretary is reviewable if it meets certain conditions.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.50
asserts: therapeutic-goods-act-1989-sec-6b-ss-2-norm

therapeutic-goods-act-1989-sec-6b-ss-2-norm
type: Obligation
modality: Deontic
part of: 6B(2) Review of certain decisions under State laws
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

6B(3) Review of certain decisions under State laws
type: Concept
realized by: sec-6b-ss-3
part of: 6B Review of certain decisions under State laws
note: Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.50
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

therapeutic-goods-act-1989-sec-6b-ss-3-norm
type: Obligation
modality: Deontic
part of: 6B(3) Review of certain decisions under State laws
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-6b-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: hasEffectAsIf
logic summary: Legal effect of the Administrative Review Tribunal Act 2024 on State laws.
premise text: State law
conclusion text: Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-6b-ss-3-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: The Administrative Review Tribunal Act 2024 has effect during the period of a corresponding State law.
premise text: State law
conclusion text: Administrative Review Tribunal Act 2024
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-6b-ss-3-logic-ltl-3
type: LogicApplication
modality: LTL
operator: during
logic summary: The Administrative Review Tribunal Act 2024 has effect during the period of a corresponding State law.
premise text: State law
conclusion text: Administrative Review Tribunal Act 2024
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-6b-ss-3-logic-cogai-4
type: LogicApplication
modality: CogAI
operator: hasEffectAsIf
logic summary: The Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act.
premise text: State law
conclusion text: Administrative Review Tribunal Act 2024
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-6b-ss-3-logic-shacl-5
type: LogicApplication
modality: SHACL
operator: hasEffectAsIf
logic summary: The Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act.
premise text: State law
conclusion text: Administrative Review Tribunal Act 2024
execution surface: modalities::logic::shacl
confidence: 1.0000
curation status: Proposed

6C Fees payable to Commonwealth under State laws
type: Concept
realized by: sec-6c
has part: 6C(1) Fees payable to Commonwealth under State laws
has part: 6C(2) Fees payable to Commonwealth under State laws
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.51

6C(1) Fees payable to Commonwealth under State laws
type: Concept
realized by: sec-6c-ss-1
part of: 6C Fees payable to Commonwealth under State laws
note: Fees payable to Commonwealth under State laws
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.51
asserts: therapeutic-goods-act-1989-sec-6c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-6c-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-6c-ss-1-norm
type: Obligation
modality: Deontic
part of: 6C(1) Fees payable to Commonwealth under State laws
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-6c-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes an obligation on States to pay fees to the Commonwealth
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

6C(2) Fees payable to Commonwealth under State laws
type: Concept
realized by: sec-6c-ss-2
part of: 6C Fees payable to Commonwealth under State laws
note: Arrangements for Commonwealth fees under State laws
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.51
asserts: therapeutic-goods-act-1989-sec-6c-ss-2-norm

7 Declaration that goods are/are not therapeutic goods
type: Concept
realized by: sec-7
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.51

7(1) Declaration that goods are/are not therapeutic goods
type: Concept
realized by: sec-7-ss-1
part of: 7 Declaration that goods are/are not therapeutic goods
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.51
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

therapeutic-goods-act-1989-sec-7-ss-1-norm
type: Obligation
modality: Deontic
part of: 7(1) Declaration that goods are/are not therapeutic goods
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-7-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: The Secretary may make an order
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Temporal interval
logic summary: The Secretary may make an order at any time
premise text: (1) Where the Secretary is satisfied that classes of goods:
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7-ss-1-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: may
logic summary: Obligation to determine goods
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

7(1A) Declaration that goods are/are not therapeutic goods
type: Concept
realized by: sec-7-ss-1a
part of: 7 Declaration that goods are/are not therapeutic goods
note: Secretary must disregard certain paragraphs when deciding if goods are therapeutic.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.51
asserts: therapeutic-goods-act-1989-sec-7-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-7-ss-1a-logic-deontic-1

therapeutic-goods-act-1989-sec-7-ss-1a-norm
type: Obligation
modality: Deontic
part of: 7(1A) Declaration that goods are/are not therapeutic goods
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-7-ss-1a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Must Disregard
logic summary: Secretary must disregard certain paragraphs.
premise text: (1A) In deciding...
conclusion text: ...must disregard paragraphs (e) and (f)
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

7(4) Declaration that goods are/are not therapeutic goods
type: Concept
realized by: sec-7-ss-4
part of: 7 Declaration that goods are/are not therapeutic goods
note: Goods are not therapeutic goods if declaration applies wholly or partly to goods that would be medical devices.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.51
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

therapeutic-goods-act-1989-sec-7-ss-4-norm
type: Obligation
modality: Deontic
part of: 7(4) Declaration that goods are/are not therapeutic goods
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-7-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Implies
logic summary: Declaration applies implies goods are not therapeutic goods.
premise text: Declaration applies wholly or partly to goods that would be medical devices.
conclusion text: Goods are not therapeutic goods.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7-ss-4-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: During
logic summary: Declaration applies during use, advertisement, or presentation for supply.
premise text: Declaration applies wholly or partly to goods that would be medical devices.
conclusion text: Goods are not therapeutic goods during use, advertisement, or presentation for supply.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7-ss-4-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Recurring
logic summary: Declaration is recurring in its application to goods.
premise text: Declaration applies wholly or partly to goods that would be medical devices.
conclusion text: Goods are not therapeutic goods due to recurring declaration.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7-ss-4-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Implication
logic summary: Declaration implies diffusion of goods being non-therapeutic goods.
premise text: Declaration applies wholly or partly to goods that would be medical devices.
conclusion text: Goods are diffused as non-therapeutic goods.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7-ss-4-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: Classification
logic summary: Declaration classifies goods using AI.
premise text: Declaration is a declaration that classes of goods are not therapeutic goods.
conclusion text: Goods are classified as non-therapeutic goods by AI.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

7(2) Declaration that goods are/are not therapeutic goods
type: Concept
realized by: sec-7-ss-2
part of: 7 Declaration that goods are/are not therapeutic goods
note: Goods are not therapeutic goods under certain conditions. Minister must consider certain matters before making a determination about regulating goods.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.51
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

therapeutic-goods-act-1989-sec-7-ss-2-norm
type: Obligation
modality: Deontic
part of: 7(2) Declaration that goods are/are not therapeutic goods
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-7-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: not
logic summary: Negative assertion of a property
premise text: (2) (excluded goods)
conclusion text: (a) are not therapeutic goods; or (b) when used, advertised, or presented for supply in a particular way, are not therapeutic goods.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-7-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: before
logic summary: Temporal relationship between conditions
premise text: (2)
conclusion text: when used, advertised, or presented for supply in a particular way
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-7-ss-2-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Minister must consider certain matters.
premise text: (2) Before making a determination under subsection (1), the Minister:
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

7AA Excluded goods
type: Concept
realized by: sec-7aa
has part: 7AA(1) Excluded goods
has part: 7AA(2) Excluded goods
has part: 7AA(3) Excluded goods
has part: 7AA(4) Excluded goods
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.52

7AA(1) Excluded goods
type: Concept
realized by: sec-7aa-ss-1
part of: 7AA Excluded goods
note: The Minister may determine that specified goods are excluded goods.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.52
asserts: therapeutic-goods-act-1989-sec-7aa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-7aa-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-7aa-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to exclude goods
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

7AA(2) Excluded goods
type: Concept
realized by: sec-7aa-ss-2
part of: 7AA Excluded goods
note: Determination of excluded goods
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.52
asserts: therapeutic-goods-act-1989-sec-7aa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-7aa-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-7aa-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to determine excluded goods
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

7AA(3) Excluded goods
type: Concept
realized by: sec-7aa-ss-3
part of: 7AA Excluded goods
note: Minister must consider certain matters before making a determination under this section.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.52
asserts: therapeutic-goods-act-1989-sec-7aa-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-7aa-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-7aa-ss-3-norm
type: Obligation
modality: Deontic
part of: 7AA(3) Excluded goods
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-7aa-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Minister must consider certain matters.
premise text: (3) Before making a determination under this section, the Minister...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

7AA(4) Excluded goods
type: Concept
realized by: sec-7aa-ss-4
part of: 7AA Excluded goods
note: Consideration of relevant matters by the Minister
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.52
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

therapeutic-goods-act-1989-sec-7aa-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to consider other matters
premise text: The Minister may have regard to...
conclusion text: Consideration of relevant matters by the Minister
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7aa-ss-4-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Temporal relation between consideration and action
premise text: The Minister may have regard to any other matter he or she considers relevant.
conclusion text: Consideration of relevant matters by the Minister
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-7aa-ss-4-logic-argumentation-3
type: LogicApplication
modality: Argumentation
operator: may
logic summary: Relevance consideration in decision-making
premise text: The Minister may have regard to any other matter he or she considers relevant.
conclusion text: Consideration of relevant matters by the Minister
execution surface: modalities::argumentation
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-7aa-ss-4-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: may
logic summary: Relevance consideration in decision-making
premise text: The Minister may have regard to any other matter he or she considers relevant.
conclusion text: Consideration of relevant matters by the Minister
execution surface: modalities::diffusion
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-7aa-ss-4-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: may
logic summary: Relevance consideration in decision-making
premise text: The Minister may have regard to any other matter he or she considers relevant.
conclusion text: Consideration of relevant matters by the Minister
execution surface: sparql_library::parsers::chk_parser
confidence: 0.5000
curation status: Proposed

7A Authorised persons
type: Concept
realized by: sec-7a
has part: 7A(1) Authorised persons
has part: 7A(2) Authorised persons
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.53

7A(1) Authorised persons
type: Concept
realized by: sec-7a-ss-1
part of: 7A Authorised persons
note: Authorises Secretary to authorise persons to exercise powers under specified provisions of the Act.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.53
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

therapeutic-goods-act-1989-sec-7a-ss-1-norm
type: Permission
modality: Deontic
part of: 7A(1) Authorised persons
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-7a-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: authorise
logic summary: Authorisation is granted.
premise text: Secretary may authorise persons to exercise powers under specified provisions of the Act.
conclusion text: Persons are authorised to exercise powers.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7a-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: The authority is granted during the term of the Secretary's office.
premise text: Authority is granted by the Secretary.
conclusion text: Authority is granted during the term of the Secretary's office.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7a-ss-1-logic-argumentation-3
type: LogicApplication
modality: Argumentation
operator: entails
logic summary: The authority implies that the person exercising powers has a specified role.
premise text: Person exercising powers has a specified role.
conclusion text: Authority implies that the person exercising powers has a specified role.
execution surface: modalities::argumentation
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7a-ss-1-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: implies
logic summary: The authority implies that the Secretary's office is responsible for enforcing health matters or law enforcement matters.
premise text: Secretary's office is responsible for enforcing health matters or law enforcement matters.
conclusion text: Authority implies that the Secretary's office is responsible for enforcing health matters or law enforcement matters.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7a-ss-1-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: implies
logic summary: The authority implies that the person exercising powers has a specified function.
premise text: Person exercising powers has a specified function.
conclusion text: Authority implies that the person exercising powers has a specified function.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

7A(2) Authorised persons
type: Concept
realized by: sec-7a-ss-2
part of: 7A Authorised persons
note: Authorised person must comply with directions of the Secretary.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.53
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

therapeutic-goods-act-1989-sec-7a-ss-2-norm
type: Obligation
modality: Deontic
part of: 7A(2) Authorised persons
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-7a-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must comply
premise text: Authorised person has power under a provision of this Act.
conclusion text: Comply with directions of the Secretary.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7a-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: CONTAINS
logic summary: Temporal relation between directions and actions
premise text: Directions are given at some point in time.
conclusion text: Action must occur after directions are given.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

7B Kits
type: Concept
realized by: sec-7b
has part: 7B(1) Kits
has part: 7B(2) Kits
has part: 7B(3) Kits
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.54

7B(1) Kits
type: Concept
realized by: sec-7b-ss-1
part of: 7B Kits
note: A package and its goods constitute a kit if they meet certain conditions.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.54
asserts: therapeutic-goods-act-1989-sec-7b-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-7b-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-7b-ss-1-norm
type: Obligation
modality: Deontic
part of: 7B(1) Kits
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-7b-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: must-be
logic summary: Kit definition
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

7B(2) Kits
type: Concept
realized by: sec-7b-ss-2
part of: 7B Kits
note: Therapeutic goods must be combined before administration or in a particular sequence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.54
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

therapeutic-goods-act-1989-sec-7b-ss-2-norm
type: Obligation
modality: Deontic
part of: 7B(2) Kits
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-7b-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Must
logic summary: Therapeutic goods must be combined before administration or in a particular sequence.
premise text: (2) A package and therapeutic goods in the package together constitute a composite pack if:...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7b-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Requires
logic summary: Combining therapeutic goods is necessary before administration.
premise text: it is necessary that the therapeutic goods be combined before administration or that they be administered in a particular sequence.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7b-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Requires
logic summary: Combining therapeutic goods must happen before administration.
premise text: it is necessary that the therapeutic goods be combined before administration or that they be administered in a particular sequence.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7b-ss-2-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Requires
logic summary: Combining therapeutic goods must happen in a particular order.
premise text: the package does not contain any medical devices; and
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-7b-ss-2-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: Classifies
logic summary: Therapeutic goods are for administration as a single treatment or course of treatment.
premise text: (c) the therapeutic goods are for administration as a single treatment or as a single course of treatment; and
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

7B(3) Kits
type: Concept
realized by: sec-7b-ss-3
part of: 7B Kits
note: A kit constitutes therapeutic goods.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.54
asserts: therapeutic-goods-act-1989-sec-7b-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-7b-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-7b-ss-3-norm
type: Obligation
modality: Deontic
part of: 7B(3) Kits
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-7b-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: is
logic summary: Definition of a kit
premise text: A kit is defined as...
conclusion text: It is declared that...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

7C Secretary may arrange for use of computer programs to make
type: Concept
realized by: sec-7c
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.55

7C(1) Secretary may arrange for use of computer programs to make
type: Concept
realized by: sec-7c-ss-1
part of: 7C Secretary may arrange for use of computer programs to make
note: The Secretary may arrange for the use of computer programs under their control.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.55
asserts: therapeutic-goods-act-1989-sec-7c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-7c-ss-1-logic-deontic-1

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

7C(2) Secretary may arrange for use of computer programs to make
type: Concept
realized by: sec-7c-ss-2
part of: 7C Secretary may arrange for use of computer programs to make
note: Decision made by computer program is taken to be Secretary's decision.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.55
asserts: therapeutic-goods-act-1989-sec-7c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-7c-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-7c-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: =
logic summary: Decision making
premise text: Computer program makes a decision
conclusion text: Secretary's decision
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

7C(3) Secretary may arrange for use of computer programs to make
type: Concept
realized by: sec-7c-ss-3
part of: 7C Secretary may arrange for use of computer programs to make
note: Secretary may correct initial decision made by computer program.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.55
asserts: therapeutic-goods-act-1989-sec-7c-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-7c-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-7c-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MAY
logic summary: May correct initial decision
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

7C(4) Secretary may arrange for use of computer programs to make
type: Concept
realized by: sec-7c-ss-4
part of: 7C Secretary may arrange for use of computer programs to make
note: Secretary must make substituted decision within 60 days of initial decision.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.55
asserts: therapeutic-goods-act-1989-sec-7c-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-7c-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-7c-ss-4-norm
type: Obligation
modality: Deontic
part of: 7C(4) Secretary may arrange for use of computer programs to make
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-7c-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide a substituted decision within the specified timeframe.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

7D Form for product information for medicine
type: Concept
realized by: sec-7d
has part: 7D(1) Form for product information for medicine
has part: 7D(2) Form for product information for medicine
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.55

7D(1) Form for product information for medicine
type: Concept
realized by: sec-7d-ss-1
part of: 7D Form for product information for medicine
note: The Secretary may approve a form for product information in relation to medicine.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.55
asserts: therapeutic-goods-act-1989-sec-7d-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-7d-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-7d-ss-1-norm
type: Obligation
modality: Deontic
part of: 7D(1) Form for product information for medicine
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-7d-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: The Secretary may approve a form.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

7D(2) Form for product information for medicine
type: Concept
realized by: sec-7d-ss-2
part of: 7D Form for product information for medicine
note: Secretary may approve different forms for different medicines or classes of medicine.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.55
asserts: therapeutic-goods-act-1989-sec-7d-ss-2-norm

therapeutic-goods-act-1989-sec-7d-ss-2-norm
type: Permission
modality: Deontic
part of: 7D(2) Form for product information for medicine
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

8 Power to obtain information with respect to therapeutic goods
type: Concept
realized by: sec-8
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.55

8(1) Power to obtain information with respect to therapeutic goods
type: Concept
realized by: sec-8-ss-1
part of: 8 Power to obtain information with respect to therapeutic goods
note: Request for information about therapeutic goods
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.55
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

therapeutic-goods-act-1989-sec-8-ss-1-norm
type: Obligation
modality: Deontic
part of: 8(1) Power to obtain information with respect to therapeutic goods
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-8-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide information
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-8-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: WITHIN
logic summary: Within a reasonable period
premise text: within such reasonable period as is specified in the notice
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

8(1A) Power to obtain information with respect to therapeutic goods
type: Concept
realized by: sec-8-ss-1a
part of: 8 Power to obtain information with respect to therapeutic goods
note: Notice may require information to be given in writing or according to specified software requirements.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.55
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

therapeutic-goods-act-1989-sec-8-ss-1a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Permit
logic summary: Permission granted
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-8-ss-1a-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: Classifies
logic summary: Classification of software requirements
premise text: (a) in writing; or (b) in accordance with specified software requirements:
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

8(2) Power to obtain information with respect to therapeutic goods
type: Concept
realized by: sec-8-ss-2
part of: 8 Power to obtain information with respect to therapeutic goods
note: Must comply with notice given under section.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.55
asserts: therapeutic-goods-act-1989-sec-8-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-8-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-8-ss-2-norm
type: Obligation
modality: Deontic
part of: 8(2) Power to obtain information with respect to therapeutic goods
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-8-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to comply
premise text: Notice given under section.
conclusion text: Must comply
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

8(3) Power to obtain information with respect to therapeutic goods
type: Concept
realized by: sec-8-ss-3
part of: 8 Power to obtain information with respect to therapeutic goods
note: A reasonable excuse is a valid reason for not applying subsection (2).
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.55
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

therapeutic-goods-act-1989-sec-8-ss-3-norm
type: Obligation
modality: Deontic
part of: 8(3) Power to obtain information with respect to therapeutic goods
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-8-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Obligation to provide a reasonable excuse.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-8-ss-3-logic-epistemic-2
type: LogicApplication
modality: Epistemic
operator: Belief
logic summary: The defendant believes they have a reasonable excuse.
execution surface: modalities::epistemic
confidence: 1.0000
curation status: Proposed

8(4) Power to obtain information with respect to therapeutic goods
type: Concept
realized by: sec-8-ss-4
part of: 8 Power to obtain information with respect to therapeutic goods
note: An offence under subsection (2) is an obligation.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.55
asserts: therapeutic-goods-act-1989-sec-8-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-8-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-8-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: An obligation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9 Arrangements with States etc.
type: Concept
realized by: sec-9
has part: 9(1) Arrangements with States etc.
has part: 9(2) Arrangements with States etc.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.56

9(1) Arrangements with States etc.
type: Concept
realized by: sec-9-ss-1
part of: 9 Arrangements with States etc.
note: The Minister may make arrangements with a State for the carrying out of certain functions on behalf of the Commonwealth.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.56
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

therapeutic-goods-act-1989-sec-9-ss-1-norm
type: Obligation
modality: Deontic
part of: 9(1) Arrangements with States etc.
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to make arrangements
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9-ss-1-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: must
logic summary: Obligation to make arrangements
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9(2) Arrangements with States etc.
type: Concept
realized by: sec-9-ss-2
part of: 9 Arrangements with States etc.
note: Payment of amounts to a State or Territory for performance of functions under an arrangement.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.56
asserts: therapeutic-goods-act-1989-sec-9-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-9-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-9-ss-2-norm
type: Obligation
modality: Deontic
part of: 9(2) Arrangements with States etc.
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Payment obligation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9A Australian Register of Therapeutic Goods
type: Concept
realized by: sec-9a
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.58

9A(1) Australian Register of Therapeutic Goods
type: Concept
realized by: sec-9a-ss-1
part of: 9A Australian Register of Therapeutic Goods
note: Maintain a register of therapeutic goods.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.58
asserts: therapeutic-goods-act-1989-sec-9a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-9a-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-9a-ss-1-norm
type: Obligation
modality: Deontic
part of: 9A(1) Australian Register of Therapeutic Goods
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9a-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to maintain a register.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9A(2) Australian Register of Therapeutic Goods
type: Concept
realized by: sec-9a-ss-2
part of: 9A Australian Register of Therapeutic Goods
note: The Register is to be kept in such form as the Secretary determines.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.58
asserts: therapeutic-goods-act-1989-sec-9a-ss-2-norm

9A(3) Australian Register of Therapeutic Goods
type: Concept
realized by: sec-9a-ss-3
part of: 9A Australian Register of Therapeutic Goods
note: Classification of goods in the Australian Register of Therapeutic Goods
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.58
asserts: therapeutic-goods-act-1989-sec-9a-ss-3-norm

9C Inspection of entries in Register
type: Concept
realized by: sec-9c
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59

9C(1) Inspection of entries in Register
type: Concept
realized by: sec-9c-ss-1
part of: 9C Inspection of entries in Register
note: Request for copy of entry in Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
asserts: therapeutic-goods-act-1989-sec-9c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-9c-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-9c-ss-1-norm
type: Obligation
modality: Deontic
part of: 9C(1) Inspection of entries in Register
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9c-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: hasObligation
logic summary: Therapeutic goods entry request
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9C(2) Inspection of entries in Register
type: Concept
realized by: sec-9c-ss-2
part of: 9C Inspection of entries in Register
note: Must provide a copy of requested entry from computer database
description: Yes
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
asserts: therapeutic-goods-act-1989-sec-9c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-9c-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-9c-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide information
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9C(3) Inspection of entries in Register
type: Concept
realized by: sec-9c-ss-3
part of: 9C Inspection of entries in Register
note: Secretary may provide information in electronic format upon request.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
asserts: therapeutic-goods-act-1989-sec-9c-ss-3-norm

9D Variation of entries in Register
type: Concept
realized by: sec-9d
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59

9D(1) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-1
part of: 9D Variation of entries in Register
note: Secretary may vary entry in Register under certain conditions.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
asserts: therapeutic-goods-act-1989-sec-9d-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-9d-ss-1-norm
type: Obligation
modality: Deontic
part of: 9D(1) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permissive obligation
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

9D(1A) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-1a
part of: 9D Variation of entries in Register
note: Secretary may vary entry in Register under certain conditions.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
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

therapeutic-goods-act-1989-sec-9d-ss-1a-norm
type: Permission
modality: Deontic
part of: 9D(1A) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-1a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permits Secretary to take action.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-1a-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: ClassInclusion
logic summary: Variation of entries in Register is a class inclusion.
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

9D(1B) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-1b
part of: 9D Variation of entries in Register
note: The Secretary may vary the entry in the Register on their own initiative.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
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

therapeutic-goods-act-1989-sec-9d-ss-1b-norm
type: Permission
modality: Deontic
part of: 9D(1B) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-1b-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permission to vary the entry in the Register.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-1b-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: Variation of entries
logic summary: Varying the entry in the Register.
premise text: (1B) If...
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

9D(1C) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-1c
part of: 9D Variation of entries in Register
note: Secretary must give notice and opportunity to submit before making variation.
description: written notice, submission
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
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

therapeutic-goods-act-1989-sec-9d-ss-1c-norm
type: Obligation
modality: Deontic
part of: 9D(1C) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-1c-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Secretary must take submission into account
premise text: Submission made in accordance with paragraph (b)
conclusion text: Decision to make variation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-1c-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: >=
logic summary: Secretary must give notice before making variation
premise text: Date of proposed variation
conclusion text: Notice given at least this far in advance
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

9D(1D) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-1d
part of: 9D Variation of entries in Register
note: Subsections (1A) and (1B) apply despite subsection 16(1).
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
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

therapeutic-goods-act-1989-sec-9d-ss-1d-norm
type: Obligation
modality: Deontic
part of: 9D(1D) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Continuation
logic summary: Continues the obligation despite a condition.
premise text: (1D) Subsections (1A) and (1B)
conclusion text: Subsections (1A) and (1B) apply despite subsection 16(1).
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Overriding Condition
logic summary: Overrides the condition.
premise text: (1D)
conclusion text: Subsections (1A) and (1B) apply despite subsection 16(1).
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-1d-logic-linearlogic-3
type: LogicApplication
modality: LinearLogic
operator: Continuation
logic summary: Continues the linear logic application.
premise text: (1D)
conclusion text: Subsections (1A) and (1B) apply despite subsection 16(1).
execution surface: modalities::linear
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Negation
logic summary: Negates the condition.
premise text: (1D)
conclusion text: Subsections (1A) and (1B) do not apply despite subsection 16(1).
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

9D(2) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-2
part of: 9D Variation of entries in Register
note: Variation of entries in Register upon request
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
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

therapeutic-goods-act-1989-sec-9d-ss-2-norm
type: Obligation
modality: Deontic
part of: 9D(2) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide variation upon request
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-2-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: CLASSIFICATION
logic summary: Classification of therapeutic goods
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

9D(2A) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-2a
part of: 9D Variation of entries in Register
note: Subsection (2) of section 16(1) applies despite subsection (2A)
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
asserts: therapeutic-goods-act-1989-sec-9d-ss-2a-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-2a-logic-deontic-1

therapeutic-goods-act-1989-sec-9d-ss-2a-norm
type: Obligation
modality: Deontic
part of: 9D(2A) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-2a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: applies
logic summary: Subsection (2) applies despite subsection (2A)
premise text: (2A)
conclusion text: (2)
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9D(2C) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-2c
part of: 9D Variation of entries in Register
note: Secretary must vary entry in Register upon request.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
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

therapeutic-goods-act-1989-sec-9d-ss-2c-norm
type: Obligation
modality: Deontic
part of: 9D(2C) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide variation upon request.
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;
conclusion text: the Secretary must vary the entry in accordance with the request.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must satisfy conditions specified in regulations.
premise text: (b) the variation is of a kind specified in the regulations;
conclusion text: the conditions (if any) specified in the regulations are satisfied;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-2c-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: BETWEEN
logic summary: Request must be made within unspecified time frame.
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;
conclusion text: the request was made at some point in time.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-2c-logic-ltl-4
type: LogicApplication
modality: LTL
operator: BETWEEN
logic summary: Request must be made within unspecified time frame.
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;
conclusion text: the request was made at some point in time.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Request must be made by person with registered or listed therapeutic goods.
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;
conclusion text: the request was made by a person who has registered or listed therapeutic goods.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9D(2D) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-2d
part of: 9D Variation of entries in Register
note: Subsection (2C) applies despite subsection 16(1).
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
asserts: therapeutic-goods-act-1989-sec-9d-ss-2d-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-2d-logic-deontic-1

therapeutic-goods-act-1989-sec-9d-ss-2d-norm
type: Obligation
modality: Deontic
part of: 9D(2D) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-2d-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Implies
logic summary: Subsection (2C) implies subsection 16(1).
premise text: (2D)
conclusion text: (2C)
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

9D(3) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-3
part of: 9D Variation of entries in Register
note: Secretary may vary entry in Register upon request.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
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

therapeutic-goods-act-1989-sec-9d-ss-3-norm
type: Permission
modality: Deontic
part of: 9D(3) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permits variation of entries in Register.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: Variation
logic summary: Specifies conditions for variation of entries in Register.
premise text: (3) If: ...; (3AA) If: ...; (3AC) If: ...;
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: Must
logic summary: Secretary must vary entry in Register upon request.
premise text: (3AA) If: ...; (3AC) If: ...;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3-logic-linearlogic-4
type: LogicApplication
modality: LinearLogic
operator: And
logic summary: Combines conditions for variation of entries in Register.
premise text: (3) If: ... And (3AA) If: ... And (3AC) If: ...;
execution surface: modalities::linear
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3-logic-descriptionlogic-5
type: LogicApplication
modality: DescriptionLogic
operator: Satisfies
logic summary: Specifies conditions for variation of entries in Register.
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;
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-6
type: LogicApplication
modality: Deontic
operator: Must
logic summary: Secretary must vary entry in Register upon request.
premise text: (3) If: ...; (3AA) If: ...; (3AC) If: ...;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9D(3A) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-3a
part of: 9D Variation of entries in Register
note: Secretary may vary entry in Register upon request.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
asserts: therapeutic-goods-act-1989-sec-9d-ss-3a-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-3a-logic-deontic-1

therapeutic-goods-act-1989-sec-9d-ss-3a-norm
type: Permission
modality: Deontic
part of: 9D(3A) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permits variation of entries in Register.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9D(3B) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-3b
part of: 9D Variation of entries in Register
note: Secretary must move entry from part of Register for biologicals to applicable part.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
asserts: therapeutic-goods-act-1989-sec-9d-ss-3b-norm
asserts: therapeutic-goods-act-1989-sec-9d-ss-3b-logic-deontic-1

therapeutic-goods-act-1989-sec-9d-ss-3b-norm
type: Obligation
modality: Deontic
part of: 9D(3B) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3b-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to move entry
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9D(3C) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-3c
part of: 9D Variation of entries in Register
note: Variation of entries in Register upon request
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
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

therapeutic-goods-act-1989-sec-9d-ss-3c-norm
type: Obligation
modality: Deontic
part of: 9D(3C) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must vary entry
premise text: (a) the person in relation to whom a kind of medical device is included in the Register has requested...
conclusion text: ...the Secretary must vary the entry in accordance with the request.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must satisfy conditions
premise text: (c) the conditions (if any) specified in the regulations are satisfied;
conclusion text: ...the Secretary must vary the entry in accordance with the request.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3c-logic-descriptionlogic-3
type: LogicApplication
modality: DescriptionLogic
operator: SUBCLASS_OF
logic summary: Variation of entries is a subclass of variation upon request
premise text: (3C) If...
conclusion text: ...the Secretary must vary the entry in accordance with the request.
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3c-logic-alleninterval-4
type: LogicApplication
modality: AllenInterval
operator: CONTAINS
logic summary: Variation of entries is contained within variation upon request
premise text: (3C) If...
conclusion text: ...the Secretary must vary the entry in accordance with the request.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: MAY
logic summary: May vary entry without conditions
premise text: (3CB) If...(a) the person in relation to whom a kind of medical device is included in the Register has requested...
conclusion text: ...the Secretary must vary the entry in accordance with the request.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-6
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must add warning, restriction or precaution
premise text: (b) the only effect of the variation would be...(ii) to add a warning, restriction or precaution...
conclusion text: ...the Secretary must vary the entry in accordance with the request.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9D(3D) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-3d
part of: 9D Variation of entries in Register
note: Secretary may vary entry in Register upon request.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
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

therapeutic-goods-act-1989-sec-9d-ss-3d-norm
type: Permission
modality: Deontic
part of: 9D(3D) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3d-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permits variation of entries in Register.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-3d-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: Variation
logic summary: Allows for variation of entries in Register.
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

9D(4) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-4
part of: 9D Variation of entries in Register
note: Must move entry from medical devices part to applicable part of Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
asserts: therapeutic-goods-act-1989-sec-9d-ss-4-norm

9D(6) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-6
part of: 9D Variation of entries in Register
note: Secretary may approve forms and manners for requests under this section.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
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

therapeutic-goods-act-1989-sec-9d-ss-6-norm
type: Permission
modality: Deontic
part of: 9D(6) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-6-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permits the Secretary to approve forms and manners.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-6-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Within
logic summary: Limits the scope to specific temporal intervals.
premise text: (6) The Secretary may, by writing:
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

9D(7) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-7
part of: 9D Variation of entries in Register
note: Request for variation of entries in Register must comply with approved form and contain required information.
description: Form, information, application fee, and prescribed documentation
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
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

therapeutic-goods-act-1989-sec-9d-ss-7-norm
type: Obligation
modality: Deontic
part of: 9D(7) Variation of entries in Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-7-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Request must comply with approved form
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9d-ss-7-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: IS_A
logic summary: Form and information are of a kind determined under subsection (8)
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

9D(8) Variation of entries in Register
type: Concept
realized by: sec-9d-ss-8
part of: 9D Variation of entries in Register
note: The Secretary may determine a kind of information for the purposes of subparagraph (7)(g)(i).
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.59
asserts: therapeutic-goods-act-1989-sec-9d-ss-8-norm

9E Publication of list of goods on Register
type: Concept
realized by: sec-9e
note: The Secretary must publish a list of therapeutic goods on the Register at least once every 12 months.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.65
asserts: therapeutic-goods-act-1989-sec-9e-norm
asserts: therapeutic-goods-act-1989-sec-9e-logic-deontic-1

therapeutic-goods-act-1989-sec-9e-norm
type: Obligation
modality: Deontic
part of: 9E Publication of list of goods on Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9e-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: The Secretary must publish a list of therapeutic goods on the Register.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9F Removal of entries from Register
type: Concept
realized by: sec-9f
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.65

9F(1) Removal of entries from Register
type: Concept
realized by: sec-9f-ss-1
part of: 9F Removal of entries from Register
note: Prohibition on removal of entries from Register if goods are therapeutic
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.65
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

therapeutic-goods-act-1989-sec-9f-ss-1-norm
type: Prohibition
modality: Deontic
part of: 9F(1) Removal of entries from Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9f-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: forbid
logic summary: Prohibits removal of entries from Register
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.
conclusion text: The removal of entries from the Register is prohibited.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9f-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Describes the temporal relationship between the provision and its application
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.
conclusion text: The provision applies during the existence of an entry on the Register related to goods that are not therapeutic goods.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9f-ss-1-logic-ltl-3
type: LogicApplication
modality: LTL
operator: everywhere
logic summary: Describes the spatial relationship between the provision and its application
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.
conclusion text: The provision applies everywhere where there is an entry on the Register related to goods that are not therapeutic goods.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

9F(2) Removal of entries from Register
type: Concept
realized by: sec-9f-ss-2
part of: 9F Removal of entries from Register
note: Secretary may remove entry from Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.65
asserts: therapeutic-goods-act-1989-sec-9f-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-9f-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-9f-ss-2-norm
type: Obligation
modality: Deontic
part of: 9F(2) Removal of entries from Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9f-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Obligation to remove entry
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9F(3) Removal of entries from Register
type: Concept
realized by: sec-9f-ss-3
part of: 9F Removal of entries from Register
note: Secretary must inform person of proposed removal and invite written submissions.
description: written submissions
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.65
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

therapeutic-goods-act-1989-sec-9f-ss-3-norm
type: Obligation
modality: Deontic
part of: 9F(3) Removal of entries from Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9f-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Secretary must inform person of proposed removal.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9f-ss-3-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: MAY
logic summary: Person may make written submissions to Secretary.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9F(4) Removal of entries from Register
type: Concept
realized by: sec-9f-ss-4
part of: 9F Removal of entries from Register
note: Secretary must consider submissions before giving notice.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.65
asserts: therapeutic-goods-act-1989-sec-9f-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-9f-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-9f-ss-4-norm
type: Obligation
modality: Deontic
part of: 9F(4) Removal of entries from Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9f-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Must
logic summary: Mandatory action
premise text: The Secretary must not...
conclusion text: ...until the Secretary has had regard to...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9F(5) Removal of entries from Register
type: Concept
realized by: sec-9f-ss-5
part of: 9F Removal of entries from Register
note: Notice under subsection (2) is not a legislative instrument.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.65
asserts: therapeutic-goods-act-1989-sec-9f-ss-5-norm

therapeutic-goods-act-1989-sec-9f-ss-5-norm
type: Obligation
modality: Deontic
part of: 9F(5) Removal of entries from Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

9F(6) Removal of entries from Register
type: Concept
realized by: sec-9f-ss-6
part of: 9F Removal of entries from Register
note: Removal of entries from Register has effect on specified day
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.65
asserts: therapeutic-goods-act-1989-sec-9f-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-9f-ss-6-logic-deontic-1

therapeutic-goods-act-1989-sec-9f-ss-6-norm
type: Obligation
modality: Deontic
part of: 9F(6) Removal of entries from Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9f-ss-6-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: hasEffect
logic summary: Imposes obligation
conclusion text: The removal has effect...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9F(7) Removal of entries from Register
type: Concept
realized by: sec-9f-ss-7
part of: 9F Removal of entries from Register
note: Secretary must publish notice after removing entry from Register.
description: Notice setting out particulars of removal
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.65
asserts: therapeutic-goods-act-1989-sec-9f-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-9f-ss-7-logic-deontic-1

therapeutic-goods-act-1989-sec-9f-ss-7-norm
type: Obligation
modality: Deontic
part of: 9F(7) Removal of entries from Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9f-ss-7-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to publish notice
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9G Criminal offences for false statements in requests for variation of
type: Concept
realized by: sec-9g
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.66

9G(1) Criminal offences for false statements in requests for variation of
type: Concept
realized by: sec-9g-ss-1
part of: 9G Criminal offences for false statements in requests for variation of
note: Making false statements in requests for variation of therapeutic goods entries is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.66
asserts: therapeutic-goods-act-1989-sec-9g-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-9g-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-9g-ss-1-norm
type: Prohibition
modality: Deontic
part of: 9G(1) Criminal offences for false statements in requests for variation of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9g-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9G(4) Criminal offences for false statements in requests for variation of
type: Concept
realized by: sec-9g-ss-4
part of: 9G Criminal offences for false statements in requests for variation of
note: Making false statements in requests for variation of therapeutic goods entries is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.66
asserts: therapeutic-goods-act-1989-sec-9g-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-9g-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-9g-ss-4-norm
type: Prohibition
modality: Deontic
part of: 9G(4) Criminal offences for false statements in requests for variation of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9g-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits making false statements in requests for variation of therapeutic goods entries.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9G(5) Criminal offences for false statements in requests for variation of
type: Concept
realized by: sec-9g-ss-5
part of: 9G Criminal offences for false statements in requests for variation of
note: Making false statements in requests for variation of therapeutic goods entries is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.66
asserts: therapeutic-goods-act-1989-sec-9g-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-9g-ss-5-logic-deontic-1

therapeutic-goods-act-1989-sec-9g-ss-5-norm
type: Prohibition
modality: Deontic
part of: 9G(5) Criminal offences for false statements in requests for variation of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9g-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits making false statements in requests for variation of therapeutic goods entries.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9G(6) Criminal offences for false statements in requests for variation of
type: Concept
realized by: sec-9g-ss-6
part of: 9G Criminal offences for false statements in requests for variation of
note: An offence against subsection (5) is an offence of strict liability.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.66
asserts: therapeutic-goods-act-1989-sec-9g-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-9g-ss-6-logic-deontic-1

therapeutic-goods-act-1989-sec-9g-ss-6-norm
type: Obligation
modality: Deontic
part of: 9G(6) Criminal offences for false statements in requests for variation of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9g-ss-6-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: is
logic summary: Strict liability
premise text: (5)
conclusion text: (6)
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9H Civil penalty for false statements in requests for variation of
type: Concept
realized by: sec-9h
note: False statements in requests for variation of entries in Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.68
asserts: therapeutic-goods-act-1989-sec-9h-norm
asserts: therapeutic-goods-act-1989-sec-9h-logic-deontic-1

therapeutic-goods-act-1989-sec-9h-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits making false statements
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9J Simplified outline of this Chapter
type: Concept
realized by: sec-9j
note: Regulations may prohibit imports, exports, manufacture, and supplies of certain goods.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.69
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

therapeutic-goods-act-1989-sec-9j-norm
type: Prohibition
modality: Deontic
part of: 9J Simplified outline of this Chapter
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9j-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Regulations prohibit imports, exports, manufacture, and supplies of certain goods.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9j-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Regulations apply to imports, exports, manufacture, and supplies within a specific temporal interval.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

9K Prohibition on import, export, manufacture or supply of
type: Concept
realized by: sec-9k
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.69

9K(1) Prohibition on import, export, manufacture or supply of
type: Concept
realized by: sec-9k-ss-1
part of: 9K Prohibition on import, export, manufacture or supply of
note: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.69
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

therapeutic-goods-act-1989-sec-9k-ss-1-norm
type: Prohibition
modality: Deontic
part of: 9K(1) Prohibition on import, export, manufacture or supply of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits the specified actions
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:
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: During
logic summary: Prohibition applies during international agreements
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:
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-1-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Until
logic summary: Prohibition ends when international agreements expire
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:
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-1-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits the specified actions
premise text: (b) the export from Australia of the therapeutic goods or vaping goods;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9K(2) Prohibition on import, export, manufacture or supply of
type: Concept
realized by: sec-9k-ss-2
part of: 9K Prohibition on import, export, manufacture or supply of
note: Regulations must prohibit or restrict import, export, manufacture and supply of certain goods before an international agreement is made.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.69
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

therapeutic-goods-act-1989-sec-9k-ss-2-norm
type: Prohibition
modality: Deontic
part of: 9K(2) Prohibition on import, export, manufacture or supply of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Regulations must prohibit or restrict certain goods.
premise text: International agreement requires parties to take steps to prohibit or restrict import, export, manufacture and supply of certain goods.
conclusion text: Regulations must prohibit or restrict import, export, manufacture and supply of certain goods.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Regulations must be made before an international agreement is made.
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.
conclusion text: Regulations must be made before an international agreement is made.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Recurring Trace
logic summary: International agreements require parties to take steps to prohibit or restrict import, export, manufacture and supply of certain goods.
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.
conclusion text: International agreements require parties to take steps to prohibit or restrict import, export, manufacture and supply of certain goods.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-2-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Diffuse
logic summary: Regulations must diffuse to all parties to the agreement.
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.
conclusion text: Regulations must diffuse to all parties to the agreement.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-2-logic-argumentation-5
type: LogicApplication
modality: Argumentation
operator: Implication
logic summary: International agreements imply regulations that prohibit or restrict import, export, manufacture and supply of certain goods.
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.
conclusion text: International agreements imply regulations that prohibit or restrict import, export, manufacture and supply of certain goods.
execution surface: modalities::argumentation
confidence: 1.0000
curation status: Proposed

9K(3) Prohibition on import, export, manufacture or supply of
type: Concept
realized by: sec-9k-ss-3
part of: 9K Prohibition on import, export, manufacture or supply of
note: Regulations may prohibit import, export, manufacture or supply of therapeutic goods or vaping goods containing a specified ingredient or component.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.69
asserts: therapeutic-goods-act-1989-sec-9k-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-9k-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-9k-ss-3-norm
type: Prohibition
modality: Deontic
part of: 9K(3) Prohibition on import, export, manufacture or supply of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Regulations prohibit certain actions.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9K(4) Prohibition on import, export, manufacture or supply of
type: Concept
realized by: sec-9k-ss-4
part of: 9K Prohibition on import, export, manufacture or supply of
note: Regulations must prohibit or restrict import, export, manufacture and supply of goods containing a specific ingredient or component.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.69
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

therapeutic-goods-act-1989-sec-9k-ss-4-norm
type: Prohibition
modality: Deontic
part of: 9K(4) Prohibition on import, export, manufacture or supply of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Regulations must prohibit the specified activity.
premise text: (4) Before regulations are made...
conclusion text: ...the Minister must be satisfied...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-4-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: The regulation must be made before a specific temporal interval.
premise text: (4) Before regulations are made...
conclusion text: ...the Minister must be satisfied...
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

9K(5) Prohibition on import, export, manufacture or supply of
type: Concept
realized by: sec-9k-ss-5
part of: 9K Prohibition on import, export, manufacture or supply of
note: Absolute or conditionally prescribed prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.69
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

therapeutic-goods-act-1989-sec-9k-ss-5-norm
type: Prohibition
modality: Deontic
part of: 9K(5) Prohibition on import, export, manufacture or supply of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Absolute prohibition
premise text: (5) A prohibition referred to in subsection (1) or (3) may be absolute
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-5-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Temporal interval for prohibition
premise text: (5) A prohibition referred to in subsection (1) or (3) may be absolute
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

9K(6) Prohibition on import, export, manufacture or supply of
type: Concept
realized by: sec-9k-ss-6
part of: 9K Prohibition on import, export, manufacture or supply of
note: Regulations containing a prohibition must be published and wait 30 days before implementation.
description: (i) the international agreement; (ii) the Minister’s satisfaction; (iii) the proposed prohibition
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.69
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

therapeutic-goods-act-1989-sec-9k-ss-6-norm
type: Prohibition
modality: Deontic
part of: 9K(6) Prohibition on import, export, manufacture or supply of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Regulations containing a prohibition
premise text: (6) Regulations containing a prohibition referred to in subsection (1) or (3)
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-6-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Notice must be published for at least 30 days before implementation
premise text: (b) a period of 30 days has passed since the notice was published
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: Permission
logic summary: Regulations must be published for public review
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
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Minister must cause publication of notice
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
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Regulations containing prohibition must be implemented after publication
premise text: (b) a period of 30 days has passed since the notice was published
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9K(7) Prohibition on import, export, manufacture or supply of
type: Concept
realized by: sec-9k-ss-7
part of: 9K Prohibition on import, export, manufacture or supply of
note: Regulations with prohibition must not start before the international agreement enters into force.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.69
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

therapeutic-goods-act-1989-sec-9k-ss-7-norm
type: Prohibition
modality: Deontic
part of: 9K(7) Prohibition on import, export, manufacture or supply of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-7-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Cannot
logic summary: Regulations with prohibition cannot start before the international agreement enters into force.
premise text: (7) Regulations containing a prohibition referred to in subsection (1) or (3)
conclusion text: must not be expressed to commence on a day earlier than the day the international agreement enters into force for Australia.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-7-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Overlaps
logic summary: Regulations with prohibition overlap with the international agreement.
premise text: (7) Regulations containing a prohibition referred to in subsection (1) or (3)
conclusion text: the day the international agreement enters into force for Australia.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-7-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Until
logic summary: Regulations with prohibition are until the international agreement enters into force.
premise text: (7) Regulations containing a prohibition referred to in subsection (1) or (3)
conclusion text: must not be expressed to commence on a day earlier than the day the international agreement enters into force for Australia.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-7-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Diffuses
logic summary: Regulations with prohibition diffuse to the international agreement.
premise text: (7) Regulations containing a prohibition referred to in subsection (1) or (3)
conclusion text: the day the international agreement enters into force for Australia.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9k-ss-7-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: Infer
logic summary: Regulations with prohibition infer the international agreement.
premise text: (7) Regulations containing a prohibition referred to in subsection (1) or (3)
conclusion text: must not be expressed to commence on a day earlier than the day the international agreement enters into force for Australia.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

9K(8) Prohibition on import, export, manufacture or supply of
type: Concept
realized by: sec-9k-ss-8
part of: 9K Prohibition on import, export, manufacture or supply of
note: Regulations may confer power on Minister or Secretary to make administrative decisions.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.69
asserts: therapeutic-goods-act-1989-sec-9k-ss-8-norm

9L Offence and civil penalty
type: Concept
realized by: sec-9l
has part: 9L(1) Offence and civil penalty
has part: 9L(2) Offence and civil penalty
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.71

9L(1) Offence and civil penalty
type: Concept
realized by: sec-9l-ss-1
part of: 9L Offence and civil penalty
note: Import, export, manufacture or supply of therapeutic goods or vaping goods is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.71
asserts: therapeutic-goods-act-1989-sec-9l-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-9l-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-9l-ss-1-norm
type: Prohibition
modality: Deontic
part of: 9L(1) Offence and civil penalty
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9l-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits the import, export, manufacture or supply of therapeutic goods or vaping goods.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

9L(2) Offence and civil penalty
type: Concept
realized by: sec-9l-ss-2
part of: 9L Offence and civil penalty
note: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.71
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

therapeutic-goods-act-1989-sec-9l-ss-2-norm
type: Prohibition
modality: Deontic
part of: 9L(2) Offence and civil penalty
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: =
logic summary: Absolute prohibition
premise text: (i) an absolute prohibition in force for the purposes of subsection 9K(1) or (3);
conclusion text: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: =
logic summary: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
premise text: (ii) one or more conditions of a prohibition in force for the purposes of subsection 9K(1) or (3).
conclusion text: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: =
logic summary: Maximum civil penalty: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
premise text: (a) for an individual—300 penalty units; and (b) for a body corporate—3,000 penalty units.
conclusion text: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9l-ss-2-logic-alleninterval-4
type: LogicApplication
modality: AllenInterval
operator: =
logic summary: Temporal interval: Maximum civil penalty
premise text: (a) for an individual—300 penalty units; and (b) for a body corporate—3,000 penalty units.
conclusion text: Maximum civil penalty: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

9M Application of Customs Act 1901
type: Concept
realized by: sec-9m
note: Customs Act 1901 applies to prohibited imports or exports if notified by Secretary.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.73
asserts: therapeutic-goods-act-1989-sec-9m-norm

therapeutic-goods-act-1989-sec-9m-norm
type: Obligation
modality: Deontic
part of: 9M Application of Customs Act 1901
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

9N Constitutional basis
type: Concept
realized by: sec-9n
has part: 9N(1) Constitutional basis
has part: 9N(2) Constitutional basis
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.73

9N(1) Constitutional basis
type: Concept
realized by: sec-9n-ss-1
part of: 9N Constitutional basis
note: Relies on Commonwealth's legislative power under paragraph 51(xxix) of the Constitution.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.73
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

therapeutic-goods-act-1989-sec-9n-ss-1-norm
type: Obligation
modality: Deontic
part of: 9N(1) Constitutional basis
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-9n-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: ReliesOn
logic summary: Relies on Commonwealth's legislative power
premise text: (1) This Chapter, and any other provision of this Act to the extent it relates to this Chapter, relies...
conclusion text: ...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3).
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9n-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: PrescribedFor
logic summary: Prescribed for the purposes of subsection 9K(1) or (3)
premise text: ...prescribed for the purposes of subsection 9K(1) or (3).
conclusion text: ...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3).
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9n-ss-1-logic-ltl-3
type: LogicApplication
modality: LTL
operator: RecurringTrace
logic summary: Recurring trace of subsection 9K(1) or (3)
premise text: ...prescribed for the purposes of subsection 9K(1) or (3).
conclusion text: ...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3).
execution surface: modalities::temporal_ltl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-9n-ss-1-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: InternationalAgreement
logic summary: International agreement
premise text: ...prescribed for the purposes of subsection 9K(1) or (3).
conclusion text: ...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3).
execution surface: modalities::diffusion
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-9n-ss-1-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: SHACL
logic summary: SHACL validation
premise text: ...prescribed for the purposes of subsection 9K(1) or (3).
conclusion text: ...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3).
execution surface: sparql_library::parsers::chk_parser
confidence: 0.5000
curation status: Proposed

9N(2) Constitutional basis
type: Concept
realized by: sec-9n-ss-2
part of: 9N Constitutional basis
note: Does not limit section 6
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.73
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

therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: does not imply
logic summary: Limits the scope of section 6
premise text: Section 9N(2)
conclusion text: Section 6 is unaffected
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: does not prohibit
logic summary: Does not ban conduct related to section 6
premise text: Section 9N(2) does not limit section 6
conclusion text: Conduct related to section 6 is permitted
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: does not create right
logic summary: Does not grant a right to conduct related to section 6
premise text: Section 9N(2) does not limit section 6
conclusion text: Conduct related to section 6 is permitted but not a right
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

10 Determination of standards
type: Concept
realized by: sec-10
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.74

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

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

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

10(2) Determination of standards
type: Concept
realized by: sec-10-ss-2
part of: 10 Determination of standards
note: Establishing standards for therapeutic goods may be specified by reference to various factors.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.74
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

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

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

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

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

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

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

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

10(3) Determination of standards
type: Concept
realized by: sec-10-ss-3
part of: 10 Determination of standards
note: Directs particulars to be set out on a label or package of therapeutic goods
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.74
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

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

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

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

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

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

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

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

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

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

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

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

13 Special provisions relating to Ministerial standards and default
type: Concept
realized by: sec-13
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.76

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

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

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

13(2) Special provisions relating to Ministerial standards and default
type: Concept
realized by: sec-13-ss-2
part of: 13 Special provisions relating to Ministerial standards and default
note: Disregard inconsistent requirements for therapeutic goods
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.76
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

therapeutic-goods-act-1989-sec-13-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits inconsistent requirements
premise text: (2) If...
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-13-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Overlap
logic summary: Overlaps with inconsistent requirements
premise text: (2) If...
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.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-13-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Overlap
logic summary: Overlaps with inconsistent requirements
premise text: (2) If...
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.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-13-ss-2-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Overlap
logic summary: Overlaps with inconsistent requirements
premise text: (2) If...
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.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-13-ss-2-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: Overlap
logic summary: Overlaps with inconsistent requirements
premise text: (2) If...
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.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

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

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

therapeutic-goods-act-1989-sec-13-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: implies
logic summary: If A implies B and C, then if A, B.
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;
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).
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

therapeutic-goods-act-1989-sec-13-ss-4-logic-alleninterval-1
type: LogicApplication
modality: AllenInterval
operator: <
logic summary: Temporal interval for applicability
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
conclusion text: The default standard does not apply if it is not applicable at the time of manufacture.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-13-ss-4-logic-ltl-2
type: LogicApplication
modality: LTL
operator: <
logic summary: Temporal interval for applicability
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
conclusion text: The default standard does not apply if it is not applicable at the time of manufacture.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

14 Criminal offences for importing, supplying or exporting goods
type: Concept
realized by: sec-14
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.78

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

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

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

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

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

therapeutic-goods-act-1989-sec-14-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits importing therapeutic goods without consent.
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.
conclusion text: The person commits an offence if they import therapeutic goods without consent.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-14-ss-4-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: During
logic summary: The prohibition applies during the time of importing therapeutic goods.
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.
conclusion text: The person commits an offence if they import therapeutic goods during this time.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-14-ss-4-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Recurring
logic summary: The prohibition is recurring and applies to each instance of importing therapeutic goods.
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.
conclusion text: The person commits an offence if they import therapeutic goods repeatedly without consent.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

14B Application of Customs Act 1901
type: Concept
realized by: sec-14b
note: Customs Act 1901 applies to importation or exportation of goods if notified by Secretary.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.85
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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-15-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission granted by the Secretary.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

therapeutic-goods-act-1989-sec-15-ss-2-norm
type: Obligation
modality: Deontic
part of: 15(2) Criminal offences relating to breaching a condition of a consent
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-15-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Obligation to not breach a condition of consent.
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.
conclusion text: A person commits an offence if they breach a condition of consent.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-15-ss-2-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibition on breaching a condition of consent.
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.
conclusion text: Breaching a condition of consent is prohibited.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-15-ss-2-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: Between
logic summary: Temporal relationship between the act and the harm.
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.
conclusion text: The act and the harm are temporally related.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-15-ss-2-logic-argumentation-4
type: LogicApplication
modality: Argumentation
operator: Implication
logic summary: Implication of breach on offence commitment.
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.
conclusion text: If the breach occurs, then the offence is committed.
execution surface: modalities::argumentation
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-15-ss-2-logic-diffusion-5
type: LogicApplication
modality: Diffusion
operator: Propagation
logic summary: Propagating the effect of the breach.
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.
conclusion text: The effect of the breach propagates.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

15(6) Criminal offences relating to breaching a condition of a consent
type: Concept
realized by: sec-15-ss-6
part of: 15 Criminal offences relating to breaching a condition of a consent
note: Breach of consent condition results in an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.86
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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-15-ss-7-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes a duty on the state.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-15b-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: CONTINUES
logic summary: Continues application of this Part.
premise text: (2) If, immediately before the commencement of this section,
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-15b-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: BEFORE
logic summary: Temporal relationship between commencement and application.
premise text: (2) If, immediately before the commencement of this section,
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.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-15b-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: UNTIL
logic summary: Temporal relationship between application and inclusion in Register.
premise text: (2) If, immediately before the commencement of this section,
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.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-15b-ss-2-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: CONTINUES
logic summary: Continued application of this Part.
premise text: (2) If, immediately before the commencement of this section,
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.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

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

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

16 Therapeutic goods and gazetted groups
type: Concept
realized by: sec-16
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;
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.89
asserts: therapeutic-goods-act-1989-sec-16-norm
asserts: therapeutic-goods-act-1989-sec-16-logic-deontic-1

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

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

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

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

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

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

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

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

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

18(2) Exempt goods
type: Concept
realized by: sec-18-ss-2
part of: 18 Exempt goods
note: Exemptions apply only to specified classes of persons.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.91
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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

19 Approvals or authorities for certain uses
type: Concept
realized by: sec-19
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.96

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

19A Approvals where unavailability etc. of therapeutic goods
type: Concept
realized by: sec-19a
note: Secretary may grant approval for importation or supply of therapeutic goods under certain conditions.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.101
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

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

therapeutic-goods-act-1989-sec-19a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: grant
logic summary: Secretary grants approval
premise text: (1) The Secretary may, by notice in writing...
conclusion text: ...the goods that are the subject of the application are registered or approved for general marketing...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-19a-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Approval is granted during a specific period
premise text: (1) The Secretary may, by notice in writing...
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);...
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-19a-logic-ltl-3
type: LogicApplication
modality: LTL
operator: everywhere
logic summary: Approval applies to all therapeutic goods
premise text: (1) The Secretary may, by notice in writing...
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);...
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-19a-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: if-then
logic summary: Approval is conditional on certain conditions being met
premise text: (a) registered goods that could act as a substitute for the goods...
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...
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-19a-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: if-then
logic summary: Approval is conditional on preliminary assessment of registration application
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...
conclusion text: ...an application under section 23 has been made for registration of the goods and the application has passed preliminary assessment;...
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

20 Criminal offences relating to notifying the Secretary and to
type: Concept
realized by: sec-20
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.114

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-20-ss-2c-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits importation of therapeutic goods exempt under section 18A.
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.
conclusion text: Penalty: 60 penalty units.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-20-ss-2c-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: During
logic summary: Importation occurs during the period when therapeutic goods are exempt.
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.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-20-ss-2c-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Recurring
logic summary: Importation is a recurring action that breaches a condition.
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.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-20-ss-2c-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Spreads
logic summary: Importation spreads to other actions that breach a condition.
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.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-20-ss-2c-logic-argumentation-5
type: LogicApplication
modality: Argumentation
operator: Implicates
logic summary: Importation implies that therapeutic goods are not exempt.
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.
execution surface: modalities::argumentation
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

therapeutic-goods-act-1989-sec-20a-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition
premise text: Importation, exportation, manufacture, or supply of therapeutic goods without proper notification.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-21a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits making false or misleading statements in certification.
premise text: The statement is made in or in connection with a certification.
conclusion text: The person commits an offence if...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

22 General offences relating to this Part
type: Concept
realized by: sec-22
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.126

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

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

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

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

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

therapeutic-goods-act-1989-sec-22-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of advertising therapeutic goods for an unaccepted indication without harm risk
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;
conclusion text: The person commits an offence if...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22-ss-2-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: Classify
logic summary: Classification of therapeutic goods based on indications
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.
conclusion text: The therapeutic goods are included in the Register;
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Trace
logic summary: Temporal tracing of advertising and harm risk
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;
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;
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22-ss-2-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of advertising therapeutic goods for an unaccepted indication without harm risk
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.
conclusion text: The therapeutic goods are included in the Register;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

22(3) General offences relating to this Part
type: Concept
realized by: sec-22-ss-3
part of: 22 General offences relating to this Part
note: Advertising therapeutic goods for an unaccepted indication is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.126
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

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

therapeutic-goods-act-1989-sec-22-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of advertising therapeutic goods for an unaccepted indication.
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.
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22-ss-3-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: Classify
logic summary: Classification of advertising as a general offence relating to this Part.
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.
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.
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22-ss-3-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Temporal interval of prohibited advertising.
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.
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.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22-ss-3-logic-ltl-4
type: LogicApplication
modality: LTL
operator: Recurring Trace
logic summary: Recurring trace of prohibited advertising.
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.
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.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22-ss-3-logic-diffusion-5
type: LogicApplication
modality: Diffusion
operator: Spread
logic summary: Spread of prohibited advertising.
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.
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.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22-ss-3-logic-cogai-6
type: LogicApplication
modality: CogAI
operator: Knowledge Representation
logic summary: Knowledge representation of prohibited advertising.
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.
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.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

22(5) General offences relating to this Part
type: Concept
realized by: sec-22-ss-5
part of: 22 General offences relating to this Part
note: Advertising therapeutic goods for an unaccepted indication is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.126
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

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

therapeutic-goods-act-1989-sec-22-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of advertising therapeutic goods for an unaccepted indication.
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.
conclusion text: (Penalty: 100 penalty units.)
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22-ss-5-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: Classify
logic summary: Classification of therapeutic goods into the Register.
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.
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22-ss-5-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Temporal interval for advertising therapeutic goods.
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.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22-ss-5-logic-ltl-4
type: LogicApplication
modality: LTL
operator: Recurring Trace
logic summary: Recurring trace of advertising therapeutic goods for unaccepted indications.
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.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22-ss-5-logic-diffusion-5
type: LogicApplication
modality: Diffusion
operator: Diffusion
logic summary: Diffusion of advertising therapeutic goods for unaccepted indications.
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.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22-ss-5-logic-cogai-6
type: LogicApplication
modality: CogAI
operator: Classification
logic summary: Classification of therapeutic goods into the Register.
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.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-22aa-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of breach
premise text: (2) A person contravenes this subsection if...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-22c-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Application must be made in accordance with a form approved by the Secretary
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

22E Period during which provisional determination is in force
type: Concept
realized by: sec-22e
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.134

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

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

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

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

22E(4) Period during which provisional determination is in force
type: Concept
realized by: sec-22e-ss-4
part of: 22E Period during which provisional determination is in force
note: Application requirements for provisional determination
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.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.134
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

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

therapeutic-goods-act-1989-sec-22e-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Application must meet certain requirements
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22e-ss-4-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: BETWEEN
logic summary: Application must be made within a certain time frame
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.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22e-ss-4-logic-ltl-3
type: LogicApplication
modality: LTL
operator: BETWEEN
logic summary: Application must be made within a certain time frame
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.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-22e-ss-4-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Application must meet certain requirements
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-22f-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Secretary must perform action
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

22G Scientific advice about aspects of quality, safety or efficacy of
type: Concept
realized by: sec-22g
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.138

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

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

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

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

therapeutic-goods-act-1989-sec-22g-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to provide information
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-23-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permission to make an application
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-24-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: requires
logic summary: Application for registration is required
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-24b-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: forbid
logic summary: Prohibition
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-24b-ss-2-logic-linearlogic-2
type: LogicApplication
modality: LinearLogic
operator: ¬(A ∧ B)
logic summary: Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid.
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...
execution surface: modalities::linear
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-24b-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: ¬(A ∧ B)
logic summary: Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid.
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...
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-24b-ss-2-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: forbid
logic summary: Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid.
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...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

25AB Registration of therapeutic goods etc.
type: Concept
realized by: sec-25ab
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.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.158

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-25ab-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Secretary must perform action.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-26-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: >=
logic summary: Temporal interval
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-26ac-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide notification
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-26ae-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: The Secretary must evaluate the medicine.
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;
conclusion text: the Secretary must evaluate the medicine having regard to...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

therapeutic-goods-act-1989-sec-26ae-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Duty obligation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-26b-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Applicant has an obligation to provide a certificate.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

26BB Permissible ingredients
type: Concept
realized by: sec-26bb
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.180

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

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

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

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

26BB(2A) Permissible ingredients
type: Concept
realized by: sec-26bb-ss-2a
part of: 26BB Permissible ingredients
note: Permits specific circumstances for a particular ingredient in medicine.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.180
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

therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Permit
logic summary: Allows specified conditions.
premise text: (2A) The requirements referred to in paragraph (1)(b)
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Defines temporal scope.
premise text: (2A) The requirements referred to in paragraph (1)(b)
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.
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Temporal Trace
logic summary: Defines temporal relationship.
premise text: (2A) The requirements referred to in paragraph (1)(b)
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.
execution surface: modalities::temporal_ltl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Spread
logic summary: Describes information spread.
premise text: (2A) The requirements referred to in paragraph (1)(b)
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.
execution surface: modalities::diffusion
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: Knowledge Representation
logic summary: Describes knowledge representation.
premise text: (2A) The requirements referred to in paragraph (1)(b)
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.
execution surface: sparql_library::parsers::chk_parser
confidence: 0.5000
curation status: Proposed

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

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

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

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

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

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

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

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

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

26BD Requirements relating to an application for variation of a
type: Concept
realized by: sec-26bd
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.182

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-26bd-ss-9-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of application lapse due to inaccurate or misleading information
premise text: (9) The Secretary may, by legislative instrument, determine a form of information for the purposes of subparagraph (3)(e)(ii).
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

therapeutic-goods-act-1989-sec-26be-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Applicable
logic summary: Classifies the legal effect as Undertaking
premise text: No obligation, prohibition, permission, or right explicitly stated
conclusion text: Undertaking
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

26BF Permissible indications
type: Concept
realized by: sec-26bf
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.186

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-26bg-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permission to vary or revoke
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-26bj-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Application must be made in accordance with a form approved by the Secretary
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-26c-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: requires
logic summary: Requires certificate for patent infringement proceedings
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).
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).
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-27-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Duty obligation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

therapeutic-goods-act-1989-sec-27-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Duty obligation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

29 Duration of registration or listing
type: Concept
realized by: sec-29
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.202

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

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

therapeutic-goods-act-1989-sec-29-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: holds
logic summary: Holds true
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-29a-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to notify
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

therapeutic-goods-act-1989-sec-29a-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

therapeutic-goods-act-1989-sec-29c-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of false or misleading information
premise text: Subsection 29B(1) notice
conclusion text: Contravention of subsection (2)
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

30 Cancellation of registration or listing
type: Concept
realized by: sec-30
note: Cancellation of registration or listing of therapeutic goods under certain conditions.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.212
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

therapeutic-goods-act-1989-sec-30-norm
type: Prohibition
modality: Deontic
part of: 30 Cancellation of registration or listing
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: >
logic summary: Risk assessment for cancellation
premise text: it appears to the Secretary that failure to cancel the registration or listing would create an imminent risk of death...
conclusion text: the person requests in writing the cancellation of the registration or listing
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: <
logic summary: Timeframe for record availability
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;
conclusion text: within 24 hours after the request was made
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: =
logic summary: Certification requirements for medicines
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...
conclusion text: the requirements under subsection 26A(3) or (4A) are not fulfilled
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: =
logic summary: Advertising regulations
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
conclusion text: the Secretary is satisfied that the contravention is significant
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30A Revocation of cancellation of registration or listing upon
type: Concept
realized by: sec-30a
has part: 30A(1) Revocation of cancellation of registration or listing upon
has part: 30A(2) Revocation of cancellation of registration or listing upon
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.218

30A(1) Revocation of cancellation of registration or listing upon
type: Concept
realized by: sec-30a-ss-1
part of: 30A Revocation of cancellation of registration or listing upon
note: Secretary may revoke cancellation upon request and payment of fee.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.218
asserts: therapeutic-goods-act-1989-sec-30a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30a-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-30a-ss-1-norm
type: Permission
modality: Deontic
part of: 30A(1) Revocation of cancellation of registration or listing upon
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30a-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permits Secretary to revoke cancellation.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30A(2) Revocation of cancellation of registration or listing upon
type: Concept
realized by: sec-30a-ss-2
part of: 30A Revocation of cancellation of registration or listing upon
note: Cancellation is taken never to have occurred upon revocation.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.218
asserts: therapeutic-goods-act-1989-sec-30a-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30a-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-30a-ss-2-norm
type: Obligation
modality: Deontic
part of: 30A(2) Revocation of cancellation of registration or listing upon
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30a-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Implies
logic summary: If cancellation is revoked, then it is never taken to have occurred.
premise text: Cancellation is revoked.
conclusion text: Cancellation is taken never to have occurred.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30AA Revocation of cancellation of registration or listing—payment
type: Concept
realized by: sec-30aa
has part: 30AA(1) Revocation of cancellation of registration or listing—payment
has part: 30AA(2) Revocation of cancellation of registration or listing—payment
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.218

30AA(1) Revocation of cancellation of registration or listing—payment
type: Concept
realized by: sec-30aa-ss-1
part of: 30AA Revocation of cancellation of registration or listing—payment
note: Secretary may revoke cancellation of registration or listing under certain conditions.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.218
asserts: therapeutic-goods-act-1989-sec-30aa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30aa-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-30aa-ss-1-norm
type: Permission
modality: Deontic
part of: 30AA(1) Revocation of cancellation of registration or listing—payment
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30aa-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to revoke cancellation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30AA(2) Revocation of cancellation of registration or listing—payment
type: Concept
realized by: sec-30aa-ss-2
part of: 30AA Revocation of cancellation of registration or listing—payment
note: If cancellation is revoked, it is taken never to have occurred.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.218
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

therapeutic-goods-act-1989-sec-30aa-ss-2-norm
type: Obligation
modality: Deontic
part of: 30AA(2) Revocation of cancellation of registration or listing—payment
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30aa-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Implies
logic summary: If A, then B.
premise text: Cancellation is revoked.
conclusion text: It is taken never to have occurred.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30aa-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Overlaps
logic summary: Temporal interval overlap.
premise text: Cancellation is revoked.
conclusion text: It is taken never to have occurred.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

30B Publication of cancellation of registration or listing
type: Concept
realized by: sec-30b
note: Secretary must publish notice after cancellation of registration or listing.
description: Notice setting out particulars of the cancellation.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.219
asserts: therapeutic-goods-act-1989-sec-30b-norm
asserts: therapeutic-goods-act-1989-sec-30b-logic-deontic-1

therapeutic-goods-act-1989-sec-30b-norm
type: Obligation
modality: Deontic
part of: 30B Publication of cancellation of registration or listing
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30b-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to publish notice.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30C Consultation with Gene Technology Regulator
type: Concept
realized by: sec-30c
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.219

30C(1) Consultation with Gene Technology Regulator
type: Concept
realized by: sec-30c-ss-1
part of: 30C Consultation with Gene Technology Regulator
note: Application for listing or registration of a therapeutic good must pass preliminary assessment.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.219
asserts: therapeutic-goods-act-1989-sec-30c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30c-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-30c-ss-1-norm
type: Obligation
modality: Deontic
part of: 30C(1) Consultation with Gene Technology Regulator
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30c-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Therapeutic good must meet conditions.
premise text: (1) This section applies to an application for listing or registration of a therapeutic good under section 23 if:
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30C(2) Consultation with Gene Technology Regulator
type: Concept
realized by: sec-30c-ss-2
part of: 30C Consultation with Gene Technology Regulator
note: Secretary must give written notice to Gene Technology Regulator about application.
description: Advice on application
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.219
asserts: therapeutic-goods-act-1989-sec-30c-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30c-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-30c-ss-2-norm
type: Obligation
modality: Deontic
part of: 30C(2) Consultation with Gene Technology Regulator
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30c-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide notice
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30C(3) Consultation with Gene Technology Regulator
type: Concept
realized by: sec-30c-ss-3
part of: 30C Consultation with Gene Technology Regulator
note: The Gene Technology Regulator must provide written advice to the Secretary about a gene technology application.
description: Yes
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.219
asserts: therapeutic-goods-act-1989-sec-30c-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-30c-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-30c-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: The Gene Technology Regulator must provide written advice.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30C(4) Consultation with Gene Technology Regulator
type: Concept
realized by: sec-30c-ss-4
part of: 30C Consultation with Gene Technology Regulator
note: Consultation with Gene Technology Regulator within specified period.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.219
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

therapeutic-goods-act-1989-sec-30c-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide consultation
premise text: The advice is to be given within the period specified in the notice.
conclusion text: Obligation to consult
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30c-ss-4-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: CONTAINS
logic summary: Temporal interval for consultation
premise text: The advice is to be given within the period specified in the notice.
conclusion text: Period defined as containing the time of consultation
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30c-ss-4-logic-argumentation-3
type: LogicApplication
modality: Argumentation
operator: IMPLIES
logic summary: Implication from consultation requirement
premise text: The advice is to be given within the period specified in the notice.
conclusion text: If advice is given, then it must be within a period
execution surface: modalities::argumentation
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30c-ss-4-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: IS_A
logic summary: Definition of consultation as giving advice
premise text: The advice is to be given within the period specified in the notice.
conclusion text: Consultation defined as giving advice
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30c-ss-4-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: IS_A
logic summary: Definition of consultation as a cognitive process
premise text: The advice is to be given within the period specified in the notice.
conclusion text: Consultation defined as a cognitive process
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

30C(5) Consultation with Gene Technology Regulator
type: Concept
realized by: sec-30c-ss-5
part of: 30C Consultation with Gene Technology Regulator
note: No notification required for therapeutic goods belonging to a class with an active advice from the Gene Technology Regulator.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.219
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

therapeutic-goods-act-1989-sec-30c-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: exemption
logic summary: Exemption from notification
premise text: Advice from the Gene Technology Regulator is in force
conclusion text: No notification required
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30c-ss-5-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: subclassOf
logic summary: Therapeutic goods belonging to a class with an active advice
premise text: Class of therapeutic goods
conclusion text: Subclass of goods subject to exemption
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

30D Secretary may seek advice about classes of GM products or
type: Concept
realized by: sec-30d
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.220

30D(1) Secretary may seek advice about classes of GM products or
type: Concept
realized by: sec-30d-ss-1
part of: 30D Secretary may seek advice about classes of GM products or
note: The Secretary may request advice from the Gene Technology Regulator.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.220
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

therapeutic-goods-act-1989-sec-30d-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MAY
logic summary: The Secretary may request advice.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30d-ss-1-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: CLASSIFICATION
logic summary: Classes of GM products specified in the request.
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

30D(2) Secretary may seek advice about classes of GM products or
type: Concept
realized by: sec-30d-ss-2
part of: 30D Secretary may seek advice about classes of GM products or
note: Request for advice must specify matters to which the advice is to relate.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.220
asserts: therapeutic-goods-act-1989-sec-30d-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30d-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-30d-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Specify matters for advice
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30D(3) Secretary may seek advice about classes of GM products or
type: Concept
realized by: sec-30d-ss-3
part of: 30D Secretary may seek advice about classes of GM products or
note: Secretary must seek advice from Gene Technology Regulator on specified matters.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.220
asserts: therapeutic-goods-act-1989-sec-30d-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-30d-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-30d-ss-3-norm
type: Obligation
modality: Deontic
part of: 30D(3) Secretary may seek advice about classes of GM products or
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30d-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide written advice
premise text: Secretary requests advice
conclusion text: Gene Technology Regulator must provide written advice
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30D(4) Secretary may seek advice about classes of GM products or
type: Concept
realized by: sec-30d-ss-4
part of: 30D Secretary may seek advice about classes of GM products or
note: Advice from the Gene Technology Regulator remains in force until withdrawn.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.220
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

therapeutic-goods-act-1989-sec-30d-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: holds
logic summary: Holds advice from the Gene Technology Regulator.
premise text: The Gene Technology Regulator gives advice to the Secretary.
conclusion text: The advice remains in force until it is withdrawn by the Gene Technology Regulator.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30d-ss-4-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Advice from the Gene Technology Regulator lasts during its validity.
premise text: The Gene Technology Regulator gives advice to the Secretary.
conclusion text: The advice remains in force until it is withdrawn by the Gene Technology Regulator.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30d-ss-4-logic-ltl-3
type: LogicApplication
modality: LTL
operator: until
logic summary: Advice from the Gene Technology Regulator ends when it is withdrawn.
premise text: The Gene Technology Regulator gives advice to the Secretary.
conclusion text: The advice remains in force until it is withdrawn by the Gene Technology Regulator.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30d-ss-4-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: diffuses
logic summary: Advice from the Gene Technology Regulator diffuses to the Secretary.
premise text: The Gene Technology Regulator gives advice to the Secretary.
conclusion text: The advice remains in force until it is withdrawn by the Gene Technology Regulator.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30d-ss-4-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: cognizes
logic summary: The Secretary cognizes the advice from the Gene Technology Regulator.
premise text: The Gene Technology Regulator gives advice to the Secretary.
conclusion text: The advice remains in force until it is withdrawn by the Gene Technology Regulator.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

30E Secretary to take advice into account
type: Concept
realized by: sec-30e
note: Secretary must take advice from Gene Technology Regulator into account when making decisions on applications.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.220
asserts: therapeutic-goods-act-1989-sec-30e-norm
asserts: therapeutic-goods-act-1989-sec-30e-logic-deontic-1

therapeutic-goods-act-1989-sec-30e-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must take advice into account
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30EA Public notification, and recall, of therapeutic goods
type: Concept
realized by: sec-30ea
note: The Secretary may impose requirements on a person if certain circumstances occur.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.222
asserts: therapeutic-goods-act-1989-sec-30ea-norm
asserts: therapeutic-goods-act-1989-sec-30ea-logic-deontic-1

therapeutic-goods-act-1989-sec-30ea-norm
type: Obligation
modality: Deontic
part of: 30EA Public notification, and recall, of therapeutic goods
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30ea-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Imposition of obligations
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30EB Publication of requirements
type: Concept
realized by: sec-30eb
note: Secretary must publish notice after imposing requirement.
description: Notice setting out particulars of the requirement
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.225
asserts: therapeutic-goods-act-1989-sec-30eb-norm
asserts: therapeutic-goods-act-1989-sec-30eb-logic-deontic-1

therapeutic-goods-act-1989-sec-30eb-norm
type: Obligation
modality: Deontic
part of: 30EB Publication of requirements
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30eb-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to publish notice
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30EC Criminal offences for non-compliance with requirements
type: Concept
realized by: sec-30ec
note: Non-compliance with requirements is a criminal offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.225
asserts: therapeutic-goods-act-1989-sec-30ec-norm
asserts: therapeutic-goods-act-1989-sec-30ec-logic-deontic-1

therapeutic-goods-act-1989-sec-30ec-norm
type: Prohibition
modality: Deontic
part of: 30EC Criminal offences for non-compliance with requirements
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30ec-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits non-compliance with requirements.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30ED Powers of suspension and cancellation unaffected
type: Concept
realized by: sec-30ed
note: Imposition of requirement under section 30EA does not affect suspension or cancellation power.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.226
asserts: therapeutic-goods-act-1989-sec-30ed-norm

therapeutic-goods-act-1989-sec-30ed-norm
type: Obligation
modality: Deontic
part of: 30ED Powers of suspension and cancellation unaffected
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

30EE Saving of other laws
type: Concept
realized by: sec-30ee
note: No exclusion or limitation of other laws
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.227
asserts: therapeutic-goods-act-1989-sec-30ee-norm

30EF Reporting medicine shortages
type: Concept
realized by: sec-30ef
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.228

30EF(1) Reporting medicine shortages
type: Concept
realized by: sec-30ef-ss-1
part of: 30EF Reporting medicine shortages
note: Notify shortage of reportable medicine within 2 working days or 10 working days.
description: True
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.228
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

therapeutic-goods-act-1989-sec-30ef-ss-1-norm
type: Obligation
modality: Deontic
part of: 30EF(1) Reporting medicine shortages
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30ef-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must notify shortage within specified timeframe.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ef-ss-1-logic-epistemic-2
type: LogicApplication
modality: Epistemic
operator: OUGHT
logic summary: Ought to reasonably know of shortage before notification.
execution surface: modalities::epistemic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ef-ss-1-logic-ltl-3
type: LogicApplication
modality: LTL
operator: BUT
logic summary: Notification within timeframe is but not required.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

30EF(2) Reporting medicine shortages
type: Concept
realized by: sec-30ef-ss-2
part of: 30EF Reporting medicine shortages
note: Reporting medicine shortages when included in an instrument under section 30EJ has a critical impact.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.228
asserts: therapeutic-goods-act-1989-sec-30ef-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30ef-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-30ef-ss-2-norm
type: Obligation
modality: Deontic
part of: 30EF(2) Reporting medicine shortages
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30ef-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Reporting medicine shortages when included in an instrument under section 30EJ is obligatory.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30EF(3) Reporting medicine shortages
type: Concept
realized by: sec-30ef-ss-3
part of: 30EF Reporting medicine shortages
note: Reporting medicine shortages when there is a critical impact on health or functioning.
description: Notification requirements
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.228
asserts: therapeutic-goods-act-1989-sec-30ef-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-30ef-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-30ef-ss-3-norm
type: Obligation
modality: Deontic
part of: 30EF(3) Reporting medicine shortages
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30ef-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Reporting medicine shortages is a duty.
conclusion text: Notification requirements must be provided.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30EF(4) Reporting medicine shortages
type: Concept
realized by: sec-30ef-ss-4
part of: 30EF Reporting medicine shortages
note: Notification requirements for medicine shortages
description: Specific period of shortage, approved form, and required information
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.228
asserts: therapeutic-goods-act-1989-sec-30ef-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-30ef-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-30ef-ss-4-norm
type: Obligation
modality: Deontic
part of: 30EF(4) Reporting medicine shortages
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30ef-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Notification requirements are mandatory
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30EF(5) Reporting medicine shortages
type: Concept
realized by: sec-30ef-ss-5
part of: 30EF Reporting medicine shortages
note: Specify software requirements for reporting medicine shortages
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.228
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

therapeutic-goods-act-1989-sec-30ef-ss-5-logic-descriptionlogic-1
type: LogicApplication
modality: DescriptionLogic
operator: hasClass
logic summary: Classifies the provision as a descriptive clause
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ef-ss-5-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Describes the temporal relationship between software requirements and reporting medicine shortages
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

30EF(6) Reporting medicine shortages
type: Concept
realized by: sec-30ef-ss-6
part of: 30EF Reporting medicine shortages
note: Reporting medicine shortages is prohibited for individuals and bodies corporate.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.228
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

therapeutic-goods-act-1989-sec-30ef-ss-6-norm
type: Prohibition
modality: Deontic
part of: 30EF(6) Reporting medicine shortages
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30ef-ss-6-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of reporting medicine shortages
premise text: (6) A person contravenes this subsection...
conclusion text: ...the person contravenes the requirement.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ef-ss-6-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Temporal interval of reporting medicine shortages
premise text: (6) A person contravenes this subsection...
conclusion text: ...if the person is subject to a requirement under subsection (1);
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ef-ss-6-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Recurring Trace
logic summary: Recurring trace of reporting medicine shortages
premise text: (6) A person contravenes this subsection...
conclusion text: ...and the person contravenes the requirement.
execution surface: modalities::temporal_ltl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ef-ss-6-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Information Diffusion
logic summary: Information diffusion of reporting medicine shortages
premise text: (6) A person contravenes this subsection...
conclusion text: ...Maximum civil penalty:
execution surface: modalities::diffusion
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ef-ss-6-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: Knowledge Representation
logic summary: Knowledge representation of reporting medicine shortages
premise text: (a) for an individual—100 penalty units;
conclusion text: ...and (b) for a body corporate—1,000 penalty units.
execution surface: sparql_library::parsers::chk_parser
confidence: 0.5000
curation status: Proposed

30EF(7) Reporting medicine shortages
type: Concept
realized by: sec-30ef-ss-7
part of: 30EF Reporting medicine shortages
note: Exemption from reporting medicine shortages under certain conditions
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.228
asserts: therapeutic-goods-act-1989-sec-30ef-ss-7-norm

therapeutic-goods-act-1989-sec-30ef-ss-7-norm
type: Obligation
modality: Deontic
part of: 30EF(7) Reporting medicine shortages
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

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

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

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

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

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

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

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

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

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

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

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

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

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

30EG Reporting discontinuation of supply of medicine
type: Concept
realized by: sec-30eg
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.232

30EG(1) Reporting discontinuation of supply of medicine
type: Concept
realized by: sec-30eg-ss-1
part of: 30EG Reporting discontinuation of supply of medicine
note: Notify Secretary of discontinuation decision at least 6 months before proposed date.
description: Notification
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.232
asserts: therapeutic-goods-act-1989-sec-30eg-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30eg-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-30eg-ss-1-norm
type: Obligation
modality: Deontic
part of: 30EG(1) Reporting discontinuation of supply of medicine
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30eg-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to notify
conclusion text: The person must notify the Secretary.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30EG(2) Reporting discontinuation of supply of medicine
type: Concept
realized by: sec-30eg-ss-2
part of: 30EG Reporting discontinuation of supply of medicine
note: Reporting required when discontinuation of supply of medicine is made under section 30EJ
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.232
asserts: therapeutic-goods-act-1989-sec-30eg-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30eg-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-30eg-ss-2-norm
type: Obligation
modality: Deontic
part of: 30EG(2) Reporting discontinuation of supply of medicine
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30eg-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Reporting obligation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30EG(3) Reporting discontinuation of supply of medicine
type: Concept
realized by: sec-30eg-ss-3
part of: 30EG Reporting discontinuation of supply of medicine
note: Notify discontinuation of medicine supply if critical impact on health or functioning
description: Notification requirements
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.232
asserts: therapeutic-goods-act-1989-sec-30eg-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-30eg-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-30eg-ss-3-norm
type: Obligation
modality: Deontic
part of: 30EG(3) Reporting discontinuation of supply of medicine
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30eg-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to notify
conclusion text: Notification requirements
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30EG(4) Reporting discontinuation of supply of medicine
type: Concept
realized by: sec-30eg-ss-4
part of: 30EG Reporting discontinuation of supply of medicine
note: Notification must be in a specified form and contain required information.
description: true
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.232
asserts: therapeutic-goods-act-1989-sec-30eg-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-30eg-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-30eg-ss-4-norm
type: Obligation
modality: Deontic
part of: 30EG(4) Reporting discontinuation of supply of medicine
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30eg-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Notification must be in a specified form.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30EG(5) Reporting discontinuation of supply of medicine
type: Concept
realized by: sec-30eg-ss-5
part of: 30EG Reporting discontinuation of supply of medicine
note: Specify software requirements for information transmission
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.232
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

therapeutic-goods-act-1989-sec-30eg-ss-5-logic-descriptionlogic-1
type: LogicApplication
modality: DescriptionLogic
operator: hasClass
logic summary: Classifies the provision as a descriptive clause
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30eg-ss-5-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Identifies the temporal relation of software requirements
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

30EH What is a reportable medicine?
type: Concept
realized by: sec-30eh
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?
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.234

30EH(1) What is a reportable medicine?
type: Concept
realized by: sec-30eh-ss-1
part of: 30EH What is a reportable medicine?
note: Defines reportable medicine under the Act.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.234
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

therapeutic-goods-act-1989-sec-30eh-ss-1-norm
type: Obligation
modality: Deontic
part of: 30EH(1) What is a reportable medicine?
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30eh-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: is
logic summary: Identifies a reportable medicine.
premise text: (1) For the purposes of this Act, registered goods are a reportable medicine if:
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30eh-ss-1-logic-linearlogic-2
type: LogicApplication
modality: LinearLogic
operator: and
logic summary: Combines conditions for a reportable medicine.
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;
execution surface: modalities::linear
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30eh-ss-1-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: contains
logic summary: Includes temporal intervals for substance inclusion.
premise text: (i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard;
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30eh-ss-1-logic-ltl-4
type: LogicApplication
modality: LTL
operator: or
logic summary: Combines conditions for a reportable medicine using LTL.
premise text: (b) either: (i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard;
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

30EH(2) What is a reportable medicine?
type: Concept
realized by: sec-30eh-ss-2
part of: 30EH What is a reportable medicine?
note: The Minister may determine medicine for the purposes of subparagraph (1)(b)(ii).
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.234
asserts: therapeutic-goods-act-1989-sec-30eh-ss-2-norm

30EH(3) What is a reportable medicine?
type: Concept
realized by: sec-30eh-ss-3
part of: 30EH What is a reportable medicine?
note: The Minister must determine a medicine if it is critical to patient health and notification of shortage would be in public health interests.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.234
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

therapeutic-goods-act-1989-sec-30eh-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: The Minister must determine a medicine.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30eh-ss-3-logic-epistemic-2
type: LogicApplication
modality: Epistemic
operator: SUFFICIENT
logic summary: Notification of shortage would be in public health interests.
execution surface: modalities::epistemic
confidence: 1.0000
curation status: Proposed

30EI When is there a medicine shortage?
type: Concept
realized by: sec-30ei
note: Defines when there is a medicine shortage in Australia.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.235
asserts: therapeutic-goods-act-1989-sec-30ei-norm

30EJ Medicines Watch List
type: Concept
realized by: sec-30ej
has part: 30EJ(1) Medicines Watch List
has part: 30EJ(2) Medicines Watch List
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.235

30EJ(1) Medicines Watch List
type: Concept
realized by: sec-30ej-ss-1
part of: 30EJ Medicines Watch List
note: Minister may determine medicine for purposes of subsections 30EF(2) and 30EG(2)
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.235
asserts: therapeutic-goods-act-1989-sec-30ej-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30ej-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-30ej-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Expresses permission or obligation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30EJ(2) Medicines Watch List
type: Concept
realized by: sec-30ej-ss-2
part of: 30EJ Medicines Watch List
note: The Minister must not determine a medicine unless certain conditions are met.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.235
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

therapeutic-goods-act-1989-sec-30ej-ss-2-norm
type: Prohibition
modality: Deontic
part of: 30EJ(2) Medicines Watch List
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30ej-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits the Minister from determining a medicine without satisfying certain conditions.
premise text: (2) The Minister must not determine a medicine...
conclusion text: ...unless the Minister is satisfied that any shortage of the medicine...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ej-ss-2-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes an obligation on the Minister to satisfy certain conditions before determining a medicine.
premise text: (2) The Minister must not determine a medicine...
conclusion text: ...unless the Minister is satisfied that any shortage of the medicine...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ej-ss-2-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: TemporalOverlap
logic summary: Defines a temporal overlap between the conditions and the determination of a medicine.
premise text: (2) The Minister must not determine a medicine unless...
conclusion text: ...the Minister is satisfied that any shortage of the medicine...
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ej-ss-2-logic-ltl-4
type: LogicApplication
modality: LTL
operator: TemporalRelevance
logic summary: Defines a temporal relevance between the conditions and the determination of a medicine.
premise text: (2) The Minister must not determine a medicine unless...
conclusion text: ...the Minister is satisfied that any shortage of the medicine...
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ej-ss-2-logic-diffusion-5
type: LogicApplication
modality: Diffusion
operator: InformationFlow
logic summary: Defines an information flow between the conditions and the determination of a medicine.
premise text: (2) The Minister must not determine a medicine unless...
conclusion text: ...the Minister is satisfied that any shortage of the medicine...
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

30EK Minister may declare a serious scarcity of medicine
type: Concept
realized by: sec-30ek
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.236

30EK(1) Minister may declare a serious scarcity of medicine
type: Concept
realized by: sec-30ek-ss-1
part of: 30EK Minister may declare a serious scarcity of medicine
note: Minister may declare a serious scarcity of medicine and specify substitution rules.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.236
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

therapeutic-goods-act-1989-sec-30ek-ss-1-norm
type: Permission
modality: Deontic
part of: 30EK(1) Minister may declare a serious scarcity of medicine
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Permit
logic summary: Permission to dispense substitutable medicine.
premise text: (a) declare that there is a serious scarcity of specified medicine
conclusion text: (b) specify the medicine (the substitutable medicine)
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Permit
logic summary: Pharmacists permitted to dispense substitutable medicine under specified circumstances.
premise text: (b) specify the circumstances in which that substitution is permitted.
conclusion text: Substitution permitted under specified circumstances.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: No prohibition on declaring scarcity or specifying substitution rules.
premise text: (a) declare that there is a serious scarcity of specified medicine
conclusion text: No prohibition.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ek-ss-1-logic-alleninterval-4
type: LogicApplication
modality: AllenInterval
operator: Overlaps
logic summary: Temporal overlap between declaration and substitution rules.
premise text: The Minister may, by legislative instrument:
conclusion text: The declaration and substitution rules overlap in time.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

30EK(2) Minister may declare a serious scarcity of medicine
type: Concept
realized by: sec-30ek-ss-2
part of: 30EK Minister may declare a serious scarcity of medicine
note: The Minister may declare a serious scarcity of medicine under certain conditions.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.236
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

therapeutic-goods-act-1989-sec-30ek-ss-2-norm
type: Obligation
modality: Deontic
part of: 30EK(2) Minister may declare a serious scarcity of medicine
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30ek-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: The Minister may declare a serious scarcity of medicine.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ek-ss-2-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: is
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.
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

30EK(3) Minister may declare a serious scarcity of medicine
type: Concept
realized by: sec-30ek-ss-3
part of: 30EK Minister may declare a serious scarcity of medicine
note: Minister must declare a serious scarcity of medicine if certain conditions are met.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.236
asserts: therapeutic-goods-act-1989-sec-30ek-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-30ek-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-30ek-ss-3-norm
type: Obligation
modality: Deontic
part of: 30EK(3) Minister may declare a serious scarcity of medicine
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30ek-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Minister must declare a serious scarcity of medicine
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30EK(4) Minister may declare a serious scarcity of medicine
type: Concept
realized by: sec-30ek-ss-4
part of: 30EK Minister may declare a serious scarcity of medicine
note: Minister must declare a serious scarcity of medicine under certain circumstances.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.236
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

therapeutic-goods-act-1989-sec-30ek-ss-4-norm
type: Obligation
modality: Deontic
part of: 30EK(4) Minister may declare a serious scarcity of medicine
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30ek-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Minister must declare a serious scarcity of medicine.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ek-ss-4-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: CLASSIFICATION
logic summary: Classification of persons for whom the substitutable medicine is suitable or not suitable.
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.
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30ek-ss-4-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: CONTAINS
logic summary: Temporal interval for declaration.
premise text: (4)
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

30EK(5) Minister may declare a serious scarcity of medicine
type: Concept
realized by: sec-30ek-ss-5
part of: 30EK Minister may declare a serious scarcity of medicine
note: Instrument remains in force for a specified period unless revoked.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.236
asserts: therapeutic-goods-act-1989-sec-30ek-ss-5-norm

30EL Substitution of prescription medicine by pharmacists
type: Concept
realized by: sec-30el
note: Pharmacist may dispense scarce medicine in substitution for another
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.237
asserts: therapeutic-goods-act-1989-sec-30el-norm
asserts: therapeutic-goods-act-1989-sec-30el-logic-deontic-1

therapeutic-goods-act-1989-sec-30el-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to dispense
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30F Criminal offences for goods exempt under section 18A not
type: Concept
realized by: sec-30f
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.238

30F(1) Criminal offences for goods exempt under section 18A not
type: Concept
realized by: sec-30f-ss-1
part of: 30F Criminal offences for goods exempt under section 18A not
note: Supplying goods of a particular kind that do not conform to a standard or are not fit for their intended purposes is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.238
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

therapeutic-goods-act-1989-sec-30f-ss-1-norm
type: Prohibition
modality: Deontic
part of: 30F(1) Criminal offences for goods exempt under section 18A not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of supplying goods that do not conform to a standard or are not fit for their intended purposes.
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: ...
conclusion text: ...is prohibited.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Overlap
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.
premise text: (c) the Secretary is satisfied that the goods included in that batch: ...
conclusion text: ...overlap with the supply of goods.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-1-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Recurring
logic summary: Recurring trace of supplying goods that do not conform to a standard or are not fit for their intended purposes.
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: ...
conclusion text: ...are recurring traces of supplying goods that do not conform to a standard or are not fit for their intended purposes.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-1-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Diffuse
logic summary: Diffusion of the prohibition on supplying goods that do not conform to a standard or are not fit for their intended purposes.
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: ...
conclusion text: ...diffuse to all persons.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-1-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: Classify
logic summary: Classification of goods as not conforming to a standard or being unfit for their intended purposes using artificial intelligence.
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.
conclusion text: ...are classified as not conforming to a standard or being unfit for their intended purposes.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

30F(2) Criminal offences for goods exempt under section 18A not
type: Concept
realized by: sec-30f-ss-2
part of: 30F Criminal offences for goods exempt under section 18A not
note: Require person to take steps to recall goods
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.238
asserts: therapeutic-goods-act-1989-sec-30f-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30f-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-30f-ss-2-norm
type: Obligation
modality: Deontic
part of: 30F(2) Criminal offences for goods exempt under section 18A not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: require
logic summary: Imposes a duty on the state
conclusion text: The person must take steps to recall the goods
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30F(3) Criminal offences for goods exempt under section 18A not
type: Concept
realized by: sec-30f-ss-3
part of: 30F Criminal offences for goods exempt under section 18A not
note: Specify steps for recall of goods
description: Steps to be taken, manner of taking, reasonable period
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.238
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

therapeutic-goods-act-1989-sec-30f-ss-3-norm
type: Obligation
modality: Deontic
part of: 30F(3) Criminal offences for goods exempt under section 18A not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Specify steps for recall of goods
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-3-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: CONTAINS
logic summary: Temporal interval for recall
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
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-3-logic-ltl-3
type: LogicApplication
modality: LTL
operator: CONTAINS
logic summary: Temporal interval for recall
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
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-3-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: CONTAINS
logic summary: Diffusion of recall requirements
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
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-3-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: CONTAINS
logic summary: Artificial intelligence application for recall requirements
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
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

30F(4) Criminal offences for goods exempt under section 18A not
type: Concept
realized by: sec-30f-ss-4
part of: 30F Criminal offences for goods exempt under section 18A not
note: Publish notice in Gazette or Department's website
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.238
asserts: therapeutic-goods-act-1989-sec-30f-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-30f-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-30f-ss-4-norm
type: Obligation
modality: Deontic
part of: 30F(4) Criminal offences for goods exempt under section 18A not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must publish notice
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30F(4A) Criminal offences for goods exempt under section 18A not
type: Concept
realized by: sec-30f-ss-4a
part of: 30F Criminal offences for goods exempt under section 18A not
note: A written notice given to a person by the Secretary under this section is not a legislative instrument.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.238
asserts: therapeutic-goods-act-1989-sec-30f-ss-4a-norm
asserts: therapeutic-goods-act-1989-sec-30f-ss-4a-logic-deontic-1

therapeutic-goods-act-1989-sec-30f-ss-4a-norm
type: Prohibition
modality: Deontic
part of: 30F(4A) Criminal offences for goods exempt under section 18A not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-4a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits notices from being considered legislative instruments.
premise text: None
conclusion text: None
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30F(4B) Criminal offences for goods exempt under section 18A not
type: Concept
realized by: sec-30f-ss-4b
part of: 30F Criminal offences for goods exempt under section 18A not
note: Failure to comply with a notice results in harm or injury.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.238
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

therapeutic-goods-act-1989-sec-30f-ss-4b-norm
type: Prohibition
modality: Deontic
part of: 30F(4B) Criminal offences for goods exempt under section 18A not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits non-compliance with a notice.
premise text: The Secretary gives a notice to the person under subsection (2); and
conclusion text: the person fails to comply with that requirement; and
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-4b-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Overlaps
logic summary: The provision applies to temporal intervals where harm or injury occurs.
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.
conclusion text: because the person failed to comply with that requirement.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-4b-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Repeats
logic summary: The provision is repeated for each occurrence of harm or injury.
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
conclusion text: or would be likely to result in, harm or injury to any person;
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes an obligation on the person to comply with the notice.
premise text: A person commits an offence if:
conclusion text: the person fails to comply with that requirement; and
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits non-compliance with the notice.
premise text: A person commits an offence if:
conclusion text: the person fails to comply with that requirement; and
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30F(5) Criminal offences for goods exempt under section 18A not
type: Concept
realized by: sec-30f-ss-5
part of: 30F Criminal offences for goods exempt under section 18A not
note: Failure to comply with notice requirement is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.238
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

therapeutic-goods-act-1989-sec-30f-ss-5-norm
type: Obligation
modality: Deontic
part of: 30F(5) Criminal offences for goods exempt under section 18A not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Obligation to comply with notice requirement.
premise text: The Secretary gives a notice to the person under subsection (2); and
conclusion text: the person fails to comply with that requirement.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-5-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Overlaps
logic summary: Compliance with notice requirement overlaps with the offence of failing to comply.
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
conclusion text: the person fails to comply with that requirement.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-5-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Recurrently
logic summary: Compliance with notice requirement is recurrently related to the offence of failing to comply.
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
conclusion text: the person fails to comply with that requirement.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-5-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Obligation to pay penalty for failing to comply with notice requirement.
premise text: Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
conclusion text: the person fails to comply with that requirement.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30F(6) Criminal offences for goods exempt under section 18A not
type: Concept
realized by: sec-30f-ss-6
part of: 30F Criminal offences for goods exempt under section 18A not
note: A person commits an offence if the Secretary gives a notice to the person under subsection (2)
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.238
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

therapeutic-goods-act-1989-sec-30f-ss-6-norm
type: Obligation
modality: Deontic
part of: 30F(6) Criminal offences for goods exempt under section 18A not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-6-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: hasObligation
logic summary: Has obligation
premise text: The Secretary gives a notice to the person under subsection (2)
conclusion text: A person commits an offence
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-30f-ss-6-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: overlaps
logic summary: Overlaps with
premise text: Chapter 3 Medicines and other therapeutic goods that are not medical devices
conclusion text: Section 30F(6)
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

30FA Civil penalty for goods exempt under section 18A not
type: Concept
realized by: sec-30fa
note: Civil penalty for non-compliance with standards
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.240
asserts: therapeutic-goods-act-1989-sec-30fa-norm
asserts: therapeutic-goods-act-1989-sec-30fa-logic-deontic-1

therapeutic-goods-act-1989-sec-30fa-norm
type: Prohibition
modality: Deontic
part of: 30FA Civil penalty for goods exempt under section 18A not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30fa-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits non-compliance
premise text: Notice specifies requirement
conclusion text: Non-compliance is prohibited
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30G Disposal of unused goods exempt under section 18A
type: Concept
realized by: sec-30g
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.240

30G(1) Disposal of unused goods exempt under section 18A
type: Concept
realized by: sec-30g-ss-1
part of: 30G Disposal of unused goods exempt under section 18A
note: Therapeutic goods must be used before an exemption ceases to have effect.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.240
asserts: therapeutic-goods-act-1989-sec-30g-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30g-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-30g-ss-1-norm
type: Obligation
modality: Deontic
part of: 30G(1) Disposal of unused goods exempt under section 18A
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30g-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Therapeutic goods must be used before an exemption ceases to have effect.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30G(2) Disposal of unused goods exempt under section 18A
type: Concept
realized by: sec-30g-ss-2
part of: 30G Disposal of unused goods exempt under section 18A
note: The Secretary must arrange for disposal of unused goods.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.240
asserts: therapeutic-goods-act-1989-sec-30g-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30g-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-30g-ss-2-norm
type: Obligation
modality: Deontic
part of: 30G(2) Disposal of unused goods exempt under section 18A
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30g-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to arrange for disposal
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30G(3) Disposal of unused goods exempt under section 18A
type: Concept
realized by: sec-30g-ss-3
part of: 30G Disposal of unused goods exempt under section 18A
note: Methods for disposal of goods
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.240
asserts: therapeutic-goods-act-1989-sec-30g-ss-3-norm

30G(4) Disposal of unused goods exempt under section 18A
type: Concept
realized by: sec-30g-ss-4
part of: 30G Disposal of unused goods exempt under section 18A
note: No benefit can be conferred on a person other than the owner of goods
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.240
asserts: therapeutic-goods-act-1989-sec-30g-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-30g-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-30g-ss-4-norm
type: Prohibition
modality: Deontic
part of: 30G(4) Disposal of unused goods exempt under section 18A
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30g-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Cannot
logic summary: No benefit can be conferred
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30H Record for goods exempt under section 18A
type: Concept
realized by: sec-30h
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.241

30H(1) Record for goods exempt under section 18A
type: Concept
realized by: sec-30h-ss-1
part of: 30H Record for goods exempt under section 18A
note: Keeping a record of therapeutic goods exempt under section 18A is required.
description: Record keeping
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.241
asserts: therapeutic-goods-act-1989-sec-30h-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-30h-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-30h-ss-1-norm
type: Obligation
modality: Deontic
part of: 30H(1) Record for goods exempt under section 18A
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30h-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Requires
logic summary: The exemption requires record keeping.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

30H(2) Record for goods exempt under section 18A
type: Concept
realized by: sec-30h-ss-2
part of: 30H Record for goods exempt under section 18A
note: Strict liability applies to paragraph (1)(b)
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.241
asserts: therapeutic-goods-act-1989-sec-30h-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-30h-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-30h-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: applies
logic summary: Strict liability obligation
premise text: (2) Strict liability applies to paragraph (1)(b)
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

30H(3) Record for goods exempt under section 18A
type: Concept
realized by: sec-30h-ss-3
part of: 30H Record for goods exempt under section 18A
note: Keeping a record about therapeutic goods exempt under section 18A is required.
description: Record keeping
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.241
asserts: therapeutic-goods-act-1989-sec-30h-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-30h-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-30h-ss-3-norm
type: Obligation
modality: Deontic
part of: 30H(3) Record for goods exempt under section 18A
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-30h-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to keep a record
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

31 Secretary may require information or documents
type: Concept
realized by: sec-31
note: The Secretary may require information or documents from a person.
description: Yes
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.242
asserts: therapeutic-goods-act-1989-sec-31-norm
asserts: therapeutic-goods-act-1989-sec-31-logic-deontic-1

therapeutic-goods-act-1989-sec-31-norm
type: Obligation
modality: Deontic
part of: 31 Secretary may require information or documents
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MAY
logic summary: The Secretary may require information or documents.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

31A Secretary may require information etc. about goods exempt
type: Concept
realized by: sec-31a
note: Secretary may require sponsor to provide specified information about exempt goods for experimental purposes in humans.
description: Yes
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.249
asserts: therapeutic-goods-act-1989-sec-31a-norm
asserts: therapeutic-goods-act-1989-sec-31a-logic-deontic-1

therapeutic-goods-act-1989-sec-31a-norm
type: Obligation
modality: Deontic
part of: 31A Secretary may require information etc. about goods exempt
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MAY
logic summary: Secretary may require information
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

31AA Secretary may require information etc. about goods exempt
type: Concept
realized by: sec-31aa
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.251

31AA(1) Secretary may require information etc. about goods exempt
type: Concept
realized by: sec-31aa-ss-1
part of: 31AA Secretary may require information etc. about goods exempt
note: Secretary may require information about goods exempt
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.251
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

therapeutic-goods-act-1989-sec-31aa-ss-1-norm
type: Obligation
modality: Deontic
part of: 31AA(1) Secretary may require information etc. about goods exempt
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31aa-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: requires
logic summary: Requires information
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31aa-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: between
logic summary: Between a condition and a person
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.
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-31aa-ss-1-logic-argumentation-3
type: LogicApplication
modality: Argumentation
operator: may lead to
logic summary: May lead to further action
execution surface: modalities::argumentation
confidence: 0.5000
curation status: Proposed

31AA(2) Secretary may require information etc. about goods exempt
type: Concept
realized by: sec-31aa-ss-2
part of: 31AA Secretary may require information etc. about goods exempt
note: The Secretary may require information from a person about goods exempt.
description: true
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.251
asserts: therapeutic-goods-act-1989-sec-31aa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-31aa-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-31aa-ss-2-norm
type: Obligation
modality: Deontic
part of: 31AA(2) Secretary may require information etc. about goods exempt
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31aa-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MAY
logic summary: The Secretary may require information.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

31AA(3) Secretary may require information etc. about goods exempt
type: Concept
realized by: sec-31aa-ss-3
part of: 31AA Secretary may require information etc. about goods exempt
note: Secretary must require information within a specified period.
description: Information about goods exempt
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.251
asserts: therapeutic-goods-act-1989-sec-31aa-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-31aa-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-31aa-ss-3-norm
type: Obligation
modality: Deontic
part of: 31AA(3) Secretary may require information etc. about goods exempt
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31aa-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide information
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

31AA(4) Secretary may require information etc. about goods exempt
type: Concept
realized by: sec-31aa-ss-4
part of: 31AA Secretary may require information etc. about goods exempt
note: Secretary must require information about goods exempt
description: Information
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.251
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

therapeutic-goods-act-1989-sec-31aa-ss-4-norm
type: Obligation
modality: Deontic
part of: 31AA(4) Secretary may require information etc. about goods exempt
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31aa-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to provide information
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31aa-ss-4-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: hasPart
logic summary: Classifies goods exempt
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

31B Secretary may require information relating to approvals and
type: Concept
realized by: sec-31b
note: Secretary may require information from a person granted an approval under subsection 19(1)
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.251
asserts: therapeutic-goods-act-1989-sec-31b-norm

therapeutic-goods-act-1989-sec-31b-norm
type: Obligation
modality: Deontic
part of: 31B Secretary may require information relating to approvals and
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

31BA Secretary may require information about therapeutic goods
type: Concept
realized by: sec-31ba
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.254

31BA(1) Secretary may require information about therapeutic goods
type: Concept
realized by: sec-31ba-ss-1
part of: 31BA Secretary may require information about therapeutic goods
note: The Secretary may require information about therapeutic goods from a person granted an approval.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.254
asserts: therapeutic-goods-act-1989-sec-31ba-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-31ba-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-31ba-ss-1-norm
type: Obligation
modality: Deontic
part of: 31BA(1) Secretary may require information about therapeutic goods
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31ba-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MAY
logic summary: The Secretary may require information.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

31BA(2) Secretary may require information about therapeutic goods
type: Concept
realized by: sec-31ba-ss-2
part of: 31BA Secretary may require information about therapeutic goods
note: Must provide information within a specified period and in the form specified by the notice.
description: true
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.254
asserts: therapeutic-goods-act-1989-sec-31ba-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-31ba-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-31ba-ss-2-norm
type: Obligation
modality: Deontic
part of: 31BA(2) Secretary may require information about therapeutic goods
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31ba-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide information within a specified period and in the form specified by the notice.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

31BA(3) Secretary may require information about therapeutic goods
type: Concept
realized by: sec-31ba-ss-3
part of: 31BA Secretary may require information about therapeutic goods
note: Secretary may require information about therapeutic goods in specified ways.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.254
asserts: therapeutic-goods-act-1989-sec-31ba-ss-3-norm

therapeutic-goods-act-1989-sec-31ba-ss-3-norm
type: Permission
modality: Deontic
part of: 31BA(3) Secretary may require information about therapeutic goods
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

31C Criminal offences for failing to give information or documents
type: Concept
realized by: sec-31c
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.254

31C(1) Criminal offences for failing to give information or documents
type: Concept
realized by: sec-31c-ss-1
part of: 31C Criminal offences for failing to give information or documents
note: Failure to comply with a notice results in an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.254
asserts: therapeutic-goods-act-1989-sec-31c-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-31c-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-31c-ss-1-norm
type: Obligation
modality: Deontic
part of: 31C(1) Criminal offences for failing to give information or documents
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31c-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: obligation
logic summary: Obligation to comply with a notice.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

31C(2) Criminal offences for failing to give information or documents
type: Concept
realized by: sec-31c-ss-2
part of: 31C Criminal offences for failing to give information or documents
note: Failure to comply with a notice results in an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.254
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

therapeutic-goods-act-1989-sec-31c-ss-2-norm
type: Prohibition
modality: Deontic
part of: 31C(2) Criminal offences for failing to give information or documents
borne by: NaturalPerson
scope note: borne by: NaturalPerson
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31c-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits failing to comply with a notice.
premise text: (2) A person commits an offence if...
conclusion text: ...Penalty: 100 penalty units.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31c-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Overlaps
logic summary: Indicates that failing to comply with a notice overlaps with committing an offence.
premise text: (2) A person commits an offence if...
conclusion text: ...Penalty: 100 penalty units.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31c-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Repeats
logic summary: Indicates that failing to comply with a notice repeats the action of committing an offence.
premise text: (2) A person commits an offence if...
conclusion text: ...Penalty: 100 penalty units.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31c-ss-2-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Diffuses
logic summary: Diffuses the information that failing to comply with a notice results in an offence.
premise text: (2) A person commits an offence if...
conclusion text: ...Penalty: 100 penalty units.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31c-ss-2-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: Recognizes
logic summary: Recognizes the pattern of failing to comply with a notice resulting in an offence.
premise text: (2) A person commits an offence if...
conclusion text: ...Penalty: 100 penalty units.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

31C(3) Criminal offences for failing to give information or documents
type: Concept
realized by: sec-31c-ss-3
part of: 31C Criminal offences for failing to give information or documents
note: Duty to provide information or documents
description: true
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.254
asserts: therapeutic-goods-act-1989-sec-31c-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-31c-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-31c-ss-3-norm
type: Obligation
modality: Deontic
part of: 31C(3) Criminal offences for failing to give information or documents
borne by: NaturalPerson
scope note: borne by: NaturalPerson
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31c-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: obligation
logic summary: Obligation to provide information or documents
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

31D False or misleading information
type: Concept
realized by: sec-31d
has part: 31D(1) False or misleading information
has part: 31D(1A) False or misleading information
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.255

31D(1) False or misleading information
type: Concept
realized by: sec-31d-ss-1
part of: 31D False or misleading information
note: Giving false or misleading information in compliance with a notice is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.255
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

therapeutic-goods-act-1989-sec-31d-ss-1-norm
type: Prohibition
modality: Deontic
part of: 31D(1) False or misleading information
borne by: NaturalPerson
scope note: borne by: NaturalPerson
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits giving false or misleading information in compliance with a notice.
premise text: The person gives information to the Secretary in compliance or purported compliance with the notice.
conclusion text: The person commits an offence if they do so knowing that the information is false or misleading.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes a duty on the person to not give false or misleading information in compliance with a notice.
premise text: The person does so knowing that the information is false or misleading.
conclusion text: The person commits an offence if they do so.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits giving false or misleading information in purported compliance with a notice.
premise text: The person gives information to the Secretary in purported compliance with the notice.
conclusion text: The person commits an offence if they do so knowing that the information is false or misleading.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes a duty on the person to not give false or misleading information in purported compliance with a notice.
premise text: The person gives information to the Secretary in purported compliance with the notice.
conclusion text: The person commits an offence if they do so knowing that the information is false or misleading.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

31D(1A) False or misleading information
type: Concept
realized by: sec-31d-ss-1a
part of: 31D False or misleading information
note: Giving false or misleading information after receiving a notice is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.255
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

therapeutic-goods-act-1989-sec-31d-ss-1a-norm
type: Prohibition
modality: Deontic
part of: 31D(1A) False or misleading information
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits giving false or misleading information after receiving a notice.
premise text: The person gives information to the Secretary in compliance or purported compliance with the notice.
conclusion text: The person commits an offence if the information is false or misleading.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes an obligation on the person to give accurate information after receiving a notice.
premise text: The person is required to give information in compliance with the notice.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31d-ss-1a-logic-ltl-3
type: LogicApplication
modality: LTL
operator: TemporalInterval
logic summary: Specifies the temporal interval for giving false or misleading information as after receiving a notice.
premise text: The person gives information to the Secretary in compliance or purported compliance with the notice.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits omitting any matter or thing without which the information is misleading.
premise text: The information omits any matter or thing without which it is misleading.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes an obligation on the person to provide accurate information that includes all necessary matters and things.
premise text: The information must include all matter and thing without which it is misleading.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

31E False or misleading documents
type: Concept
realized by: sec-31e
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.256

31E(1) False or misleading documents
type: Concept
realized by: sec-31e-ss-1
part of: 31E False or misleading documents
note: Producing false or misleading documents is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.256
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

therapeutic-goods-act-1989-sec-31e-ss-1-norm
type: Prohibition
modality: Deontic
part of: 31E(1) False or misleading documents
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31e-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits producing false or misleading documents.
premise text: The document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA.
conclusion text: The person commits an offence if the document is produced knowing that it is false or misleading.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31e-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Defines a temporal interval for producing documents.
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.
conclusion text: The temporal interval for producing documents starts at (1)
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31e-ss-1-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Recurring Trace
logic summary: Defines a recurring trace of document production.
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.
conclusion text: The recurring trace of document production starts at (1)
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31e-ss-1-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Diffuse
logic summary: Diffuses the prohibition to all agents.
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.
conclusion text: The prohibition diffuses to all agents who produce documents.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31e-ss-1-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: Classify
logic summary: Classifies the document as true or false/misleading using AI.
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.
conclusion text: The document is classified as true or false/misleading using AI.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

31E(1A) False or misleading documents
type: Concept
realized by: sec-31e-ss-1a
part of: 31E False or misleading documents
note: Producing false or misleading documents in compliance with a notice is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.256
asserts: therapeutic-goods-act-1989-sec-31e-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-31e-ss-1a-logic-deontic-1

therapeutic-goods-act-1989-sec-31e-ss-1a-norm
type: Prohibition
modality: Deontic
part of: 31E(1A) False or misleading documents
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31e-ss-1a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits producing false or misleading documents in compliance with a notice.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

31E(1B) False or misleading documents
type: Concept
realized by: sec-31e-ss-1b
part of: 31E False or misleading documents
note: Offence of strict liability for false or misleading documents
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.256
asserts: therapeutic-goods-act-1989-sec-31e-ss-1b-norm
asserts: therapeutic-goods-act-1989-sec-31e-ss-1b-logic-deontic-1

therapeutic-goods-act-1989-sec-31e-ss-1b-norm
type: Prohibition
modality: Deontic
part of: 31E(1B) False or misleading documents
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31e-ss-1b-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits offence of strict liability
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

31E(2) False or misleading documents
type: Concept
realized by: sec-31e-ss-2
part of: 31E False or misleading documents
note: Defendant bears evidential burden in relation to the matter.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.256
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

therapeutic-goods-act-1989-sec-31e-ss-2-norm
type: Obligation
modality: Deontic
part of: 31E(2) False or misleading documents
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31e-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: obligation
logic summary: Defendant bears evidential burden.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-31e-ss-2-logic-epistemic-2
type: LogicApplication
modality: Epistemic
operator: evidential burden
logic summary: Defendant has a duty to provide evidence.
execution surface: modalities::epistemic
confidence: 1.0000
curation status: Proposed

31E(3) False or misleading documents
type: Concept
realized by: sec-31e-ss-3
part of: 31E False or misleading documents
note: Exemption from subsection (1) or (1A) for documents accompanied by a written statement
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.256
asserts: therapeutic-goods-act-1989-sec-31e-ss-3-norm

31F Self-incrimination
type: Concept
realized by: sec-31f
has part: 31F(1) Self-incrimination
has part: 31F(2) Self-incrimination
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.257

31F(1) Self-incrimination
type: Concept
realized by: sec-31f-ss-1
part of: 31F Self-incrimination
note: No excuse for giving information under certain notices
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.257
asserts: therapeutic-goods-act-1989-sec-31f-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-31f-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-31f-ss-1-norm
type: Obligation
modality: Deontic
part of: 31F(1) Self-incrimination
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31f-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Obligation to provide information
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

31F(2) Self-incrimination
type: Concept
realized by: sec-31f-ss-2
part of: 31F Self-incrimination
note: Protection against self-incrimination in certain cases
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.257
asserts: therapeutic-goods-act-1989-sec-31f-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-31f-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-31f-ss-2-norm
type: Prohibition
modality: Deontic
part of: 31F(2) Self-incrimination
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-31f-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits admissibility of self-incrimination evidence in certain cases
premise text: None
conclusion text: None
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32 What this Part is about
type: Concept
realized by: sec-32
note: Regulates biologicals by providing a process for inclusion in the Register and enforcement through criminal offences and civil penalties.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.259
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

therapeutic-goods-act-1989-sec-32-norm
type: Obligation
modality: Deontic
part of: 32 What this Part is about
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: regulates
logic summary: Establishes a regulatory framework for biologicals.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32-logic-linearlogic-2
type: LogicApplication
modality: LinearLogic
operator: provides
logic summary: Establishes administrative processes for regulating biologicals.
execution surface: modalities::linear
confidence: 1.0000
curation status: Proposed

32A Meaning of biological
type: Concept
realized by: sec-32a
note: Defines what constitutes a biological.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.259
asserts: therapeutic-goods-act-1989-sec-32a-norm

32AA Biological classes
type: Concept
realized by: sec-32aa
note: Regulations may prescribe different classes of biologicals.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.260
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

therapeutic-goods-act-1989-sec-32aa-norm
type: Obligation
modality: Deontic
part of: 32AA Biological classes
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32aa-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: mayPrescribe
logic summary: May prescribe different classes of biologicals.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32aa-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: classify
logic summary: Classify biologicals into different classes.
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

32AB When biologicals are separate and distinct from other
type: Concept
realized by: sec-32ab
has part: 32AB(1) When biologicals are separate and distinct from other
has part: 32AB(2) When biologicals are separate and distinct from other
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.260

32AB(1) When biologicals are separate and distinct from other
type: Concept
realized by: sec-32ab-ss-1
part of: 32AB When biologicals are separate and distinct from other
note: Regulations may prescribe circumstances for separate and distinct biologicals.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.260
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

therapeutic-goods-act-1989-sec-32ab-ss-1-norm
type: Obligation
modality: Deontic
part of: 32AB(1) When biologicals are separate and distinct from other
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ab-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: mayPrescribe
logic summary: Regulations may prescribe circumstances.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ab-ss-1-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: classify
logic summary: Classify biologicals by specified class.
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

32AB(2) When biologicals are separate and distinct from other
type: Concept
realized by: sec-32ab-ss-2
part of: 32AB When biologicals are separate and distinct from other
note: Different provision for different classes of biologicals
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.260
asserts: therapeutic-goods-act-1989-sec-32ab-ss-2-norm

therapeutic-goods-act-1989-sec-32ab-ss-2-norm
type: Obligation
modality: Deontic
part of: 32AB(2) When biologicals are separate and distinct from other
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32B What this Division is about
type: Concept
realized by: sec-32b
note: Defines criminal offences and civil penalties relating to biologicals.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.262
asserts: therapeutic-goods-act-1989-sec-32b-norm
asserts: therapeutic-goods-act-1989-sec-32b-logic-deontic-1

therapeutic-goods-act-1989-sec-32b-norm
type: Obligation
modality: Deontic
part of: 32B What this Division is about
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32b-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: is
logic summary: Identifies the subject of the obligation.
conclusion text: State
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BA Criminal offences for importing a biological
type: Concept
realized by: sec-32ba
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.262

32BA(1) Criminal offences for importing a biological
type: Concept
realized by: sec-32ba-ss-1
part of: 32BA Criminal offences for importing a biological
note: Importing a biological for use in humans is prohibited unless certain exemptions apply.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.262
asserts: therapeutic-goods-act-1989-sec-32ba-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32ba-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32ba-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32BA(1) Criminal offences for importing a biological
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ba-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BA(4) Criminal offences for importing a biological
type: Concept
realized by: sec-32ba-ss-4
part of: 32BA Criminal offences for importing a biological
note: Importing a biological for use in humans is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.262
asserts: therapeutic-goods-act-1989-sec-32ba-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32ba-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32ba-ss-4-norm
type: Prohibition
modality: Deontic
part of: 32BA(4) Criminal offences for importing a biological
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ba-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits the importation of a biological for use in humans.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BA(4A) Criminal offences for importing a biological
type: Concept
realized by: sec-32ba-ss-4a
part of: 32BA Criminal offences for importing a biological
note: Importing a biological for use in humans without registration is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.262
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

therapeutic-goods-act-1989-sec-32ba-ss-4a-norm
type: Prohibition
modality: Deontic
part of: 32BA(4A) Criminal offences for importing a biological
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits importing a biological for use in humans without registration.
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:
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Defines the temporal interval during which importing a biological for use in humans without registration is an offence.
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:
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Recurring Trace
logic summary: Defines a recurring trace of importing a biological for use in humans without registration as an offence.
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:
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-cogai-4
type: LogicApplication
modality: CogAI
operator: Knowledge Representation
logic summary: Represents importing a biological for use in humans without registration as an offence using 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:
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-shacl-5
type: LogicApplication
modality: SHACL
operator: Schema Definition
logic summary: Defines a schema definition for importing a biological for use in humans without registration as an offence.
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:
execution surface: modalities::logic::shacl
confidence: 1.0000
curation status: Proposed

32BB Criminal offences for exporting a biological
type: Concept
realized by: sec-32bb
has part: 32BB(1) Criminal offences for exporting a biological
has part: 32BB(4) Criminal offences for exporting a biological
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.265

32BB(1) Criminal offences for exporting a biological
type: Concept
realized by: sec-32bb-ss-1
part of: 32BB Criminal offences for exporting a biological
note: Exporting a biological for use in humans is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.265
asserts: therapeutic-goods-act-1989-sec-32bb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32bb-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32bb-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32BB(1) Criminal offences for exporting a biological
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bb-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits the export of a biological for use in humans.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BB(4) Criminal offences for exporting a biological
type: Concept
realized by: sec-32bb-ss-4
part of: 32BB Criminal offences for exporting a biological
note: Exporting a biological for use in humans is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.265
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

therapeutic-goods-act-1989-sec-32bb-ss-4-norm
type: Prohibition
modality: Deontic
part of: 32BB(4) Criminal offences for exporting a biological
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bb-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits exporting a biological for use in humans.
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:
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32bb-ss-4-logic-linearlogic-2
type: LogicApplication
modality: LinearLogic
operator: Prohibit
logic summary: Prohibits exporting a biological for use in humans.
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:
execution surface: modalities::linear
confidence: 1.0000
curation status: Proposed

32BC Criminal offences for manufacturing a biological
type: Concept
realized by: sec-32bc
note: Manufacturing a biological without proper authorization is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.267
asserts: therapeutic-goods-act-1989-sec-32bc-norm
asserts: therapeutic-goods-act-1989-sec-32bc-logic-deontic-1

therapeutic-goods-act-1989-sec-32bc-norm
type: Prohibition
modality: Deontic
part of: 32BC Criminal offences for manufacturing a biological
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bc-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits the manufacture of biologicals without authorization.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BD Criminal offences for supplying a biological
type: Concept
realized by: sec-32bd
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.270

32BD(1) Criminal offences for supplying a biological
type: Concept
realized by: sec-32bd-ss-1
part of: 32BD Criminal offences for supplying a biological
note: Supplying a biological for use in humans is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.270
asserts: therapeutic-goods-act-1989-sec-32bd-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32bd-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32bd-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32BD(1) Criminal offences for supplying a biological
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bd-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits supplying a biological for use in humans.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BD(4) Criminal offences for supplying a biological
type: Concept
realized by: sec-32bd-ss-4
part of: 32BD Criminal offences for supplying a biological
note: Supplying a biological for use in humans is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.270
asserts: therapeutic-goods-act-1989-sec-32bd-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32bd-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32bd-ss-4-norm
type: Prohibition
modality: Deontic
part of: 32BD(4) Criminal offences for supplying a biological
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bd-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits supplying a biological for use in humans.
premise text: (4) A person commits an offence if...
conclusion text: The supply of a biological for use in humans is prohibited.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BD(4A) Criminal offences for supplying a biological
type: Concept
realized by: sec-32bd-ss-4a
part of: 32BD Criminal offences for supplying a biological
note: Supplying a biological for use in humans is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.270
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

therapeutic-goods-act-1989-sec-32bd-ss-4a-norm
type: Prohibition
modality: Deontic
part of: 32BD(4A) Criminal offences for supplying a biological
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits supplying a biological for use in humans.
premise text: (4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-ltl-2
type: LogicApplication
modality: LTL
operator: Trace
logic summary: Traces supplying a biological for use in humans to an offence.
premise text: (4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: Between
logic summary: Places supplying a biological for use in humans between committing an offence.
premise text: (4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Diffuse
logic summary: Diffuses the prohibition of supplying a biological for use in humans.
premise text: (4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

32BE Notice required to adduce evidence in support of exception to
type: Concept
realized by: sec-32be
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.273

32BE(1) Notice required to adduce evidence in support of exception to
type: Concept
realized by: sec-32be-ss-1
part of: 32BE Notice required to adduce evidence in support of exception to
note: Defendant must be informed of requirements and given a copy of the section.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.273
asserts: therapeutic-goods-act-1989-sec-32be-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32be-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32be-ss-1-norm
type: Obligation
modality: Deontic
part of: 32BE(1) Notice required to adduce evidence in support of exception to
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32be-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Defendant must be informed.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BE(2) Notice required to adduce evidence in support of exception to
type: Concept
realized by: sec-32be-ss-2
part of: 32BE Notice required to adduce evidence in support of exception to
note: No evidence can be adduced without notice of particulars of the exception.
description: Notice of particulars of the exception
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.273
asserts: therapeutic-goods-act-1989-sec-32be-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32be-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32be-ss-2-norm
type: Prohibition
modality: Deontic
part of: 32BE(2) Notice required to adduce evidence in support of exception to
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32be-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BE(3) Notice required to adduce evidence in support of exception to
type: Concept
realized by: sec-32be-ss-3
part of: 32BE Notice required to adduce evidence in support of exception to
note: Defendant cannot call another person to give evidence without leave of the court.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.273
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

therapeutic-goods-act-1989-sec-32be-ss-3-norm
type: Prohibition
modality: Deontic
part of: 32BE(3) Notice required to adduce evidence in support of exception to
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32be-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition on calling another person to give evidence.
premise text: (3) A defendant must not, without leave of the court...
conclusion text: ...call any other person to give evidence in support of the exception unless...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32be-ss-3-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: Classify
logic summary: Classification of individuals based on notice and address information.
premise text: (a) the notice under subsection (2) includes the name and address of the person or...
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;
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32be-ss-3-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: Temporal relation
logic summary: Temporal relation between notice and address information.
premise text: (b) if the name or the address is not included in the notice—the court is satisfied that...
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;
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32be-ss-3-logic-ltl-4
type: LogicApplication
modality: LTL
operator: Recurring trace
logic summary: Recurring trace of defendant's actions.
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...
conclusion text: ...the name or address; and
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32be-ss-3-logic-diffusion-5
type: LogicApplication
modality: Diffusion
operator: Information dissemination
logic summary: Dissemination of information about defendant's actions.
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...
conclusion text: ...to ascertain the name or address;
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32be-ss-3-logic-cogai-6
type: LogicApplication
modality: CogAI
operator: Knowledge representation
logic summary: Knowledge representation of defendant's actions.
premise text: (a) the notice under subsection (2) includes the name and address of the person or...
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;
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

32BF Civil penalties for importing, exporting, manufacturing or
type: Concept
realized by: sec-32bf
has part: 32BF(1) Civil penalties for importing, exporting, manufacturing or
has part: 32BF(2) Civil penalties for importing, exporting, manufacturing or
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.275

32BF(1) Civil penalties for importing, exporting, manufacturing or
type: Concept
realized by: sec-32bf-ss-1
part of: 32BF Civil penalties for importing, exporting, manufacturing or
note: Importing, exporting, manufacturing biologicals for use in humans without approval is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.275
asserts: therapeutic-goods-act-1989-sec-32bf-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32bf-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32bf-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32BF(1) Civil penalties for importing, exporting, manufacturing or
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bf-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of importing, exporting, manufacturing biologicals for use in humans.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BF(2) Civil penalties for importing, exporting, manufacturing or
type: Concept
realized by: sec-32bf-ss-2
part of: 32BF Civil penalties for importing, exporting, manufacturing or
note: Exporting biologicals for human use without registration is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.275
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

therapeutic-goods-act-1989-sec-32bf-ss-2-norm
type: Prohibition
modality: Deontic
part of: 32BF(2) Civil penalties for importing, exporting, manufacturing or
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bf-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of exporting biologicals for human use without registration.
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:
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32bf-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Temporal interval between export and registration.
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:
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32bf-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Recurring Trace
logic summary: Recurring trace of unregistered exports.
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:
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32bf-ss-2-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Diffusion
logic summary: Diffusion of prohibited knowledge.
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:
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32bf-ss-2-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: Knowledge Graph
logic summary: Knowledge graph representation of prohibited knowledge.
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:
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

32BG Criminal offences and civil penalty relating to a failure to
type: Concept
realized by: sec-32bg
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.279

32BG(1) Criminal offences and civil penalty relating to a failure to
type: Concept
realized by: sec-32bg-ss-1
part of: 32BG Criminal offences and civil penalty relating to a failure to
note: Importing, exporting, manufacturing, or supplying a biological for use in humans without proper notification is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.279
asserts: therapeutic-goods-act-1989-sec-32bg-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32bg-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32bg-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32BG(1) Criminal offences and civil penalty relating to a failure to
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bg-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BG(1A) Criminal offences and civil penalty relating to a failure to
type: Concept
realized by: sec-32bg-ss-1a
part of: 32BG Criminal offences and civil penalty relating to a failure to
note: Importing or exporting biologicals for use in humans is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.279
asserts: therapeutic-goods-act-1989-sec-32bg-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-32bg-ss-1a-logic-deontic-1

therapeutic-goods-act-1989-sec-32bg-ss-1a-norm
type: Prohibition
modality: Deontic
part of: 32BG(1A) Criminal offences and civil penalty relating to a failure to
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bg-ss-1a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits the action.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BH Criminal offence relating to wholesale supply
type: Concept
realized by: sec-32bh
note: Supplying biologicals for use in humans without proper exemption or approval is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.281
asserts: therapeutic-goods-act-1989-sec-32bh-norm
asserts: therapeutic-goods-act-1989-sec-32bh-logic-deontic-1

therapeutic-goods-act-1989-sec-32bh-norm
type: Prohibition
modality: Deontic
part of: 32BH Criminal offence relating to wholesale supply
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bh-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits supplying biologicals for use in humans without proper exemption or approval.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BI Criminal offence for using a biological not included in the
type: Concept
realized by: sec-32bi
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.282

32BI(1) Criminal offence for using a biological not included in the
type: Concept
realized by: sec-32bi-ss-1
part of: 32BI Criminal offence for using a biological not included in the
note: Using a biological without proper authorization is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.282
asserts: therapeutic-goods-act-1989-sec-32bi-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32bi-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32bi-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32BI(1) Criminal offence for using a biological not included in the
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bi-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BI(4) Criminal offence for using a biological not included in the
type: Concept
realized by: sec-32bi-ss-4
part of: 32BI Criminal offence for using a biological not included in the
note: Using a biological not included in the Register for certain purposes is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.282
asserts: therapeutic-goods-act-1989-sec-32bi-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32bi-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32bi-ss-4-norm
type: Prohibition
modality: Deontic
part of: 32BI(4) Criminal offence for using a biological not included in the
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bi-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition
premise text: The biological is used in the treatment of another person or solely for experimental purposes in humans.
conclusion text: An offence has been committed.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BJ General criminal offences relating to this Part
type: Concept
realized by: sec-32bj
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.284

32BJ(1) General criminal offences relating to this Part
type: Concept
realized by: sec-32bj-ss-1
part of: 32BJ General criminal offences relating to this Part
note: Setting out false biological numbers on containers or labels is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.284
asserts: therapeutic-goods-act-1989-sec-32bj-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32bj-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32bj-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of false biological numbers
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BJ(2) General criminal offences relating to this Part
type: Concept
realized by: sec-32bj-ss-2
part of: 32BJ General criminal offences relating to this Part
note: Defines what constitutes a number for the purposes of subsection (1)
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.284
asserts: therapeutic-goods-act-1989-sec-32bj-ss-2-norm

therapeutic-goods-act-1989-sec-32bj-ss-2-norm
type: Obligation
modality: Deontic
part of: 32BJ(2) General criminal offences relating to this Part
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32BJ(2A) General criminal offences relating to this Part
type: Concept
realized by: sec-32bj-ss-2a
part of: 32BJ General criminal offences relating to this Part
note: Advertising a biological for an indication that is not accepted in relation to its inclusion in the Register is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.284
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

therapeutic-goods-act-1989-sec-32bj-ss-2a-norm
type: Prohibition
modality: Deontic
part of: 32BJ(2A) General criminal offences relating to this Part
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bj-ss-2a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of advertising a biological for an indication that is not accepted in relation to its inclusion in the Register.
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
conclusion text: Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32bj-ss-2a-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: Classify
logic summary: Classification of the advertisement as a prohibited act.
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
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.
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

32BJ(2B) General criminal offences relating to this Part
type: Concept
realized by: sec-32bj-ss-2b
part of: 32BJ General criminal offences relating to this Part
note: Advertising a biological for an indication without proper inclusion in the Register is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.284
asserts: therapeutic-goods-act-1989-sec-32bj-ss-2b-norm
asserts: therapeutic-goods-act-1989-sec-32bj-ss-2b-logic-deontic-1

therapeutic-goods-act-1989-sec-32bj-ss-2b-norm
type: Prohibition
modality: Deontic
part of: 32BJ(2B) General criminal offences relating to this Part
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bj-ss-2b-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of advertising a biological for an indication without proper inclusion in the Register.
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.
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BK Civil penalty for making misrepresentations about biologicals
type: Concept
realized by: sec-32bk
has part: 32BK(1) Civil penalty for making misrepresentations about biologicals
has part: 32BK(2) Civil penalty for making misrepresentations about biologicals
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.286

32BK(1) Civil penalty for making misrepresentations about biologicals
type: Concept
realized by: sec-32bk-ss-1
part of: 32BK Civil penalty for making misrepresentations about biologicals
note: Making false or misleading representations about biologicals is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.286
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

therapeutic-goods-act-1989-sec-32bk-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32BK(1) Civil penalty for making misrepresentations about biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bk-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits making false or misleading representations about biologicals.
premise text: (a) the person makes a representation of a kind referred to in subsection (2); and (b) the representation is false or misleading.
conclusion text: (1) A person contravenes this section if:...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32bk-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Defines a temporal interval for the prohibition.
premise text: (1) A person contravenes this section if:
conclusion text: ...and (b) for an individual—5,000 penalty units; and
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32bk-ss-1-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Temporal Interval
logic summary: Defines a temporal interval for the prohibition.
premise text: (1) A person contravenes this section if:
conclusion text: ...and (b) for a body corporate—50,000 penalty units.
execution surface: modalities::temporal_ltl
confidence: 0.5000
curation status: Proposed

32BK(2) Civil penalty for making misrepresentations about biologicals
type: Concept
realized by: sec-32bk-ss-2
part of: 32BK Civil penalty for making misrepresentations about biologicals
note: Making misrepresentations about biologicals is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.286
asserts: therapeutic-goods-act-1989-sec-32bk-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32bk-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32bk-ss-2-norm
type: Prohibition
modality: Deontic
part of: 32BK(2) Civil penalty for making misrepresentations about biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bk-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of making misrepresentations about biologicals.
premise text: Subsection (1) applies to the following representations:
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32BL Civil penalty for advertising biological for an indication
type: Concept
realized by: sec-32bl
note: Advertising biological for an indication without proper registration is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.287
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

therapeutic-goods-act-1989-sec-32bl-norm
type: Prohibition
modality: Deontic
part of: 32BL Civil penalty for advertising biological for an indication
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32bl-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits advertising biological for an indication without proper registration.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32bl-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: Classify
logic summary: Classifies advertisements as prohibited if they include unregistered biologicals.
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

32C What this Division is about
type: Concept
realized by: sec-32c
note: Exemptions of biologicals under regulations, emergencies, special and experimental uses, and substitutes unavailable.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.288
asserts: therapeutic-goods-act-1989-sec-32c-norm

32CA Exempt biologicals
type: Concept
realized by: sec-32ca
has part: 32CA(1) Exempt biologicals
has part: 32CA(2) Exempt biologicals
has part: 32CA(3) Exempt biologicals
has part: 32CA(5) Exempt biologicals
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.288

32CA(1) Exempt biologicals
type: Concept
realized by: sec-32ca-ss-1
part of: 32CA Exempt biologicals
note: Exempts specified persons from Division 4 operation in relation to specified biologicals.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.288
asserts: therapeutic-goods-act-1989-sec-32ca-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32ca-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32ca-ss-1-norm
type: Obligation
modality: Deontic
part of: 32CA(1) Exempt biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ca-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: exemption
logic summary: Exempts
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CA(2) Exempt biologicals
type: Concept
realized by: sec-32ca-ss-2
part of: 32CA Exempt biologicals
note: Exempt biologicals from Division 4 operation.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.288
asserts: therapeutic-goods-act-1989-sec-32ca-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32ca-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32ca-ss-2-norm
type: Obligation
modality: Deontic
part of: 32CA(2) Exempt biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ca-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: exemption
logic summary: Regulations may exempt specified biologicals.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CA(3) Exempt biologicals
type: Concept
realized by: sec-32ca-ss-3
part of: 32CA Exempt biologicals
note: Exemptions may be subject to conditions prescribed in regulations.
references: sec-32CP
references: sec-32CQ
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.288
asserts: therapeutic-goods-act-1989-sec-32ca-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32ca-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32ca-ss-3-norm
type: Obligation
modality: Deontic
part of: 32CA(3) Exempt biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ca-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to exempt biologicals with conditions.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CA(5) Exempt biologicals
type: Concept
realized by: sec-32ca-ss-5
part of: 32CA Exempt biologicals
note: Revocation of exemption takes effect after specified day
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.288
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

therapeutic-goods-act-1989-sec-32ca-ss-5-norm
type: Obligation
modality: Deontic
part of: 32CA(5) Exempt biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ca-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: takesEffect
logic summary: Obligation to revoke exemption on specified day
premise text: (5) If the regulations revoke an exemption, the revocation takes effect...
conclusion text: ...than 28 days after the day on which the regulations revoking the exemption take effect.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ca-ss-5-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: meetsBefore
logic summary: Temporal relationship between revocation and commencement of revocation
premise text: (5) If the regulations revoke an exemption, the revocation takes effect...
conclusion text: ...than 28 days after the day on which the regulations revoking the exemption take effect.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ca-ss-5-logic-ltl-3
type: LogicApplication
modality: LTL
operator: holdsForAll
logic summary: Temporal relationship between revocation and commencement of revocation
premise text: (5) If the regulations revoke an exemption, the revocation takes effect...
conclusion text: ...than 28 days after the day on which the regulations revoking the exemption take effect.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ca-ss-5-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: diffusesTo
logic summary: Revocation of exemption diffuses to affected parties
premise text: (5) If the regulations revoke an exemption, the revocation takes effect...
conclusion text: ...than 28 days after the day on which the regulations revoking the exemption take effect.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ca-ss-5-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: recognizes
logic summary: Revocation of exemption recognized by regulatory agency
premise text: (5) If the regulations revoke an exemption, the revocation takes effect...
conclusion text: ...than 28 days after the day on which the regulations revoking the exemption take effect.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

32CB Minister may make exemptions
type: Concept
realized by: sec-32cb
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.289

32CB(1) Minister may make exemptions
type: Concept
realized by: sec-32cb-ss-1
part of: 32CB Minister may make exemptions
note: Minister may exempt specified biologicals from Division 4 operation.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.289
asserts: therapeutic-goods-act-1989-sec-32cb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32cb-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32cb-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to exempt
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CB(1A) Minister may make exemptions
type: Concept
realized by: sec-32cb-ss-1a
part of: 32CB Minister may make exemptions
note: Minister must make exemption under certain conditions.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.289
asserts: therapeutic-goods-act-1989-sec-32cb-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-32cb-ss-1a-logic-deontic-1

therapeutic-goods-act-1989-sec-32cb-ss-1a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to make exemption
premise text: Minister is satisfied of the matter in subsection (2) or (2A)
conclusion text: Exemption must be made
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

32CB(2) Minister may make exemptions
type: Concept
realized by: sec-32cb-ss-2
part of: 32CB Minister may make exemptions
note: Minister may make exemptions in national interest.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.289
asserts: therapeutic-goods-act-1989-sec-32cb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32cb-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32cb-ss-2-norm
type: Permission
modality: Deontic
part of: 32CB(2) Minister may make exemptions
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cb-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to make exemptions.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CB(2A) Minister may make exemptions
type: Concept
realized by: sec-32cb-ss-2a
part of: 32CB Minister may make exemptions
note: Minister may make exemptions under certain conditions.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.289
asserts: therapeutic-goods-act-1989-sec-32cb-ss-2a-norm

therapeutic-goods-act-1989-sec-32cb-ss-2a-norm
type: Permission
modality: Deontic
part of: 32CB(2A) Minister may make exemptions
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32CC Conditions of exemptions
type: Concept
realized by: sec-32cc
note: Conditions for exemptions under section 32CB
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.290
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

therapeutic-goods-act-1989-sec-32cc-norm
type: Obligation
modality: Deontic
part of: 32CC Conditions of exemptions
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cc-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Conditions for exemptions
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cc-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: ClassHierarchy
logic summary: Exemptions under section 32CB are subject to conditions
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

32CD Variation or revocation of exemption
type: Concept
realized by: sec-32cd
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.291

32CD(1) Variation or revocation of exemption
type: Concept
realized by: sec-32cd-ss-1
part of: 32CD Variation or revocation of exemption
note: Variation of exemption by Minister
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.291
asserts: therapeutic-goods-act-1989-sec-32cd-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32cd-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32cd-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Granting permission
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CD(2) Variation or revocation of exemption
type: Concept
realized by: sec-32cd-ss-2
part of: 32CD Variation or revocation of exemption
note: Revocation of exemption by Minister
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.291
asserts: therapeutic-goods-act-1989-sec-32cd-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32cd-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32cd-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to revoke exemption
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CD(3) Variation or revocation of exemption
type: Concept
realized by: sec-32cd-ss-3
part of: 32CD Variation or revocation of exemption
note: The Minister may vary or revoke the conditions of an exemption made under section 32CB.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.291
asserts: therapeutic-goods-act-1989-sec-32cd-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32cd-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32cd-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Expresses permission or obligation.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CE Informing persons of exemption etc.
type: Concept
realized by: sec-32ce
note: Must inform persons of exemption under section 32CB
description: copy of exemption and variation/revocation
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.292
asserts: therapeutic-goods-act-1989-sec-32ce-norm
asserts: therapeutic-goods-act-1989-sec-32ce-logic-deontic-1

therapeutic-goods-act-1989-sec-32ce-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to inform
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CF Notification and tabling
type: Concept
realized by: sec-32cf
has part: 32CF(1) Notification and tabling
has part: 32CF(2) Notification and tabling
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.292

32CF(1) Notification and tabling
type: Concept
realized by: sec-32cf-ss-1
part of: 32CF Notification and tabling
note: Publish notice in Gazette within 7 days after exemption, variation or revocation is made.
description: Notice setting out particulars of exemption, variation or revocation
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.292
asserts: therapeutic-goods-act-1989-sec-32cf-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32cf-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32cf-ss-1-norm
type: Obligation
modality: Deontic
part of: 32CF(1) Notification and tabling
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cf-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must publish notice in Gazette within 7 days
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CF(2) Notification and tabling
type: Concept
realized by: sec-32cf-ss-2
part of: 32CF Notification and tabling
note: Notification and tabling of exemptions, variations, or revocations made under section 32CB.
description: document setting out particulars
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.292
asserts: therapeutic-goods-act-1989-sec-32cf-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32cf-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32cf-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to notify and table
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CG Disposal of unused biologicals
type: Concept
realized by: sec-32cg
note: This section applies to a biological if an exemption under section 32CB ceases to have effect.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.293
asserts: therapeutic-goods-act-1989-sec-32cg-norm

32CJ Criminal offences and civil penalty for biologicals not
type: Concept
realized by: sec-32cj
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.294

32CJ(1) Criminal offences and civil penalty for biologicals not
type: Concept
realized by: sec-32cj-ss-1
part of: 32CJ Criminal offences and civil penalty for biologicals not
note: Supplying non-conforming biologicals is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.294
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

therapeutic-goods-act-1989-sec-32cj-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32CJ(1) Criminal offences and civil penalty for biologicals not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition
premise text: (a) a biological is exempt under section 32CB; and (b) a person supplies a batch of the biologicals;
conclusion text: Supplying non-conforming biologicals is prohibited.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-1-logic-linearlogic-2
type: LogicApplication
modality: LinearLogic
operator: Imply
logic summary: Implication from exemption and supply
premise text: (a) a biological is exempt under section 32CB; and (b) a person supplies a batch of the biologicals;
conclusion text: Supplying non-conforming biologicals implies violation of exemption.
execution surface: modalities::linear
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-1-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: Within
logic summary: Temporal interval within supply period
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.
conclusion text: Supply period includes non-conforming biologicals.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-1-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Imply
logic summary: Implication from supply and non-compliance
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.
conclusion text: Non-compliance implies supply.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

32CJ(2) Criminal offences and civil penalty for biologicals not
type: Concept
realized by: sec-32cj-ss-2
part of: 32CJ Criminal offences and civil penalty for biologicals not
note: Require person to take steps to recall biologicals
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.294
asserts: therapeutic-goods-act-1989-sec-32cj-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32cj-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32cj-ss-2-norm
type: Obligation
modality: Deontic
part of: 32CJ(2) Criminal offences and civil penalty for biologicals not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: require
logic summary: Imposes a duty on the state
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CJ(3) Criminal offences and civil penalty for biologicals not
type: Concept
realized by: sec-32cj-ss-3
part of: 32CJ Criminal offences and civil penalty for biologicals not
note: Requirements for recalling biologicals
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.294
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

therapeutic-goods-act-1989-sec-32cj-ss-3-norm
type: Obligation
modality: Deontic
part of: 32CJ(3) Criminal offences and civil penalty for biologicals not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: requires
logic summary: Requires steps to be taken
premise text: (3) The notice may specify one or more of the following requirements:
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-3-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: within
logic summary: Steps must be taken within a reasonable period
premise text: c) a reasonable period within which the steps are to be taken.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

32CJ(4) Criminal offences and civil penalty for biologicals not
type: Concept
realized by: sec-32cj-ss-4
part of: 32CJ Criminal offences and civil penalty for biologicals not
note: Publish notice in Gazette or Department's website
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.294
asserts: therapeutic-goods-act-1989-sec-32cj-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32cj-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32cj-ss-4-norm
type: Obligation
modality: Deontic
part of: 32CJ(4) Criminal offences and civil penalty for biologicals not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must publish notice
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CJ(5) Criminal offences and civil penalty for biologicals not
type: Concept
realized by: sec-32cj-ss-5
part of: 32CJ Criminal offences and civil penalty for biologicals not
note: Notice given under subsection (2) is not a legislative instrument.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.294
asserts: therapeutic-goods-act-1989-sec-32cj-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32cj-ss-5-logic-deontic-1

therapeutic-goods-act-1989-sec-32cj-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits notice given under subsection (2) from being a legislative instrument.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CJ(6) Criminal offences and civil penalty for biologicals not
type: Concept
realized by: sec-32cj-ss-6
part of: 32CJ Criminal offences and civil penalty for biologicals not
note: Failure to comply with notice requirement results in harm or injury.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.294
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

therapeutic-goods-act-1989-sec-32cj-ss-6-norm
type: Prohibition
modality: Deontic
part of: 32CJ(6) Criminal offences and civil penalty for biologicals not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibition of non-compliance with notice requirement.
premise text: The person fails to comply with the specified requirement.
conclusion text: Harm or injury results.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Notice requirement is a duty.
premise text: The Secretary gives a notice to the person under subsection (2).
conclusion text: Compliance with notice requirement is required.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-6-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: Overlaps
logic summary: Temporal overlap between notice and harm/injury.
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.
conclusion text: Notice requirement overlaps with potential harm/injury.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Non-compliance with notice requirement is prohibited.
premise text: (c) the person fails to comply with that requirement; and
conclusion text: Harm or injury results from non-compliance.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Compliance with notice requirement is a duty.
premise text: (a) the Secretary gives a notice to the person under subsection (2); and
conclusion text: Compliance with notice requirement is required.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CJ(7) Criminal offences and civil penalty for biologicals not
type: Concept
realized by: sec-32cj-ss-7
part of: 32CJ Criminal offences and civil penalty for biologicals not
note: Failure to comply with notice requirement is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.294
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

therapeutic-goods-act-1989-sec-32cj-ss-7-norm
type: Obligation
modality: Deontic
part of: 32CJ(7) Criminal offences and civil penalty for biologicals not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-7-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Obligation to comply with notice requirement.
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.
conclusion text: Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-7-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Overlaps
logic summary: The provision has an overlapping temporal interval.
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.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-7-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Recurrently
logic summary: The provision has a recurring trace.
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.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-7-logic-argumentation-4
type: LogicApplication
modality: Argumentation
operator: Implication
logic summary: The provision implies a consequence if the person fails to comply.
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.
conclusion text: Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
execution surface: modalities::argumentation
confidence: 1.0000
curation status: Proposed

32CJ(9) Criminal offences and civil penalty for biologicals not
type: Concept
realized by: sec-32cj-ss-9
part of: 32CJ Criminal offences and civil penalty for biologicals not
note: Failure to comply with notice requirement is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.294
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

therapeutic-goods-act-1989-sec-32cj-ss-9-norm
type: Obligation
modality: Deontic
part of: 32CJ(9) Criminal offences and civil penalty for biologicals not
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-9-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: obligation
logic summary: Obligation to comply with notice requirement.
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.
conclusion text: The person commits an offence if...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-9-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: prohibition
logic summary: Prohibition on non-compliance with notice requirement.
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.
conclusion text: Penalty: 100 penalty units.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-9-logic-linearlogic-3
type: LogicApplication
modality: LinearLogic
operator: implies
logic summary: Implies penalty for non-compliance.
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.
conclusion text: Penalty: 100 penalty units.
execution surface: modalities::linear
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cj-ss-9-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: right
logic summary: Right to receive notice from Secretary.
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.
conclusion text: The person has a right to receive notice from the Secretary.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CJ(10) Criminal offences and civil penalty for biologicals not
type: Concept
realized by: sec-32cj-ss-10
part of: 32CJ Criminal offences and civil penalty for biologicals not
note: An offence against subsection (9) is an offence of strict liability.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.294
asserts: therapeutic-goods-act-1989-sec-32cj-ss-10-norm
asserts: therapeutic-goods-act-1989-sec-32cj-ss-10-logic-deontic-1

therapeutic-goods-act-1989-sec-32cj-ss-10-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: is
logic summary: Strict liability
premise text: (9)
conclusion text: (10)
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CK Approvals for importing, exporting or supplying a biological
type: Concept
realized by: sec-32ck
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.296

32CK(1) Approvals for importing, exporting or supplying a biological
type: Concept
realized by: sec-32ck-ss-1
part of: 32CK Approvals for importing, exporting or supplying a biological
note: Approval for importing, exporting or supplying a biological
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.296
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

therapeutic-goods-act-1989-sec-32ck-ss-1-norm
type: Permission
modality: Deontic
part of: 32CK(1) Approvals for importing, exporting or supplying a biological
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: grant
logic summary: Granting approval
premise text: (1) The Secretary may, by notice in writing...
conclusion text: ...a person for one or more of the following:
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ck-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Temporal relation for approval
premise text: (1)(e) for use solely for experimental purposes in humans.
conclusion text: ...for variation of an approval...
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ck-ss-1-logic-ltl-3
type: LogicApplication
modality: LTL
operator: until
logic summary: Conditional commencement
premise text: For variation of an approval...
conclusion text: ...see subsection (9A).
execution surface: modalities::temporal_ltl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: forbid
logic summary: Prohibition on experimental use
premise text: (e) for use solely for experimental purposes in humans.
conclusion text: ...or for use in the treatment of another person;
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: forbid
logic summary: Prohibition on unauthorized use
premise text: (d) for use in the treatment of another person.
conclusion text: ...or for use solely for experimental purposes in humans.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

32CK(1A) Approvals for importing, exporting or supplying a biological
type: Concept
realized by: sec-32ck-ss-1a
part of: 32CK Approvals for importing, exporting or supplying a biological
note: Approval for use of a biological must be granted only to a health practitioner.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.296
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

therapeutic-goods-act-1989-sec-32ck-ss-1a-norm
type: Prohibition
modality: Deontic
part of: 32CK(1A) Approvals for importing, exporting or supplying a biological
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits granting approval unless the person is a health practitioner.
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Restrict
logic summary: Restricts the approval to only those who are health practitioners.
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.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: Temporal Restriction
logic summary: Restricts the approval to only those who are health practitioners at the time of granting.
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.
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Enforce
logic summary: Ensures that only health practitioners are granted approval.
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.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: Justify
logic summary: Justifies the restriction on approval to only those who are health practitioners.
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.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

32CK(2) Approvals for importing, exporting or supplying a biological
type: Concept
realized by: sec-32ck-ss-2
part of: 32CK Approvals for importing, exporting or supplying a biological
note: Exemption from subsection 32CA(1) for biologicals in the Register or under subsection 32CA(2)
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.296
asserts: therapeutic-goods-act-1989-sec-32ck-ss-2-norm

32CK(3) Approvals for importing, exporting or supplying a biological
type: Concept
realized by: sec-32ck-ss-3
part of: 32CK Approvals for importing, exporting or supplying a biological
note: Application for approval must be made to the Secretary and accompanied by required information.
description: Information relating to the biological subject of the application
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.296
asserts: therapeutic-goods-act-1989-sec-32ck-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32ck-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32ck-ss-3-norm
type: Obligation
modality: Deontic
part of: 32CK(3) Approvals for importing, exporting or supplying a biological
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ck-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Application must be made
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CK(4) Approvals for importing, exporting or supplying a biological
type: Concept
realized by: sec-32ck-ss-4
part of: 32CK Approvals for importing, exporting or supplying a biological
note: Application for approval must be made to the Secretary and meet certain requirements.
description: Information relating to the biological subject of the application, prescribed evaluation fee
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.296
asserts: therapeutic-goods-act-1989-sec-32ck-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32ck-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32ck-ss-4-norm
type: Obligation
modality: Deontic
part of: 32CK(4) Approvals for importing, exporting or supplying a biological
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ck-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Application must be made
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CK(5) Approvals for importing, exporting or supplying a biological
type: Concept
realized by: sec-32ck-ss-5
part of: 32CK Approvals for importing, exporting or supplying a biological
note: Secretary must notify applicant of decision on application as soon as practicable.
description: Reasons for decision if not granting approval
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.296
asserts: therapeutic-goods-act-1989-sec-32ck-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32ck-ss-5-logic-deontic-1

therapeutic-goods-act-1989-sec-32ck-ss-5-norm
type: Obligation
modality: Deontic
part of: 32CK(5) Approvals for importing, exporting or supplying a biological
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ck-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Secretary must notify applicant
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CL Conditions of use of biological for experimental purposes in
type: Concept
realized by: sec-32cl
note: Use of biological for experimental purposes in humans subject to conditions specified in regulations.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.299
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

therapeutic-goods-act-1989-sec-32cl-norm
type: Obligation
modality: Deontic
part of: 32CL Conditions of use of biological for experimental purposes in
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cl-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes a duty on the experimenter.
premise text: The use by a person (the experimenter) for experimental purposes in humans of a biological...
conclusion text: is subject to the conditions specified in the regulations.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cl-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Overlaps
logic summary: Describes the temporal relationship between the regulation and its application.
premise text: The use by a person (the experimenter) for experimental purposes...
conclusion text: occurs during the period specified in the regulations.
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cl-logic-argumentation-3
type: LogicApplication
modality: Argumentation
operator: Implication
logic summary: Describes the relationship between the regulation and its consequences.
premise text: The use by a person (the experimenter) for experimental purposes...
conclusion text: must comply with the conditions specified in the regulations.
execution surface: modalities::argumentation
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cl-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Propagation
logic summary: Describes the spread of information about the regulation.
premise text: The use by a person (the experimenter) for experimental purposes...
conclusion text: is disseminated through the regulations.
execution surface: modalities::diffusion
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cl-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: Inference
logic summary: Describes the process of reasoning about the regulation.
premise text: The use by a person (the experimenter) for experimental purposes...
conclusion text: can be inferred from the regulations.
execution surface: sparql_library::parsers::chk_parser
confidence: 0.5000
curation status: Proposed

32CM Authorities for health practitioners
type: Concept
realized by: sec-32cm
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.300

32CM(1) Authorities for health practitioners
type: Concept
realized by: sec-32cm-ss-1
part of: 32CM Authorities for health practitioners
note: The Secretary may authorise a medical practitioner to supply biologicals.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.300
asserts: therapeutic-goods-act-1989-sec-32cm-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32cm-ss-1-norm
type: Obligation
modality: Deontic
part of: 32CM(1) Authorities for health practitioners
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cm-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: authorise
logic summary: Authorisation is an obligation.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CM(1A) Authorities for health practitioners
type: Concept
realized by: sec-32cm-ss-1a
part of: 32CM Authorities for health practitioners
note: Application for authority must be in approved form
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.300
asserts: therapeutic-goods-act-1989-sec-32cm-ss-1a-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-1a-logic-deontic-1

therapeutic-goods-act-1989-sec-32cm-ss-1a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide approved application form
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CM(2) Authorities for health practitioners
type: Concept
realized by: sec-32cm-ss-2
part of: 32CM Authorities for health practitioners
note: The Secretary may give an authority under subsection (1) subject to conditions.
references: sec-32cp
references: sec-32cq
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.300
asserts: therapeutic-goods-act-1989-sec-32cm-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32cm-ss-2-norm
type: Obligation
modality: Deontic
part of: 32CM(2) Authorities for health practitioners
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cm-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Authority may be given subject to conditions.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

32CM(3) Authorities for health practitioners
type: Concept
realized by: sec-32cm-ss-3
part of: 32CM Authorities for health practitioners
note: Secretary may impose conditions on an authority
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.300
asserts: therapeutic-goods-act-1989-sec-32cm-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32cm-ss-3-norm
type: Obligation
modality: Deontic
part of: 32CM(3) Authorities for health practitioners
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cm-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Imposes obligation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CM(4) Authorities for health practitioners
type: Concept
realized by: sec-32cm-ss-4
part of: 32CM Authorities for health practitioners
note: Authority for medical practitioners to supply specified biologicals.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.300
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

therapeutic-goods-act-1989-sec-32cm-ss-4-norm
type: Obligation
modality: Deontic
part of: 32CM(4) Authorities for health practitioners
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cm-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may only be given
logic summary: Authority restriction
premise text: (4) An authority under subsection (1)
conclusion text: to a medical practitioner
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cm-ss-4-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: includes
logic summary: Class of medical practitioners
premise text: (a) who is included in a class of medical practitioners prescribed by the regulations
conclusion text: for the purposes of this paragraph
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cm-ss-4-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: has approval
logic summary: Approval requirement for supply
premise text: (b) who has the approval of an ethics committee to supply the specified biological
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cm-ss-4-logic-alleninterval-4
type: LogicApplication
modality: AllenInterval
operator: prescribed by
logic summary: Temporal interval relation
premise text: for the purposes of this subsection
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

32CM(5) Authorities for health practitioners
type: Concept
realized by: sec-32cm-ss-5
part of: 32CM Authorities for health practitioners
note: Authority for health practitioners limited to prescribed classes of recipients.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.300
asserts: therapeutic-goods-act-1989-sec-32cm-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-5-logic-deontic-1

therapeutic-goods-act-1989-sec-32cm-ss-5-norm
type: Obligation
modality: Deontic
part of: 32CM(5) Authorities for health practitioners
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cm-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: only
logic summary: Limited authority
premise text: (5) An authority under subsection (1)
conclusion text: may only be given in relation to a class or classes of recipients prescribed by the regulations
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CM(6) Authorities for health practitioners
type: Concept
realized by: sec-32cm-ss-6
part of: 32CM Authorities for health practitioners
note: Regulations may prescribe circumstances for supplying biologicals under authority.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.300
asserts: therapeutic-goods-act-1989-sec-32cm-ss-6-norm

therapeutic-goods-act-1989-sec-32cm-ss-6-norm
type: Obligation
modality: Deontic
part of: 32CM(6) Authorities for health practitioners
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32CM(7) Authorities for health practitioners
type: Concept
realized by: sec-32cm-ss-7
part of: 32CM Authorities for health practitioners
note: An authority under subsection (1) is not a legislative instrument.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.300
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7-norm

therapeutic-goods-act-1989-sec-32cm-ss-7-norm
type: Obligation
modality: Deontic
part of: 32CM(7) Authorities for health practitioners
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32CM(7A) Authorities for health practitioners
type: Concept
realized by: sec-32cm-ss-7a
part of: 32CM Authorities for health practitioners
note: The Minister may make rules authorising health practitioners to supply biologicals.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.300
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

therapeutic-goods-act-1989-sec-32cm-ss-7a-norm
type: Permission
modality: Deontic
part of: 32CM(7A) Authorities for health practitioners
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cm-ss-7a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permission to supply biologicals
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cm-ss-7a-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: Class inclusion
logic summary: Rules specify class of health practitioners and recipients
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

32CM(7B) Authorities for health practitioners
type: Concept
realized by: sec-32cm-ss-7b
part of: 32CM Authorities for health practitioners
note: Comply with regulations when making rules under subsection (7A)
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.300
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7b-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7b-logic-deontic-1

therapeutic-goods-act-1989-sec-32cm-ss-7b-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Must
logic summary: Minister must comply with regulations
premise text: (7B) In making rules under subsection (7A), the Minister...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CM(7C) Authorities for health practitioners
type: Concept
realized by: sec-32cm-ss-7c
part of: 32CM Authorities for health practitioners
note: Notify supply to Secretary within 28 days after supply.
description: true
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.300
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7c-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7c-logic-deontic-1

therapeutic-goods-act-1989-sec-32cm-ss-7c-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide notification.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CM(7D) Authorities for health practitioners
type: Concept
realized by: sec-32cm-ss-7d
part of: 32CM Authorities for health practitioners
note: Notification requirements for health practitioners
description: Information as prescribed by regulations
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.300
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7d-norm
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7d-logic-deontic-1

therapeutic-goods-act-1989-sec-32cm-ss-7d-norm
type: Obligation
modality: Deontic
part of: 32CM(7D) Authorities for health practitioners
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cm-ss-7d-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide information
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CM(7E) Authorities for health practitioners
type: Concept
realized by: sec-32cm-ss-7e
part of: 32CM Authorities for health practitioners
note: Approval of a form may require or permit information to be given in accordance with specified software requirements.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.300
asserts: therapeutic-goods-act-1989-sec-32cm-ss-7e-norm

32CN Criminal offences relating to the giving of an authority to a
type: Concept
realized by: sec-32cn
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.302

32CN(1) Criminal offences relating to the giving of an authority to a
type: Concept
realized by: sec-32cn-ss-1
part of: 32CN Criminal offences relating to the giving of an authority to a
note: Supplying a biological without proper authority is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.302
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

therapeutic-goods-act-1989-sec-32cn-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32CN(1) Criminal offences relating to the giving of an authority to a
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits supplying a biological without proper authority.
premise text: (a) the Secretary has authorised, under subsection 32CM(1), the person to supply a biological; and (b) the person supplies the biological;
conclusion text: The supply is not in accordance with the authority.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits supplying a biological that would result in harm or injury to any person.
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;
conclusion text: The supply is not in accordance with the authority.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cn-ss-1-logic-linearlogic-3
type: LogicApplication
modality: LinearLogic
operator: Implication
logic summary: If supplying a biological without proper authority would result in harm or injury, then it is prohibited.
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;
conclusion text: The supply is prohibited.
execution surface: modalities::linear
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits supplying a biological that would not result in harm or injury to any person.
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).
conclusion text: The supply is not in accordance with the authority.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CN(4) Criminal offences relating to the giving of an authority to a
type: Concept
realized by: sec-32cn-ss-4
part of: 32CN Criminal offences relating to the giving of an authority to a
note: Supplying a biological without proper authority is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.302
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

therapeutic-goods-act-1989-sec-32cn-ss-4-norm
type: Prohibition
modality: Deontic
part of: 32CN(4) Criminal offences relating to the giving of an authority to a
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cn-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits supplying a biological without proper authority.
premise text: (4) A person commits an offence if...
conclusion text: ...the supply is not in accordance with the authority;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cn-ss-4-logic-ltl-2
type: LogicApplication
modality: LTL
operator: Recurring Trace
logic summary: Requires recurring trace of supplying a biological.
premise text: (4) A person commits an offence if...
conclusion text: ...the supply is not in accordance with the authority;
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cn-ss-4-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits supplying a biological without proper authority.
premise text: (4) A person commits an offence if...
conclusion text: ...the supply is not in accordance with the regulations;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CN(4A) Criminal offences relating to the giving of an authority to a
type: Concept
realized by: sec-32cn-ss-4a
part of: 32CN Criminal offences relating to the giving of an authority to a
note: Supplying a biological without authorization is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.302
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

therapeutic-goods-act-1989-sec-32cn-ss-4a-norm
type: Prohibition
modality: Deontic
part of: 32CN(4A) Criminal offences relating to the giving of an authority to a
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits supplying a biological.
premise text: (4A) A person commits an offence if...
conclusion text: ...and (b) the person supplies the biological;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Defines temporal interval for supply of a biological.
premise text: (4A) A person commits an offence if...
conclusion text: ...and (b) the person supplies the biological;
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Temporal Trace
logic summary: Defines temporal trace for supply of a biological.
premise text: (4A) A person commits an offence if...
conclusion text: ...and (c) either of the following applies:
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Diffuse
logic summary: Diffuses prohibition to related provisions.
premise text: (4A) A person commits an offence if...
conclusion text: ...and (b) the person supplies the biological;
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: Recognize
logic summary: Recognizes prohibition in supply of a biological.
premise text: (4A) A person commits an offence if...
conclusion text: ...and (c) either of the following applies:
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

32CO Approvals where substitutes for biologicals are unavailable
type: Concept
realized by: sec-32co
note: Secretary may grant approval for importation of specified biologicals
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.305
asserts: therapeutic-goods-act-1989-sec-32co-norm

therapeutic-goods-act-1989-sec-32co-norm
type: Permission
modality: Deontic
part of: 32CO Approvals where substitutes for biologicals are unavailable
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32CP Offences for breaching a condition of an exemption, approval
type: Concept
realized by: sec-32cp
note: Offence for breaching a condition of an exemption, approval
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.309
asserts: therapeutic-goods-act-1989-sec-32cp-norm
asserts: therapeutic-goods-act-1989-sec-32cp-logic-deontic-1

therapeutic-goods-act-1989-sec-32cp-norm
type: Prohibition
modality: Deontic
part of: 32CP Offences for breaching a condition of an exemption, approval
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cp-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits breaching a condition of an exemption, approval
premise text: The person does an act or omits to do an act
conclusion text: The person commits an offence
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32CQ Civil penalty for breaching a condition of an exemption,
type: Concept
realized by: sec-32cq
note: Civil penalty for breaching a condition of an exemption
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.311
asserts: therapeutic-goods-act-1989-sec-32cq-norm
asserts: therapeutic-goods-act-1989-sec-32cq-logic-deontic-1

therapeutic-goods-act-1989-sec-32cq-norm
type: Prohibition
modality: Deontic
part of: 32CQ Civil penalty for breaching a condition of an exemption,
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32cq-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits breach of conditions
premise text: Section 32CQ
conclusion text: Civil penalty for breaching a condition of an exemption
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32D Simplified outline of this Division
type: Concept
realized by: sec-32d
note: Application requirements for inclusion in the Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.313
asserts: therapeutic-goods-act-1989-sec-32d-norm

therapeutic-goods-act-1989-sec-32d-norm
type: Obligation
modality: Deontic
part of: 32D Simplified outline of this Division
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32DA Application for inclusion in the Register
type: Concept
realized by: sec-32da
has part: 32DA(1) Application for inclusion in the Register
has part: 32DA(2) Application for inclusion in the Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.313

32DA(1) Application for inclusion in the Register
type: Concept
realized by: sec-32da-ss-1
part of: 32DA Application for inclusion in the Register
note: Application for inclusion in the Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.313
asserts: therapeutic-goods-act-1989-sec-32da-ss-1-norm

therapeutic-goods-act-1989-sec-32da-ss-1-norm
type: Permission
modality: Deontic
part of: 32DA(1) Application for inclusion in the Register
borne by: NaturalPerson
scope note: borne by: NaturalPerson
deontic status: HeuristicDerived
curation status: Proposed

32DA(2) Application for inclusion in the Register
type: Concept
realized by: sec-32da-ss-2
part of: 32DA Application for inclusion in the Register
note: Application must be made in accordance with a form approved by the Secretary and accompanied by a statement certifying matters.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.313
asserts: therapeutic-goods-act-1989-sec-32da-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32da-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32da-ss-2-norm
type: Obligation
modality: Deontic
part of: 32DA(2) Application for inclusion in the Register
borne by: NaturalPerson
scope note: borne by: NaturalPerson
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32da-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Application must be made in accordance with a form approved by the Secretary.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DB Inclusion of Class 1 biological in the Register
type: Concept
realized by: sec-32db
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.315

32DB(1) Inclusion of Class 1 biological in the Register
type: Concept
realized by: sec-32db-ss-1
part of: 32DB Inclusion of Class 1 biological in the Register
note: Secretary must include biological in Register if application is made.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.315
asserts: therapeutic-goods-act-1989-sec-32db-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32db-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32db-ss-1-norm
type: Obligation
modality: Deontic
part of: 32DB(1) Inclusion of Class 1 biological in the Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32db-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must include biological
premise text: Application made for inclusion
conclusion text: Biological included in Register
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DB(2) Inclusion of Class 1 biological in the Register
type: Concept
realized by: sec-32db-ss-2
part of: 32DB Inclusion of Class 1 biological in the Register
note: Secretary must assign a unique number to the biological if included in the Register.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.315
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

therapeutic-goods-act-1989-sec-32db-ss-2-norm
type: Obligation
modality: Deontic
part of: 32DB(2) Inclusion of Class 1 biological in the Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32db-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Duty obligation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32db-ss-2-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: CLASSIFICATION
logic summary: Classification of biological in Register
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

32DB(3) Inclusion of Class 1 biological in the Register
type: Concept
realized by: sec-32db-ss-3
part of: 32DB Inclusion of Class 1 biological in the Register
note: Secretary must provide certificate upon inclusion in Register
description: Certificate of inclusion
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.315
asserts: therapeutic-goods-act-1989-sec-32db-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32db-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32db-ss-3-norm
type: Obligation
modality: Deontic
part of: 32DB(3) Inclusion of Class 1 biological in the Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32db-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide certificate
conclusion text: The Secretary must give to the applicant a certificate of the inclusion of the biological in the Register.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DB(4) Inclusion of Class 1 biological in the Register
type: Concept
realized by: sec-32db-ss-4
part of: 32DB Inclusion of Class 1 biological in the Register
note: Specify biological number and commencement day for inclusion in Register
description: Yes
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.315
asserts: therapeutic-goods-act-1989-sec-32db-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32db-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32db-ss-4-norm
type: Obligation
modality: Deontic
part of: 32DB(4) Inclusion of Class 1 biological in the Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32db-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Specify biological number and commencement day
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DC Refusal to include Class 1 biological in the Register
type: Concept
realized by: sec-32dc
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.316

32DC(1) Refusal to include Class 1 biological in the Register
type: Concept
realized by: sec-32dc-ss-1
part of: 32DC Refusal to include Class 1 biological in the Register
note: Application for inclusion of export only biological in the Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.316
asserts: therapeutic-goods-act-1989-sec-32dc-ss-1-norm

therapeutic-goods-act-1989-sec-32dc-ss-1-norm
type: Permission
modality: Deontic
part of: 32DC(1) Refusal to include Class 1 biological in the Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32DC(2) Refusal to include Class 1 biological in the Register
type: Concept
realized by: sec-32dc-ss-2
part of: 32DC Refusal to include Class 1 biological in the Register
note: Application must be made in accordance with a form approved by the Secretary and accompanied by a statement certifying certain matters.
description: Form, statement, and fee
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.316
asserts: therapeutic-goods-act-1989-sec-32dc-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32dc-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32dc-ss-2-norm
type: Obligation
modality: Deontic
part of: 32DC(2) Refusal to include Class 1 biological in the Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dc-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Application must be made in accordance with a form approved by the Secretary.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DC(3) Refusal to include Class 1 biological in the Register
type: Concept
realized by: sec-32dc-ss-3
part of: 32DC Refusal to include Class 1 biological in the Register
note: Application may be required for approval of a form
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.316
asserts: therapeutic-goods-act-1989-sec-32dc-ss-3-norm

32DC(4) Refusal to include Class 1 biological in the Register
type: Concept
realized by: sec-32dc-ss-4
part of: 32DC Refusal to include Class 1 biological in the Register
note: Certification requirements for export only biologicals
description: Certification of safety, presentation, and compliance with standards
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.316
asserts: therapeutic-goods-act-1989-sec-32dc-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32dc-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32dc-ss-4-norm
type: Obligation
modality: Deontic
part of: 32DC(4) Refusal to include Class 1 biological in the Register
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dc-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Certification is required
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DD Application for inclusion in the Register
type: Concept
realized by: sec-32dd
has part: 32DD(1) Application for inclusion in the Register
has part: 32DD(2) Application for inclusion in the Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.321

32DD(1) Application for inclusion in the Register
type: Concept
realized by: sec-32dd-ss-1
part of: 32DD Application for inclusion in the Register
note: Secretary must carry out assessment of application requirements
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.321
asserts: therapeutic-goods-act-1989-sec-32dd-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32dd-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32dd-ss-1-norm
type: Obligation
modality: Deontic
part of: 32DD(1) Application for inclusion in the Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dd-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must perform assessment
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DD(2) Application for inclusion in the Register
type: Concept
realized by: sec-32dd-ss-2
part of: 32DD Application for inclusion in the Register
note: Application requirements for inclusion in the Register
description: Information of a kind determined under subsection (9) and in a form determined under subsection (10)
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.321
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

therapeutic-goods-act-1989-sec-32dd-ss-2-norm
type: Obligation
modality: Deontic
part of: 32DD(2) Application for inclusion in the Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dd-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligate
logic summary: Application requirements for inclusion in the Register
conclusion text: Information of a kind determined under subsection (9) and in a form determined under subsection (10)
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dd-ss-2-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: hasClass
logic summary: Application must be made in accordance with the approved form
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dd-ss-2-logic-descriptionlogic-3
type: LogicApplication
modality: DescriptionLogic
operator: hasValue
logic summary: Prescribed application fee must be paid
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dd-ss-2-logic-alleninterval-4
type: LogicApplication
modality: AllenInterval
operator: >=
logic summary: Application must be delivered to an office of the Department within a reasonable time frame
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

32DE Evaluation of biologicals
type: Concept
realized by: sec-32de
has part: 32DE(1) Evaluation of biologicals
has part: 32DE(2) Evaluation of biologicals
has part: 32DE(3) Evaluation of biologicals
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.324

32DE(1) Evaluation of biologicals
type: Concept
realized by: sec-32de-ss-1
part of: 32DE Evaluation of biologicals
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.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.324
asserts: therapeutic-goods-act-1989-sec-32de-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32de-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32de-ss-1-norm
type: Obligation
modality: Deontic
part of: 32DE(1) Evaluation of biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32de-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: The Secretary must evaluate a biological.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DE(2) Evaluation of biologicals
type: Concept
realized by: sec-32de-ss-2
part of: 32DE Evaluation of biologicals
note: Determination of priority applicant for section 32DD applications Corresponding application of subsections for paragraph (1)(g)
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.324
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

therapeutic-goods-act-1989-sec-32de-ss-2-norm
type: Obligation
modality: Deontic
part of: 32DE(2) Evaluation of biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32de-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: has
logic summary: Priority applicant designation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32de-ss-2-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Obligate
logic summary: Corresponding application of subsections for paragraph (1)(g)
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

32DE(3) Evaluation of biologicals
type: Concept
realized by: sec-32de-ss-3
part of: 32DE Evaluation of biologicals
note: Regulations for applications of biologicals
description: information that must accompany an application
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.324
asserts: therapeutic-goods-act-1989-sec-32de-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32de-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32de-ss-3-norm
type: Obligation
modality: Deontic
part of: 32DE(3) Evaluation of biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32de-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST PROVIDE
logic summary: Regulations require information to be provided
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

32DF Inclusion of biological in the Register
type: Concept
realized by: sec-32df
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.327

32DF(1) Inclusion of biological in the Register
type: Concept
realized by: sec-32df-ss-1
part of: 32DF Inclusion of biological in the Register
note: Secretary must include biological in Register if certain conditions met.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.327
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

therapeutic-goods-act-1989-sec-32df-ss-1-norm
type: Obligation
modality: Deontic
part of: 32DF(1) Inclusion of biological in the Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32df-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide
premise text: (1) If...
conclusion text: the Secretary must include the biological in the Register.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32df-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: >=
logic summary: Evaluation must occur before inclusion
premise text: (b) the Secretary decides that it is appropriate to include the biological in the Register after an evaluation under section 32DE;
conclusion text: the evaluation must occur before inclusion.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32df-ss-1-logic-ltl-3
type: LogicApplication
modality: LTL
operator: <=
logic summary: Evaluation fee must be paid before inclusion
premise text: (c) no part of an evaluation fee under section 32DI that is due and payable by the person remains unpaid;
conclusion text: the evaluation fee must be paid before inclusion.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32df-ss-1-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: No exceptions allowed
premise text: (1) If...
conclusion text: no exceptions are allowed.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DF(2) Inclusion of biological in the Register
type: Concept
realized by: sec-32df-ss-2
part of: 32DF Inclusion of biological in the Register
note: Secretary must assign a unique number to the biological if included in the Register.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.327
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

therapeutic-goods-act-1989-sec-32df-ss-2-norm
type: Obligation
modality: Deontic
part of: 32DF(2) Inclusion of biological in the Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32df-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Duty obligation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32df-ss-2-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: CLASSIFICATION
logic summary: Classification of biological in the Register
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

32DF(3) Inclusion of biological in the Register
type: Concept
realized by: sec-32df-ss-3
part of: 32DF Inclusion of biological in the Register
note: Secretary must provide certificate upon inclusion in Register
description: Certificate of inclusion
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.327
asserts: therapeutic-goods-act-1989-sec-32df-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32df-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32df-ss-3-norm
type: Obligation
modality: Deontic
part of: 32DF(3) Inclusion of biological in the Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32df-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide certificate
conclusion text: The Secretary must give to the applicant a certificate of the inclusion of the biological in the Register.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DF(4) Inclusion of biological in the Register
type: Concept
realized by: sec-32df-ss-4
part of: 32DF Inclusion of biological in the Register
note: Specifies requirements for a certificate's content regarding biological inclusion in the Register.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.327
asserts: therapeutic-goods-act-1989-sec-32df-ss-4-norm

32DG Refusal to include biological in the Register
type: Concept
realized by: sec-32dg
note: Secretary must provide notice after refusing application to include biological in the Register.
description: Notice of refusal and reasons for refusal
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.328
asserts: therapeutic-goods-act-1989-sec-32dg-norm
asserts: therapeutic-goods-act-1989-sec-32dg-logic-deontic-1

therapeutic-goods-act-1989-sec-32dg-norm
type: Obligation
modality: Deontic
part of: 32DG Refusal to include biological in the Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dg-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Must
logic summary: Secretary must provide notice
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DH Lapsing of application
type: Concept
realized by: sec-32dh
has part: 32DH(1) Lapsing of application
has part: 32DH(2) Lapsing of application
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.328

32DH(1) Lapsing of application
type: Concept
realized by: sec-32dh-ss-1
part of: 32DH Lapsing of application
note: Application lapse due to unpaid fee, false information, or non-compliance with patient data requirements.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.328
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

therapeutic-goods-act-1989-sec-32dh-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32DH(1) Lapsing of application
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of application lapse due to unpaid fee.
premise text: Unpaid fee
conclusion text: Application lapse.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of application lapse due to false information.
premise text: False information
conclusion text: Application lapse.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of application lapse due to non-compliance with patient data requirements.
premise text: Non-compliance with patient data requirements
conclusion text: Application lapse.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DH(2) Lapsing of application
type: Concept
realized by: sec-32dh-ss-2
part of: 32DH Lapsing of application
note: Defines patient data in relation to a biological.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.328
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

therapeutic-goods-act-1989-sec-32dh-ss-2-norm
type: Obligation
modality: Deontic
part of: 32DH(2) Lapsing of application
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dh-ss-2-logic-descriptionlogic-1
type: LogicApplication
modality: DescriptionLogic
operator: =
logic summary: Identifies specific information types
premise text: patient data, in relation to a biological
conclusion text: information derived from clinical trials
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dh-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Describes temporal relationship
premise text: before, during and after
conclusion text: clinical trials
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

32DI Evaluation fee
type: Concept
realized by: sec-32di
has part: 32DI(1) Evaluation fee
has part: 32DI(2) Evaluation fee
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.329

32DI(1) Evaluation fee
type: Concept
realized by: sec-32di-ss-1
part of: 32DI Evaluation fee
note: Pay evaluation fee for biological inclusion in Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.329
asserts: therapeutic-goods-act-1989-sec-32di-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32di-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32di-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Duty to pay evaluation fee
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DI(2) Evaluation fee
type: Concept
realized by: sec-32di-ss-2
part of: 32DI Evaluation fee
note: The Secretary must notify the applicant in writing of the evaluation fee.
description: yes
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.329
asserts: therapeutic-goods-act-1989-sec-32di-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32di-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32di-ss-2-norm
type: Obligation
modality: Deontic
part of: 32DI(2) Evaluation fee
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32di-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: The Secretary must notify the applicant in writing of the evaluation fee.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DJ When evaluation fee due for payment
type: Concept
realized by: sec-32dj
has part: 32DJ(1) When evaluation fee due for payment
has part: 32DJ(2) When evaluation fee due for payment
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.329

32DJ(1) When evaluation fee due for payment
type: Concept
realized by: sec-32dj-ss-1
part of: 32DJ When evaluation fee due for payment
note: Evaluation fee due on notification of amount
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.329
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

therapeutic-goods-act-1989-sec-32dj-ss-1-norm
type: Obligation
modality: Deontic
part of: 32DJ(1) When evaluation fee due for payment
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dj-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: due
logic summary: Obligation to pay evaluation fee
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dj-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: on
logic summary: Temporal relation between notification and payment
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.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dj-ss-1-logic-ltl-3
type: LogicApplication
modality: LTL
operator: on
logic summary: Temporal trace between notification and payment
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.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dj-ss-1-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: on
logic summary: Spread of obligation to pay evaluation fee
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.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

32DJ(2) When evaluation fee due for payment
type: Concept
realized by: sec-32dj-ss-2
part of: 32DJ When evaluation fee due for payment
note: Evaluation fee must be paid in the manner prescribed by regulations.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.329
asserts: therapeutic-goods-act-1989-sec-32dj-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32dj-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32dj-ss-2-norm
type: Obligation
modality: Deontic
part of: 32DJ(2) When evaluation fee due for payment
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dj-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to pay evaluation fee
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DK Payment of evaluation fee by instalments
type: Concept
realized by: sec-32dk
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.329

32DK(1) Payment of evaluation fee by instalments
type: Concept
realized by: sec-32dk-ss-1
part of: 32DK Payment of evaluation fee by instalments
note: Payment of evaluation fee by instalments is obligatory.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.329
asserts: therapeutic-goods-act-1989-sec-32dk-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32dk-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32dk-ss-1-norm
type: Obligation
modality: Deontic
part of: 32DK(1) Payment of evaluation fee by instalments
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dk-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Payment of evaluation fee by instalments is obligatory.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DK(2) Payment of evaluation fee by instalments
type: Concept
realized by: sec-32dk-ss-2
part of: 32DK Payment of evaluation fee by instalments
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.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.329
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

therapeutic-goods-act-1989-sec-32dk-ss-2-norm
type: Prohibition
modality: Deontic
part of: 32DK(2) Payment of evaluation fee by instalments
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dk-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits payment of evaluation fee by instalments if any part was unpaid immediately after it became due.
premise text: (2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments...
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dk-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Overlaps
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.
premise text: (2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments...
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.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dk-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Contains
logic summary: Payment of evaluation fee by instalments contains the condition that any part of an instalment was unpaid immediately after it became due.
premise text: (2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments...
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.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dk-ss-2-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Diffuses
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.
premise text: (2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments...
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.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dk-ss-2-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: Recognizes
logic summary: Payment of evaluation fee by instalments is recognized as a prohibited action if any part was unpaid immediately after it became due.
premise text: (2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments...
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.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

32DK(3) Payment of evaluation fee by instalments
type: Concept
realized by: sec-32dk-ss-3
part of: 32DK Payment of evaluation fee by instalments
note: Payment of evaluation fee by instalments
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.329
asserts: therapeutic-goods-act-1989-sec-32dk-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32dk-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32dk-ss-3-norm
type: Obligation
modality: Deontic
part of: 32DK(3) Payment of evaluation fee by instalments
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dk-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must pay evaluation fee
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DL Recovery of evaluation fee
type: Concept
realized by: sec-32dl
note: The Commonwealth may recover an evaluation fee as a debt.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.330
asserts: therapeutic-goods-act-1989-sec-32dl-norm
asserts: therapeutic-goods-act-1989-sec-32dl-logic-deontic-1

therapeutic-goods-act-1989-sec-32dl-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Implies obligation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DM Reduction of evaluation fee where evaluation not completed
type: Concept
realized by: sec-32dm
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.330

32DM(1) Reduction of evaluation fee where evaluation not completed
type: Concept
realized by: sec-32dm-ss-1
part of: 32DM Reduction of evaluation fee where evaluation not completed
note: No payment of more than 3/4 evaluation fee before completion if a period is prescribed for completing the evaluation.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.330
asserts: therapeutic-goods-act-1989-sec-32dm-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32dm-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32dm-ss-1-norm
type: Obligation
modality: Deontic
part of: 32DM(1) Reduction of evaluation fee where evaluation not completed
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dm-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes an obligation on the state.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DM(2) Reduction of evaluation fee where evaluation not completed
type: Concept
realized by: sec-32dm-ss-2
part of: 32DM Reduction of evaluation fee where evaluation not completed
note: Secretary must notify applicant of evaluation completion date
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.330
asserts: therapeutic-goods-act-1989-sec-32dm-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32dm-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32dm-ss-2-norm
type: Obligation
modality: Deontic
part of: 32DM(2) Reduction of evaluation fee where evaluation not completed
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dm-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to notify
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DM(3) Reduction of evaluation fee where evaluation not completed
type: Concept
realized by: sec-32dm-ss-3
part of: 32DM Reduction of evaluation fee where evaluation not completed
note: Reduction of evaluation fee if evaluation not completed within period
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.330
asserts: therapeutic-goods-act-1989-sec-32dm-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32dm-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32dm-ss-3-norm
type: Obligation
modality: Deontic
part of: 32DM(3) Reduction of evaluation fee where evaluation not completed
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dm-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: if
logic summary: Conditional obligation
premise text: (evaluation not completed within period)
conclusion text: (evaluation fee is reduced)
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DM(4) Reduction of evaluation fee where evaluation not completed
type: Concept
realized by: sec-32dm-ss-4
part of: 32DM Reduction of evaluation fee where evaluation not completed
note: Payment of unpaid evaluation fee upon completion of evaluation.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.330
asserts: therapeutic-goods-act-1989-sec-32dm-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32dm-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32dm-ss-4-norm
type: Obligation
modality: Deontic
part of: 32DM(4) Reduction of evaluation fee where evaluation not completed
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dm-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes a duty on the state.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DM(5) Reduction of evaluation fee where evaluation not completed
type: Concept
realized by: sec-32dm-ss-5
part of: 32DM Reduction of evaluation fee where evaluation not completed
note: Evaluation fee reduction where report is given to applicant or committee.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.330
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

therapeutic-goods-act-1989-sec-32dm-ss-5-norm
type: Obligation
modality: Deontic
part of: 32DM(5) Reduction of evaluation fee where evaluation not completed
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dm-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Duty to pay full evaluation fee if applicant withdraws after report is given.
premise text: (5) For the purposes of this section, if a copy of the evaluation report...
conclusion text: then the evaluation is taken to be completed immediately before the first copy or summary is so given.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dm-ss-5-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Overlaps
logic summary: Evaluation fee reduction applies when report is given within a specified period.
premise text: (5) For the purposes of this section, if a copy of the evaluation report...
conclusion text: then the evaluation is taken to be completed immediately before the first copy or summary is so given.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dm-ss-5-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Until
logic summary: Evaluation fee reduction applies until report is given to applicant or committee.
premise text: (5) For the purposes of this section, if a copy of the evaluation report...
conclusion text: then the evaluation is taken to be completed immediately before the first copy or summary is so given.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dm-ss-5-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Diffuses
logic summary: Report being given to applicant or committee diffuses the obligation to pay full evaluation fee.
premise text: (5) For the purposes of this section, if a copy of the evaluation report...
conclusion text: then the evaluation is taken to be completed immediately before the first copy or summary is so given.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32dm-ss-5-logic-argumentation-5
type: LogicApplication
modality: Argumentation
operator: Implication
logic summary: Withdrawal after report being given implies obligation to pay full evaluation fee.
premise text: (5) For the purposes of this section, if a copy of the evaluation report...
conclusion text: then the evaluation is taken to be completed immediately before the first copy or summary is so given.
execution surface: modalities::argumentation
confidence: 1.0000
curation status: Proposed

32DM(6) Reduction of evaluation fee where evaluation not completed
type: Concept
realized by: sec-32dm-ss-6
part of: 32DM Reduction of evaluation fee where evaluation not completed
note: Notification under subsection (2) is not a legislative instrument.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.330
asserts: therapeutic-goods-act-1989-sec-32dm-ss-6-norm

therapeutic-goods-act-1989-sec-32dm-ss-6-norm
type: Obligation
modality: Deontic
part of: 32DM(6) Reduction of evaluation fee where evaluation not completed
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32DN Transitional provisions for existing biologicals
type: Concept
realized by: sec-32dn
note: Secretary must cancel inclusion of goods in part and include biological in Register under Part
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.331
asserts: therapeutic-goods-act-1989-sec-32dn-norm
asserts: therapeutic-goods-act-1989-sec-32dn-logic-deontic-1

therapeutic-goods-act-1989-sec-32dn-norm
type: Obligation
modality: Deontic
part of: 32DN Transitional provisions for existing biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dn-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Secretary must perform action
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DO Criminal offences for false statements in applications for
type: Concept
realized by: sec-32do
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.334

32DO(1) Criminal offences for false statements in applications for
type: Concept
realized by: sec-32do-ss-1
part of: 32DO Criminal offences for false statements in applications for
note: Making false statements in applications for biological inclusion is a criminal offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.334
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

therapeutic-goods-act-1989-sec-32do-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32DO(1) Criminal offences for false statements in applications for
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32do-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits making false statements in applications for biological inclusion.
premise text: The statement is made in, or in connection with, an application for inclusion of a biological in the Register.
conclusion text: A person commits an offence if...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32do-ss-1-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits harm or injury to any person resulting from the use of the biological.
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;
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32do-ss-1-logic-linearlogic-3
type: LogicApplication
modality: LinearLogic
operator: Imply
logic summary: Implies that the provision is related to harm or injury.
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;
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.
execution surface: modalities::linear
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32do-ss-1-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits making false statements in applications for biological inclusion.
premise text: (a) the person makes a statement;
conclusion text: and (b) the statement is made in, or in connection with, an application for inclusion of a biological in the Register.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DO(4) Criminal offences for false statements in applications for
type: Concept
realized by: sec-32do-ss-4
part of: 32DO Criminal offences for false statements in applications for
note: Making false statements in applications for inclusion of biologicals in the Register is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.334
asserts: therapeutic-goods-act-1989-sec-32do-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32do-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32do-ss-4-norm
type: Prohibition
modality: Deontic
part of: 32DO(4) Criminal offences for false statements in applications for
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32do-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of false statements
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DO(5) Criminal offences for false statements in applications for
type: Concept
realized by: sec-32do-ss-5
part of: 32DO Criminal offences for false statements in applications for
note: Making false statements in applications for inclusion of a biological in the Register is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.334
asserts: therapeutic-goods-act-1989-sec-32do-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32do-ss-5-logic-deontic-1

therapeutic-goods-act-1989-sec-32do-ss-5-norm
type: Prohibition
modality: Deontic
part of: 32DO(5) Criminal offences for false statements in applications for
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32do-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits making false statements in applications.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DO(6) Criminal offences for false statements in applications for
type: Concept
realized by: sec-32do-ss-6
part of: 32DO Criminal offences for false statements in applications for
note: An offence against subsection (5) is an offence of strict liability.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.334
asserts: therapeutic-goods-act-1989-sec-32do-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-32do-ss-6-logic-deontic-1

therapeutic-goods-act-1989-sec-32do-ss-6-norm
type: Obligation
modality: Deontic
part of: 32DO(6) Criminal offences for false statements in applications for
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32do-ss-6-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes a duty on the state.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DP Civil penalty for false statements in applications for including
type: Concept
realized by: sec-32dp
note: False statements in applications for inclusion of biologicals in the Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.335
asserts: therapeutic-goods-act-1989-sec-32dp-norm
asserts: therapeutic-goods-act-1989-sec-32dp-logic-deontic-1

therapeutic-goods-act-1989-sec-32dp-norm
type: Prohibition
modality: Deontic
part of: 32DP Civil penalty for false statements in applications for including
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dp-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition on false statements
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DQ Criminal offence and civil penalty for failing to notify adverse
type: Concept
realized by: sec-32dq
note: Failure to notify adverse effects of a biological included in the Register is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.335
asserts: therapeutic-goods-act-1989-sec-32dq-norm
asserts: therapeutic-goods-act-1989-sec-32dq-logic-deontic-1

therapeutic-goods-act-1989-sec-32dq-norm
type: Obligation
modality: Deontic
part of: 32DQ Criminal offence and civil penalty for failing to notify adverse
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dq-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Obligation to notify adverse effects of a biological included in the Register.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DR Criminal offences and civil penalties for failing to notify
type: Concept
realized by: sec-32dr
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.337

32DR(1) Criminal offences and civil penalties for failing to notify
type: Concept
realized by: sec-32dr-ss-1
part of: 32DR Criminal offences and civil penalties for failing to notify
note: Notify the Secretary of known information within 14 days after application withdrawal or lapse.
description: Yes
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.337
asserts: therapeutic-goods-act-1989-sec-32dr-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32dr-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32dr-ss-1-norm
type: Obligation
modality: Deontic
part of: 32DR(1) Criminal offences and civil penalties for failing to notify
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dr-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must notify the Secretary.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DR(2) Criminal offences and civil penalties for failing to notify
type: Concept
realized by: sec-32dr-ss-2
part of: 32DR Criminal offences and civil penalties for failing to notify
note: Failing to notify of certain information may result in criminal offences or civil penalties.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.337
asserts: therapeutic-goods-act-1989-sec-32dr-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32dr-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32dr-ss-2-norm
type: Prohibition
modality: Deontic
part of: 32DR(2) Criminal offences and civil penalties for failing to notify
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dr-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of failing to notify
premise text: Notification is required
conclusion text: Failing to notify is prohibited
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DR(3) Criminal offences and civil penalties for failing to notify
type: Concept
realized by: sec-32dr-ss-3
part of: 32DR Criminal offences and civil penalties for failing to notify
note: Failure to comply with notice within 30 days results in imprisonment or penalty units.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.337
asserts: therapeutic-goods-act-1989-sec-32dr-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32dr-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32dr-ss-3-norm
type: Obligation
modality: Deontic
part of: 32DR(3) Criminal offences and civil penalties for failing to notify
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32dr-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: obligation
logic summary: Obligation to comply with notice.
premise text: Secretary gives notice.
conclusion text: Failure to comply results in penalty.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DS Consultation with Gene Technology Regulator
type: Concept
realized by: sec-32ds
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.339

32DS(1) Consultation with Gene Technology Regulator
type: Concept
realized by: sec-32ds-ss-1
part of: 32DS Consultation with Gene Technology Regulator
note: Application for inclusion of a biological in the Register must consult with the Gene Technology Regulator.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.339
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

therapeutic-goods-act-1989-sec-32ds-ss-1-norm
type: Obligation
modality: Deontic
part of: 32DS(1) Consultation with Gene Technology Regulator
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ds-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Application must comply with consultation requirement.
premise text: The application for inclusion of a biological in the Register...
conclusion text: ...must consult with the Gene Technology Regulator.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ds-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: >=
logic summary: Consultation must occur before the application is processed.
premise text: The application for inclusion of a biological in the Register...
conclusion text: ...must consult with the Gene Technology Regulator.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ds-ss-1-logic-argumentation-3
type: LogicApplication
modality: Argumentation
operator: IMPLIES
logic summary: Consultation implies that the application is not exempt from regulation.
premise text: The application for inclusion of a biological in the Register...
conclusion text: ...must consult with the Gene Technology Regulator.
execution surface: modalities::argumentation
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ds-ss-1-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: IS_A
logic summary: Consultation is a necessary step for the regulation of genetic modification.
premise text: The application for inclusion of a biological in the Register...
conclusion text: ...must consult with the Gene Technology Regulator.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ds-ss-1-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: IS_A
logic summary: Consultation is an artificial intelligence-powered regulation mechanism.
premise text: The application for inclusion of a biological in the Register...
conclusion text: ...must consult with the Gene Technology Regulator.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

32DS(2) Consultation with Gene Technology Regulator
type: Concept
realized by: sec-32ds-ss-2
part of: 32DS Consultation with Gene Technology Regulator
note: The Secretary must give written notice to the Gene Technology Regulator.
description: Yes
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.339
asserts: therapeutic-goods-act-1989-sec-32ds-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32ds-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32ds-ss-2-norm
type: Obligation
modality: Deontic
part of: 32DS(2) Consultation with Gene Technology Regulator
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ds-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: The Secretary must give written notice.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DS(3) Consultation with Gene Technology Regulator
type: Concept
realized by: sec-32ds-ss-3
part of: 32DS Consultation with Gene Technology Regulator
note: The Gene Technology Regulator must provide written advice to the Secretary about a gene technology application.
description: Yes
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.339
asserts: therapeutic-goods-act-1989-sec-32ds-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32ds-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32ds-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: The Gene Technology Regulator must provide written advice.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DS(4) Consultation with Gene Technology Regulator
type: Concept
realized by: sec-32ds-ss-4
part of: 32DS Consultation with Gene Technology Regulator
note: Consultation with Gene Technology Regulator within specified period.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.339
asserts: therapeutic-goods-act-1989-sec-32ds-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32ds-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32ds-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide consultation
premise text: The advice is to be given within the period specified in the notice.
conclusion text: Consultation with Gene Technology Regulator within specified period.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32DS(5) Consultation with Gene Technology Regulator
type: Concept
realized by: sec-32ds-ss-5
part of: 32DS Consultation with Gene Technology Regulator
note: No notification required for applications within a class of biologicals subject to Gene Technology Regulator advice.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.339
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

therapeutic-goods-act-1989-sec-32ds-ss-5-norm
type: Obligation
modality: Deontic
part of: 32DS(5) Consultation with Gene Technology Regulator
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ds-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Exemption
logic summary: No notification required for applications within a class of biologicals subject to Gene Technology Regulator advice.
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ds-ss-5-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: Class Inclusion
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.
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.
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ds-ss-5-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: Temporal Exemption
logic summary: The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT.
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.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ds-ss-5-logic-ltl-4
type: LogicApplication
modality: LTL
operator: Temporal Exemption
logic summary: The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT.
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.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ds-ss-5-logic-diffusion-5
type: LogicApplication
modality: Diffusion
operator: Information Dissemination
logic summary: The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT.
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.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ds-ss-5-logic-cogai-6
type: LogicApplication
modality: CogAI
operator: Knowledge Representation
logic summary: The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT.
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.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

32DS(6) Consultation with Gene Technology Regulator
type: Concept
realized by: sec-32ds-ss-6
part of: 32DS Consultation with Gene Technology Regulator
note: Notice under subsection (2) is not a legislative instrument.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.339
asserts: therapeutic-goods-act-1989-sec-32ds-ss-6-norm

32DT Secretary may seek advice about classes of GM products or
type: Concept
realized by: sec-32dt
note: The Secretary may request advice from the Gene Technology Regulator about specific GM products or organisms.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.339
asserts: therapeutic-goods-act-1989-sec-32dt-norm

32DU Secretary to take advice into account
type: Concept
realized by: sec-32du
note: Secretary must take advice into account when making a decision on an application.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.340
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

therapeutic-goods-act-1989-sec-32du-norm
type: Obligation
modality: Deontic
part of: 32DU Secretary to take advice into account
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32du-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Secretary must take advice into account.
premise text: The Secretary receives advice from the Gene Technology Regulator.
conclusion text: The Secretary must ensure that the advice is taken into account in making a decision on the application.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32du-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Secretary informs the Gene Technology Regulator of the decision on the application.
premise text: The Secretary must inform the Gene Technology Regulator of the decision on the application.
conclusion text: The Secretary must inform the Gene Technology Regulator of the decision on the application.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32E What this Division is about
type: Concept
realized by: sec-32e
note: Exemptions from automatic conditions for inclusions of biologicals in the Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.341
asserts: therapeutic-goods-act-1989-sec-32e-norm

32EA Conditions applying automatically
type: Concept
realized by: sec-32ea
note: Allow entry and inspection of premises for authorized persons.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.341
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

therapeutic-goods-act-1989-sec-32ea-norm
type: Obligation
modality: Deontic
part of: 32EA Conditions applying automatically
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ea-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Allow
logic summary: Grant permission for entry and inspection.
premise text: The person in relation to whom the biological is included in the Register...
conclusion text: ...to allow an authorised person to enter, inspect, and examine.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ea-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: During
logic summary: Entry is allowed during reasonable hours.
premise text: at any reasonable time
conclusion text: ...to enter, inspect, and examine at any reasonable time.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

32EB Certification of manufacturing steps outside Australia
type: Concept
realized by: sec-32eb
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.345

32EB(1) Certification of manufacturing steps outside Australia
type: Concept
realized by: sec-32eb-ss-1
part of: 32EB Certification of manufacturing steps outside Australia
note: Application for certification of manufacturing steps outside Australia
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.345
asserts: therapeutic-goods-act-1989-sec-32eb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32eb-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32eb-ss-1-norm
type: Obligation
modality: Deontic
part of: 32EB(1) Certification of manufacturing steps outside Australia
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32eb-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: obligation
logic summary: Obligation to apply for certification
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32EB(2) Certification of manufacturing steps outside Australia
type: Concept
realized by: sec-32eb-ss-2
part of: 32EB Certification of manufacturing steps outside Australia
note: Secretary must certify manufacturing procedures upon request.
description: written notice
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.345
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

therapeutic-goods-act-1989-sec-32eb-ss-2-norm
type: Obligation
modality: Deontic
part of: 32EB(2) Certification of manufacturing steps outside Australia
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32eb-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide written notice
conclusion text: The Secretary must give the person written notice of the certification.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32eb-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: BETWEEN
logic summary: Certification is within a specific time frame
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.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32eb-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: BETWEEN
logic summary: Certification is within a specific time frame
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.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32eb-ss-2-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: IS_A
logic summary: Certification is a form of diffusion
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.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32eb-ss-2-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: IS_A
logic summary: Certification is a form of artificial intelligence
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.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

32EB(3) Certification of manufacturing steps outside Australia
type: Concept
realized by: sec-32eb-ss-3
part of: 32EB Certification of manufacturing steps outside Australia
note: Applying subsections for certification decision
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.345
asserts: therapeutic-goods-act-1989-sec-32eb-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32eb-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32eb-ss-3-norm
type: Obligation
modality: Deontic
part of: 32EB(3) Certification of manufacturing steps outside Australia
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32eb-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: apply
logic summary: Applying relevant rules
premise text: Subsections apply for certification decision
conclusion text: Decision made under subsections
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32EC Imposition of conditions by legislative instrument
type: Concept
realized by: sec-32ec
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.345

32EC(1) Imposition of conditions by legislative instrument
type: Concept
realized by: sec-32ec-ss-1
part of: 32EC Imposition of conditions by legislative instrument
note: Conditions for inclusion of a biological in the Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.345
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

therapeutic-goods-act-1989-sec-32ec-ss-1-norm
type: Obligation
modality: Deontic
part of: 32EC(1) Imposition of conditions by legislative instrument
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ec-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: imposes
logic summary: Imposes conditions on inclusion of a biological in the Register
premise text: (1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2).
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ec-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Conditions apply during the process of inclusion
premise text: (1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2).
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ec-ss-1-logic-ltl-3
type: LogicApplication
modality: LTL
operator: during
logic summary: Conditions apply during the process of inclusion
premise text: (1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2).
execution surface: modalities::temporal_ltl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ec-ss-1-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: appliesTo
logic summary: Applies to the process of inclusion
premise text: (1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2).
execution surface: modalities::diffusion
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ec-ss-1-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: appliesTo
logic summary: Applies to the process of inclusion
premise text: (1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2).
execution surface: sparql_library::parsers::chk_parser
confidence: 0.5000
curation status: Proposed

32EC(2) Imposition of conditions by legislative instrument
type: Concept
realized by: sec-32ec-ss-2
part of: 32EC Imposition of conditions by legislative instrument
note: Minister may impose conditions on the manufacture, custody, use, supply, disposal or destruction of a biological.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.345
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

therapeutic-goods-act-1989-sec-32ec-ss-2-norm
type: Obligation
modality: Deontic
part of: 32EC(2) Imposition of conditions by legislative instrument
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Imposition of conditions
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ec-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: between
logic summary: Temporal intervals for conditions
premise text: (2) The Minister may, by legislative instrument, make a determination setting out conditions for the purposes of subsection (1);
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ec-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: for all
logic summary: Temporal scope of conditions
premise text: (2) The Minister may, by legislative instrument, make a determination setting out conditions for the purposes of subsection (1);
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: must be met
logic summary: Conditions for the biological
premise text: (a) the manufacture of the biological; or (b) the custody, use, supply, disposal or destruction of the biological;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: must be met
logic summary: Reporting requirements for the biological
premise text: (ca) reporting requirements relating to the biological;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32EC(3) Imposition of conditions by legislative instrument
type: Concept
realized by: sec-32ec-ss-3
part of: 32EC Imposition of conditions by legislative instrument
note: Different conditions may be specified for different classes of biologicals.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.345
asserts: therapeutic-goods-act-1989-sec-32ec-ss-3-norm

therapeutic-goods-act-1989-sec-32ec-ss-3-norm
type: Obligation
modality: Deontic
part of: 32EC(3) Imposition of conditions by legislative instrument
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32ED Imposition of conditions at time biological included in the
type: Concept
realized by: sec-32ed
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.346

32ED(1) Imposition of conditions at time biological included in the
type: Concept
realized by: sec-32ed-ss-1
part of: 32ED Imposition of conditions at time biological included in the
note: Secretary may impose conditions on inclusion of biological in Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.346
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

therapeutic-goods-act-1989-sec-32ed-ss-1-norm
type: Obligation
modality: Deontic
part of: 32ED(1) Imposition of conditions at time biological included in the
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ed-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Imposes obligation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ed-ss-1-logic-descriptionlogic-2
type: LogicApplication
modality: DescriptionLogic
operator: includes
logic summary: Includes biological in Register
execution surface: modalities::dl
confidence: 1.0000
curation status: Proposed

32ED(2) Imposition of conditions at time biological included in the
type: Concept
realized by: sec-32ed-ss-2
part of: 32ED Imposition of conditions at time biological included in the
note: A notice under subsection (1) is not a legislative instrument.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.346
asserts: therapeutic-goods-act-1989-sec-32ed-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32ed-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32ed-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: not
logic summary: Negative obligation
premise text: A notice under subsection (1) is a legislative instrument.
conclusion text: A notice under subsection (1) is not a legislative instrument.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

32EE Imposition or variation or removal of conditions after
type: Concept
realized by: sec-32ee
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.346

32EE(1) Imposition or variation or removal of conditions after
type: Concept
realized by: sec-32ee-ss-1
part of: 32EE Imposition or variation or removal of conditions after
note: Secretary may impose new conditions on biological inclusion
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.346
asserts: therapeutic-goods-act-1989-sec-32ee-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32ee-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32ee-ss-1-norm
type: Obligation
modality: Deontic
part of: 32EE(1) Imposition or variation or removal of conditions after
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ee-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Imposes obligation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32EE(2) Imposition or variation or removal of conditions after
type: Concept
realized by: sec-32ee-ss-2
part of: 32EE Imposition or variation or removal of conditions after
note: Request must be accompanied by prescribed fee.
description: fee
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.346
asserts: therapeutic-goods-act-1989-sec-32ee-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32ee-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32ee-ss-2-norm
type: Obligation
modality: Deontic
part of: 32EE(2) Imposition or variation or removal of conditions after
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ee-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to provide fee
conclusion text: fee must be provided
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32EE(3) Imposition or variation or removal of conditions after
type: Concept
realized by: sec-32ee-ss-3
part of: 32EE Imposition or variation or removal of conditions after
note: Conditions for imposition or variation of conditions after notice is given to the person.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.346
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

therapeutic-goods-act-1989-sec-32ee-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: takes effect
logic summary: Imposition or variation takes effect on specified day.
premise text: (3) The imposition or variation or removal of a condition under subsection (1) takes effect:
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ee-ss-3-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: within interval
logic summary: Notice specifies start date for imposition or variation.
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;
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ee-ss-3-logic-ltl-3
type: LogicApplication
modality: LTL
operator: recurring trace
logic summary: Notice specifies recurring pattern for imposition or variation.
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;
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ee-ss-3-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: must provide
logic summary: Person must agree to earlier start date for imposition or variation.
premise text: unless the person has agreed to an earlier day;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32EE(3A) Imposition or variation or removal of conditions after
type: Concept
realized by: sec-32ee-ss-3a
part of: 32EE Imposition or variation or removal of conditions after
note: The earlier day must not be earlier than the day the notice is given to the person.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.346
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

therapeutic-goods-act-1989-sec-32ee-ss-3a-norm
type: Obligation
modality: Deontic
part of: 32EE(3A) Imposition or variation or removal of conditions after
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ee-ss-3a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: >=
logic summary: Temporal constraint
premise text: The earlier day must not be earlier than the given day.
conclusion text: The notice must be given on or after the given day.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ee-ss-3a-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: =
logic summary: Temporal relation
premise text: The earlier day is a temporal interval before the given day.
conclusion text: The notice must be given on or after the day before the given day.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

32EE(4) Imposition or variation or removal of conditions after
type: Concept
realized by: sec-32ee-ss-4
part of: 32EE Imposition or variation or removal of conditions after
note: Legislative instrument notice is not a legislative instrument.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.346
asserts: therapeutic-goods-act-1989-sec-32ee-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32ee-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32ee-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits notices from being legislative instruments.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32EF Criminal offences for breach of condition
type: Concept
realized by: sec-32ef
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.347

32EF(1) Criminal offences for breach of condition
type: Concept
realized by: sec-32ef-ss-1
part of: 32EF Criminal offences for breach of condition
note: Breach of condition results in harm or injury to any person.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.347
asserts: therapeutic-goods-act-1989-sec-32ef-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32ef-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32ef-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits breach of condition.
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.
conclusion text: (Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.)
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32EF(4) Criminal offences for breach of condition
type: Concept
realized by: sec-32ef-ss-4
part of: 32EF Criminal offences for breach of condition
note: Breach of condition results in criminal offence
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.347
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

therapeutic-goods-act-1989-sec-32ef-ss-4-norm
type: Obligation
modality: Deontic
part of: 32EF(4) Criminal offences for breach of condition
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ef-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Obligation to comply with conditions
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;
conclusion text: The person commits an offence if...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ef-ss-4-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibition on breach of conditions
premise text: (c) the act or omission breaches a condition of the inclusion of the biological in the Register.
conclusion text: Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ef-ss-4-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: Between
logic summary: Temporal interval for breach of conditions
premise text: (c) the act or omission breaches a condition of the inclusion of the biological in the Register.
conclusion text: The person commits an offence if...
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ef-ss-4-logic-ltl-4
type: LogicApplication
modality: LTL
operator: Until
logic summary: Temporal constraint on breach of conditions
premise text: (c) the act or omission breaches a condition of the inclusion of the biological in the Register.
conclusion text: The person commits an offence if...
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

32EF(5) Criminal offences for breach of condition
type: Concept
realized by: sec-32ef-ss-5
part of: 32EF Criminal offences for breach of condition
note: Breach of condition results in criminal offence
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.347
asserts: therapeutic-goods-act-1989-sec-32ef-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32ef-ss-5-logic-deontic-1

therapeutic-goods-act-1989-sec-32ef-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits breach of condition
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32EG Civil penalty for breach of condition
type: Concept
realized by: sec-32eg
note: Civil penalty for breach of condition
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.348
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

therapeutic-goods-act-1989-sec-32eg-norm
type: Prohibition
modality: Deontic
part of: 32EG Civil penalty for breach of condition
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32eg-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits breach of condition
premise text: A person contravenes this section if...
conclusion text: ...breaches a condition of the inclusion of the biological in the Register.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32eg-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits breach of condition for individuals and bodies corporate
premise text: Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units.
conclusion text: ...for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32eg-logic-linearlogic-3
type: LogicApplication
modality: LinearLogic
operator: Imply
logic summary: Implicates breach of condition on inclusion in Register
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;
conclusion text: ...breaches a condition...
execution surface: modalities::linear
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32eg-logic-alleninterval-4
type: LogicApplication
modality: AllenInterval
operator: Within
logic summary: Indicates temporal interval for breach of condition
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;
conclusion text: ...breaches a condition...
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32eg-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits breach of condition for individuals and bodies corporate
premise text: (a) for an individual—5,000 penalty units; (b) for a body corporate—50,000 penalty units.
conclusion text: ...for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32F What this Division is about
type: Concept
realized by: sec-32f
note: The Secretary may suspend biologicals from the Register in certain circumstances.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.349
asserts: therapeutic-goods-act-1989-sec-32f-norm

therapeutic-goods-act-1989-sec-32f-norm
type: Obligation
modality: Deontic
part of: 32F What this Division is about
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32FA Suspension of biological from the Register
type: Concept
realized by: sec-32fa
has part: 32FA(1) Suspension of biological from the Register
has part: 32FA(2) Suspension of biological from the Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.349

32FA(1) Suspension of biological from the Register
type: Concept
realized by: sec-32fa-ss-1
part of: 32FA Suspension of biological from the Register
note: Suspension of biological from the Register is allowed under certain conditions.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.349
asserts: therapeutic-goods-act-1989-sec-32fa-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32fa-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32fa-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32FA(1) Suspension of biological from the Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32fa-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits suspension of biological from the Register.
premise text: (1) The Secretary may, by written notice given to a person in relation to whom a biological is included in the Register...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32FA(2) Suspension of biological from the Register
type: Concept
realized by: sec-32fa-ss-2
part of: 32FA Suspension of biological from the Register
note: Secretary must suspend biological from Register before cancelling entry under section 32GC
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.349
asserts: therapeutic-goods-act-1989-sec-32fa-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32fa-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32fa-ss-2-norm
type: Obligation
modality: Deontic
part of: 32FA(2) Suspension of biological from the Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32fa-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Duty to suspend biological from Register
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32FB When suspension takes effect etc.
type: Concept
realized by: sec-32fb
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.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.350

32FB(1) When suspension takes effect etc.
type: Concept
realized by: sec-32fb-ss-1
part of: 32FB When suspension takes effect etc.
note: Suspension of therapeutic goods takes effect under certain conditions.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.350
asserts: therapeutic-goods-act-1989-sec-32fb-ss-1-norm

32FB(2) When suspension takes effect etc.
type: Concept
realized by: sec-32fb-ss-2
part of: 32FB When suspension takes effect etc.
note: Suspension duration
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.350
asserts: therapeutic-goods-act-1989-sec-32fb-ss-2-norm

32FB(3) When suspension takes effect etc.
type: Concept
realized by: sec-32fb-ss-3
part of: 32FB When suspension takes effect etc.
note: Secretary may extend period specified under subsection 32FA(4) by a further specified period not exceeding 6 months.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.350
asserts: therapeutic-goods-act-1989-sec-32fb-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32fb-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32fb-ss-3-norm
type: Permission
modality: Deontic
part of: 32FB(3) When suspension takes effect etc.
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32fb-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permission to extend period
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32FB(4) When suspension takes effect etc.
type: Concept
realized by: sec-32fb-ss-4
part of: 32FB When suspension takes effect etc.
note: Publish notice of extension particulars
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.350
asserts: therapeutic-goods-act-1989-sec-32fb-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32fb-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32fb-ss-4-norm
type: Obligation
modality: Deontic
part of: 32FB(4) When suspension takes effect etc.
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32fb-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must publish notice
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32FB(5) When suspension takes effect etc.
type: Concept
realized by: sec-32fb-ss-5
part of: 32FB When suspension takes effect etc.
note: Notice under subsection (3) is not a legislative instrument.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.350
asserts: therapeutic-goods-act-1989-sec-32fb-ss-5-norm

therapeutic-goods-act-1989-sec-32fb-ss-5-norm
type: Obligation
modality: Deontic
part of: 32FB(5) When suspension takes effect etc.
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32FC Revocation of suspension
type: Concept
realized by: sec-32fc
has part: 32FC(1) Revocation of suspension
has part: 32FC(2) Revocation of suspension
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.351

32FC(1) Revocation of suspension
type: Concept
realized by: sec-32fc-ss-1
part of: 32FC Revocation of suspension
note: Secretary must revoke suspension under certain conditions.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.351
asserts: therapeutic-goods-act-1989-sec-32fc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32fc-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32fc-ss-1-norm
type: Obligation
modality: Deontic
part of: 32FC(1) Revocation of suspension
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32fc-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Must
logic summary: Secretary must revoke suspension
premise text: Ground on which biological was suspended no longer applies
conclusion text: Revocation required
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32FC(2) Revocation of suspension
type: Concept
realized by: sec-32fc-ss-2
part of: 32FC Revocation of suspension
note: Exercise of power by Secretary
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.351
asserts: therapeutic-goods-act-1989-sec-32fc-ss-2-norm

therapeutic-goods-act-1989-sec-32fc-ss-2-norm
type: Permission
modality: Deontic
part of: 32FC(2) Revocation of suspension
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32FD Effect of suspension
type: Concept
realized by: sec-32fd
note: Dealing in a biological not included in the Register may be a criminal offence or contravene a civil penalty provision.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.352
asserts: therapeutic-goods-act-1989-sec-32fd-norm
asserts: therapeutic-goods-act-1989-sec-32fd-logic-deontic-1

therapeutic-goods-act-1989-sec-32fd-norm
type: Prohibition
modality: Deontic
part of: 32FD Effect of suspension
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32fd-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits dealing in a biological not included in the Register.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32G What this Division is about
type: Concept
realized by: sec-32g
note: Secretary may cancel inclusions of biologicals in the Register under certain circumstances.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.353
asserts: therapeutic-goods-act-1989-sec-32g-norm

32GA Immediate cancellation of biological from the Register in
type: Concept
realized by: sec-32ga
note: Cancellation of biological entry from Register under specified circumstances.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.353
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

therapeutic-goods-act-1989-sec-32ga-norm
type: Prohibition
modality: Deontic
part of: 32GA Immediate cancellation of biological from the Register in
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ga-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition on biological entry
premise text: The Secretary may cancel the entry of a biological from the Register.
conclusion text: The entry must be cancelled.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ga-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Temporal Interval
logic summary: Temporal interval for cancellation
premise text: The cancellation is effective immediately.
conclusion text: The cancellation is effective from the date of notice.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

32GB Immediate cancellation of biological from the Register after
type: Concept
realized by: sec-32gb
has part: 32GB(1) Immediate cancellation of biological from the Register after
has part: 32GB(2) Immediate cancellation of biological from the Register after
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.355

32GB(1) Immediate cancellation of biological from the Register after
type: Concept
realized by: sec-32gb-ss-1
part of: 32GB Immediate cancellation of biological from the Register after
note: The Secretary may cancel a biological entry from the Register if the person fails to comply with a notice.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.355
asserts: therapeutic-goods-act-1989-sec-32gb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32gb-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32gb-ss-1-norm
type: Obligation
modality: Deontic
part of: 32GB(1) Immediate cancellation of biological from the Register after
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32gb-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: obligation
logic summary: The Secretary has an obligation to cancel the biological entry.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32GB(2) Immediate cancellation of biological from the Register after
type: Concept
realized by: sec-32gb-ss-2
part of: 32GB Immediate cancellation of biological from the Register after
note: Secretary must provide notice to person before cancelling biological entry from Register.
description: Notice under section 32JA
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.355
asserts: therapeutic-goods-act-1989-sec-32gb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32gb-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32gb-ss-2-norm
type: Obligation
modality: Deontic
part of: 32GB(2) Immediate cancellation of biological from the Register after
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32gb-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Secretary must provide notice
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32GC Cancellation of biological from the Register after notice of
type: Concept
realized by: sec-32gc
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.356

32GC(1) Cancellation of biological from the Register after notice of
type: Concept
realized by: sec-32gc-ss-1
part of: 32GC Cancellation of biological from the Register after notice of
note: Cancellation of biological from the Register after notice of unacceptable quality, safety or efficacy.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.356
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

therapeutic-goods-act-1989-sec-32gc-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32GC(1) Cancellation of biological from the Register after notice of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition
premise text: The Secretary may cancel the entry of the biological from the Register.
conclusion text: The person must not include the biological in the Register.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of advertising
premise text: The person contravenes subsection 32DQ(1) or (2) in relation to the biological.
conclusion text: The person must not advertise the biological.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of advertising by related body corporate
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.
conclusion text: The related body corporate must not advertise the biological.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of non-compliance with Therapeutic Goods Advertising Code
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.
conclusion text: The person must comply with the Therapeutic Goods Advertising Code.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of non-compliance with regulatory requirements
premise text: The person contravenes subsection 32DQ(1) or (2) in relation to the biological.
conclusion text: The person must comply with regulatory requirements.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32GC(2) Cancellation of biological from the Register after notice of
type: Concept
realized by: sec-32gc-ss-2
part of: 32GC Cancellation of biological from the Register after notice of
note: Secretary must inform person of proposed cancellation and invite written submissions.
description: written notice, written submissions
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.356
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

therapeutic-goods-act-1989-sec-32gc-ss-2-norm
type: Obligation
modality: Deontic
part of: 32GC(2) Cancellation of biological from the Register after notice of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32gc-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Secretary must inform person of proposed cancellation.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32gc-ss-2-logic-epistemic-2
type: LogicApplication
modality: Epistemic
operator: OBLIGES
logic summary: Secretary is obligated to inform person of proposed cancellation.
execution surface: modalities::epistemic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32gc-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: CONTAINS
logic summary: Cancellation must be made within a specified period after notice.
premise text: 28 days after day notice is given.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32gc-ss-2-logic-argumentation-4
type: LogicApplication
modality: Argumentation
operator: REQUIRES
logic summary: Person must provide written submissions in response to notice.
execution surface: modalities::argumentation
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32gc-ss-2-logic-alleninterval-5
type: LogicApplication
modality: AllenInterval
operator: DURING
logic summary: Cancellation period is specified as a duration after notice.
premise text: 28 days after day notice is given.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

32GC(3) Cancellation of biological from the Register after notice of
type: Concept
realized by: sec-32gc-ss-3
part of: 32GC Cancellation of biological from the Register after notice of
note: Secretary must consider submissions before making a decision on cancellation.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.356
asserts: therapeutic-goods-act-1989-sec-32gc-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32gc-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32gc-ss-3-norm
type: Obligation
modality: Deontic
part of: 32GC(3) Cancellation of biological from the Register after notice of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32gc-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must consider submissions
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32GC(4) Cancellation of biological from the Register after notice of
type: Concept
realized by: sec-32gc-ss-4
part of: 32GC Cancellation of biological from the Register after notice of
note: A notice under subsection (1) must not be a legislative instrument.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.356
asserts: therapeutic-goods-act-1989-sec-32gc-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32gc-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32gc-ss-4-norm
type: Obligation
modality: Deontic
part of: 32GC(4) Cancellation of biological from the Register after notice of
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32gc-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MustNot
logic summary: Prohibition of notice being a legislative instrument.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32GD Revocation of cancellation of biological upon request
type: Concept
realized by: sec-32gd
note: Request for revocation of cancellation of biological upon request
description: Application fee
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.357
asserts: therapeutic-goods-act-1989-sec-32gd-norm

therapeutic-goods-act-1989-sec-32gd-norm
type: Obligation
modality: Deontic
part of: 32GD Revocation of cancellation of biological upon request
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32GE Publication of cancellation of entry from Register
type: Concept
realized by: sec-32ge
note: Publish notice of cancellation from Register
description: Notice with particulars of cancellation
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.358
asserts: therapeutic-goods-act-1989-sec-32ge-norm
asserts: therapeutic-goods-act-1989-sec-32ge-logic-deontic-1

therapeutic-goods-act-1989-sec-32ge-norm
type: Obligation
modality: Deontic
part of: 32GE Publication of cancellation of entry from Register
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ge-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Publish notice
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32GF Date of effect of cancellation of entries from Register
type: Concept
realized by: sec-32gf
note: Date of effect of cancellation of entries from Register
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.359
asserts: therapeutic-goods-act-1989-sec-32gf-norm

32H What this Division is about
type: Concept
realized by: sec-32h
note: The Secretary may require a person to recall biologicals or inform the public about non-compliant biologicals.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.360
asserts: therapeutic-goods-act-1989-sec-32h-norm
asserts: therapeutic-goods-act-1989-sec-32h-logic-deontic-1

therapeutic-goods-act-1989-sec-32h-norm
type: Obligation
modality: Deontic
part of: 32H What this Division is about
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32h-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: require
logic summary: Imposes a duty on the Secretary to require recall or notification.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32HA Public notification, and recall, of biologicals
type: Concept
realized by: sec-32ha
note: The Secretary may impose requirements on a person supplying a biological if certain circumstances occur.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.360
asserts: therapeutic-goods-act-1989-sec-32ha-norm
asserts: therapeutic-goods-act-1989-sec-32ha-logic-deontic-1

therapeutic-goods-act-1989-sec-32ha-norm
type: Obligation
modality: Deontic
part of: 32HA Public notification, and recall, of biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ha-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Imposition of requirements is an obligation.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32HB Publication of requirements
type: Concept
realized by: sec-32hb
note: Secretary must publish notice after imposing requirement.
description: Notice setting out particulars of the requirement
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.364
asserts: therapeutic-goods-act-1989-sec-32hb-norm
asserts: therapeutic-goods-act-1989-sec-32hb-logic-deontic-1

therapeutic-goods-act-1989-sec-32hb-norm
type: Obligation
modality: Deontic
part of: 32HB Publication of requirements
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32hb-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to publish notice
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32HC Criminal offences for non-compliance with requirements
type: Concept
realized by: sec-32hc
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.364

32HC(1) Criminal offences for non-compliance with requirements
type: Concept
realized by: sec-32hc-ss-1
part of: 32HC Criminal offences for non-compliance with requirements
note: Non-compliance with requirements is a criminal offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.364
asserts: therapeutic-goods-act-1989-sec-32hc-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32hc-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32hc-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32HC(1) Criminal offences for non-compliance with requirements
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32hc-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits non-compliance with requirements.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32HC(4) Criminal offences for non-compliance with requirements
type: Concept
realized by: sec-32hc-ss-4
part of: 32HC Criminal offences for non-compliance with requirements
note: Non-compliance with section 32HA requirements is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.364
asserts: therapeutic-goods-act-1989-sec-32hc-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32hc-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32hc-ss-4-norm
type: Obligation
modality: Deontic
part of: 32HC(4) Criminal offences for non-compliance with requirements
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32hc-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: is
logic summary: Definition of obligation
conclusion text: The person commits an offence.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32HC(5) Criminal offences for non-compliance with requirements
type: Concept
realized by: sec-32hc-ss-5
part of: 32HC Criminal offences for non-compliance with requirements
note: Offence for non-compliance with requirements
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.364
asserts: therapeutic-goods-act-1989-sec-32hc-ss-5-norm
asserts: therapeutic-goods-act-1989-sec-32hc-ss-5-logic-deontic-1

therapeutic-goods-act-1989-sec-32hc-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits non-compliance with requirements
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32HC(6) Criminal offences for non-compliance with requirements
type: Concept
realized by: sec-32hc-ss-6
part of: 32HC Criminal offences for non-compliance with requirements
note: Offence of strict liability for non-compliance with requirements
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.364
asserts: therapeutic-goods-act-1989-sec-32hc-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-32hc-ss-6-logic-deontic-1

therapeutic-goods-act-1989-sec-32hc-ss-6-norm
type: Obligation
modality: Deontic
part of: 32HC(6) Criminal offences for non-compliance with requirements
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32hc-ss-6-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: is
logic summary: Definition of strict liability
premise text: (6) An offence against subsection (5)
conclusion text: An offence of strict liability
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32HD Civil penalty for non-compliance with requirements
type: Concept
realized by: sec-32hd
note: Civil penalty for non-compliance with requirements
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.365
asserts: therapeutic-goods-act-1989-sec-32hd-norm
asserts: therapeutic-goods-act-1989-sec-32hd-logic-deontic-1

therapeutic-goods-act-1989-sec-32hd-norm
type: Prohibition
modality: Deontic
part of: 32HD Civil penalty for non-compliance with requirements
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32hd-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits civil penalty for non-compliance
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32HE Powers of suspension and cancellation unaffected
type: Concept
realized by: sec-32he
note: Powers of suspension and cancellation unaffected
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.365
asserts: therapeutic-goods-act-1989-sec-32he-norm

32HF Saving of other laws
type: Concept
realized by: sec-32hf
note: No exclusion or limitation of other laws
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.365
asserts: therapeutic-goods-act-1989-sec-32hf-norm
asserts: therapeutic-goods-act-1989-sec-32hf-logic-deontic-1

therapeutic-goods-act-1989-sec-32hf-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: prohibition
logic summary: Prohibiting exclusion
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32J What this Division is about
type: Concept
realized by: sec-32j
note: The Secretary may seek information or documents from applicants, biologicals included in the Register, and suppliers of exempted biologicals.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.366
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

therapeutic-goods-act-1989-sec-32j-norm
type: Obligation
modality: Deontic
part of: 32J What this Division is about
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32j-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: The Secretary may seek information or documents.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32j-logic-epistemic-2
type: LogicApplication
modality: Epistemic
operator: must provide
logic summary: There are penalties for failing to comply with a notice.
execution surface: modalities::epistemic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32j-logic-ltl-3
type: LogicApplication
modality: LTL
operator: for
logic summary: The Secretary may seek information or documents from applicants, biologicals included in the Register, and suppliers of exempted biologicals.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32j-logic-argumentation-4
type: LogicApplication
modality: Argumentation
operator: for
logic summary: There are criminal offences for failing to comply with a notice and civil penalties for giving false or misleading information or documents.
execution surface: modalities::argumentation
confidence: 1.0000
curation status: Proposed

32JA Secretary may require information or documents
type: Concept
realized by: sec-32ja
note: The Secretary may require information or documents from a person.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.366
asserts: therapeutic-goods-act-1989-sec-32ja-norm
asserts: therapeutic-goods-act-1989-sec-32ja-logic-deontic-1

therapeutic-goods-act-1989-sec-32ja-norm
type: Obligation
modality: Deontic
part of: 32JA Secretary may require information or documents
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ja-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MAY
logic summary: May require
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JB Criminal offences for failing to comply with a notice etc.
type: Concept
realized by: sec-32jb
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.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.368

32JB(1) Criminal offences for failing to comply with a notice etc.
type: Concept
realized by: sec-32jb-ss-1
part of: 32JB Criminal offences for failing to comply with a notice etc.
note: Failure to comply with a notice results in an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.368
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32jb-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32JB(1) Criminal offences for failing to comply with a notice etc.
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jb-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits failing to comply with a notice.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JB(1A) Criminal offences for failing to comply with a notice etc.
type: Concept
realized by: sec-32jb-ss-1a
part of: 32JB Criminal offences for failing to comply with a notice etc.
note: Defendant bears evidential burden for reasonable excuse
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.368
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

therapeutic-goods-act-1989-sec-32jb-ss-1a-norm
type: Obligation
modality: Deontic
part of: 32JB(1A) Criminal offences for failing to comply with a notice etc.
borne by: NaturalPerson
scope note: borne by: NaturalPerson
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jb-ss-1a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Defendant has an obligation to provide a reasonable excuse
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32jb-ss-1a-logic-epistemic-2
type: LogicApplication
modality: Epistemic
operator: Burden of Proof
logic summary: Defendant bears the burden of proof for their excuse
execution surface: modalities::epistemic
confidence: 1.0000
curation status: Proposed

32JB(1B) Criminal offences for failing to comply with a notice etc.
type: Concept
realized by: sec-32jb-ss-1b
part of: 32JB Criminal offences for failing to comply with a notice etc.
note: Failure to comply with a notice results in an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.368
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

therapeutic-goods-act-1989-sec-32jb-ss-1b-norm
type: Prohibition
modality: Deontic
part of: 32JB(1B) Criminal offences for failing to comply with a notice etc.
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jb-ss-1b-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits failing to comply with a notice.
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.
conclusion text: Penalty: 100 penalty units.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32jb-ss-1b-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes an obligation to comply with a notice.
premise text: (c) the person fails to comply with the notice.
conclusion text: Penalty: 100 penalty units.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32jb-ss-1b-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: Overlaps
logic summary: Defines the temporal interval during which the obligation to comply applies.
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

32JB(1C) Criminal offences for failing to comply with a notice etc.
type: Concept
realized by: sec-32jb-ss-1c
part of: 32JB Criminal offences for failing to comply with a notice etc.
note: Offence of strict liability for failing to comply with a notice.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.368
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1c-norm
asserts: therapeutic-goods-act-1989-sec-32jb-ss-1c-logic-deontic-1

therapeutic-goods-act-1989-sec-32jb-ss-1c-norm
type: Obligation
modality: Deontic
part of: 32JB(1C) Criminal offences for failing to comply with a notice etc.
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jb-ss-1c-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes an obligation on the state.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JB(1D) Criminal offences for failing to comply with a notice etc.
type: Concept
realized by: sec-32jb-ss-1d
part of: 32JB Criminal offences for failing to comply with a notice etc.
note: Defendant bears evidential burden for reasonable excuse
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.368
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

therapeutic-goods-act-1989-sec-32jb-ss-1d-norm
type: Obligation
modality: Deontic
part of: 32JB(1D) Criminal offences for failing to comply with a notice etc.
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jb-ss-1d-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: has
logic summary: Bearing of evidential burden
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32jb-ss-1d-logic-epistemic-2
type: LogicApplication
modality: Epistemic
operator: justification
logic summary: Reasonable excuse justification
execution surface: modalities::epistemic
confidence: 1.0000
curation status: Proposed

32JB(2) Criminal offences for failing to comply with a notice etc.
type: Concept
realized by: sec-32jb-ss-2
part of: 32JB Criminal offences for failing to comply with a notice etc.
note: Failure to comply with a notice results in an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.368
asserts: therapeutic-goods-act-1989-sec-32jb-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32jb-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32jb-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits failing to comply with a notice.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JC Civil penalty for giving false or misleading information or
type: Concept
realized by: sec-32jc
note: Giving false or misleading information in compliance with a notice is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.370
asserts: therapeutic-goods-act-1989-sec-32jc-norm
asserts: therapeutic-goods-act-1989-sec-32jc-logic-deontic-1

therapeutic-goods-act-1989-sec-32jc-norm
type: Prohibition
modality: Deontic
part of: 32JC Civil penalty for giving false or misleading information or
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jc-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of giving false or misleading information.
premise text: The person is given a notice under section 32JA.
conclusion text: The person contravenes this section if...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JD Self-incrimination
type: Concept
realized by: sec-32jd
has part: 32JD(1) Self-incrimination
has part: 32JD(2) Self-incrimination
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.371

32JD(1) Self-incrimination
type: Concept
realized by: sec-32jd-ss-1
part of: 32JD Self-incrimination
note: No excuse for self-incrimination
description: Information or document
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.371
asserts: therapeutic-goods-act-1989-sec-32jd-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32jd-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32jd-ss-1-norm
type: Obligation
modality: Deontic
part of: 32JD(1) Self-incrimination
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jd-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide information or document
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JD(2) Self-incrimination
type: Concept
realized by: sec-32jd-ss-2
part of: 32JD Self-incrimination
note: Exemptions from self-incrimination in certain cases
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.371
asserts: therapeutic-goods-act-1989-sec-32jd-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32jd-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32jd-ss-2-norm
type: Obligation
modality: Deontic
part of: 32JD(2) Self-incrimination
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jd-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Exemptions from self-incrimination
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JE Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32je
note: Secretary may require information about biologicals from exempt persons.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.371
asserts: therapeutic-goods-act-1989-sec-32je-norm
asserts: therapeutic-goods-act-1989-sec-32je-logic-deontic-1

therapeutic-goods-act-1989-sec-32je-norm
type: Obligation
modality: Deontic
part of: 32JE Secretary may require information etc. about biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32je-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Implies an obligation.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

32JF Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jf
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.373

32JF(1) Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jf-ss-1
part of: 32JF Secretary may require information etc. about biologicals
note: Secretary may require information about biologicals
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.373
asserts: therapeutic-goods-act-1989-sec-32jf-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32jf-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32jf-ss-1-norm
type: Obligation
modality: Deontic
part of: 32JF(1) Secretary may require information etc. about biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jf-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: requires
logic summary: Requires information from a person
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JF(2) Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jf-ss-2
part of: 32JF Secretary may require information etc. about biologicals
note: The Secretary may require information or documents from a person.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.373
asserts: therapeutic-goods-act-1989-sec-32jf-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32jf-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32jf-ss-2-norm
type: Obligation
modality: Deontic
part of: 32JF(2) Secretary may require information etc. about biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jf-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Implies an obligation.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JF(3) Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jf-ss-3
part of: 32JF Secretary may require information etc. about biologicals
note: Must provide information within a specified period and in a specified form.
description: true
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.373
asserts: therapeutic-goods-act-1989-sec-32jf-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32jf-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32jf-ss-3-norm
type: Obligation
modality: Deontic
part of: 32JF(3) Secretary may require information etc. about biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jf-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST PROVIDE
logic summary: Must provide information within a specified period and in a specified form.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JF(4) Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jf-ss-4
part of: 32JF Secretary may require information etc. about biologicals
note: The form may require or permit the information to be given, or the documents to be produced, in accordance with specified software requirements.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.373
asserts: therapeutic-goods-act-1989-sec-32jf-ss-4-norm

therapeutic-goods-act-1989-sec-32jf-ss-4-norm
type: Permission
modality: Deontic
part of: 32JF(4) Secretary may require information etc. about biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32JG Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jg
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.374

32JG(1) Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jg-ss-1
part of: 32JG Secretary may require information etc. about biologicals
note: The Secretary may require information from a person granted an approval under subsection 32CK(1) in relation to a biological.
description: specified information or documents relating to the supply, handling, monitoring of the supply, and results of the supply of the biological
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.374
asserts: therapeutic-goods-act-1989-sec-32jg-ss-1-norm

therapeutic-goods-act-1989-sec-32jg-ss-1-norm
type: Obligation
modality: Deontic
part of: 32JG(1) Secretary may require information etc. about biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32JG(2) Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jg-ss-2
part of: 32JG Secretary may require information etc. about biologicals
note: The Secretary may require information etc. about biologicals.
description: specified information or documents relating to the use of the biological
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.374
asserts: therapeutic-goods-act-1989-sec-32jg-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32jg-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32jg-ss-2-norm
type: Obligation
modality: Deontic
part of: 32JG(2) Secretary may require information etc. about biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jg-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MAY
logic summary: The Secretary may require information etc.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JG(3) Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jg-ss-3
part of: 32JG Secretary may require information etc. about biologicals
note: The Secretary may require specified information or documents from a person granted an authority under subsection 32CM(1) in relation to a biological.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.374
asserts: therapeutic-goods-act-1989-sec-32jg-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32jg-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32jg-ss-3-norm
type: Obligation
modality: Deontic
part of: 32JG(3) Secretary may require information etc. about biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jg-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MAY
logic summary: The Secretary may require specified information or documents.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JG(3A) Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jg-ss-3a
part of: 32JG Secretary may require information etc. about biologicals
note: Secretary may require specified information or documents from a person authorized to supply a biological.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.374
asserts: therapeutic-goods-act-1989-sec-32jg-ss-3a-norm
asserts: therapeutic-goods-act-1989-sec-32jg-ss-3a-logic-deontic-1

therapeutic-goods-act-1989-sec-32jg-ss-3a-norm
type: Obligation
modality: Deontic
part of: 32JG(3A) Secretary may require information etc. about biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jg-ss-3a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MAY
logic summary: Implies an obligation.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JG(4) Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jg-ss-4
part of: 32JG Secretary may require information etc. about biologicals
note: Must provide information or documents within a specified period and in a specified form.
description: true
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.374
asserts: therapeutic-goods-act-1989-sec-32jg-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32jg-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32jg-ss-4-norm
type: Obligation
modality: Deontic
part of: 32JG(4) Secretary may require information etc. about biologicals
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jg-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide information or documents within a specified period and in a specified form.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JH Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jh
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.376

32JH(1) Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jh-ss-1
part of: 32JH Secretary may require information etc. about biologicals
note: The Secretary may require information about a biological.
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.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.376
asserts: therapeutic-goods-act-1989-sec-32jh-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32jh-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32jh-ss-1-norm
type: Obligation
modality: Deontic
part of: 32JH(1) Secretary may require information etc. about biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jh-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MAY
logic summary: The Secretary may require information.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JH(2) Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jh-ss-2
part of: 32JH Secretary may require information etc. about biologicals
note: Must provide information or documents within a specified period and in the form specified by the notice.
description: true
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.376
asserts: therapeutic-goods-act-1989-sec-32jh-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32jh-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32jh-ss-2-norm
type: Obligation
modality: Deontic
part of: 32JH(2) Secretary may require information etc. about biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jh-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Must provide information or documents within a specified period and in the form specified by the notice.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JH(3) Secretary may require information etc. about biologicals
type: Concept
realized by: sec-32jh-ss-3
part of: 32JH Secretary may require information etc. about biologicals
note: The form may require or permit the information to be given, or the documents to be produced in accordance with specified software requirements.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.376
asserts: therapeutic-goods-act-1989-sec-32jh-ss-3-norm

therapeutic-goods-act-1989-sec-32jh-ss-3-norm
type: Permission
modality: Deontic
part of: 32JH(3) Secretary may require information etc. about biologicals
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

32JI Criminal offences for failing to comply with a notice etc.
type: Concept
realized by: sec-32ji
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.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.377

32JI(1) Criminal offences for failing to comply with a notice etc.
type: Concept
realized by: sec-32ji-ss-1
part of: 32JI Criminal offences for failing to comply with a notice etc.
note: Failure to comply with a notice results in an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.377
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

therapeutic-goods-act-1989-sec-32ji-ss-1-norm
type: Prohibition
modality: Deontic
part of: 32JI(1) Criminal offences for failing to comply with a notice etc.
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ji-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits failing to comply with a notice.
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.
conclusion text: Penalty: 500 penalty units.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ji-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Overlaps
logic summary: Defines a temporal interval during which failing to comply with a notice results in an offence.
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.
conclusion text: ...and penalty: 500 penalty units.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ji-ss-1-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Recurrently
logic summary: Defines a recurring obligation to comply with notices.
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.
conclusion text: ...and penalty: 500 penalty units.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ji-ss-1-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes an obligation on persons to comply with notices.
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.
conclusion text: ...and penalty: 500 penalty units.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ji-ss-1-logic-argumentation-5
type: LogicApplication
modality: Argumentation
operator: Implication
logic summary: Justifies the imposition of a penalty for failing to comply with notices.
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.
conclusion text: ...and penalty: 500 penalty units.
execution surface: modalities::argumentation
confidence: 1.0000
curation status: Proposed

32JI(1A) Criminal offences for failing to comply with a notice etc.
type: Concept
realized by: sec-32ji-ss-1a
part of: 32JI Criminal offences for failing to comply with a notice etc.
note: Failure to comply with a notice results in an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.377
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

therapeutic-goods-act-1989-sec-32ji-ss-1a-norm
type: Prohibition
modality: Deontic
part of: 32JI(1A) Criminal offences for failing to comply with a notice etc.
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits failing to comply with a notice.
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.
conclusion text: Penalty: 100 penalty units.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Overlaps
logic summary: Notices issued under sections 32JE, 32JF, 32JG or 32JH overlap with the offence.
premise text: (1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Repeats
logic summary: Notice must be repeated for each failure to comply.
premise text: (1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and
execution surface: modalities::temporal_ltl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes an obligation to comply with the notice.
premise text: (1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits failure to comply with the notice.
premise text: (1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

32JI(1B) Criminal offences for failing to comply with a notice etc.
type: Concept
realized by: sec-32ji-ss-1b
part of: 32JI Criminal offences for failing to comply with a notice etc.
note: Offence of strict liability for failing to comply with a notice
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.377
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1b-norm
asserts: therapeutic-goods-act-1989-sec-32ji-ss-1b-logic-deontic-1

therapeutic-goods-act-1989-sec-32ji-ss-1b-norm
type: Prohibition
modality: Deontic
part of: 32JI(1B) Criminal offences for failing to comply with a notice etc.
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ji-ss-1b-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits an offence of strict liability
premise text: (1B) An offence against subsection (1A)
conclusion text: An offence of strict liability
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JI(2) Criminal offences for failing to comply with a notice etc.
type: Concept
realized by: sec-32ji-ss-2
part of: 32JI Criminal offences for failing to comply with a notice etc.
note: Failing to comply with a notice results in an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.377
asserts: therapeutic-goods-act-1989-sec-32ji-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32ji-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32ji-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits failing to comply with a notice.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JI(3) Criminal offences for failing to comply with a notice etc.
type: Concept
realized by: sec-32ji-ss-3
part of: 32JI Criminal offences for failing to comply with a notice etc.
note: Offence for failing to comply with a notice
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.377
asserts: therapeutic-goods-act-1989-sec-32ji-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32ji-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32ji-ss-3-norm
type: Prohibition
modality: Deontic
part of: 32JI(3) Criminal offences for failing to comply with a notice etc.
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32ji-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits failure to comply with a notice
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JJ Civil penalty for giving false or misleading information or
type: Concept
realized by: sec-32jj
note: Giving false or misleading information in compliance with a notice is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.378
asserts: therapeutic-goods-act-1989-sec-32jj-norm
asserts: therapeutic-goods-act-1989-sec-32jj-logic-deontic-1

therapeutic-goods-act-1989-sec-32jj-norm
type: Prohibition
modality: Deontic
part of: 32JJ Civil penalty for giving false or misleading information or
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jj-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits giving false or misleading information in compliance with a notice.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JK Self-incrimination
type: Concept
realized by: sec-32jk
has part: 32JK(1) Self-incrimination
has part: 32JK(2) Self-incrimination
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.378

32JK(1) Self-incrimination
type: Concept
realized by: sec-32jk-ss-1
part of: 32JK Self-incrimination
note: No excuse for self-incrimination
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.378
asserts: therapeutic-goods-act-1989-sec-32jk-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-32jk-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-32jk-ss-1-norm
type: Obligation
modality: Deontic
part of: 32JK(1) Self-incrimination
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jk-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Obligation to provide information
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JK(2) Self-incrimination
type: Concept
realized by: sec-32jk-ss-2
part of: 32JK Self-incrimination
note: Exemptions from self-incrimination in certain circumstances
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.378
asserts: therapeutic-goods-act-1989-sec-32jk-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32jk-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32jk-ss-2-norm
type: Obligation
modality: Deontic
part of: 32JK(2) Self-incrimination
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jk-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Exemptions from self-incrimination
premise text: None
conclusion text: None
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JL Secretary may inspect and copy documents
type: Concept
realized by: sec-32jl
note: Inspect and copy documents produced under certain sections.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.379
asserts: therapeutic-goods-act-1989-sec-32jl-norm
asserts: therapeutic-goods-act-1989-sec-32jl-logic-deontic-1

therapeutic-goods-act-1989-sec-32jl-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: can
logic summary: Permits inspection and copying.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

32JM Secretary may retain documents
type: Concept
realized by: sec-32jm
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.379

32JM(1) Secretary may retain documents
type: Concept
realized by: sec-32jm-ss-1
part of: 32JM Secretary may retain documents
note: The Secretary may retain documents for a reasonable period.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.379
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

therapeutic-goods-act-1989-sec-32jm-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to retain documents
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-32jm-ss-1-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Temporal relation to document retention
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

32JM(2) Secretary may retain documents
type: Concept
realized by: sec-32jm-ss-2
part of: 32JM Secretary may retain documents
note: Secretary must provide a copy of the document upon request.
description: true
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.379
asserts: therapeutic-goods-act-1989-sec-32jm-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-32jm-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-32jm-ss-2-norm
type: Obligation
modality: Deontic
part of: 32JM(2) Secretary may retain documents
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jm-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Secretary has an obligation to provide a copy of the document.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JM(3) Secretary may retain documents
type: Concept
realized by: sec-32jm-ss-3
part of: 32JM Secretary may retain documents
note: The certified copy must be received as evidence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.379
asserts: therapeutic-goods-act-1989-sec-32jm-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-32jm-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-32jm-ss-3-norm
type: Obligation
modality: Deontic
part of: 32JM(3) Secretary may retain documents
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-32jm-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Obligation to receive certified copy
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

32JM(4) Secretary may retain documents
type: Concept
realized by: sec-32jm-ss-4
part of: 32JM Secretary may retain documents
note: Must provide access to documents for inspection and copying.
description: Yes
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.379
asserts: therapeutic-goods-act-1989-sec-32jm-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-32jm-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-32jm-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Obligation to provide access
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

33A Part does not apply to a medical device
type: Concept
realized by: sec-33a
note: Part does not apply to medical devices.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.380
asserts: therapeutic-goods-act-1989-sec-33a-norm

33B Application of this Part to biologicals
type: Concept
realized by: sec-33b
note: This Part does not apply to a Class 1 biological.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.380
asserts: therapeutic-goods-act-1989-sec-33b-norm

34 Exempt goods and exempt persons
type: Concept
realized by: sec-34
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.380

34(1) Exempt goods and exempt persons
type: Concept
realized by: sec-34-ss-1
part of: 34 Exempt goods and exempt persons
note: Therapeutic goods may be exempt from the operation of this Part.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.380
asserts: therapeutic-goods-act-1989-sec-34-ss-1-norm

therapeutic-goods-act-1989-sec-34-ss-1-norm
type: Obligation
modality: Deontic
part of: 34(1) Exempt goods and exempt persons
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

34(2) Exempt goods and exempt persons
type: Concept
realized by: sec-34-ss-2
part of: 34 Exempt goods and exempt persons
note: Exempts a person from the operation of this Part in relation to the manufacture or a step in the manufacture of therapeutic goods.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.380
asserts: therapeutic-goods-act-1989-sec-34-ss-2-norm

34(3) Exempt goods and exempt persons
type: Concept
realized by: sec-34-ss-3
part of: 34 Exempt goods and exempt persons
note: Revocation of exemption takes effect after 28 days
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.380
asserts: therapeutic-goods-act-1989-sec-34-ss-3-norm

35 Criminal offences relating to manufacturing therapeutic goods
type: Concept
realized by: sec-35
has part: 35(1) Criminal offences relating to manufacturing therapeutic goods
has part: 35(4) Criminal offences relating to manufacturing therapeutic goods
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.380

35(1) Criminal offences relating to manufacturing therapeutic goods
type: Concept
realized by: sec-35-ss-1
part of: 35 Criminal offences relating to manufacturing therapeutic goods
note: Manufacturing therapeutic goods without proper authorization is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.380
asserts: therapeutic-goods-act-1989-sec-35-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-35-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-35-ss-1-norm
type: Prohibition
modality: Deontic
part of: 35(1) Criminal offences relating to manufacturing therapeutic goods
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-35-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits the manufacture of therapeutic goods without proper authorization.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

35(4) Criminal offences relating to manufacturing therapeutic goods
type: Concept
realized by: sec-35-ss-4
part of: 35 Criminal offences relating to manufacturing therapeutic goods
note: Manufacturing therapeutic goods without proper license
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.380
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

therapeutic-goods-act-1989-sec-35-ss-4-norm
type: Prohibition
modality: Deontic
part of: 35(4) Criminal offences relating to manufacturing therapeutic goods
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits manufacturing therapeutic goods without license
premise text: (a) the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods...
conclusion text: ...and none of the following applies: (i) the goods are exempt goods;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits manufacturing therapeutic goods without proper license
premise text: (b) the goods are for supply for use in humans;
conclusion text: ...and none of the following applies: (i) the goods are exempt goods;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits manufacturing therapeutic goods without proper license
premise text: (c) none of the following applies:
conclusion text: ...and none of the following applies: (i) the goods are exempt goods;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits manufacturing therapeutic goods without proper license
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.
conclusion text: ...and none of the following applies: (i) the goods are exempt goods;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

35A Civil penalties relating to manufacturing therapeutic goods
type: Concept
realized by: sec-35a
note: Carrying out steps in manufacturing therapeutic goods at Australian premises is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.383
asserts: therapeutic-goods-act-1989-sec-35a-norm
asserts: therapeutic-goods-act-1989-sec-35a-logic-deontic-1

therapeutic-goods-act-1989-sec-35a-norm
type: Prohibition
modality: Deontic
part of: 35A Civil penalties relating to manufacturing therapeutic goods
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-35a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of manufacturing therapeutic goods at Australian premises.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

35B Criminal offences relating to breaching a condition of a licence
type: Concept
realized by: sec-35b
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.384

35B(1) Criminal offences relating to breaching a condition of a licence
type: Concept
realized by: sec-35b-ss-1
part of: 35B Criminal offences relating to breaching a condition of a licence
note: A person commits an offence if they hold a licence and breach a condition of the licence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.384
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

therapeutic-goods-act-1989-sec-35b-ss-1-norm
type: Obligation
modality: Deontic
part of: 35B(1) Criminal offences relating to breaching a condition of a licence
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: has
logic summary: Licence is a necessary condition for committing an offence.
premise text: The person holds a licence.
conclusion text: The person commits an offence.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: has
logic summary: Breach of the licence's condition is a necessary condition for committing an offence.
premise text: The act or omission has resulted in, will result in, or is likely to result in harm or injury to any person.
conclusion text: The person commits an offence.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: has
logic summary: Imprisonment for 5 years or 4,000 penalty units is a possible consequence of committing an offence.
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.
conclusion text: The penalty for committing an offence is imprisonment for 5 years or 4,000 penalty units.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: has
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.
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.
conclusion text: The court has discretion to acquit or convict a person of an offence.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

35B(4) Criminal offences relating to breaching a condition of a licence
type: Concept
realized by: sec-35b-ss-4
part of: 35B Criminal offences relating to breaching a condition of a licence
note: Breach of licence condition is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.384
asserts: therapeutic-goods-act-1989-sec-35b-ss-4-norm
asserts: therapeutic-goods-act-1989-sec-35b-ss-4-logic-deontic-1

therapeutic-goods-act-1989-sec-35b-ss-4-norm
type: Obligation
modality: Deontic
part of: 35B(4) Criminal offences relating to breaching a condition of a licence
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-35b-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: is
logic summary: Licence breach is a duty.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

35B(5) Criminal offences relating to breaching a condition of a licence
type: Concept
realized by: sec-35b-ss-5
part of: 35B Criminal offences relating to breaching a condition of a licence
note: Breach of licence condition is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.384
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

therapeutic-goods-act-1989-sec-35b-ss-5-norm
type: Obligation
modality: Deontic
part of: 35B(5) Criminal offences relating to breaching a condition of a licence
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-35b-ss-5-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: is
logic summary: Licence breach is a duty.
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.
conclusion text: The person is obligated to comply with the licence conditions.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-35b-ss-5-logic-linearlogic-2
type: LogicApplication
modality: LinearLogic
operator: =>
logic summary: Licence breach implies obligation to comply.
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.
conclusion text: The person is obligated to comply with the licence conditions.
execution surface: modalities::linear
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-35b-ss-5-logic-alleninterval-3
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Licence breach occurs during licence period.
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.
conclusion text: The licence breach occurs during the licence period.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

35B(6) Criminal offences relating to breaching a condition of a licence
type: Concept
realized by: sec-35b-ss-6
part of: 35B Criminal offences relating to breaching a condition of a licence
note: An offence against subsection (5) is an offence of strict liability.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.384
asserts: therapeutic-goods-act-1989-sec-35b-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-35b-ss-6-logic-deontic-1

therapeutic-goods-act-1989-sec-35b-ss-6-norm
type: Obligation
modality: Deontic
part of: 35B(6) Criminal offences relating to breaching a condition of a licence
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-35b-ss-6-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes a duty on the state.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

35C Civil penalty relating to breaching a condition of a licence
type: Concept
realized by: sec-35c
note: Breach of licence condition results in civil penalty
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.385
asserts: therapeutic-goods-act-1989-sec-35c-norm
asserts: therapeutic-goods-act-1989-sec-35c-logic-deontic-1

therapeutic-goods-act-1989-sec-35c-norm
type: Prohibition
modality: Deontic
part of: 35C Civil penalty relating to breaching a condition of a licence
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-35c-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: forbid
logic summary: Prohibits breaching a licence condition
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

36 Manufacturing principles
type: Concept
realized by: sec-36
note: The Minister may determine written principles for the manufacture of therapeutic goods.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.385
asserts: therapeutic-goods-act-1989-sec-36-norm
asserts: therapeutic-goods-act-1989-sec-36-logic-deontic-1

therapeutic-goods-act-1989-sec-36-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Permission to determine principles
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

37 Application for licence
type: Concept
realized by: sec-37
has part: 37(1) Application for licence
has part: 37(1A) Application for licence
has part: 37(1B) Application for licence
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.386

37(1) Application for licence
type: Concept
realized by: sec-37-ss-1
part of: 37 Application for licence
note: Application for licence must be made in accordance with a form approved by the Secretary.
description: a form approved by the Secretary, identification of therapeutic goods or classes of therapeutic goods, manufacturing sites, steps in manufacture, and control measures
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.386
asserts: therapeutic-goods-act-1989-sec-37-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-37-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-37-ss-1-norm
type: Obligation
modality: Deontic
part of: 37(1) Application for licence
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-37-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Application must be made in accordance with a form approved by the Secretary.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

37(1A) Application for licence
type: Concept
realized by: sec-37-ss-1a
part of: 37 Application for licence
note: Application must relate to one manufacturing site only.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.386
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

therapeutic-goods-act-1989-sec-37-ss-1a-norm
type: Obligation
modality: Deontic
part of: 37(1A) Application for licence
borne by: LegalPerson
scope note: borne by: LegalPerson
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-37-ss-1a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligate
logic summary: Application must relate to one manufacturing site only.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-37-ss-1a-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Temporal relation between manufacturing sites
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

37(1B) Application for licence
type: Concept
realized by: sec-37-ss-1b
part of: 37 Application for licence
note: Applicant may identify multiple manufacturing sites in application.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.386
asserts: therapeutic-goods-act-1989-sec-37-ss-1b-norm

therapeutic-goods-act-1989-sec-37-ss-1b-norm
type: Permission
modality: Deontic
part of: 37(1B) Application for licence
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

38 Grant of licence
type: Concept
realized by: sec-38
note: Grant of licence for manufacturing therapeutic goods
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.388
asserts: therapeutic-goods-act-1989-sec-38-norm
asserts: therapeutic-goods-act-1989-sec-38-logic-deontic-1

therapeutic-goods-act-1989-sec-38-norm
type: Obligation
modality: Deontic
part of: 38 Grant of licence
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-38-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligate
logic summary: Grant of licence for manufacturing therapeutic goods
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

38A Guidelines for multi-site licences
type: Concept
realized by: sec-38a
note: The Secretary must make guidelines for multi-site licences.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.391
asserts: therapeutic-goods-act-1989-sec-38a-norm

38B Splitting multi-site licences
type: Concept
realized by: sec-38b
note: This section applies if a licence (the old licence):
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.391
asserts: therapeutic-goods-act-1989-sec-38b-norm

39 Term of licence
type: Concept
realized by: sec-39
has part: 39(1) Term of licence
has part: 39(2) Term of licence
has part: 39(3) Term of licence
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.394

39(1) Term of licence
type: Concept
realized by: sec-39-ss-1
part of: 39 Term of licence
note: Licence commencement and duration
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.394
asserts: therapeutic-goods-act-1989-sec-39-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-39-ss-1-logic-alleninterval-1

therapeutic-goods-act-1989-sec-39-ss-1-logic-alleninterval-1
type: LogicApplication
modality: AllenInterval
operator: Applicable
logic summary: Defines temporal interval for licence commencement
premise text: Commencement day is specified
conclusion text: Licence commences on specified day
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

39(2) Term of licence
type: Concept
realized by: sec-39-ss-2
part of: 39 Term of licence
note: Licence ceases to be in force if goods cease to be exempt under section 18A.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.394
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

therapeutic-goods-act-1989-sec-39-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: cease
logic summary: Ceases to be in force
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;
conclusion text: the licence ceases to be in force in relation to those goods when those goods cease to be exempt under that section.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-39-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Temporal relation between exemption and licence revocation
premise text: (b) those goods cease to be exempt under that section before the licence is revoked;
conclusion text: when those goods cease to be exempt under that section.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-39-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: during
logic summary: Temporal relation between exemption and licence revocation
premise text: (b) those goods cease to be exempt under that section before the licence is revoked;
conclusion text: when those goods cease to be exempt under that section.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

39(3) Term of licence
type: Concept
realized by: sec-39-ss-3
part of: 39 Term of licence
note: Licence ceases in force if biological ceases to be exempt under section 32CB.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.394
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

therapeutic-goods-act-1989-sec-39-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: CEASES
logic summary: Ceases in force
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;
conclusion text: the licence ceases to be in force in relation to the biological when the biological ceases to be exempt under that section.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-39-ss-3-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: MEETS
logic summary: Biological ceases to be exempt under section 32CB before licence is revoked
premise text: (b) the biological ceases to be exempt under that section before the licence is revoked;
execution surface: modalities::interval_reasoning
confidence: 0.8000
curation status: Proposed

therapeutic-goods-act-1989-sec-39-ss-3-logic-ltl-3
type: LogicApplication
modality: LTL
operator: MEETS
logic summary: Biological ceases to be exempt under section 32CB at some point in time
premise text: (b) the biological ceases to be exempt under that section before the licence is revoked;
execution surface: modalities::temporal_ltl
confidence: 0.8000
curation status: Proposed

therapeutic-goods-act-1989-sec-39-ss-3-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: MEETS
logic summary: Licence ceases in force when biological ceases to be exempt under section 32CB
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;
execution surface: modalities::diffusion
confidence: 0.8000
curation status: Proposed

therapeutic-goods-act-1989-sec-39-ss-3-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: MEETS
logic summary: Licence ceases in force when biological ceases to be exempt under section 32CB
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;
execution surface: sparql_library::parsers::chk_parser
confidence: 0.8000
curation status: Proposed

40 Conditions of licences
type: Concept
realized by: sec-40
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.394

40(1) Conditions of licences
type: Concept
realized by: sec-40-ss-1
part of: 40 Conditions of licences
note: Conditions for granting a licence
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.394
asserts: therapeutic-goods-act-1989-sec-40-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-40-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-40-ss-1-norm
type: Obligation
modality: Deontic
part of: 40(1) Conditions of licences
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-40-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: shall
logic summary: Imposes an obligation on the State
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

40(2) Conditions of licences
type: Concept
realized by: sec-40-ss-2
part of: 40 Conditions of licences
note: Secretary may impose new conditions on a licence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.394
asserts: therapeutic-goods-act-1989-sec-40-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-40-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-40-ss-2-norm
type: Obligation
modality: Deontic
part of: 40(2) Conditions of licences
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-40-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: may
logic summary: Imposes obligation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

40(3) Conditions of licences
type: Concept
realized by: sec-40-ss-3
part of: 40 Conditions of licences
note: Conditions for imposing, varying or removing conditions on licences.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.394
asserts: therapeutic-goods-act-1989-sec-40-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-40-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-40-ss-3-norm
type: Obligation
modality: Deontic
part of: 40(3) Conditions of licences
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-40-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposition of obligations.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

40(3A) Conditions of licences
type: Concept
realized by: sec-40-ss-3a
part of: 40 Conditions of licences
note: The earlier day must not be earlier than the day the notice is given to the person.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.394
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

therapeutic-goods-act-1989-sec-40-ss-3a-norm
type: Obligation
modality: Deontic
part of: 40(3A) Conditions of licences
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-40-ss-3a-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Necessity
logic summary: The earlier day must be on or after the notice day.
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.
conclusion text: (3A) For the purposes of paragraph (3)(b), the earlier day must be on or after the notice day.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-40-ss-3a-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: Meets
logic summary: The earlier day meets the notice day.
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.
conclusion text: (3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-40-ss-3a-logic-ltl-3
type: LogicApplication
modality: LTL
operator: Meets
logic summary: The earlier day meets the notice day.
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.
conclusion text: (3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day.
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-40-ss-3a-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: Meets
logic summary: The earlier day meets the notice day.
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.
conclusion text: (3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day.
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-40-ss-3a-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: Meets
logic summary: The earlier day meets the notice day.
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.
conclusion text: (3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day.
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

40(4) Conditions of licences
type: Concept
realized by: sec-40-ss-4
part of: 40 Conditions of licences
note: Ensure goods conform to standards and follow manufacturing principles.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.394
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

therapeutic-goods-act-1989-sec-40-ss-4-norm
type: Obligation
modality: Deontic
part of: 40(4) Conditions of licences
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-40-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: must
logic summary: Ensure compliance with standards and principles.
premise text: The holder of the licence must ensure that...
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-40-ss-4-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Manufacturing principles apply during the manufacture of goods.
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;
conclusion text: ...the goods conform to any standard applicable to the goods; and...
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-40-ss-4-logic-ltl-3
type: LogicApplication
modality: LTL
operator: until
logic summary: Manufacturing principles apply until the circumstances prescribed by the regulations have occurred.
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;
conclusion text: ...the goods are a biological and are for supply after the circumstances prescribed by the regulations...
execution surface: modalities::temporal_ltl
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-40-ss-4-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: if
logic summary: Manufacturing principles apply if certain conditions are met.
premise text: The holder of the licence will: (a) ensure that:...
conclusion text: ...the goods conform to any standard applicable to the goods; and...
execution surface: modalities::diffusion
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-40-ss-4-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: has
logic summary: Goods have a certain property if they conform to standards.
premise text: (i) the goods conform to any standard applicable to the goods;
conclusion text: ...the goods are a biological and are for supply after the circumstances prescribed by the regulations...
execution surface: sparql_library::parsers::chk_parser
confidence: 1.0000
curation status: Proposed

40A Variation of manufacturing site authorisations—Secretary’s
type: Concept
realized by: sec-40a
has part: 40A(1) Variation of manufacturing site authorisations—Secretary’s
has part: 40A(2) Variation of manufacturing site authorisations—Secretary’s
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.397

40A(1) Variation of manufacturing site authorisations—Secretary’s
type: Concept
realized by: sec-40a-ss-1
part of: 40A Variation of manufacturing site authorisations—Secretary’s
note: The Secretary may vary a manufacturing site authorisation on their own initiative.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.397
asserts: therapeutic-goods-act-1989-sec-40a-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-40a-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-40a-ss-1-norm
type: Obligation
modality: Deontic
part of: 40A(1) Variation of manufacturing site authorisations—Secretary’s
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-40a-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: The Secretary has the power to vary a manufacturing site authorisation.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

40A(2) Variation of manufacturing site authorisations—Secretary’s
type: Concept
realized by: sec-40a-ss-2
part of: 40A Variation of manufacturing site authorisations—Secretary’s
note: Variation of manufacturing site authorisations—Secretary’s
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.397
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

therapeutic-goods-act-1989-sec-40a-ss-2-norm
type: Obligation
modality: Deontic
part of: 40A(2) Variation of manufacturing site authorisations—Secretary’s
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-40a-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: takes effect
logic summary: Effectiveness of variation
premise text: (2) A variation under subsection (1)
conclusion text: Chapter 3 Medicines and other therapeutic goods that are not medical devices
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-40a-ss-2-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: begins at
logic summary: Temporal relationship of variation effectiveness
premise text: (2) A variation under subsection (1)
conclusion text: Chapter 3 Medicines and other therapeutic goods that are not medical devices
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-40a-ss-2-logic-ltl-3
type: LogicApplication
modality: LTL
operator: is a trace of
logic summary: Recurring relationship of variation effectiveness
premise text: (2) A variation under subsection (1)
conclusion text: Chapter 3 Medicines and other therapeutic goods that are not medical devices
execution surface: modalities::temporal_ltl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-40a-ss-2-logic-diffusion-4
type: LogicApplication
modality: Diffusion
operator: diffuses to
logic summary: Spread of variation effectiveness
premise text: (2) A variation under subsection (1)
conclusion text: Chapter 3 Medicines and other therapeutic goods that are not medical devices
execution surface: modalities::diffusion
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-40a-ss-2-logic-cogai-5
type: LogicApplication
modality: CogAI
operator: is a capability of
logic summary: Artificial intelligence application for variation effectiveness
premise text: (2) A variation under subsection (1)
conclusion text: Chapter 3 Medicines and other therapeutic goods that are not medical devices
execution surface: sparql_library::parsers::chk_parser
confidence: 0.5000
curation status: Proposed

40B Variation of licences—application by licence holder
type: Concept
realized by: sec-40b
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.398

40B(1) Variation of licences—application by licence holder
type: Concept
realized by: sec-40b-ss-1
part of: 40B Variation of licences—application by licence holder
note: Licence holder may apply for variation of licence to cover additional manufacturing sites.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.398
asserts: therapeutic-goods-act-1989-sec-40b-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-40b-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-40b-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permission granted by the holder.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

40B(2) Variation of licences—application by licence holder
type: Concept
realized by: sec-40b-ss-2
part of: 40B Variation of licences—application by licence holder
note: Application requirements for variation of licences
description: information relating to manufacturing steps, quality control measures, and personnel
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.398
asserts: therapeutic-goods-act-1989-sec-40b-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-40b-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-40b-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Application must be made in accordance with a form approved by the Secretary
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

40B(3) Variation of licences—application by licence holder
type: Concept
realized by: sec-40b-ss-3
part of: 40B Variation of licences—application by licence holder
note: Variation of licences—application by licence holder
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.398
asserts: therapeutic-goods-act-1989-sec-40b-ss-3-norm

therapeutic-goods-act-1989-sec-40b-ss-3-norm
type: Permission
modality: Deontic
part of: 40B(3) Variation of licences—application by licence holder
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

40B(4) Variation of licences—application by licence holder
type: Concept
realized by: sec-40b-ss-4
part of: 40B Variation of licences—application by licence holder
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.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.398
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

therapeutic-goods-act-1989-sec-40b-ss-4-norm
type: Obligation
modality: Deontic
part of: 40B(4) Variation of licences—application by licence holder
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-40b-ss-4-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: The Secretary must vary the licence.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-40b-ss-4-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: AT A SPECIFIED MANUFACTURING SITE
logic summary: The variation is specified for each manufacturing site.
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

40B(5) Variation of licences—application by licence holder
type: Concept
realized by: sec-40b-ss-5
part of: 40B Variation of licences—application by licence holder
note: Variation of manufacturing site authorisations takes effect on the day notice is given to the holder.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.398
asserts: therapeutic-goods-act-1989-sec-40b-ss-5-norm

40B(6) Variation of licences—application by licence holder
type: Concept
realized by: sec-40b-ss-6
part of: 40B Variation of licences—application by licence holder
note: Holder of a licence may apply for variation of manufacturing site authorisation.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.398
asserts: therapeutic-goods-act-1989-sec-40b-ss-6-norm
asserts: therapeutic-goods-act-1989-sec-40b-ss-6-logic-deontic-1

therapeutic-goods-act-1989-sec-40b-ss-6-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permission to apply for variation
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

40B(7) Variation of licences—application by licence holder
type: Concept
realized by: sec-40b-ss-7
part of: 40B Variation of licences—application by licence holder
note: Application for variation of licence must be made in accordance with a form approved by the Secretary.
description: Form, application fee
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.398
asserts: therapeutic-goods-act-1989-sec-40b-ss-7-norm
asserts: therapeutic-goods-act-1989-sec-40b-ss-7-logic-deontic-1

therapeutic-goods-act-1989-sec-40b-ss-7-norm
type: Obligation
modality: Deontic
part of: 40B(7) Variation of licences—application by licence holder
borne by: LegalPerson
scope note: borne by: LegalPerson
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-40b-ss-7-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MUST
logic summary: Application must be made in accordance with a form approved by the Secretary.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

40B(8) Variation of licences—application by licence holder
type: Concept
realized by: sec-40b-ss-8
part of: 40B Variation of licences—application by licence holder
note: Secretary may vary manufacturing site authorisation upon application and payment of inspection fees.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.398
asserts: therapeutic-goods-act-1989-sec-40b-ss-8-norm
asserts: therapeutic-goods-act-1989-sec-40b-ss-8-logic-deontic-1

therapeutic-goods-act-1989-sec-40b-ss-8-norm
type: Permission
modality: Deontic
part of: 40B(8) Variation of licences—application by licence holder
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-40b-ss-8-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: May
logic summary: Permits variation of manufacturing site authorisation.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

40B(9) Variation of licences—application by licence holder
type: Concept
realized by: sec-40b-ss-9
part of: 40B Variation of licences—application by licence holder
note: Variation of licences—application by licence holder
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.398
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

therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: takes effect
logic summary: Effectiveness of variation
premise text: (9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder.
conclusion text: The variation takes effect on the specified day.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-40b-ss-9-logic-alleninterval-2
type: LogicApplication
modality: AllenInterval
operator: specifies temporal interval
logic summary: Temporal specification of variation
premise text: (9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder.
conclusion text: The variation's effectiveness is tied to a specific date.
execution surface: modalities::interval_reasoning
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-40b-ss-9-logic-ltl-3
type: LogicApplication
modality: LTL
operator: specifies trace
logic summary: Tracing variation application
premise text: (9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder.
conclusion text: The variation's application can be traced back to its notification date.
execution surface: modalities::temporal_ltl
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: applies to licence holder
logic summary: Application of variation obligation
premise text: (9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder.
conclusion text: The licence holder must comply with the variation's terms.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: specifies variation type
logic summary: Variation type specification
premise text: (9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder.
conclusion text: The variation's application is subject to specific rules.
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

41 Revocation and suspension of licences
type: Concept
realized by: sec-41
note: Revocation or suspension of a licence for specified reasons
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.401
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

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

therapeutic-goods-act-1989-sec-41-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits revocation or suspension of a licence for specified reasons
premise text: (1) Subject to subsection (2), the Secretary may, by notice in writing...
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-41-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibits breach of a condition of a manufacturing licence
premise text: (viii) breached a condition of a manufacturing licence;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

41AA Spent convictions scheme
type: Concept
realized by: sec-41aa
note: Relieves persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.404
asserts: therapeutic-goods-act-1989-sec-41aa-norm

41AB Secretary may require information or documents
type: Concept
realized by: sec-41ab
note: The Secretary may require a person to provide information or documents.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.404
asserts: therapeutic-goods-act-1989-sec-41ab-norm
asserts: therapeutic-goods-act-1989-sec-41ab-logic-deontic-1

therapeutic-goods-act-1989-sec-41ab-norm
type: Obligation
modality: Deontic
part of: 41AB Secretary may require information or documents
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-41ab-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: MAY
logic summary: The Secretary may require the person to provide information or documents.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

41AC Criminal offence for contravening a requirement in a notice
type: Concept
realized by: sec-41ac
note: Failure to comply with a notice results in an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.406
asserts: therapeutic-goods-act-1989-sec-41ac-norm
asserts: therapeutic-goods-act-1989-sec-41ac-logic-deontic-1

therapeutic-goods-act-1989-sec-41ac-norm
type: Obligation
modality: Deontic
part of: 41AC Criminal offence for contravening a requirement in a notice
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-41ac-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: obligation
logic summary: Obligation to comply with a notice.
premise text: Given a notice under section 41AB, the person must do an act.
conclusion text: Failure to do so results in an offence.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

41AD False or misleading information—offence
type: Concept
realized by: sec-41ad
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
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.406

41AD(1) False or misleading information—offence
type: Concept
realized by: sec-41ad-ss-1
part of: 41AD False or misleading information—offence
note: Providing false or misleading information to the Secretary is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.406
asserts: therapeutic-goods-act-1989-sec-41ad-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ad-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-41ad-ss-1-norm
type: Prohibition
modality: Deontic
part of: 41AD(1) False or misleading information—offence
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-41ad-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of providing false or misleading information.
premise text: The person gives information to the Secretary in compliance, or purported compliance, with the notice.
conclusion text: Providing false or misleading information is an offence.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

41AD(2) False or misleading information—offence
type: Concept
realized by: sec-41ad-ss-2
part of: 41AD False or misleading information—offence
note: Defendant bears evidential burden in relation to the matter.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.406
asserts: therapeutic-goods-act-1989-sec-41ad-ss-2-norm
asserts: therapeutic-goods-act-1989-sec-41ad-ss-2-logic-deontic-1

therapeutic-goods-act-1989-sec-41ad-ss-2-norm
type: Obligation
modality: Deontic
part of: 41AD(2) False or misleading information—offence
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-41ad-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Defendant bears evidential burden.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

41AD(3) False or misleading information—offence
type: Concept
realized by: sec-41ad-ss-3
part of: 41AD False or misleading information—offence
note: Defendant bears evidential burden in relation to matter in subsection (3)
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.406
asserts: therapeutic-goods-act-1989-sec-41ad-ss-3-norm
asserts: therapeutic-goods-act-1989-sec-41ad-ss-3-logic-deontic-1

therapeutic-goods-act-1989-sec-41ad-ss-3-norm
type: Obligation
modality: Deontic
part of: 41AD(3) False or misleading information—offence
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-41ad-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Defendant bears evidential burden
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

41AE False or misleading documents—offence
type: Concept
realized by: sec-41ae
has part: 41AE(1) False or misleading documents—offence
has part: 41AE(2) False or misleading documents—offence
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.407

41AE(1) False or misleading documents—offence
type: Concept
realized by: sec-41ae-ss-1
part of: 41AE False or misleading documents—offence
note: Producing false or misleading documents is an offence.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.407
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

therapeutic-goods-act-1989-sec-41ae-ss-1-norm
type: Prohibition
modality: Deontic
part of: 41AE(1) False or misleading documents—offence
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits producing false or misleading documents.
premise text: (1) A person commits an offence if...
conclusion text: ...the document is produced in compliance, or purported compliance, with a notice given under section 41AB.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes an obligation to not produce false or misleading documents.
premise text: (1) A person commits an offence if...
conclusion text: ...the document is produced in compliance, or purported compliance, with a notice given under section 41AB.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits knowing that the document is false or misleading.
premise text: (a) the person produces a document to the Secretary; and
conclusion text: ...the person does so knowing that the document is false or misleading;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits producing in compliance with a notice given under section 41AB.
premise text: (c) the document is produced in compliance, or purported compliance, with a notice given under section 41AB.
conclusion text: ...the document is produced in compliance, or purported compliance, with a notice given under section 41AB.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Imposes an obligation to not produce false or misleading documents.
premise text: (b) the person does so knowing that the document is false or misleading;
conclusion text: ...the document is produced in compliance, or purported compliance, with a notice given under section 41AB.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

41AE(2) False or misleading documents—offence
type: Concept
realized by: sec-41ae-ss-2
part of: 41AE False or misleading documents—offence
note: Defendant bears evidential burden in relation to the matter.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.407
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

therapeutic-goods-act-1989-sec-41ae-ss-2-norm
type: Obligation
modality: Deontic
part of: 41AE(2) False or misleading documents—offence
borne by: Agent
scope note: borne by: Agent
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-41ae-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: obligation
logic summary: Defendant bears evidential burden.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-41ae-ss-2-logic-epistemic-2
type: LogicApplication
modality: Epistemic
operator: evidential burden
logic summary: Defendant must provide evidence.
execution surface: modalities::epistemic
confidence: 1.0000
curation status: Proposed

41AF False or misleading information or documents—civil penalty
type: Concept
realized by: sec-41af
has part: 41AF(1) False or misleading information or documents—civil penalty
has part: 41AF(2) False or misleading information or documents—civil penalty
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.408

41AF(1) False or misleading information or documents—civil penalty
type: Concept
realized by: sec-41af-ss-1
part of: 41AF False or misleading information or documents—civil penalty
note: Giving false or misleading information in compliance with a notice is prohibited.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.408
asserts: therapeutic-goods-act-1989-sec-41af-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41af-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-41af-ss-1-norm
type: Prohibition
modality: Deontic
part of: 41AF(1) False or misleading information or documents—civil penalty
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-41af-ss-1-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibit
logic summary: Prohibition of false or misleading information
premise text: Notice under section 41AB
conclusion text: Civil penalty for contravention
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

41AF(2) False or misleading information or documents—civil penalty
type: Concept
realized by: sec-41af-ss-2
part of: 41AF False or misleading information or documents—civil penalty
note: Exemption from subsection (1) for documents accompanied by a written statement
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.408
asserts: therapeutic-goods-act-1989-sec-41af-ss-2-norm

41AG Self-incrimination
type: Concept
realized by: sec-41ag
has part: 41AG(1) Self-incrimination
has part: 41AG(2) Self-incrimination
has part: 41AG(3) Self-incrimination
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.409

41AG(1) Self-incrimination
type: Concept
realized by: sec-41ag-ss-1
part of: 41AG Self-incrimination
note: Regulations may make provision for the transfer of licences. No excuse for giving information or producing a document under a section 41AB notice
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.409
asserts: therapeutic-goods-act-1989-sec-41ag-ss-1-norm
asserts: therapeutic-goods-act-1989-sec-41ag-ss-1-logic-deontic-1

therapeutic-goods-act-1989-sec-41ag-ss-1-norm
type: Obligation
modality: Deontic
part of: 41AG(1) Self-incrimination
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

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

41AG(2) Self-incrimination
type: Concept
realized by: sec-41ag-ss-2
part of: 41AG Self-incrimination
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.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.409
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

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

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits admissibility of self-incrimination evidence in criminal proceedings.
premise text: (2) However, in the case of an individual:
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;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Prohibition
logic summary: Prohibits admissibility of self-incrimination evidence in pecuniary penalty order proceedings.
premise text: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision.
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: Permission
logic summary: Permits admissibility of self-incrimination evidence in certain proceedings.
premise text: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;
conclusion text: is admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-4
type: LogicApplication
modality: Deontic
operator: Permission
logic summary: Permits admissibility of self-incrimination evidence in certain proceedings.
premise text: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision.
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;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-5
type: LogicApplication
modality: Deontic
operator: Right
logic summary: Establishes right to self-incrimination protection.
premise text: (2) However, in the case of an individual:
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;
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-6
type: LogicApplication
modality: Deontic
operator: Undertaking
logic summary: Establishes undertaking to protect self-incrimination.
premise text: (2) However, in the case of an individual:
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-7
type: LogicApplication
modality: Deontic
operator: Permit
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.
execution surface: modalities::logic::deontic
confidence: 1.0000
curation status: Proposed

therapeutic-goods-act-1989-sec-41ag-ss-2-logic-alleninterval-8
type: LogicApplication
modality: AllenInterval
operator: during
logic summary: Temporal interval
execution surface: modalities::interval_reasoning
confidence: 1.0000
curation status: Proposed

41AG(3) Self-incrimination
type: Concept
realized by: sec-41ag-ss-3
part of: 41AG Self-incrimination
note: No self-incrimination for subsection (1) beyond what is limited by subsection (2)
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.409
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

therapeutic-goods-act-1989-sec-41ag-ss-3-norm
type: Obligation
modality: Deontic
part of: 41AG(3) Self-incrimination
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-1
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes obligation on the state
premise text: Subsection (2) does not limit subsection (1)
conclusion text: State must not incriminate under subsection (1)
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-2
type: LogicApplication
modality: Deontic
operator: Permission
logic summary: Permits self-incrimination under subsection (1)
premise text: Subsection (2) does not limit subsection (1)
conclusion text: State may incriminate under subsection (1)
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-3
type: LogicApplication
modality: Deontic
operator: Obligation
logic summary: Imposes obligation on the state to limit self-incrimination under subsection (1)
premise text: Subsection (2) does not limit subsection (1)
conclusion text: State must limit self-incrimination under subsection (1)
execution surface: modalities::logic::deontic
confidence: 0.5000
curation status: Proposed

41A Publication of list of manufacturers etc.
type: Concept
realized by: sec-41a
note: The Secretary must publish a list of licensed persons and goods.
curation status: Proposed
schema version: 2
proposed by: legis2cml
source: therapeutic-goods-act-1989.pdf, p.410
asserts: therapeutic-goods-act-1989-sec-41a-norm
asserts: therapeutic-goods-act-1989-sec-41a-logic-deontic-1

therapeutic-goods-act-1989-sec-41a-norm
type: Obligation
modality: Deontic
part of: 41A Publication of list of manufacturers etc.
borne by: State
scope note: borne by: State
deontic status: HeuristicDerived
curation status: Proposed

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