1 Short title
1 March 2024 and end on 31 March 2024 (see section 30EIA).
Notify Secretary of change to medicine shortage period within specified timeframe.
1(1) March 2024 and end on 31 March 2024 (see section 30EIA).
Temporal relation between notification and change
Notify Secretary of shortage resolution within 2 working days or 10 working days.
1(2) March 2024 and end on 31 March 2024 (see section 30EIA).
Should reasonably know of shortage end date.
Notification requirements for shortage of medicine in Australia.
1(3) March 2024 and end on 31 March 2024 (see section 30EIA).
10 Determination of standards
The Minister may make an order determining standards for therapeutic goods.
10(1) Determination of standards
Therapeutic goods or class of therapeutic goods
Establishing standards for therapeutic goods may be specified by reference to various factors.
10(2) Determination of standards
Establishing standards for therapeutic goods may be done within a specified time frame.
(2) Without limiting the generality of subsection (1), an order establishing a standard for therapeutic goods may...
...or (vii) a standard published by Standards Australia; or ...
Requires the specification of standards for therapeutic goods.
Requires the determination of matters relating to standards for therapeutic goods.
(b) require that a matter relating to the standard be determined in accordance with a particular test;...
Requires therapeutic goods or a class of therapeutic goods to be labelled or packaged in a manner specified in the order.
(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.
Specifies standards for therapeutic goods by reference to various factors.
Establishing standards for therapeutic goods may be done in a recurring manner.
Directs particulars to be set out on a label or package of therapeutic goods
10(3) Determination of standards
such particulars as are required by the order.
Establishes relation between particulars and order
(3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard...
Implies that particulars must be set out if order is established
Recognizes requirement to set out particulars
or (b) a container or package containing therapeutic goods or a class of therapeutic goods identified in the order;
(a) therapeutic goods or a class of therapeutic goods identified in the order;
Diffuses requirement to set out particulars
Variation or revocation of orders made under subsection (1)
10(3A) Determination of standards
May incorporate existing provisions from instruments or writings.
10(4) Determination of standards
Obligation to incorporate existing provisions
13 Special provisions relating to Ministerial standards and default
Statement in one publication is taken to include another statement.
13(1) Special provisions relating to Ministerial standards and default
Main statement includes other statement.
Disregard inconsistent requirements for therapeutic goods
13(2) Special provisions relating to Ministerial standards and default
...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act.
If two default standards apply to different parts of a class of therapeutic goods, the more restrictive standard applies.
13(3) Special provisions relating to Ministerial standards and default
(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).
(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;
the standard referred to in paragraph (a) does not apply in relation to the goods referred to in paragraph (b).
The excerpt defines a subclass relationship between two default standards.
(a) a default standard applies to a class of therapeutic goods; and (b) another default standard applies to only some of the therapeutic goods within that class;
Therapeutic goods with a mixture of ingredients or component parts do not have to meet the default standard.
13(4) Special provisions relating to Ministerial standards and default
The default standard does not apply if it is not applicable at the time of manufacture.
(4) If a default standard is applicable to one or more of the ingredients or one or more of the component parts; and
The standard does not apply if it is not applicable at the time of manufacture.
If a default standard is applicable to one or more of the ingredients or one or more of the component parts; and
(c) a default standard is applicable to the mixture or combination;
Minister may determine standard does not apply to therapeutic goods
13(5) Special provisions relating to Ministerial standards and default
Minister has the power to determine a standard does not apply
An order under subsection (5) is not a legislative instrument.
13(6) Special provisions relating to Ministerial standards and default
If multiple default standards apply, they are taken not to apply if goods conform with at least one but not all.
13(7) Special provisions relating to Ministerial standards and default
If a statement in a monograph refers to another statement, the main statement includes the other statement.
13A Special provisions relating to homoeopathic standards and
Includes other statement when referring to it
14 Criminal offences for importing, supplying or exporting goods
Importing therapeutic goods without consent is prohibited.
14(1) Criminal offences for importing, supplying or exporting goods
Prohibits the importation of therapeutic goods without consent.
14(4) Criminal offences for importing, supplying or exporting goods
The person commits an offence if they import therapeutic goods during this time.
The prohibition applies during the time of importing therapeutic goods.
(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.
The person commits an offence if they import therapeutic goods without consent.
Prohibits importing therapeutic goods without consent.
The person commits an offence if they import therapeutic goods repeatedly without consent.
The prohibition is recurring and applies to each instance of importing therapeutic goods.
14(4A) Criminal offences for importing, supplying or exporting goods
Criminal offences for importing, supplying or exporting goods
14(4B) Criminal offences for importing, supplying or exporting goods
Exemptions from subsection (1), (4) or (4A)
14(5A) Criminal offences for importing, supplying or exporting goods
Importing, supplying or exporting goods without a license is prohibited.
14(6) Criminal offences for importing, supplying or exporting goods
14A Civil penalties for importing, supplying or exporting goods that
Importing therapeutic goods without consent
14A(1) Civil penalties for importing, supplying or exporting goods that
Exempts biological goods from subsection (1) of section 14A(1)
14A(1A) Civil penalties for importing, supplying or exporting goods that
Customs Act 1901 applies to importation or exportation of goods if notified by Secretary.
14B Application of Customs Act 1901
Customs Act 1901 applies during importation or exportation.
Secretary's notification implies Customs Act 1901 applies.
Secretary notifies Comptroller-General of Customs.
Customs Act 1901 recognizes goods described as forfeited to the Crown.
Customs Act 1901 obliges the Secretary to notify Comptroller-General of Customs.
Secretary wishes Customs Act 1901 to apply.
Customs Act 1901 diffuses to goods described as forfeited to the Crown.
15 Criminal offences relating to breaching a condition of a consent
Secretary's consent may be given unconditionally or subject to conditions.
15(1) Criminal offences relating to breaching a condition of a consent
A person commits an offence if they breach a condition of consent.
15(2) Criminal offences relating to breaching a condition of a consent
The act and the harm are temporally related.
Temporal relationship between the act and the harm.
(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.
If the breach occurs, then the offence is committed.
Implication of breach on offence commitment.
Obligation to not breach a condition of consent.
Breaching a condition of consent is prohibited.
Prohibition on breaching a condition of consent.
Breach of consent condition results in an offence.
15(5) Criminal offences relating to breaching a condition of a consent
The temporal interval for breach of consent is not specified.
Temporal interval for breach of consent.
(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.
The cognitive AI application is not specified.
Cognitive AI application for consent conditions.
If an act or omission breaches a consent condition, it is an offence.
Obligation to comply with consent conditions.
The diffusion of obligation is not specified.
Diffusion of obligation to comply with consent conditions.
The temporal logic for consent conditions is not specified.
15(6) Criminal offences relating to breaching a condition of a consent
(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.
Artificial agent's knowledge for breach of consent.
Conditional diffusion for breach of consent.
Temporal constraint for breach of consent.
An offence against subsection (6) is an offence of strict liability.
15(7) Criminal offences relating to breaching a condition of a consent
15A Part does not apply to a medical device
Breach of consent condition results in civil penalty
15AA Civil penalty relating to breaching a condition of a consent
15AB Conditions relating to exceptional release of biologicals
Regulations may prescribe conditions for the supply of a biological after specified circumstances have occurred.
15AB(1) Conditions relating to exceptional release of biologicals
Conditions must apply only to the person supplying biologicals.
15AB(2) Conditions relating to exceptional release of biologicals
Committing an offence for breach of conditions
15AB(3) Conditions relating to exceptional release of biologicals
Penalty for contravention of this subsection:60 penalty units.
Temporal relationship between breach and penalty
(3) A person commits an offence if: (a) the person does an act or omits to do an act;
15B Application of this Part to a biological
Application of this Part to biologicals on and after commencement.
15B(1) Application of this Part to a biological
Continues application of this Part to biological goods after commencement.
15B(2) Application of this Part to a biological
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.
Temporal relationship between commencement and application.
(2) If, immediately before the commencement of this section,
the therapeutic goods that are a biological were registered goods or listed goods.
Temporal relationship between application and inclusion in Register.
Continuation of Part application to biological on commencement
15B(3) Application of this Part to a biological
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;
16 Therapeutic goods and gazetted groups
Imposes an obligation to classify therapeutic goods based on the specified criteria.
18 Exempt goods
Exempts therapeutic goods from operation of this Part
18(1) Exempt goods
(a) all therapeutic goods, except those included in a class of goods prescribed for the purposes of this paragraph;
(c) a specified class of therapeutic goods;
Exemptions apply only to specified classes of persons.
18(2) Exempt goods
relation to such classes of persons as are prescribed for the purposes of this subsection.
(2) An exemption in terms of paragraph (1)(a)
has effect only in relation to such classes of persons as are prescribed for the purposes of this subsection.
Revocation of exemption takes effect after 28 days
18(3) Exempt goods
After 28 days from the regulations' effective date
Defines temporal interval for revocation
Revocation takes effect on a specified day
18A Exemption because of emergency
Exemption from Division 2 operation due to emergency
18A(1) Exemption because of emergency
Exemption from goods under subsection (1) based on Minister's satisfaction
18A(1A) Exemption because of emergency
(1A) The Minister may exempt goods under subsection (1)
Exemption for stockpiling goods in emergency
18A(2) Exemption because of emergency
Creates an obligation for the state to make exemptions
19 Approvals or authorities for certain uses
Approval for therapeutic goods importation or exportation with conditions.
19(1) Approvals or authorities for certain uses
Approval conditions are subject to additional regulations.
19(1A) Approvals or authorities for certain uses
Information relating to goods subject to application, evaluation fee
Application for approval must be made to the Secretary and meet certain requirements.
19(2) Approvals or authorities for certain uses
Approval conditions may include charges for therapeutic goods.
19(3) Approvals or authorities for certain uses
Includes charges in approval conditions.
Reasons for decision (if not granting approval)
Notify applicant of decision on approval within 28 days.
19(4) Approvals or authorities for certain uses
Temporal interval for decision notification.
Conditions for experimental use of therapeutic goods in humans
19(4A) Approvals or authorities for certain uses
is subject to the conditions specified in the regulations
Use by a person for experimental purposes in humans
Request for variation of therapeutic goods approval
19(4B) Approvals or authorities for certain uses
Secretary may grant approval for importation or supply of therapeutic goods under certain conditions.
19A Approvals where unavailability etc. of therapeutic goods
...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);...
Approval is granted during a specific period
(1) The Secretary may, by notice in writing...
...an application under section 23 has been made for registration of the goods and the application has passed preliminary assessment;...
Approval is conditional on preliminary assessment of registration application
(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...
...the goods that are the subject of the application are registered or approved for general marketing...
...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...
Approval is conditional on certain conditions being met
(a) registered goods that could act as a substitute for the goods...
Approval applies to all therapeutic goods
Offences relating to importing, exporting, manufacturing or supplying goods for use in humans
19B Criminal offences relating to registration or listing etc. of
Prohibits importing, exporting, manufacturing or supplying goods for use in humans
19C Notice required to adduce evidence in support of exception
Defendant must be informed of requirements and given a copy of the section.
19C(1) Notice required to adduce evidence in support of exception
No evidence in support of exception can be adduced without notice.
19C(2) Notice required to adduce evidence in support of exception
Importing, exporting, manufacturing or supplying therapeutic goods for use in humans is prohibited.
19D Civil penalties relating to registration or listing etc. of imported,
Prohibition of importing, exporting, manufacturing or supplying therapeutic goods for use in humans.
2 Commencement
20 Criminal offences relating to notifying the Secretary and to
Importing, exporting, manufacturing, or supplying therapeutic goods without proper notification is prohibited.
20(1B) Criminal offences relating to notifying the Secretary and to
Manufacturer and premises must be notified to the Secretary.
20(1C) Criminal offences relating to notifying the Secretary and to
Manufacturer and premises must be notified
Importation of therapeutic goods into Australia without exemption breaches a condition.
20(2A) Criminal offences relating to notifying the Secretary and to
...if the importation breaches a condition of the exemption.
Identifies overlap between exemption conditions and importation.
...if the goods are exempt under section 18A; and...
Analyzes importation of therapeutic goods without exemption.
...breaches a condition of the exemption.
Prohibits importation of therapeutic goods without exemption.
Diffuses breach of exemption conditions.
Identifies recurring breach of exemption conditions.
Prohibition on strict liability for notifying the Secretary
20(2B) Criminal offences relating to notifying the Secretary and to
Importation of therapeutic goods exempt under section 18A breaches a condition, committing an offence.
20(2C) Criminal offences relating to notifying the Secretary and to
Importation occurs during the period when therapeutic goods are exempt.
(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.
Importation implies that therapeutic goods are not exempt.
Prohibits importation of therapeutic goods exempt under section 18A.
(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.
Importation spreads to other actions that breach a condition.
Importation is a recurring action that breaches a condition.
Offence of strict liability for notifying the Secretary and to
20(2D) Criminal offences relating to notifying the Secretary and to
Prohibits an offence under subsection (2C)
An offence under subsection (2C) is an offence of strict liability.
20A Civil penalty relating to the importation, exportation,
Importation, exportation, manufacture, or supply of therapeutic goods without proper notification.
20A(1) Civil penalty relating to the importation, exportation,
20A(2) Civil penalty relating to the importation, exportation,
Supplying therapeutic goods without proper authorization is prohibited.
21 Offence relating to wholesale supply
Prohibits supplying therapeutic goods without proper authorization.
Making false or misleading statements in certification is prohibited.
21A General criminal offences relating to this Part
The use of the medicine has resulted in, will result in, or is likely to result in harm or injury.
(i) the use of the medicine has resulted in, will result in, or is likely to result in, harm or injury to any person;
Prohibits making false or misleading statements in certification.
The statement is made in or in connection with a certification.
The use of the medicine would result in, or would be likely to result in, harm or injury.
(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.
21B General civil penalties relating to this Part
False statement in certification is prohibited
21B(1) General civil penalties relating to this Part
Falsely representing therapeutic goods is prohibited.
21B(2) General civil penalties relating to this Part
Prohibition of falsely representing therapeutic goods.
Representing false information about therapeutic goods is prohibited.
21B(3) General civil penalties relating to this Part
This subsection prohibits representing false information about therapeutic goods.
Prohibition of representing false information about therapeutic goods.
Representing false information is generally prohibited.
22 General offences relating to this Part
Do not misrepresent therapeutic goods registration numbers.
22(1) General offences relating to this Part
No registration number may be misrepresented.
Advertising therapeutic goods for an unaccepted indication without harm risk
22(2) General offences relating to this Part
Prohibition of advertising therapeutic goods for an unaccepted indication without harm risk
(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;
The therapeutic goods are included in the Register;
(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.
Classification of therapeutic goods based on indications
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;
Temporal tracing of advertising and harm risk
(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;
Advertising therapeutic goods for an unaccepted indication is prohibited.
22(3) General offences relating to this Part
(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.
Temporal interval of prohibited advertising.
Knowledge representation of prohibited advertising.
Prohibition of advertising therapeutic goods for an unaccepted indication.
Classification of advertising as a general offence relating to this Part.
Recurring trace of prohibited advertising.
22(5) General offences relating to this Part
Temporal interval for advertising therapeutic goods.
(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.
Classification of therapeutic goods into the Register.
Diffusion of advertising therapeutic goods for unaccepted indications.
Recurring trace of advertising therapeutic goods for unaccepted indications.
An offence against subsection (5) is an obligation.
22(5A) General offences relating to this Part
Committing an offence requires doing or omitting an act.
22(6) General offences relating to this Part
Act or omission overlaps with the provision's scope.
The act or omission must overlap with the provision's scope.
22A Criminal offences for false statements in applications for
Making false statements in applications for registration of therapeutic goods is a criminal offence.
22A(1) Criminal offences for false statements in applications for
Prohibits making false statements in applications for registration of therapeutic goods.
22A(4) Criminal offences for false statements in applications for
Making false statements in applications for registration of therapeutic goods is an offence.
22A(5) Criminal offences for false statements in applications for
22AA Civil penalty for breaching conditions
22AA(1) Civil penalty for breaching conditions
...and (c) the act or omission breaches a condition of the exemption.
Identifies overlapping conditions and exemptions
(b) the goods are exempt under section 18A;
Implies breach of conditions from exemptions
Analyzes breach of conditions from exemptions
(a) the person does an act or omits to do an act in relation to...
(1) A person contravenes this subsection...
Spreads breach of conditions to exemptions
22AA(2) Civil penalty for breaching conditions
(2) A person contravenes this subsection if...
False statements in applications for registration are prohibited.
22B Civil penalty for false statements in applications for registration
22C Applications for provisional determination
Application for provisional determination of a medicine
22C(1) Applications for provisional determination
Permission to apply for provisional determination
Relates to a medicine of a kind prescribed by the regulations
Information, application fee, and required documents
Application requirements for provisional determination
22C(2) Applications for provisional determination
Application must be made in accordance with a form approved by the Secretary
Application for provisional determination may be required or permitted
22C(3) Applications for provisional determination
Secretary must decide on provisional determination
22D Provisional determinations
22E Period during which provisional determination is in force
22E(1) Period during which provisional determination is in force
Defines initial period for provisional determination
22E(2) Period during which provisional determination is in force
Application for extension of initial period
22E(3) Period during which provisional determination is in force
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.
22E(4) Period during which provisional determination is in force
Application must be made within a certain time frame
(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.
Application must meet certain requirements
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.
Secretary must decide to extend or refuse initial period
22E(5) Period during which provisional determination is in force
Secretary may extend provisional determination period
22E(6) Period during which provisional determination is in force
Provide written notice of decision and reasons for refusal
22E(7) Period during which provisional determination is in force
Limitation on extension of provisional determination
22E(8) Period during which provisional determination is in force
Provisional determination remains in force until application for provisional registration is made.
22E(9) Period during which provisional determination is in force
22F Revocation of provisional determination
Secretary may revoke provisional determination under certain conditions.
22F(1) Revocation of provisional determination
Secretary must revoke provisional determination upon request.
22F(2) Revocation of provisional determination
Secretary must give written notice of revocation and set out reasons for revocation.
22F(3) Revocation of provisional determination
Revocation of provisional determination takes effect on the day notice is given.
22F(4) Revocation of provisional determination
22G Scientific advice about aspects of quality, safety or efficacy of
Request for scientific advice on medicine registration
22G(1) Scientific advice about aspects of quality, safety or efficacy of
Each request must relate only to one aspect of the quality of the medicine.
22G(2) Scientific advice about aspects of quality, safety or efficacy of
Request for scientific advice on medicine safety
22G(3) Scientific advice about aspects of quality, safety or efficacy of
Each request must relate only to one aspect of the safety of the medicine.
22G(4) Scientific advice about aspects of quality, safety or efficacy of
relate only to one aspect of the safety of the medicine.
Request for scientific advice on efficacy of medicine
22G(5) Scientific advice about aspects of quality, safety or efficacy of
Each request must relate only to one aspect of the efficacy of the medicine.
22G(6) Scientific advice about aspects of quality, safety or efficacy of
Secretary must provide scientific advice in response to a request.
22G(7) Scientific advice about aspects of quality, safety or efficacy of
Request must be made in accordance with a form approved by the Secretary and accompanied by the prescribed fee.
22G(8) Scientific advice about aspects of quality, safety or efficacy of
Request must be made in accordance with a form approved by the Secretary.
Request for information or document may be required or permitted
22G(9) Scientific advice about aspects of quality, safety or efficacy of
A person may make an application to the Secretary for registration or listing of therapeutic goods.
23 Applications generally
23A Classes of therapeutic goods
The Secretary may specify different classes of therapeutic goods.
23A(1) Classes of therapeutic goods
Specifies classes of therapeutic goods by reference to certain matters.
23A(2) Classes of therapeutic goods
23AA Applications for provisional registration of medicine
Application for provisional registration of medicine is taken to be an application for provisional registration if certain conditions are met.
23AA(1) Applications for provisional registration of medicine
Provisional determination under section 22D is in force
Application made under section 23 for registration of medicine
Application for provisional registration of new medicine must be made before end of provisional registration period.
23AA(2) Applications for provisional registration of medicine
23B Requirements relating to applications for registration of
Secretary must carry out assessment of requirements met in relation to application.
23B(1) Requirements relating to applications for registration of
Application must be made in a specific manner
23B(2) Requirements relating to applications for registration of
Must be made in accordance with the approved form
Application must be made in a manner that is approved by the Secretary
23C Requirements relating to applications for listing of therapeutic
Application requirement for listing of therapeutic goods under section 26 or 26A.
23C(1) Requirements relating to applications for listing of therapeutic
Information, application fee, and samples (if required)
Application must comply with requirements to be listed.
23C(2) Requirements relating to applications for listing of therapeutic
Application must comply with requirements.
Secretary may determine forms of information for application purposes.
23C(3) Requirements relating to applications for listing of therapeutic
24 Applications for registration
Application for registration of therapeutic goods under section 23 is required if certain conditions are met.
24(1) Applications for registration
Application for registration is required
(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.
24(1A) Applications for registration
Application for registration lapses if fee remains unpaid or application contains inaccurate information.
24(2) Applications for registration
...the day on which the amount became due and payable;
Temporal overlap between application lapse and fee payment deadline.
(2) An application for registration of therapeutic goods lapses if...
Application lapse due to non-payment or inaccuracy.
Defines individual patient data in relation to therapeutic goods.
24(3) Applications for registration
Describes temporal relationship between administration of goods and collection of data
Before, during and after the administration of the goods
Demographic, biochemical and haematological information
Evaluation fee due on notification of amount
24A When evaluation fee due for payment
24B Payment of evaluation fee by instalments
Payment of evaluation fee by instalments
24B(1) Payment of evaluation fee by instalments
Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid.
24B(2) Payment of evaluation fee by instalments
(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...
Payment of evaluation fee by instalments is obligatory.
24B(3) Payment of evaluation fee by instalments
Recovery of evaluation fee is an obligation for the Commonwealth.
24C Recovery of evaluation fee
Recovery of evaluation fee is an obligation.
24D Refund of evaluation fee where evaluation not completed within
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).
24D(1) Refund of evaluation fee where evaluation not completed within
Section applies to an application under section 23
Refund of evaluation fee if not completed within period
24D(2) Refund of evaluation fee where evaluation not completed within
25% of the evaluation fee must be refunded
Evaluation period is a temporal interval
but not within the period referred to in subsection (1)
Notification of decision constitutes completion of evaluation.
24D(3) Refund of evaluation fee where evaluation not completed within
24E Deemed refusal of application
24E(1) Deemed refusal of application
Applicant may give notice to treat application as refused if evaluation not completed
24E(2) Deemed refusal of application
Applicant may give notice to treat application as refused
Notice may be given at any time before evaluation is completed.
24E(3) Deemed refusal of application
24E(4) Deemed refusal of application
The Secretary must evaluate therapeutic goods for registration having regard to the quality, safety and efficacy of the goods.
25 Evaluation of therapeutic goods
The Secretary must evaluate therapeutic goods for registration.
25A When the Secretary must not use protected information
Prohibition on using protected information when evaluating therapeutic goods for registration
25A(1) When the Secretary must not use protected information
Prohibition on using protected information
(1) When evaluating therapeutic goods for registration, the Secretary must not use information about other therapeutic goods that is protected information.
Duty to refrain from using protected information
The Secretary must not use protected information.
25A(2) When the Secretary must not use protected information
...the Secretary must not use protected information.
Prohibition of using protected information.
(2) Information is protected information if...
25AA Approved product information for medicine
The Secretary must approve product information for therapeutic goods if certain conditions are met.
25AA(1) Approved product information for medicine
The Secretary has a duty to approve product information.
Secretary must approve product information reflecting basis for registration.
25AA(1A) Approved product information for medicine
Require person to provide product information for restricted medicine.
25AA(1B) Approved product information for medicine
Secretary must approve product information if person complies with subsection (1B)
25AA(1C) Approved product information for medicine
Obligation to approve product information
25AB Registration of therapeutic goods etc.
Secretary must notify applicant within 28 days of decision to register therapeutic goods.
25AB(2) Registration of therapeutic goods etc.
The notice must set out certain information about the decision to register goods.
25AB(3) Registration of therapeutic goods etc.
The notice must contain certain information.
Secretary must include goods in Register and give applicant a certificate of registration.
25AB(4) Registration of therapeutic goods etc.
Secretary must register therapeutic goods without inquiry into correctness of certificate or notice.
25AB(5) Registration of therapeutic goods etc.
Secretary must register therapeutic goods.
Commencement of therapeutic goods registration
25AB(6) Registration of therapeutic goods etc.
The registration occurs during the specified day.
Indicates a temporal relationship between two events
(6) The registration of therapeutic goods commences on the day specified in the certificate of registration.
The registration is processed by the specified day.
Indicates a means of processing or application
The registration of therapeutic goods begins on the specified day.
The registration is transmitted through the specified day.
Indicates a means of transmission or application
The registration then occurs on the specified day.
Indicates a causal relationship between two events
Secretary must notify applicant of decision within 28 days.
25AC Notice of decision not to register therapeutic goods
26 Listing of therapeutic goods
26A Listing of certain medicines
The Secretary must list a medicine if certain conditions are met.
26A(1) Listing of certain medicines
Secretary must list medicine under subsection (1) without inquiring into the correctness of the certificate or notice.
26A(1A) Listing of certain medicines
Certification of eligibility, safety, and presentation.
Certify that medicine meets certain requirements.
26A(2) Listing of certain medicines
Application for listing of certain medicines following efficacy
26AB Application for listing of certain medicines following efficacy
26AC Evaluation fees for listing of medicine under section 26AE
Application must pass preliminary assessment to be eligible for listing under section 26AE.
26AC(1) Evaluation fees for listing of medicine under section 26AE
Eligible for listing under section 26AE.
Preliminary assessment must occur before listing under section 26AE.
Preliminary assessment is a type of evaluation required for listing under section 26AE.
Application must pass preliminary assessment.
Preliminary assessment is a necessary condition for listing under section 26AE.
Preliminary assessment is a schema required for listing under section 26AE.
Payable evaluation fee for listing of medicine under section 26AE
26AC(2) Evaluation fees for listing of medicine under section 26AE
Secretary must notify applicant of evaluation fee amount.
26AC(3) Evaluation fees for listing of medicine under section 26AE
Evaluation fee payable by applicant on notification of evaluation fee amount
26AC(4) Evaluation fees for listing of medicine under section 26AE
(4) The evaluation fee payable by an applicant:
(b) may be recovered by the Commonwealth as a debt due to the Commonwealth.
Pay evaluation fee before listing medicine under section 26AE
26AC(5) Evaluation fees for listing of medicine under section 26AE
26AD Lapsing and deemed refusal of applications for listing of
Application lapses if evaluation fee remains unpaid or application contains inaccurate information.
26AD(1) Lapsing and deemed refusal of applications for listing of
Applicant may give notice to treat application as refused if evaluation not completed within prescribed period.
26AD(2) Lapsing and deemed refusal of applications for listing of
...the applicant may give the Secretary written notice...
Prescribed period within which evaluation must be completed.
(a) regulations made for the purposes of paragraph 63(2)(daaaa)...
...the applicant wishes to treat the application as having been refused.
the applicant may give the Secretary written notice...
Obligation to complete evaluation within prescribed period.
Evaluation must be completed within prescribed period.
(b) at the end of that period, the evaluation has not been completed;
26AD(3) Lapsing and deemed refusal of applications for listing of
Refusal of listing of medicine without notice
26AD(4) Lapsing and deemed refusal of applications for listing of
26AE Evaluation and listing of certain medicines
The Secretary must evaluate a medicine if an application has passed preliminary assessment.
26AE(1) Evaluation and listing of certain medicines
the Secretary must evaluate the medicine having regard to...
The Secretary must evaluate the medicine.
(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;
the Secretary must not use restricted information when evaluating the medicine for listing:
The Secretary must not use restricted information when evaluating the medicine.
Note: The Secretary must not use restricted information when evaluating the medicine for listing: see section 26AF;
Evaluation must be completed within a prescribed period.
26AE(2) Evaluation and listing of certain medicines
Secretary must decide whether to list a medicine after evaluation.
26AE(3) Evaluation and listing of certain medicines
26AF When the Secretary must not use restricted information in
Must not use restricted information in evaluating a medicine under section 26AE.
26AF(1) When the Secretary must not use restricted information in
Evaluating the medicine under section 26AE
Use of restricted information during evaluation of a medicine under section 26AE
Section 23 application for listing a medicine under section 26AE
Prohibition on using restricted information
Application for listing a medicine under section 26AE
Prohibition on using restricted information in evaluating a medicine under section 26AE
Use of restricted information through evaluation of a medicine under section 26AE
Prohibition on using restricted information until evaluation of a medicine under section 26AE is complete
The Secretary must not use restricted information in certain circumstances.
26AF(2) When the Secretary must not use restricted information in
Prohibition of using restricted information
26B Certificates required in relation to patents
Applicant must provide a certificate stating their intentions regarding patent infringement.
26B(1) Certificates required in relation to patents
Applicant has an obligation to provide a certificate.
Applicant must provide evidence or information submitted by another person.
26B(1A) Certificates required in relation to patents
Giving a false or misleading certificate is an offence.
26B(2) Certificates required in relation to patents
The person commits an offence if the certificate is false or misleading in a material particular.
Prohibits giving a false or misleading certificate.
The person gives a certificate required under subsection (1).
The person must give a true and accurate certificate.
Requires giving a true and accurate certificate.
A person commits an offence if: (a) the person gives a certificate required under subsection (1);
Permits notice to be given in accordance with specified software requirements.
26BA Approved form for notices
Requires notice to be given in accordance with specified software requirements
26BB Permissible ingredients
The Minister may make a determination specifying ingredients for medicine.
26BB(1) Permissible ingredients
Permits particular ingredients not being contained in particular medicine.
26BB(2) Permissible ingredients
Permits specific circumstances for a particular ingredient in medicine.
26BB(2A) Permissible ingredients
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.
(2A) The requirements referred to in paragraph (1)(b)
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.
may relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient.
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.
Permitted concentrations or amounts of ingredients
26BB(3) Permissible ingredients
Permits certain subsections not to limit paragraph (1)(b)
26BB(4) Permissible ingredients
Determination may make different provision for different classes of medicine.
26BB(5) Permissible ingredients
The Minister may make a determination specifying ingredients and requirements.
26BB(6) Permissible ingredients
Permission to determine ingredients and requirements.
Different classes of medicine may be treated differently under a determination.
26BB(7) Permissible ingredients
Allows provision in relation to a matter by applying, adopting or incorporating any matter contained in an instrument or other writing.
26BB(8) Permissible ingredients
Minister may vary a determination under section 26BB.
26BC Variation of determination under section 26BB—Minister’s
26BD Requirements relating to an application for variation of a
A person may make an application to the Secretary for a recommendation by the Secretary that the Minister vary a section 26BB determination.
26BD(1) Requirements relating to an application for variation of a
26BD(2) Requirements relating to an application for variation of a
information determined under subsection (8) and in a form determined under subsection (9)
Application requirements for variation of a
26BD(3) Requirements relating to an application for variation of a
The Secretary must be satisfied that the requirements have been met.
26BD(4) Requirements relating to an application for variation of a
The assessment occurs during this time period.
The assessment must occur during a specific time period.
(a) has carried out an assessment, under subsection (2), in relation to the application;
The assessment implies that the requirements are met.
There is a logical implication between the assessment and the satisfaction of the requirements.
is satisfied that the requirements set out in subsection (3) have been met in relation to the application.
There is a conditional relationship between the assessment and the satisfaction of the requirements.
The requirements are met until this point in time.
The requirements must be met until a specific point in time.
(b) is satisfied that the requirements set out in subsection (3) have been met in relation to the application;
Secretary must give written notice to applicant stating application has passed preliminary assessment.
26BD(5) Requirements relating to an application for variation of a
Refuse application if not passed preliminary assessment.
26BD(6) Requirements relating to an application for variation of a
Application not passed preliminary assessment.
Specify software requirements for an application or information
26BD(7) Requirements relating to an application for variation of a
may require or permit an application or information to be given in accordance with specified software requirements
Requires specified software requirements
(7) An approval of a form mentioned in paragraph (3)(a)
The Secretary may determine a kind of information for the purposes of subparagraph (3)(e)(i).
26BD(8) Requirements relating to an application for variation of a
Application lapse due to inaccurate or misleading information
26BD(9) Requirements relating to an application for variation of a
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.
Prohibition of application lapse due to inaccurate or misleading information
(9) The Secretary may, by legislative instrument, determine a form of information for the purposes of subparagraph (3)(e)(ii).
Evaluation of whether to make recommendation for variation of a section 26BB determination
26BE Evaluation of whether to make recommendation for variation
Classifies the legal effect as Undertaking
No obligation, prohibition, permission, or right explicitly stated
26BF Permissible indications
The Minister may make a determination in relation to indications.
26BF(1) Permissible indications
The Minister may consider therapeutic uses of a substance when making a determination.
26BF(2) Permissible indications
The Minister may have regard in deciding whether to make a determination under subsection (1) in relation to a particular indication.
26BF(3) Permissible indications
Permits use of particular indications in specified circumstances or under certain conditions.
26BF(4) Permissible indications
Describes the temporal relationship between the use of indications and specified circumstances or conditions.
Specifies the permitted use of particular indications.
Permits different classes of medicines to have varying determinations.
26BF(5) Permissible indications
Allows for incorporation of existing instruments or writings with modifications.
26BF(6) Permissible indications
Permits modification of incorporated matter
26BG Limitations on determination under section 26BF
Minister may make a determination specifying indications that must not be covered by a determination under section 26BF(1)(a).
26BG(1) Limitations on determination under section 26BF
The determination may specify an indication either generally or in relation to specified circumstances.
26BG(2) Limitations on determination under section 26BF
Minister may vary or revoke determination under subsection (1)
26BG(3) Limitations on determination under section 26BF
Minister may vary determination under section 26BF on own initiative.
26BH Variation of determination under section 26BF—Minister’s
26BJ Variation of determination under section 26BF—application
A person may apply for a recommendation to vary a determination under section 26BF.
26BJ(1) Variation of determination under section 26BF—application
Form, application fee (if any), recommendation sought
Application requirements for variation of determination under section 26BF
26BJ(2) Variation of determination under section 26BF—application
Cannot make an application for a recommendation that would affect certain types of indications.
26BJ(3) Variation of determination under section 26BF—application
for the effect of which would be for the determination to cover any of the following:
Prohibition on making an application for a recommendation that would affect certain types of indications.
(3) A person cannot make an application under subsection (1)
26C Certificates required in relation to patent infringement
Certificate required for therapeutic goods patent infringement proceedings
26C(1) Certificates required in relation to patent infringement
(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).
Requires certificate for patent infringement proceedings
Second person must provide certificate before commencement of proceedings.
26C(2) Certificates required in relation to patent infringement
Certificate must be signed in good faith, with reasonable prospects of success, and without unreasonable delay.
26C(3) Certificates required in relation to patent infringement
Obligation to sign certificate in good faith, with reasonable prospects of success, and without unreasonable delay.
Second person must have reasonable grounds for proceedings to have a chance of success
26C(4) Certificates required in relation to patent infringement
Second person must have reasonable grounds
Second person has knowledge of circumstances
Second person must know the circumstances
Circumstances known to the second person
26D Requirements for interlocutory injunction
Notice to patentee required before applying for interlocutory injunction.
26D(1) Requirements for interlocutory injunction
Application for interlocutory injunction.
No application for interlocutory relief can be instituted without prior notification to the Attorney-General.
26D(2) Requirements for interlocutory injunction
No application can be instituted without prior notification.
Prohibition of instituting an application without prior notification.
The patentee must notify the Attorney-General before applying for interlocutory relief.
27 Registration or listing number
Secretary must assign a unique registration or listing number to therapeutic goods included in the Register.
27(1) Registration or listing number
Secretary must assign a unique registration or listing number to grouped therapeutic goods.
27(2) Registration or listing number
Classification of grouped therapeutic goods
Conditions for registration or listing of therapeutic goods
28 Conditions of registration or listing
28A Certification of manufacturing steps outside Australia following
Step in manufacture of medicine to be carried out outside Australia
Certification required for manufacture of medicine outside Australia
28A(1) Certification of manufacturing steps outside Australia following
Secretary must give written notice of certification.
28A(2) Certification of manufacturing steps outside Australia following
The Secretary must give the person written notice of the certification.
Certification requirement for manufacturing steps outside Australia
28A(3) Certification of manufacturing steps outside Australia following
29 Duration of registration or listing
Goods remain in the Register until registration or listing is cancelled.
29(1) Duration of registration or listing
Medicine provisional registration period
29(2) Duration of registration or listing
Defines provisional registration period for medicines
29(3) Duration of registration or listing
Defines provisional registration period for a new medicine
29(3A) Duration of registration or listing
Defines a temporal interval for the provisional registration period
(3A) Subject to this section, the provisional registration period...
Application for extension of provisional registration period
29(4) Duration of registration or listing
The application must be in a form approved by the Secretary and contain all required information.
Application must be in a specific form and contain required information.
29(5) Duration of registration or listing
Application must meet specific requirements.
29A Criminal offence for failing to notify adverse effects etc. of
Information of a kind mentioned in subsection (2)
Notify adverse effects of therapeutic goods to the Secretary.
29A(1) Criminal offence for failing to notify adverse effects etc. of
Failing to notify adverse effects of goods may be a criminal offence.
29A(2) Criminal offence for failing to notify adverse effects etc. of
29AA Civil penalty for failing to notify adverse effects etc. of goods
Failure to notify adverse effects of goods is prohibited.
29AA(1) Civil penalty for failing to notify adverse effects etc. of goods
Failing to notify adverse effects of goods is a civil penalty.
29AA(2) Civil penalty for failing to notify adverse effects etc. of goods
Prohibits failing to notify adverse effects of goods.
The person under this Act must provide information about adverse effects.
Secretary must give applicant written notice requiring action upon withdrawal or lapse of application.
29B Notification of adverse effects etc. where application withdrawn
29C Civil penalties for failing to notify adverse effects etc. where
Failure to comply with notice requirements within 30 days
29C(1) Civil penalties for failing to notify adverse effects etc. where
False or misleading information in purported compliance with a notice
29C(2) Civil penalties for failing to notify adverse effects etc. where
Prohibition of false or misleading information
29D Suspension of registration or listing
Suspension of registration or listing of therapeutic goods
29D(1) Suspension of registration or listing
Prohibition on therapeutic goods registration or listing
(1) The Secretary may, by written notice...
Secretary must inform person of proposed suspension and set out reasons.
29D(2) Suspension of registration or listing
29E When suspension takes effect etc.
Suspension takes effect on specified day under certain conditions.
29E(1) When suspension takes effect etc.
29E(2) When suspension takes effect etc.
Secretary may extend period specified in notice under subsection 29D(4) by a further specified period not exceeding 6 months.
29E(3) When suspension takes effect etc.
29E(4) When suspension takes effect etc.
29F Revocation of suspension
Secretary must revoke suspension upon certain conditions.
29F(1) Revocation of suspension
...revocation of suspension under section 29D
Secretary's power to revoke suspension may be exercised
29F(2) Revocation of suspension
Notice setting out particulars of the revocation
Publish notice of revocation within a specified timeframe.
29F(3) Revocation of suspension
The Secretary must cause to be published...
Therapeutic goods not included in Register during suspension.
29G Effect of suspension
3 Interpretation
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.
3(1) Interpretation
Accessory means a thing specifically intended to be used with the device.
State or Territory must issue search warrants.
label, in relation to therapeutic goods, means a display of printed information:
product information, in relation to therapeutic goods, means information relating to the safe and effective use of the goods
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...
reportable medicine has the meaning given by section 30EH
Class hierarchy for reportable medical device
reportable medical device means a medical device of a kind prescribed by regulations made for the purposes of this definition
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)
biologicals, medical devices and goods declared to be therapeutic goods under an order in force under section 7 but do not include...
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...
Accessory means a thing that the manufacturer of the thing specifically intended to be used together with the device.
Customs officer means an officer of Customs within the meaning of the Customs Act 1901.
The term 'customs officer' is defined as an officer of Customs within the meaning of the Customs Act 1901.
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.
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.
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.
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.
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.
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.
Export only biological means a biological that is: (a) manufactured in Australia for export only; or (b) imported into Australia for export only.
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.
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).
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).
Therapeutic goods are taken to be for use in humans if they are not solely for use in animals.
3(2) Interpretation
Therapeutic goods are taken to be for use in humans during the period when they are not solely for use in animals.
(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.
Specify medicines for restricted medicine purposes
3(2A) Interpretation
Specify classes of medicine for restricted medicine purposes
3(2B) Interpretation
Permission to specify classes of medicine
Provisions of this Act are in addition to, and not in substitution for, the provisions of any other Act that relate to therapeutic goods.
3(4) Interpretation
Presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing.
3(5) Interpretation
Defines a temporal interval for when presentation of therapeutic goods is unacceptable.
(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
Recognizes the presentation of therapeutic goods that is misleading or confusing.
Prohibits the presentation of therapeutic goods that is misleading or confusing.
Classifies presentation of therapeutic goods as unacceptable if it is misleading or confusing.
Diffuses the prohibition on presentation of therapeutic goods that is misleading or confusing.
Defines a recurring trace for when presentation of therapeutic goods is unacceptable.
Specify advisory statements in relation to medicine
3(5A) Interpretation
Permission to specify advisory statements
Specify different advisory statements for medicines or classes of medicine.
3(5B) Interpretation
References charges under Therapeutic Goods (Charges) Act 1989.
3(6) Interpretation
Charge reference defined as such a charge imposed under the Act
Annual charges under Therapeutic Goods (Charges) Act 1989
References an offence against this Act to related offences under other laws.
3(7) Interpretation
an offence against section 6 of the Crimes Act 1914, or section 11.1, 11.4 or 11.5 of the Criminal Code
A reference to an offence against this Act includes a reference to...
an offence against section 136.1, 137.1 or 137.2 of the Criminal Code
Imposes a duty on Commonwealth authorities if corresponding State law confers function or power and gives rise to obligation.
3(7A) Interpretation
(7A) For the purposes of this Act, a corresponding State law imposes a duty...
Clarifies interpretation of registered therapeutic goods and provisional registration.
3(8) Interpretation
Cancellation of registration or listing of therapeutic goods under certain conditions.
30 Cancellation of registration or listing
within 24 hours after the request was made
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;
the person requests in writing the cancellation of the registration or listing
it appears to the Secretary that failure to cancel the registration or listing would create an imminent risk of death...
the requirements under subsection 26A(3) or (4A) are not fulfilled
Certification requirements for medicines
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...
the Secretary is satisfied that the contravention is significant
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
30A Revocation of cancellation of registration or listing upon
Secretary may revoke cancellation upon request and payment of fee.
30A(1) Revocation of cancellation of registration or listing upon
Permits Secretary to revoke cancellation.
Cancellation is taken never to have occurred upon revocation.
30A(2) Revocation of cancellation of registration or listing upon
Cancellation is taken never to have occurred.
If cancellation is revoked, then it is never taken to have occurred.
30AA Revocation of cancellation of registration or listing—payment
Secretary may revoke cancellation of registration or listing under certain conditions.
30AA(1) Revocation of cancellation of registration or listing—payment
If cancellation is revoked, it is taken never to have occurred.
30AA(2) Revocation of cancellation of registration or listing—payment
Notice setting out particulars of the cancellation.
Secretary must publish notice after cancellation of registration or listing.
30B Publication of cancellation of registration or listing
30C Consultation with Gene Technology Regulator
Application for listing or registration of a therapeutic good must pass preliminary assessment.
30C(1) Consultation with Gene Technology Regulator
(1) This section applies to an application for listing or registration of a therapeutic good under section 23 if:
Secretary must give written notice to Gene Technology Regulator about application.
30C(2) Consultation with Gene Technology Regulator
The Gene Technology Regulator must provide written advice to the Secretary about a gene technology application.
30C(3) Consultation with Gene Technology Regulator
The Gene Technology Regulator must provide written advice.
Consultation with Gene Technology Regulator within specified period.
30C(4) Consultation with Gene Technology Regulator
Period defined as containing the time of consultation
The advice is to be given within the period specified in the notice.
If advice is given, then it must be within a period
Implication from consultation requirement
Consultation defined as a cognitive process
Definition of consultation as a cognitive process
Definition of consultation as giving advice
No notification required for therapeutic goods belonging to a class with an active advice from the Gene Technology Regulator.
30C(5) Consultation with Gene Technology Regulator
Advice from the Gene Technology Regulator is in force
Therapeutic goods belonging to a class with an active advice
30D Secretary may seek advice about classes of GM products or
The Secretary may request advice from the Gene Technology Regulator.
30D(1) Secretary may seek advice about classes of GM products or
Classes of GM products specified in the request.
Request for advice must specify matters to which the advice is to relate.
30D(2) Secretary may seek advice about classes of GM products or
Secretary must seek advice from Gene Technology Regulator on specified matters.
30D(3) Secretary may seek advice about classes of GM products or
Gene Technology Regulator must provide written advice
Advice from the Gene Technology Regulator remains in force until withdrawn.
30D(4) Secretary may seek advice about classes of GM products or
The advice remains in force until it is withdrawn by the Gene Technology Regulator.
Advice from the Gene Technology Regulator lasts during its validity.
The Gene Technology Regulator gives advice to the Secretary.
The Secretary cognizes the advice from the Gene Technology Regulator.
Holds advice from the Gene Technology Regulator.
Advice from the Gene Technology Regulator diffuses to the Secretary.
Advice from the Gene Technology Regulator ends when it is withdrawn.
Secretary must take advice from Gene Technology Regulator into account when making decisions on applications.
30E Secretary to take advice into account
The Secretary may impose requirements on a person if certain circumstances occur.
30EA Public notification, and recall, of therapeutic goods
Notice setting out particulars of the requirement
Secretary must publish notice after imposing requirement.
30EB Publication of requirements
Non-compliance with requirements is a criminal offence.
30EC Criminal offences for non-compliance with requirements
Prohibits non-compliance with requirements.
Imposition of requirement under section 30EA does not affect suspension or cancellation power.
30ED Powers of suspension and cancellation unaffected
No exclusion or limitation of other laws
30EE Saving of other laws
30EF Reporting medicine shortages
Notify shortage of reportable medicine within 2 working days or 10 working days.
30EF(1) Reporting medicine shortages
Must notify shortage within specified timeframe.
Ought to reasonably know of shortage before notification.
Notification within timeframe is but not required.
Reporting medicine shortages when included in an instrument under section 30EJ has a critical impact.
30EF(2) Reporting medicine shortages
Reporting medicine shortages when included in an instrument under section 30EJ is obligatory.
Reporting medicine shortages when there is a critical impact on health or functioning.
30EF(3) Reporting medicine shortages
Notification requirements must be provided.
Specific period of shortage, approved form, and required information
Notification requirements for medicine shortages
30EF(4) Reporting medicine shortages
Specify software requirements for reporting medicine shortages
30EF(5) Reporting medicine shortages
Describes the temporal relationship between software requirements and reporting medicine shortages
Classifies the provision as a descriptive clause
Reporting medicine shortages is prohibited for individuals and bodies corporate.
30EF(6) Reporting medicine shortages
...if the person is subject to a requirement under subsection (1);
Temporal interval of reporting medicine shortages
(6) A person contravenes this subsection...
...and (b) for a body corporate—1,000 penalty units.
Knowledge representation of reporting medicine shortages
(a) for an individual—100 penalty units;
...the person contravenes the requirement.
Prohibition of reporting medicine shortages
Information diffusion of reporting medicine shortages
...and the person contravenes the requirement.
Recurring trace of reporting medicine shortages
Exemption from reporting medicine shortages under certain conditions
30EF(7) Reporting medicine shortages
30EG Reporting discontinuation of supply of medicine
Notify Secretary of discontinuation decision at least 6 months before proposed date.
30EG(1) Reporting discontinuation of supply of medicine
Reporting required when discontinuation of supply of medicine is made under section 30EJ
30EG(2) Reporting discontinuation of supply of medicine
Notify discontinuation of medicine supply if critical impact on health or functioning
30EG(3) Reporting discontinuation of supply of medicine
Notification must be in a specified form and contain required information.
30EG(4) Reporting discontinuation of supply of medicine
Notification must be in a specified form.
Specify software requirements for information transmission
30EG(5) Reporting discontinuation of supply of medicine
Identifies the temporal relation of software requirements
30EH What is a reportable medicine?
Defines reportable medicine under the Act.
30EH(1) What is a reportable medicine?
Includes temporal intervals for substance inclusion.
(i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard;
(1) For the purposes of this Act, registered goods are a reportable medicine if:
Combines conditions for a reportable medicine.
(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;
Combines conditions for a reportable medicine using LTL.
(b) either: (i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard;
The Minister may determine medicine for the purposes of subparagraph (1)(b)(ii).
30EH(2) What is a reportable medicine?
The Minister must determine a medicine if it is critical to patient health and notification of shortage would be in public health interests.
30EH(3) What is a reportable medicine?
Notification of shortage would be in public health interests.
Defines when there is a medicine shortage in Australia.
30EI When is there a medicine shortage?
30EJ Medicines Watch List
Minister may determine medicine for purposes of subsections 30EF(2) and 30EG(2)
30EJ(1) Medicines Watch List
The Minister must not determine a medicine unless certain conditions are met.
30EJ(2) Medicines Watch List
...the Minister is satisfied that any shortage of the medicine...
Defines a temporal overlap between the conditions and the determination of a medicine.
(2) The Minister must not determine a medicine unless...
...unless the Minister is satisfied that any shortage of the medicine...
Prohibits the Minister from determining a medicine without satisfying certain conditions.
(2) The Minister must not determine a medicine...
Imposes an obligation on the Minister to satisfy certain conditions before determining a medicine.
Defines an information flow between the conditions and the determination of a medicine.
Defines a temporal relevance between the conditions and the determination of a medicine.
30EK Minister may declare a serious scarcity of medicine
Minister may declare a serious scarcity of medicine and specify substitution rules.
30EK(1) Minister may declare a serious scarcity of medicine
The declaration and substitution rules overlap in time.
Temporal overlap between declaration and substitution rules.
The Minister may, by legislative instrument:
(b) specify the medicine (the substitutable medicine)
Permission to dispense substitutable medicine.
(a) declare that there is a serious scarcity of specified medicine
Substitution permitted under specified circumstances.
Pharmacists permitted to dispense substitutable medicine under specified circumstances.
(b) specify the circumstances in which that substitution is permitted.
No prohibition on declaring scarcity or specifying substitution rules.
The Minister may declare a serious scarcity of medicine under certain conditions.
30EK(2) Minister may declare a serious scarcity of medicine
The Minister may declare a serious scarcity of medicine.
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.
Minister must declare a serious scarcity of medicine if certain conditions are met.
30EK(3) Minister may declare a serious scarcity of medicine
Minister must declare a serious scarcity of medicine
Minister must declare a serious scarcity of medicine under certain circumstances.
30EK(4) Minister may declare a serious scarcity of medicine
Classification of persons for whom the substitutable medicine is suitable or not suitable.
(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.
Instrument remains in force for a specified period unless revoked.
30EK(5) Minister may declare a serious scarcity of medicine
Pharmacist may dispense scarce medicine in substitution for another
30EL Substitution of prescription medicine by pharmacists
30F Criminal offences for goods exempt under section 18A not
Supplying goods of a particular kind that do not conform to a standard or are not fit for their intended purposes is prohibited.
30F(1) Criminal offences for goods exempt under section 18A not
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.
(c) the Secretary is satisfied that the goods included in that batch: ...
...are classified as not conforming to a standard or being unfit for their intended purposes.
Classification of goods as not conforming to a standard or being unfit for their intended purposes using artificial intelligence.
(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.
Prohibition of supplying goods that do not conform to a standard or are not fit for their intended purposes.
(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: ...
Diffusion of the prohibition on supplying goods that do not conform to a standard or are not fit for their intended purposes.
...are recurring traces of supplying goods that do not conform to a standard or are not fit for their intended purposes.
Recurring trace of supplying goods that do not conform to a standard or are not fit for their intended purposes.
Require person to take steps to recall goods
30F(2) Criminal offences for goods exempt under section 18A not
The person must take steps to recall the goods
Steps to be taken, manner of taking, reasonable period
30F(3) Criminal offences for goods exempt under section 18A not
(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
Artificial intelligence application for recall requirements
Publish notice in Gazette or Department's website
30F(4) Criminal offences for goods exempt under section 18A not
A written notice given to a person by the Secretary under this section is not a legislative instrument.
30F(4A) Criminal offences for goods exempt under section 18A not
Prohibits notices from being considered legislative instruments.
Failure to comply with a notice results in harm or injury.
30F(4B) Criminal offences for goods exempt under section 18A not
because the person failed to comply with that requirement.
The provision applies to temporal intervals where harm or injury occurs.
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.
the person fails to comply with that requirement; and
The Secretary gives a notice to the person under subsection (2); and
Imposes an obligation on the person to comply with the notice.
Prohibits non-compliance with the notice.
or would be likely to result in, harm or injury to any person;
The provision is repeated for each occurrence of harm or injury.
the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or
Failure to comply with notice requirement is an offence.
30F(5) Criminal offences for goods exempt under section 18A not
the person fails to comply with that requirement.
Compliance with notice requirement overlaps with the offence of failing to comply.
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
Obligation to comply with notice requirement.
Obligation to pay penalty for failing to comply with notice requirement.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
Compliance with notice requirement is recurrently related to the offence of failing to comply.
A person commits an offence if the Secretary gives a notice to the person under subsection (2)
30F(6) Criminal offences for goods exempt under section 18A not
Chapter 3 Medicines and other therapeutic goods that are not medical devices
The Secretary gives a notice to the person under subsection (2)
Civil penalty for non-compliance with standards
30FA Civil penalty for goods exempt under section 18A not
30G Disposal of unused goods exempt under section 18A
Therapeutic goods must be used before an exemption ceases to have effect.
30G(1) Disposal of unused goods exempt under section 18A
The Secretary must arrange for disposal of unused goods.
30G(2) Disposal of unused goods exempt under section 18A
30G(3) Disposal of unused goods exempt under section 18A
No benefit can be conferred on a person other than the owner of goods
30G(4) Disposal of unused goods exempt under section 18A
30H Record for goods exempt under section 18A
Keeping a record of therapeutic goods exempt under section 18A is required.
30H(1) Record for goods exempt under section 18A
Strict liability applies to paragraph (1)(b)
30H(2) Record for goods exempt under section 18A
(2) Strict liability applies to paragraph (1)(b)
Keeping a record about therapeutic goods exempt under section 18A is required.
30H(3) Record for goods exempt under section 18A
The Secretary may require information or documents from a person.
31 Secretary may require information or documents
The Secretary may require information or documents.
Secretary may require sponsor to provide specified information about exempt goods for experimental purposes in humans.
31A Secretary may require information etc. about goods exempt
31AA Secretary may require information etc. about goods exempt
Secretary may require information about goods exempt
31AA(1) Secretary may require information etc. about goods exempt
(1) This section applies to a person who is required to comply with a condition of an exemption of therapeutic goods under section 18A.
The Secretary may require information from a person about goods exempt.
31AA(2) Secretary may require information etc. about goods exempt
Secretary must require information within a specified period.
31AA(3) Secretary may require information etc. about goods exempt
Secretary must require information about goods exempt
31AA(4) Secretary may require information etc. about goods exempt
Secretary may require information from a person granted an approval under subsection 19(1)
31B Secretary may require information relating to approvals and
31BA Secretary may require information about therapeutic goods
The Secretary may require information about therapeutic goods from a person granted an approval.
31BA(1) Secretary may require information about therapeutic goods
Must provide information within a specified period and in the form specified by the notice.
31BA(2) Secretary may require information about therapeutic goods
Secretary may require information about therapeutic goods in specified ways.
31BA(3) Secretary may require information about therapeutic goods
31C Criminal offences for failing to give information or documents
Failure to comply with a notice results in an offence.
31C(1) Criminal offences for failing to give information or documents
31C(2) Criminal offences for failing to give information or documents
Indicates that failing to comply with a notice overlaps with committing an offence.
Recognizes the pattern of failing to comply with a notice resulting in an offence.
Prohibits failing to comply with a notice.
Diffuses the information that failing to comply with a notice results in an offence.
Indicates that failing to comply with a notice repeats the action of committing an offence.
Duty to provide information or documents
31C(3) Criminal offences for failing to give information or documents
Obligation to provide information or documents
31D False or misleading information
Giving false or misleading information in compliance with a notice is an offence.
31D(1) False or misleading information
The person commits an offence if they do so knowing that the information is false or misleading.
Prohibits giving false or misleading information in compliance with a notice.
The person gives information to the Secretary in compliance or purported compliance with the notice.
The person commits an offence if they do so.
Imposes a duty on the person to not give false or misleading information in compliance with a notice.
The person does so knowing that the information is false or misleading.
Prohibits giving false or misleading information in purported compliance with a notice.
The person gives information to the Secretary in purported compliance with the notice.
Imposes a duty on the person to not give false or misleading information in purported compliance with a notice.
Giving false or misleading information after receiving a notice is an offence.
31D(1A) False or misleading information
The person commits an offence if the information is false or misleading.
Prohibits giving false or misleading information after receiving a notice.
Imposes an obligation on the person to give accurate information after receiving a notice.
The person is required to give information in compliance with the notice.
Prohibits omitting any matter or thing without which the information is misleading.
The information omits any matter or thing without which it is misleading.
Imposes an obligation on the person to provide accurate information that includes all necessary matters and things.
The information must include all matter and thing without which it is misleading.
Specifies the temporal interval for giving false or misleading information as after receiving a notice.
31E False or misleading documents
Producing false or misleading documents is an offence.
31E(1) False or misleading documents
The temporal interval for producing documents starts at (1)
Defines a temporal interval for producing documents.
(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.
The document is classified as true or false/misleading using AI.
Classifies the document as true or false/misleading using AI.
The person commits an offence if the document is produced knowing that it is false or misleading.
Prohibits producing false or misleading documents.
The document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA.
The prohibition diffuses to all agents who produce documents.
The recurring trace of document production starts at (1)
Defines a recurring trace of document production.
Producing false or misleading documents in compliance with a notice is an offence.
31E(1A) False or misleading documents
Prohibits producing false or misleading documents in compliance with a notice.
Offence of strict liability for false or misleading documents
31E(1B) False or misleading documents
Defendant bears evidential burden in relation to the matter.
31E(2) False or misleading documents
Defendant has a duty to provide evidence.
Exemption from subsection (1) or (1A) for documents accompanied by a written statement
31E(3) False or misleading documents
31F Self-incrimination
No excuse for giving information under certain notices
31F(1) Self-incrimination
Protection against self-incrimination in certain cases
31F(2) Self-incrimination
Prohibits admissibility of self-incrimination evidence in certain cases
Regulates biologicals by providing a process for inclusion in the Register and enforcement through criminal offences and civil penalties.
32 What this Part is about
Establishes a regulatory framework for biologicals.
Establishes administrative processes for regulating biologicals.
32A Meaning of biological
Regulations may prescribe different classes of biologicals.
32AA Biological classes
May prescribe different classes of biologicals.
Classify biologicals into different classes.
32AB When biologicals are separate and distinct from other
Regulations may prescribe circumstances for separate and distinct biologicals.
32AB(1) When biologicals are separate and distinct from other
Regulations may prescribe circumstances.
Classify biologicals by specified class.
Different provision for different classes of biologicals
32AB(2) When biologicals are separate and distinct from other
Defines criminal offences and civil penalties relating to biologicals.
32B What this Division is about
Identifies the subject of the obligation.
32BA Criminal offences for importing a biological
Importing a biological for use in humans is prohibited unless certain exemptions apply.
32BA(1) Criminal offences for importing a biological
Importing a biological for use in humans is prohibited.
32BA(4) Criminal offences for importing a biological
Prohibits the importation of a biological for use in humans.
Importing a biological for use in humans without registration is an offence.
32BA(4A) Criminal offences for importing a biological
Defines the temporal interval during which importing a biological for use in humans without registration is an offence.
(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:
Represents importing a biological for use in humans without registration as an offence using knowledge representation.
Prohibits importing a biological for use in humans without registration.
Defines a recurring trace of importing a biological for use in humans without registration as an offence.
Defines a schema definition for importing a biological for use in humans without registration as an offence.
32BB Criminal offences for exporting a biological
Exporting a biological for use in humans is prohibited.
32BB(1) Criminal offences for exporting a biological
Prohibits the export of a biological for use in humans.
32BB(4) Criminal offences for exporting a biological
Prohibits exporting a biological for use in humans.
(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:
Manufacturing a biological without proper authorization is prohibited.
32BC Criminal offences for manufacturing a biological
Prohibits the manufacture of biologicals without authorization.
32BD Criminal offences for supplying a biological
Supplying a biological for use in humans is prohibited.
32BD(1) Criminal offences for supplying a biological
Prohibits supplying a biological for use in humans.
Supplying a biological for use in humans is an offence.
32BD(4) Criminal offences for supplying a biological
The supply of a biological for use in humans is prohibited.
32BD(4A) Criminal offences for supplying a biological
Places supplying a biological for use in humans between committing an offence.
(4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;
Diffuses the prohibition of supplying a biological for use in humans.
Traces supplying a biological for use in humans to an offence.
32BE Notice required to adduce evidence in support of exception to
32BE(1) Notice required to adduce evidence in support of exception to
No evidence can be adduced without notice of particulars of the exception.
32BE(2) Notice required to adduce evidence in support of exception to
Defendant cannot call another person to give evidence without leave of the court.
32BE(3) Notice required to adduce evidence in support of exception to
...the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address;
Temporal relation between notice and address information.
(b) if the name or the address is not included in the notice—the court is satisfied that...
...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;
Knowledge representation of defendant's actions.
(a) the notice under subsection (2) includes the name and address of the person or...
...call any other person to give evidence in support of the exception unless...
Prohibition on calling another person to give evidence.
(3) A defendant must not, without leave of the court...
Classification of individuals based on notice and address information.
Dissemination of information about defendant's actions.
...the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps...
32BF Civil penalties for importing, exporting, manufacturing or
Importing, exporting, manufacturing biologicals for use in humans without approval is prohibited.
32BF(1) Civil penalties for importing, exporting, manufacturing or
Prohibition of importing, exporting, manufacturing biologicals for use in humans.
Exporting biologicals for human use without registration is prohibited.
32BF(2) Civil penalties for importing, exporting, manufacturing or
Temporal interval between export and registration.
(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:
Knowledge graph representation of prohibited knowledge.
Prohibition of exporting biologicals for human use without registration.
Recurring trace of unregistered exports.
32BG Criminal offences and civil penalty relating to a failure to
Importing, exporting, manufacturing, or supplying a biological for use in humans without proper notification is prohibited.
32BG(1) Criminal offences and civil penalty relating to a failure to
Importing or exporting biologicals for use in humans is prohibited.
32BG(1A) Criminal offences and civil penalty relating to a failure to
Supplying biologicals for use in humans without proper exemption or approval is prohibited.
32BH Criminal offence relating to wholesale supply
Prohibits supplying biologicals for use in humans without proper exemption or approval.
32BI Criminal offence for using a biological not included in the
Using a biological without proper authorization is prohibited.
32BI(1) Criminal offence for using a biological not included in the
Using a biological not included in the Register for certain purposes is an offence.
32BI(4) Criminal offence for using a biological not included in the
The biological is used in the treatment of another person or solely for experimental purposes in humans.
32BJ General criminal offences relating to this Part
Setting out false biological numbers on containers or labels is prohibited.
32BJ(1) General criminal offences relating to this Part
Defines what constitutes a number for the purposes of subsection (1)
32BJ(2) General criminal offences relating to this Part
Advertising a biological for an indication that is not accepted in relation to its inclusion in the Register is prohibited.
32BJ(2A) General criminal offences relating to this Part
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Prohibition of advertising a biological for an indication that is not accepted in relation to its inclusion in the Register.
(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
(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.
Classification of the advertisement as a prohibited act.
Advertising a biological for an indication without proper inclusion in the Register is prohibited.
32BJ(2B) General criminal offences relating to this Part
(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.
Prohibition of advertising a biological for an indication without proper inclusion in the Register.
32BK Civil penalty for making misrepresentations about biologicals
Making false or misleading representations about biologicals is prohibited.
32BK(1) Civil penalty for making misrepresentations about biologicals
...and (b) for an individual—5,000 penalty units; and
Defines a temporal interval for the prohibition.
(1) A person contravenes this section if:
Prohibits making false or misleading representations about biologicals.
(a) the person makes a representation of a kind referred to in subsection (2); and (b) the representation is false or misleading.
...and (b) for a body corporate—50,000 penalty units.
Making misrepresentations about biologicals is prohibited.
32BK(2) Civil penalty for making misrepresentations about biologicals
Prohibition of making misrepresentations about biologicals.
Subsection (1) applies to the following representations:
Advertising biological for an indication without proper registration is prohibited.
32BL Civil penalty for advertising biological for an indication
Prohibits advertising biological for an indication without proper registration.
Classifies advertisements as prohibited if they include unregistered biologicals.
Exemptions of biologicals under regulations, emergencies, special and experimental uses, and substitutes unavailable.
32C What this Division is about
32CA Exempt biologicals
Exempts specified persons from Division 4 operation in relation to specified biologicals.
32CA(1) Exempt biologicals
Exempt biologicals from Division 4 operation.
32CA(2) Exempt biologicals
Regulations may exempt specified biologicals.
Exemptions may be subject to conditions prescribed in regulations.
32CA(3) Exempt biologicals
Permission to exempt biologicals with conditions.
Revocation of exemption takes effect after specified day
32CA(5) Exempt biologicals
...than 28 days after the day on which the regulations revoking the exemption take effect.
Temporal relationship between revocation and commencement of revocation
(5) If the regulations revoke an exemption, the revocation takes effect...
Revocation of exemption recognized by regulatory agency
Obligation to revoke exemption on specified day
Revocation of exemption diffuses to affected parties
32CB Minister may make exemptions
Minister may exempt specified biologicals from Division 4 operation.
32CB(1) Minister may make exemptions
Minister must make exemption under certain conditions.
32CB(1A) Minister may make exemptions
Minister is satisfied of the matter in subsection (2) or (2A)
Minister may make exemptions in national interest.
32CB(2) Minister may make exemptions
Minister may make exemptions under certain conditions.
32CB(2A) Minister may make exemptions
Conditions for exemptions under section 32CB
32CC Conditions of exemptions
Exemptions under section 32CB are subject to conditions
32CD Variation or revocation of exemption
32CD(1) Variation or revocation of exemption
32CD(2) Variation or revocation of exemption
The Minister may vary or revoke the conditions of an exemption made under section 32CB.
32CD(3) Variation or revocation of exemption
copy of exemption and variation/revocation
Must inform persons of exemption under section 32CB
32CE Informing persons of exemption etc.
32CF Notification and tabling
Notice setting out particulars of exemption, variation or revocation
Publish notice in Gazette within 7 days after exemption, variation or revocation is made.
32CF(1) Notification and tabling
Must publish notice in Gazette within 7 days
Notification and tabling of exemptions, variations, or revocations made under section 32CB.
32CF(2) Notification and tabling
This section applies to a biological if an exemption under section 32CB ceases to have effect.
32CG Disposal of unused biologicals
32CJ Criminal offences and civil penalty for biologicals not
Supplying non-conforming biologicals is prohibited.
32CJ(1) Criminal offences and civil penalty for biologicals not
Supply period includes non-conforming biologicals.
(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.
(a) a biological is exempt under section 32CB; and (b) a person supplies a batch of the biologicals;
Implication from supply and non-compliance
Supplying non-conforming biologicals implies violation of exemption.
An offence against subsection (9) is an offence of strict liability.
32CJ(10) Criminal offences and civil penalty for biologicals not
Require person to take steps to recall biologicals
32CJ(2) Criminal offences and civil penalty for biologicals not
32CJ(3) Criminal offences and civil penalty for biologicals not
Steps must be taken within a reasonable period
c) a reasonable period within which the steps are to be taken.
(3) The notice may specify one or more of the following requirements:
32CJ(4) Criminal offences and civil penalty for biologicals not
Notice given under subsection (2) is not a legislative instrument.
32CJ(5) Criminal offences and civil penalty for biologicals not
Prohibits notice given under subsection (2) from being a legislative instrument.
Failure to comply with notice requirement results in harm or injury.
32CJ(6) Criminal offences and civil penalty for biologicals not
Notice requirement overlaps with potential harm/injury.
Temporal overlap between notice and harm/injury.
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.
Prohibition of non-compliance with notice requirement.
The person fails to comply with the specified requirement.
Compliance with notice requirement is required.
Harm or injury results from non-compliance.
Non-compliance with notice requirement is prohibited.
(c) the person fails to comply with that requirement; and
Compliance with notice requirement is a duty.
(a) the Secretary gives a notice to the person under subsection (2); and
32CJ(7) Criminal offences and civil penalty for biologicals not
The provision has an overlapping temporal interval.
(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.
The provision implies a consequence if the person fails to comply.
32CJ(9) Criminal offences and civil penalty for biologicals not
(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.
Prohibition on non-compliance with notice requirement.
(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.
The person has a right to receive notice from the Secretary.
32CK Approvals for importing, exporting or supplying a biological
Approval for importing, exporting or supplying a biological
32CK(1) Approvals for importing, exporting or supplying a biological
(1)(e) for use solely for experimental purposes in humans.
...a person for one or more of the following:
...or for use in the treatment of another person;
(e) for use solely for experimental purposes in humans.
...or for use solely for experimental purposes in humans.
(d) for use in the treatment of another person.
Approval for use of a biological must be granted only to a health practitioner.
32CK(1A) Approvals for importing, exporting or supplying a biological
Restricts the approval to only those who are health practitioners at the time of granting.
(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.
Prohibits granting approval unless the person is a health practitioner.
Restricts the approval to only those who are health practitioners.
Ensures that only health practitioners are granted approval.
Justifies the restriction on approval to only those who are health practitioners.
Exemption from subsection 32CA(1) for biologicals in the Register or under subsection 32CA(2)
32CK(2) Approvals for importing, exporting or supplying a biological
Information relating to the biological subject of the application
Application for approval must be made to the Secretary and accompanied by required information.
32CK(3) Approvals for importing, exporting or supplying a biological
Information relating to the biological subject of the application, prescribed evaluation fee
32CK(4) Approvals for importing, exporting or supplying a biological
Reasons for decision if not granting approval
Secretary must notify applicant of decision on application as soon as practicable.
32CK(5) Approvals for importing, exporting or supplying a biological
Use of biological for experimental purposes in humans subject to conditions specified in regulations.
32CL Conditions of use of biological for experimental purposes in
occurs during the period specified in the regulations.
Describes the temporal relationship between the regulation and its application.
The use by a person (the experimenter) for experimental purposes...
must comply with the conditions specified in the regulations.
Describes the relationship between the regulation and its consequences.
Describes the process of reasoning about the regulation.
The use by a person (the experimenter) for experimental purposes in humans of a biological...
is disseminated through the regulations.
Describes the spread of information about the regulation.
32CM Authorities for health practitioners
The Secretary may authorise a medical practitioner to supply biologicals.
32CM(1) Authorities for health practitioners
Application for authority must be in approved form
32CM(1A) Authorities for health practitioners
The Secretary may give an authority under subsection (1) subject to conditions.
32CM(2) Authorities for health practitioners
Authority may be given subject to conditions.
Secretary may impose conditions on an authority
32CM(3) Authorities for health practitioners
Authority for medical practitioners to supply specified biologicals.
32CM(4) Authorities for health practitioners
(b) who has the approval of an ethics committee to supply the specified biological
(a) who is included in a class of medical practitioners prescribed by the regulations
Authority for health practitioners limited to prescribed classes of recipients.
32CM(5) Authorities for health practitioners
may only be given in relation to a class or classes of recipients prescribed by the regulations
Regulations may prescribe circumstances for supplying biologicals under authority.
32CM(6) Authorities for health practitioners
An authority under subsection (1) is not a legislative instrument.
32CM(7) Authorities for health practitioners
The Minister may make rules authorising health practitioners to supply biologicals.
32CM(7A) Authorities for health practitioners
Rules specify class of health practitioners and recipients
Comply with regulations when making rules under subsection (7A)
32CM(7B) Authorities for health practitioners
(7B) In making rules under subsection (7A), the Minister...
Notify supply to Secretary within 28 days after supply.
32CM(7C) Authorities for health practitioners
Information as prescribed by regulations
Notification requirements for health practitioners
32CM(7D) Authorities for health practitioners
Approval of a form may require or permit information to be given in accordance with specified software requirements.
32CM(7E) Authorities for health practitioners
32CN Criminal offences relating to the giving of an authority to a
Supplying a biological without proper authority is prohibited.
32CN(1) Criminal offences relating to the giving of an authority to a
The supply is not in accordance with the authority.
Prohibits supplying a biological without proper authority.
(a) the Secretary has authorised, under subsection 32CM(1), the person to supply a biological; and (b) the person supplies the biological;
Prohibits supplying a biological that would result in harm or injury to any person.
(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;
Prohibits supplying a biological that would not result in harm or injury to any person.
(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).
If supplying a biological without proper authority would result in harm or injury, then it is prohibited.
32CN(4) Criminal offences relating to the giving of an authority to a
...the supply is not in accordance with the authority;
...the supply is not in accordance with the regulations;
Requires recurring trace of supplying a biological.
Supplying a biological without authorization is prohibited.
32CN(4A) Criminal offences relating to the giving of an authority to a
...and (b) the person supplies the biological;
Defines temporal interval for supply of a biological.
...and (c) either of the following applies:
Recognizes prohibition in supply of a biological.
Diffuses prohibition to related provisions.
Defines temporal trace for supply of a biological.
Secretary may grant approval for importation of specified biologicals
32CO Approvals where substitutes for biologicals are unavailable
Offence for breaching a condition of an exemption, approval
32CP Offences for breaching a condition of an exemption, approval
Prohibits breaching a condition of an exemption, approval
The person does an act or omits to do an act
Civil penalty for breaching a condition of an exemption
32CQ Civil penalty for breaching a condition of an exemption,
Application requirements for inclusion in the Register
32D Simplified outline of this Division
32DA Application for inclusion in the Register
Application for inclusion in the Register
32DA(1) Application for inclusion in the Register
Application must be made in accordance with a form approved by the Secretary and accompanied by a statement certifying matters.
32DA(2) Application for inclusion in the Register
32DB Inclusion of Class 1 biological in the Register
Secretary must include biological in Register if application is made.
32DB(1) Inclusion of Class 1 biological in the Register
Secretary must assign a unique number to the biological if included in the Register.
32DB(2) Inclusion of Class 1 biological in the Register
Classification of biological in Register
Secretary must provide certificate upon inclusion in Register
32DB(3) Inclusion of Class 1 biological in the Register
The Secretary must give to the applicant a certificate of the inclusion of the biological in the Register.
Specify biological number and commencement day for inclusion in Register
32DB(4) Inclusion of Class 1 biological in the Register
Specify biological number and commencement day
32DC Refusal to include Class 1 biological in the Register
Application for inclusion of export only biological in the Register
32DC(1) Refusal to include Class 1 biological in the Register
Application must be made in accordance with a form approved by the Secretary and accompanied by a statement certifying certain matters.
32DC(2) Refusal to include Class 1 biological in the Register
Application may be required for approval of a form
32DC(3) Refusal to include Class 1 biological in the Register
Certification of safety, presentation, and compliance with standards
Certification requirements for export only biologicals
32DC(4) Refusal to include Class 1 biological in the Register
32DD Application for inclusion in the Register
Secretary must carry out assessment of application requirements
32DD(1) Application for inclusion in the Register
Information of a kind determined under subsection (9) and in a form determined under subsection (10)
32DD(2) Application for inclusion in the Register
Application must be delivered to an office of the Department within a reasonable time frame
Application must be made in accordance with the approved form
32DE Evaluation of biologicals
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.
32DE(1) Evaluation of biologicals
The Secretary must evaluate a biological.
Determination of priority applicant for section 32DD applications Corresponding application of subsections for paragraph (1)(g)
32DE(2) Evaluation of biologicals
Corresponding application of subsections for paragraph (1)(g)
information that must accompany an application
Regulations for applications of biologicals
32DE(3) Evaluation of biologicals
Regulations require information to be provided
32DF Inclusion of biological in the Register
Secretary must include biological in Register if certain conditions met.
32DF(1) Inclusion of biological in the Register
the evaluation must occur before inclusion.
(b) the Secretary decides that it is appropriate to include the biological in the Register after an evaluation under section 32DE;
the Secretary must include the biological in the Register.
the evaluation fee must be paid before inclusion.
Evaluation fee must be paid before inclusion
(c) no part of an evaluation fee under section 32DI that is due and payable by the person remains unpaid;
32DF(2) Inclusion of biological in the Register
Classification of biological in the Register
32DF(3) Inclusion of biological in the Register
Specifies requirements for a certificate's content regarding biological inclusion in the Register.
32DF(4) Inclusion of biological in the Register
Notice of refusal and reasons for refusal
Secretary must provide notice after refusing application to include biological in the Register.
32DG Refusal to include biological in the Register
32DH Lapsing of application
Application lapse due to unpaid fee, false information, or non-compliance with patient data requirements.
32DH(1) Lapsing of application
Prohibition of application lapse due to unpaid fee.
Prohibition of application lapse due to false information.
Prohibition of application lapse due to non-compliance with patient data requirements.
Non-compliance with patient data requirements
Defines patient data in relation to a biological.
32DH(2) Lapsing of application
information derived from clinical trials
patient data, in relation to a biological
32DI Evaluation fee
Pay evaluation fee for biological inclusion in Register
32DI(1) Evaluation fee
The Secretary must notify the applicant in writing of the evaluation fee.
32DI(2) Evaluation fee
32DJ When evaluation fee due for payment
32DJ(1) When evaluation fee due for payment
Temporal relation between notification and payment
(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.
Spread of obligation to pay evaluation fee
Temporal trace between notification and payment
Evaluation fee must be paid in the manner prescribed by regulations.
32DJ(2) When evaluation fee due for payment
32DK Payment of evaluation fee by instalments
32DK(1) Payment of evaluation fee by instalments
Payment of evaluation fee by instalments is not allowed if any part of an instalment was unpaid immediately after it became due for payment.
32DK(2) Payment of evaluation fee by instalments
...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.
Payment of evaluation fee by instalments overlaps with the condition that any part of an instalment was unpaid immediately after it became due.
(2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments...
Payment of evaluation fee by instalments is recognized as a prohibited action if any part was unpaid immediately after it became due.
Prohibits payment of evaluation fee by instalments if any part was unpaid immediately after it became due.
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.
Payment of evaluation fee by instalments contains the condition that any part of an instalment was unpaid immediately after it became due.
32DK(3) Payment of evaluation fee by instalments
The Commonwealth may recover an evaluation fee as a debt.
32DL Recovery of evaluation fee
32DM Reduction of evaluation fee where evaluation not completed
No payment of more than 3/4 evaluation fee before completion if a period is prescribed for completing the evaluation.
32DM(1) Reduction of evaluation fee where evaluation not completed
Secretary must notify applicant of evaluation completion date
32DM(2) Reduction of evaluation fee where evaluation not completed
Reduction of evaluation fee if evaluation not completed within period
32DM(3) Reduction of evaluation fee where evaluation not completed
(evaluation not completed within period)
Payment of unpaid evaluation fee upon completion of evaluation.
32DM(4) Reduction of evaluation fee where evaluation not completed
Evaluation fee reduction where report is given to applicant or committee.
32DM(5) Reduction of evaluation fee where evaluation not completed
then the evaluation is taken to be completed immediately before the first copy or summary is so given.
Evaluation fee reduction applies when report is given within a specified period.
(5) For the purposes of this section, if a copy of the evaluation report...
Withdrawal after report being given implies obligation to pay full evaluation fee.
Duty to pay full evaluation fee if applicant withdraws after report is given.
Report being given to applicant or committee diffuses the obligation to pay full evaluation fee.
Evaluation fee reduction applies until report is given to applicant or committee.
Notification under subsection (2) is not a legislative instrument.
32DM(6) Reduction of evaluation fee where evaluation not completed
Secretary must cancel inclusion of goods in part and include biological in Register under Part
32DN Transitional provisions for existing biologicals
32DO Criminal offences for false statements in applications for
Making false statements in applications for biological inclusion is a criminal offence.
32DO(1) Criminal offences for false statements in applications for
Prohibits making false statements in applications for biological inclusion.
The statement is made in, or in connection with, an application for inclusion of a biological in the Register.
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.
Prohibits harm or injury to any person resulting from the use of the biological.
(i) the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person;
and (b) the statement is made in, or in connection with, an application for inclusion of a biological in the Register.
Implies that the provision is related to harm or injury.
Making false statements in applications for inclusion of biologicals in the Register is an offence.
32DO(4) Criminal offences for false statements in applications for
Making false statements in applications for inclusion of a biological in the Register is an offence.
32DO(5) Criminal offences for false statements in applications for
Prohibits making false statements in applications.
An offence against subsection (5) is an offence of strict liability.
32DO(6) Criminal offences for false statements in applications for
False statements in applications for inclusion of biologicals in the Register
32DP Civil penalty for false statements in applications for including
Failure to notify adverse effects of a biological included in the Register is an offence.
32DQ Criminal offence and civil penalty for failing to notify adverse
Obligation to notify adverse effects of a biological included in the Register.
32DR Criminal offences and civil penalties for failing to notify
Notify the Secretary of known information within 14 days after application withdrawal or lapse.
32DR(1) Criminal offences and civil penalties for failing to notify
Failing to notify of certain information may result in criminal offences or civil penalties.
32DR(2) Criminal offences and civil penalties for failing to notify
Failure to comply with notice within 30 days results in imprisonment or penalty units.
32DR(3) Criminal offences and civil penalties for failing to notify
32DS Consultation with Gene Technology Regulator
Application for inclusion of a biological in the Register must consult with the Gene Technology Regulator.
32DS(1) Consultation with Gene Technology Regulator
...must consult with the Gene Technology Regulator.
Consultation must occur before the application is processed.
The application for inclusion of a biological in the Register...
Consultation implies that the application is not exempt from regulation.
Consultation is an artificial intelligence-powered regulation mechanism.
Application must comply with consultation requirement.
Consultation is a necessary step for the regulation of genetic modification.
The Secretary must give written notice to the Gene Technology Regulator.
32DS(2) Consultation with Gene Technology Regulator
32DS(3) Consultation with Gene Technology Regulator
32DS(4) Consultation with Gene Technology Regulator
No notification required for applications within a class of biologicals subject to Gene Technology Regulator advice.
32DS(5) Consultation with Gene Technology Regulator
The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT.
(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.
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.
Notice under subsection (2) is not a legislative instrument.
32DS(6) Consultation with Gene Technology Regulator
The Secretary may request advice from the Gene Technology Regulator about specific GM products or organisms.
32DT Secretary may seek advice about classes of GM products or
Secretary must take advice into account when making a decision on an application.
32DU Secretary to take advice into account
The Secretary must ensure that the advice is taken into account in making a decision on the application.
Secretary must take advice into account.
The Secretary receives advice from the Gene Technology Regulator.
The Secretary must inform the Gene Technology Regulator of the decision on the application.
Secretary informs the Gene Technology Regulator of the decision on the application.
Exemptions from automatic conditions for inclusions of biologicals in the Register
32E What this Division is about
Allow entry and inspection of premises for authorized persons.
32EA Conditions applying automatically
...to enter, inspect, and examine at any reasonable time.
Entry is allowed during reasonable hours.
...to allow an authorised person to enter, inspect, and examine.
Grant permission for entry and inspection.
The person in relation to whom the biological is included in the Register...
32EB Certification of manufacturing steps outside Australia
Application for certification of manufacturing steps outside Australia
32EB(1) Certification of manufacturing steps outside Australia
Secretary must certify manufacturing procedures upon request.
32EB(2) Certification of manufacturing steps outside Australia
Certification is within a specific time frame
(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.
Certification is a form of artificial intelligence
Applying subsections for certification decision
32EB(3) Certification of manufacturing steps outside Australia
Subsections apply for certification decision
32EC Imposition of conditions by legislative instrument
Conditions for inclusion of a biological in the Register
32EC(1) Imposition of conditions by legislative instrument
Conditions apply during the process of inclusion
(1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2).
Imposes conditions on inclusion of a biological in the Register
Minister may impose conditions on the manufacture, custody, use, supply, disposal or destruction of a biological.
32EC(2) Imposition of conditions by legislative instrument
(2) The Minister may, by legislative instrument, make a determination setting out conditions for the purposes of subsection (1);
(a) the manufacture of the biological; or (b) the custody, use, supply, disposal or destruction of the biological;
Reporting requirements for the biological
(ca) reporting requirements relating to the biological;
Different conditions may be specified for different classes of biologicals.
32EC(3) Imposition of conditions by legislative instrument
32ED Imposition of conditions at time biological included in the
Secretary may impose conditions on inclusion of biological in Register
32ED(1) Imposition of conditions at time biological included in the
A notice under subsection (1) is not a legislative instrument.
32ED(2) Imposition of conditions at time biological included in the
A notice under subsection (1) is a legislative instrument.
32EE Imposition or variation or removal of conditions after
Secretary may impose new conditions on biological inclusion
32EE(1) Imposition or variation or removal of conditions after
Request must be accompanied by prescribed fee.
32EE(2) Imposition or variation or removal of conditions after
Conditions for imposition or variation of conditions after notice is given to the person.
32EE(3) Imposition or variation or removal of conditions after
Notice specifies start date for imposition or variation.
(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;
Imposition or variation takes effect on specified day.
(3) The imposition or variation or removal of a condition under subsection (1) takes effect:
Person must agree to earlier start date for imposition or variation.
unless the person has agreed to an earlier day;
Notice specifies recurring pattern for imposition or variation.
(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;
The earlier day must not be earlier than the day the notice is given to the person.
32EE(3A) Imposition or variation or removal of conditions after
The notice must be given on or after the day before the given day.
The earlier day is a temporal interval before the given day.
The notice must be given on or after the given day.
The earlier day must not be earlier than the given day.
Legislative instrument notice is not a legislative instrument.
32EE(4) Imposition or variation or removal of conditions after
Prohibits notices from being legislative instruments.
32EF Criminal offences for breach of condition
Breach of condition results in harm or injury to any person.
32EF(1) Criminal offences for breach of condition
(Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.)
(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.
Breach of condition results in criminal offence
32EF(4) Criminal offences for breach of condition
Temporal interval for breach of conditions
(c) the act or omission breaches a condition of the inclusion of the biological in the Register.
(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;
Temporal constraint on breach of conditions
32EF(5) Criminal offences for breach of condition
32EG Civil penalty for breach of condition
Indicates temporal interval for breach of condition
...breaches a condition of the inclusion of the biological in the Register.
...for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units.
Prohibits breach of condition for individuals and bodies corporate
Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units.
(a) for an individual—5,000 penalty units; (b) for a body corporate—50,000 penalty units.
Implicates breach of condition on inclusion in Register
The Secretary may suspend biologicals from the Register in certain circumstances.
32F What this Division is about
32FA Suspension of biological from the Register
Suspension of biological from the Register is allowed under certain conditions.
32FA(1) Suspension of biological from the Register
Prohibits suspension of biological from the Register.
(1) The Secretary may, by written notice given to a person in relation to whom a biological is included in the Register...
Secretary must suspend biological from Register before cancelling entry under section 32GC
32FA(2) Suspension of biological from the Register
Duty to suspend biological from Register
32FB When suspension takes effect etc.
Suspension of therapeutic goods takes effect under certain conditions.
32FB(1) When suspension takes effect etc.
32FB(2) When suspension takes effect etc.
Secretary may extend period specified under subsection 32FA(4) by a further specified period not exceeding 6 months.
32FB(3) When suspension takes effect etc.
32FB(4) When suspension takes effect etc.
Notice under subsection (3) is not a legislative instrument.
32FB(5) When suspension takes effect etc.
32FC Revocation of suspension
Secretary must revoke suspension under certain conditions.
32FC(1) Revocation of suspension
Ground on which biological was suspended no longer applies
32FC(2) Revocation of suspension
Dealing in a biological not included in the Register may be a criminal offence or contravene a civil penalty provision.
32FD Effect of suspension
Prohibits dealing in a biological not included in the Register.
Secretary may cancel inclusions of biologicals in the Register under certain circumstances.
32G What this Division is about
Cancellation of biological entry from Register under specified circumstances.
32GA Immediate cancellation of biological from the Register in
The cancellation is effective from the date of notice.
The cancellation is effective immediately.
The Secretary may cancel the entry of a biological from the Register.
32GB Immediate cancellation of biological from the Register after
The Secretary may cancel a biological entry from the Register if the person fails to comply with a notice.
32GB(1) Immediate cancellation of biological from the Register after
The Secretary has an obligation to cancel the biological entry.
Secretary must provide notice to person before cancelling biological entry from Register.
32GB(2) Immediate cancellation of biological from the Register after
32GC Cancellation of biological from the Register after notice of
Cancellation of biological from the Register after notice of unacceptable quality, safety or efficacy.
32GC(1) Cancellation of biological from the Register after notice of
The person must not include the biological in the Register.
The Secretary may cancel the entry of the biological from the Register.
The person must not advertise the biological.
The person contravenes subsection 32DQ(1) or (2) in relation to the biological.
The related body corporate must not advertise the biological.
Prohibition of advertising by related body corporate
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.
The person must comply with the Therapeutic Goods Advertising Code.
Prohibition of non-compliance with Therapeutic Goods Advertising Code
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.
The person must comply with regulatory requirements.
Prohibition of non-compliance with regulatory requirements
Secretary must inform person of proposed cancellation and invite written submissions.
32GC(2) Cancellation of biological from the Register after notice of
Cancellation period is specified as a duration after notice.
Person must provide written submissions in response to notice.
Secretary must inform person of proposed cancellation.
Secretary is obligated to inform person of proposed cancellation.
Cancellation must be made within a specified period after notice.
Secretary must consider submissions before making a decision on cancellation.
32GC(3) Cancellation of biological from the Register after notice of
A notice under subsection (1) must not be a legislative instrument.
32GC(4) Cancellation of biological from the Register after notice of
Prohibition of notice being a legislative instrument.
Request for revocation of cancellation of biological upon request
32GD Revocation of cancellation of biological upon request
Publish notice of cancellation from Register
32GE Publication of cancellation of entry from Register
Date of effect of cancellation of entries from Register
32GF Date of effect of cancellation of entries from Register
The Secretary may require a person to recall biologicals or inform the public about non-compliant biologicals.
32H What this Division is about
Imposes a duty on the Secretary to require recall or notification.
The Secretary may impose requirements on a person supplying a biological if certain circumstances occur.
32HA Public notification, and recall, of biologicals
Imposition of requirements is an obligation.
32HB Publication of requirements
32HC Criminal offences for non-compliance with requirements
32HC(1) Criminal offences for non-compliance with requirements
Non-compliance with section 32HA requirements is an offence.
32HC(4) Criminal offences for non-compliance with requirements
Offence for non-compliance with requirements
32HC(5) Criminal offences for non-compliance with requirements
Offence of strict liability for non-compliance with requirements
32HC(6) Criminal offences for non-compliance with requirements
Civil penalty for non-compliance with requirements
32HD Civil penalty for non-compliance with requirements
Prohibits civil penalty for non-compliance
Powers of suspension and cancellation unaffected
32HE Powers of suspension and cancellation unaffected
32HF Saving of other laws
The Secretary may seek information or documents from applicants, biologicals included in the Register, and suppliers of exempted biologicals.
32J What this Division is about
There are criminal offences for failing to comply with a notice and civil penalties for giving false or misleading information or documents.
The Secretary may seek information or documents.
There are penalties for failing to comply with a notice.
32JA Secretary may require information or documents
32JB Criminal offences for failing to comply with a notice etc.
32JB(1) Criminal offences for failing to comply with a notice etc.
Defendant bears evidential burden for reasonable excuse
32JB(1A) Criminal offences for failing to comply with a notice etc.
Defendant has an obligation to provide a reasonable excuse
Defendant bears the burden of proof for their excuse
32JB(1B) Criminal offences for failing to comply with a notice etc.
Defines the temporal interval during which the obligation to comply applies.
(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.
Imposes an obligation to comply with a notice.
(c) the person fails to comply with the notice.
Offence of strict liability for failing to comply with a notice.
32JB(1C) Criminal offences for failing to comply with a notice etc.
32JB(1D) Criminal offences for failing to comply with a notice etc.
32JB(2) Criminal offences for failing to comply with a notice etc.
Giving false or misleading information in compliance with a notice is prohibited.
32JC Civil penalty for giving false or misleading information or
The person contravenes this section if...
Prohibition of giving false or misleading information.
The person is given a notice under section 32JA.
32JD Self-incrimination
32JD(1) Self-incrimination
Exemptions from self-incrimination in certain cases
32JD(2) Self-incrimination
Secretary may require information about biologicals from exempt persons.
32JE Secretary may require information etc. about biologicals
32JF Secretary may require information etc. about biologicals
Secretary may require information about biologicals
32JF(1) Secretary may require information etc. about biologicals
32JF(2) Secretary may require information etc. about biologicals
Must provide information within a specified period and in a specified form.
32JF(3) Secretary may require information etc. about biologicals
The form may require or permit the information to be given, or the documents to be produced, in accordance with specified software requirements.
32JF(4) Secretary may require information etc. about biologicals
32JG Secretary may require information etc. about biologicals
specified information or documents relating to the supply, handling, monitoring of the supply, and results of the supply of the biological
The Secretary may require information from a person granted an approval under subsection 32CK(1) in relation to a biological.
32JG(1) Secretary may require information etc. about biologicals
specified information or documents relating to the use of the biological
The Secretary may require information etc. about biologicals.
32JG(2) Secretary may require information etc. about biologicals
The Secretary may require information etc.
The Secretary may require specified information or documents from a person granted an authority under subsection 32CM(1) in relation to a biological.
32JG(3) Secretary may require information etc. about biologicals
The Secretary may require specified information or documents.
Secretary may require specified information or documents from a person authorized to supply a biological.
32JG(3A) Secretary may require information etc. about biologicals
Must provide information or documents within a specified period and in a specified form.
32JG(4) Secretary may require information etc. about biologicals
32JH Secretary may require information etc. about biologicals
(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.
The Secretary may require information about a biological.
32JH(1) Secretary may require information etc. about biologicals
Must provide information or documents within a specified period and in the form specified by the notice.
32JH(2) Secretary may require information etc. about biologicals
The form may require or permit the information to be given, or the documents to be produced in accordance with specified software requirements.
32JH(3) Secretary may require information etc. about biologicals
32JI Criminal offences for failing to comply with a notice etc.
32JI(1) Criminal offences for failing to comply with a notice etc.
Defines a temporal interval during which failing to comply with a notice results in an offence.
(a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice.
Justifies the imposition of a penalty for failing to comply with notices.
Imposes an obligation on persons to comply with notices.
Defines a recurring obligation to comply with notices.
32JI(1A) Criminal offences for failing to comply with a notice etc.
Notices issued under sections 32JE, 32JF, 32JG or 32JH overlap with the offence.
(1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and
Imposes an obligation to comply with the notice.
Prohibits failure to comply with the notice.
Notice must be repeated for each failure to comply.
32JI(1B) Criminal offences for failing to comply with a notice etc.
Prohibits an offence of strict liability
Failing to comply with a notice results in an offence.
32JI(2) Criminal offences for failing to comply with a notice etc.
Offence for failing to comply with a notice
32JI(3) Criminal offences for failing to comply with a notice etc.
Prohibits failure to comply with a notice
32JJ Civil penalty for giving false or misleading information or
32JK Self-incrimination
32JK(1) Self-incrimination
Exemptions from self-incrimination in certain circumstances
32JK(2) Self-incrimination
Inspect and copy documents produced under certain sections.
32JL Secretary may inspect and copy documents
32JM Secretary may retain documents
The Secretary may retain documents for a reasonable period.
32JM(1) Secretary may retain documents
Secretary must provide a copy of the document upon request.
32JM(2) Secretary may retain documents
Secretary has an obligation to provide a copy of the document.
The certified copy must be received as evidence.
32JM(3) Secretary may retain documents
Must provide access to documents for inspection and copying.
32JM(4) Secretary may retain documents
33A Part does not apply to a medical device
This Part does not apply to a Class 1 biological.
33B Application of this Part to biologicals
34 Exempt goods and exempt persons
Therapeutic goods may be exempt from the operation of this Part.
34(1) Exempt goods and exempt persons
Exempts a person from the operation of this Part in relation to the manufacture or a step in the manufacture of therapeutic goods.
34(2) Exempt goods and exempt persons
34(3) Exempt goods and exempt persons
35 Criminal offences relating to manufacturing therapeutic goods
Manufacturing therapeutic goods without proper authorization is prohibited.
35(1) Criminal offences relating to manufacturing therapeutic goods
Prohibits the manufacture of therapeutic goods without proper authorization.
Manufacturing therapeutic goods without proper license
35(4) Criminal offences relating to manufacturing therapeutic goods
...and none of the following applies: (i) the goods are exempt goods;
Prohibits manufacturing therapeutic goods without license
(a) the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods...
Prohibits manufacturing therapeutic goods without proper license
(b) the goods are for supply for use in humans;
(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.
Carrying out steps in manufacturing therapeutic goods at Australian premises is prohibited.
35A Civil penalties relating to manufacturing therapeutic goods
Prohibition of manufacturing therapeutic goods at Australian premises.
35B Criminal offences relating to breaching a condition of a licence
A person commits an offence if they hold a licence and breach a condition of the licence.
35B(1) Criminal offences relating to breaching a condition of a licence
Licence is a necessary condition for committing an offence.
Breach of the licence's condition is a necessary condition for committing an offence.
The act or omission has resulted in, will result in, or is likely to result in harm or injury to any person.
The penalty for committing an offence is imprisonment for 5 years or 4,000 penalty units.
Imprisonment for 5 years or 4,000 penalty units is a possible consequence of committing an offence.
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.
The court has discretion to acquit or convict a person of an offence.
A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead.
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.
Breach of licence condition is an offence.
35B(4) Criminal offences relating to breaching a condition of a licence
35B(5) Criminal offences relating to breaching a condition of a licence
The licence breach occurs during the licence period.
Licence breach occurs during licence period.
(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.
The person is obligated to comply with the licence conditions.
Licence breach implies obligation to comply.
35B(6) Criminal offences relating to breaching a condition of a licence
Breach of licence condition results in civil penalty
35C Civil penalty relating to breaching a condition of a licence
The Minister may determine written principles for the manufacture of therapeutic goods.
36 Manufacturing principles
37 Application for licence
a form approved by the Secretary, identification of therapeutic goods or classes of therapeutic goods, manufacturing sites, steps in manufacture, and control measures
Application for licence must be made in accordance with a form approved by the Secretary.
37(1) Application for licence
Application must relate to one manufacturing site only.
37(1A) Application for licence
Temporal relation between manufacturing sites
Applicant may identify multiple manufacturing sites in application.
37(1B) Application for licence
Grant of licence for manufacturing therapeutic goods
38 Grant of licence
The Secretary must make guidelines for multi-site licences.
38A Guidelines for multi-site licences
This section applies if a licence (the old licence):
38B Splitting multi-site licences
39 Term of licence
39(1) Term of licence
Defines temporal interval for licence commencement
Licence ceases to be in force if goods cease to be exempt under section 18A.
39(2) Term of licence
when those goods cease to be exempt under that section.
Temporal relation between exemption and licence revocation
(b) those goods cease to be exempt under that section before the licence is revoked;
the licence ceases to be in force in relation to those goods when those goods cease to be exempt under that section.
(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;
Licence ceases in force if biological ceases to be exempt under section 32CB.
39(3) Term of licence
Biological ceases to be exempt under section 32CB before licence is revoked
(b) the biological ceases to be exempt under that section before the licence is revoked;
Licence ceases in force when biological ceases to be exempt under section 32CB
(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;
the licence ceases to be in force in relation to the biological when the biological ceases to be exempt under that section.
Biological ceases to be exempt under section 32CB at some point in time
3A Declaration—member of European Community
Declaration of membership in European Community or EFTA
3A(1) Declaration—member of European Community
Declaration must be published in Gazette or on Department's website.
3A(2) Declaration—member of European Community
3AA Homoeopathic preparations and homoeopathic standards
Definition of homoeopathic preparation and standard.
3AA(1) Homoeopathic preparations and homoeopathic standards
a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia
(1) For the purposes of this Act, a homoeopathic preparation is a...
Defines a concept that can be processed by AI.
A homoeopathic standard is constituted by the statements in monographs describing manufacturing procedures.
3AA(2) Homoeopathic preparations and homoeopathic standards
Specify publications and/or parts of publications for homoeopathic pharmacopoeia definition
3AA(3) Homoeopathic preparations and homoeopathic standards
Minister may exempt specified monographs from certain requirements.
3AA(4) Homoeopathic preparations and homoeopathic standards
The Minister may determine exemptions for specified statements in monographs.
3AA(5) Homoeopathic preparations and homoeopathic standards
3AB Anthroposophic preparations and anthroposophic standards
Definition of anthroposophic preparation
3AB(1) Anthroposophic preparations and anthroposophic standards
(1) For the purposes of this Act, an anthroposophic preparation is a...
An anthroposophic standard is constituted by the statements in monographs describing manufacturing procedures.
3AB(2) Anthroposophic preparations and anthroposophic standards
Anthroposophic standard is constituted by statements in monographs
Specify publications and/or parts of publications for the definition of anthroposophic pharmacopoeia.
3AB(3) Anthroposophic preparations and anthroposophic standards
Specify publications and/or parts of publications.
Minister may exempt specified monographs from paragraph (2)(b) purposes.
3AB(4) Anthroposophic preparations and anthroposophic standards
Minister may exempt specified statements from subsection (2)
3AB(5) Anthroposophic preparations and anthroposophic standards
3B Declaration—country covered by non-EC/EFTA MRA
Minister may declare a country covered by non-EC/EFTA MRA.
3B(1) Declaration—country covered by non-EC/EFTA MRA
3B(2) Declaration—country covered by non-EC/EFTA MRA
3C Exempting monographs in pharmacopoeias
The Minister may determine exemptions for specified monographs in relation to therapeutic goods.
3C(1) Exempting monographs in pharmacopoeias
Determination of exemptions for therapeutic goods
3C(2) Exempting monographs in pharmacopoeias
Exempts monographs in pharmacopoeias from certain legislation
3C(3) Exempting monographs in pharmacopoeias
Requires temporal relation between instrument and writing
4 Objects of Act
List therapeutic goods for national system of controls
4(1) Objects of Act
Manufacturer's intent for medical devices
4(1A) Objects of Act
The efficacy of therapeutic goods is a reference to the performance of devices as the manufacturer intended.
Act does not exclude concurrent operation with other laws.
4(2) Objects of Act
to the extent that the law is capable of operating concurrently with this Act.
(2) This Act is therefore not intended to apply...
to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory.
Cognitive framework for concurrent operation
40 Conditions of licences
40(1) Conditions of licences
Secretary may impose new conditions on a licence.
40(2) Conditions of licences
Conditions for imposing, varying or removing conditions on licences.
40(3) Conditions of licences
40(3A) Conditions of licences
(3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day.
(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.
(3A) For the purposes of paragraph (3)(b), the earlier day must be on or after the notice day.
The earlier day must be on or after the notice day.
Ensure goods conform to standards and follow manufacturing principles.
40(4) Conditions of licences
...the goods conform to any standard applicable to the goods; and...
Manufacturing principles apply during the manufacture of goods.
The holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence;
...the goods are a biological and are for supply after the circumstances prescribed by the regulations...
Goods have a certain property if they conform to standards.
(i) the goods conform to any standard applicable to the goods;
...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.
Ensure compliance with standards and principles.
The holder of the licence must ensure that...
Manufacturing principles apply if certain conditions are met.
The holder of the licence will: (a) ensure that:...
Manufacturing principles apply until the circumstances prescribed by the regulations have occurred.
40A Variation of manufacturing site authorisations—Secretary’s
The Secretary may vary a manufacturing site authorisation on their own initiative.
40A(1) Variation of manufacturing site authorisations—Secretary’s
The Secretary has the power to vary a manufacturing site authorisation.
Variation of manufacturing site authorisations—Secretary’s
40A(2) Variation of manufacturing site authorisations—Secretary’s
Temporal relationship of variation effectiveness
Artificial intelligence application for variation effectiveness
Recurring relationship of variation effectiveness
40B Variation of licences—application by licence holder
Licence holder may apply for variation of licence to cover additional manufacturing sites.
40B(1) Variation of licences—application by licence holder
information relating to manufacturing steps, quality control measures, and personnel
Application requirements for variation of licences
40B(2) Variation of licences—application by licence holder
Variation of licences—application by licence holder
40B(3) Variation of licences—application by licence holder
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.
40B(4) Variation of licences—application by licence holder
The variation is specified for each manufacturing site.
Variation of manufacturing site authorisations takes effect on the day notice is given to the holder.
40B(5) Variation of licences—application by licence holder
Holder of a licence may apply for variation of manufacturing site authorisation.
40B(6) Variation of licences—application by licence holder
Application for variation of licence must be made in accordance with a form approved by the Secretary.
40B(7) Variation of licences—application by licence holder
Secretary may vary manufacturing site authorisation upon application and payment of inspection fees.
40B(8) Variation of licences—application by licence holder
Permits variation of manufacturing site authorisation.
40B(9) Variation of licences—application by licence holder
The variation's effectiveness is tied to a specific date.
(9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder.
The variation takes effect on the specified day.
The licence holder must comply with the variation's terms.
The variation's application is subject to specific rules.
The variation's application can be traced back to its notification date.
Revocation or suspension of a licence for specified reasons
41 Revocation and suspension of licences
Prohibits revocation or suspension of a licence for specified reasons
(1) Subject to subsection (2), the Secretary may, by notice in writing...
Prohibits breach of a condition of a manufacturing licence
(viii) breached a condition of a manufacturing licence;
The Secretary must publish a list of licensed persons and goods.
41A Publication of list of manufacturers etc.
Relieves persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them.
41AA Spent convictions scheme
The Secretary may require a person to provide information or documents.
41AB Secretary may require information or documents
The Secretary may require the person to provide information or documents.
41AC Criminal offence for contravening a requirement in a notice
Given a notice under section 41AB, the person must do an act.
41AD False or misleading information—offence
Providing false or misleading information to the Secretary is an offence.
41AD(1) False or misleading information—offence
Providing false or misleading information is an offence.
Prohibition of providing false or misleading information.
The person gives information to the Secretary in compliance, or purported compliance, with the notice.
41AD(2) False or misleading information—offence
Defendant bears evidential burden in relation to matter in subsection (3)
41AD(3) False or misleading information—offence
41AE False or misleading documents—offence
41AE(1) False or misleading documents—offence
...the document is produced in compliance, or purported compliance, with a notice given under section 41AB.
Imposes an obligation to not produce false or misleading documents.
...the person does so knowing that the document is false or misleading;
Prohibits knowing that the document is false or misleading.
(a) the person produces a document to the Secretary; and
Prohibits producing in compliance with a notice given under section 41AB.
(c) the document is produced in compliance, or purported compliance, with a notice given under section 41AB.
(b) the person does so knowing that the document is false or misleading;
41AE(2) False or misleading documents—offence
41AF False or misleading information or documents—civil penalty
41AF(1) False or misleading information or documents—civil penalty
Exemption from subsection (1) for documents accompanied by a written statement
41AF(2) False or misleading information or documents—civil penalty
41AG Self-incrimination
Regulations may make provision for the transfer of licences. No excuse for giving information or producing a document under a section 41AB notice
41AG(1) Self-incrimination
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.
41AG(2) Self-incrimination
is not admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;
Prohibits admissibility of self-incrimination evidence in criminal proceedings.
(2) However, in the case of an individual:
is not admissible in evidence in: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision.
Prohibits admissibility of self-incrimination evidence in pecuniary penalty order proceedings.
(e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision.
is admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;
Permits admissibility of self-incrimination evidence in certain proceedings.
(d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;
is admissible in evidence in: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision;
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;
Establishes right to self-incrimination protection.
Establishes undertaking to protect self-incrimination.
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.
No self-incrimination for subsection (1) beyond what is limited by subsection (2)
41AG(3) Self-incrimination
State must not incriminate under subsection (1)
Subsection (2) does not limit subsection (1)
State may incriminate under subsection (1)
Permits self-incrimination under subsection (1)
State must limit self-incrimination under subsection (1)
Imposes obligation on the state to limit self-incrimination under subsection (1)
Compilation information and notes on amendments.
5 September 2025
5 Act to bind Crown
The Crown is obligated to comply with the Act.
Jurisdiction applies to specific offences
5A Application of the Criminal Code—extended geographical
to offences against specified subsections
Applicable to corporations and natural persons/corporations in certain trade/commerce contexts.
6 Operation of Act
Applicable to corporations and natural persons/corporations.
(1) This Act (other than Part 4-8A or Part 6-1A)
(a) things done by corporations; (b) things done by natural persons or corporations in so far as those things are done:
Applicable to trade/commerce between Australia and a place outside Australia, among the States, between a State and a Territory or between 2 Territories.
(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;
6B Review of certain decisions under State laws
Application for review of a State decision may be made.
6B(1) Review of certain decisions under State laws
A decision made by the Secretary is reviewable if it meets certain conditions.
6B(2) Review of certain decisions under State laws
Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act.
6B(3) Review of certain decisions under State laws
The Administrative Review Tribunal Act 2024 has effect during the period of a corresponding State law.
The Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act.
Legal effect of the Administrative Review Tribunal Act 2024 on State laws.
6C Fees payable to Commonwealth under State laws
Fees payable to Commonwealth under State laws
6C(1) Fees payable to Commonwealth under State laws
Imposes an obligation on States to pay fees to the Commonwealth
Arrangements for Commonwealth fees under State laws
6C(2) Fees payable to Commonwealth under State laws
7 Declaration that goods are/are not therapeutic goods
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
7(1) Declaration that goods are/are not therapeutic goods
The Secretary may make an order at any time
(1) Where the Secretary is satisfied that classes of goods:
Secretary must disregard certain paragraphs when deciding if goods are therapeutic.
7(1A) Declaration that goods are/are not therapeutic goods
...must disregard paragraphs (e) and (f)
Secretary must disregard certain paragraphs.
Goods are not therapeutic goods under certain conditions. Minister must consider certain matters before making a determination about regulating goods.
7(2) Declaration that goods are/are not therapeutic goods
when used, advertised, or presented for supply in a particular way
Temporal relationship between conditions
(a) are not therapeutic goods; or (b) when used, advertised, or presented for supply in a particular way, are not therapeutic goods.
(2) Before making a determination under subsection (1), the Minister:
Goods are not therapeutic goods if declaration applies wholly or partly to goods that would be medical devices.
7(4) Declaration that goods are/are not therapeutic goods
Goods are not therapeutic goods during use, advertisement, or presentation for supply.
Declaration applies during use, advertisement, or presentation for supply.
Declaration applies wholly or partly to goods that would be medical devices.
Goods are classified as non-therapeutic goods by AI.
Declaration is a declaration that classes of goods are not therapeutic goods.
Declaration applies implies goods are not therapeutic goods.
Goods are diffused as non-therapeutic goods.
Declaration implies diffusion of goods being non-therapeutic goods.
Goods are not therapeutic goods due to recurring declaration.
Declaration is recurring in its application to goods.
7A Authorised persons
Authorises Secretary to authorise persons to exercise powers under specified provisions of the Act.
7A(1) Authorised persons
Authority is granted during the term of the Secretary's office.
The authority is granted during the term of the Secretary's office.
Authority implies that the person exercising powers has a specified role.
The authority implies that the person exercising powers has a specified role.
Person exercising powers has a specified role.
Authority implies that the person exercising powers has a specified function.
The authority implies that the person exercising powers has a specified function.
Person exercising powers has a specified function.
Persons are authorised to exercise powers.
Secretary may authorise persons to exercise powers under specified provisions of the Act.
Authority implies that the Secretary's office is responsible for enforcing health matters or law enforcement matters.
The authority implies that the Secretary's office is responsible for enforcing health matters or law enforcement matters.
Secretary's office is responsible for enforcing health matters or law enforcement matters.
Authorised person must comply with directions of the Secretary.
7A(2) Authorised persons
Action must occur after directions are given.
Temporal relation between directions and actions
Directions are given at some point in time.
Comply with directions of the Secretary.
Authorised person has power under a provision of this Act.
7AA Excluded goods
The Minister may determine that specified goods are excluded goods.
7AA(1) Excluded goods
7AA(2) Excluded goods
Minister must consider certain matters before making a determination under this section.
7AA(3) Excluded goods
(3) Before making a determination under this section, the Minister...
Consideration of relevant matters by the Minister
7AA(4) Excluded goods
Temporal relation between consideration and action
The Minister may have regard to any other matter he or she considers relevant.
Relevance consideration in decision-making
7B Kits
A package and its goods constitute a kit if they meet certain conditions.
7B(1) Kits
Therapeutic goods must be combined before administration or in a particular sequence.
7B(2) Kits
Combining therapeutic goods is necessary before administration.
it is necessary that the therapeutic goods be combined before administration or that they be administered in a particular sequence.
Therapeutic goods are for administration as a single treatment or course of treatment.
(c) the therapeutic goods are for administration as a single treatment or as a single course of treatment; and
(2) A package and therapeutic goods in the package together constitute a composite pack if:...
Combining therapeutic goods must happen in a particular order.
the package does not contain any medical devices; and
Combining therapeutic goods must happen before administration.
7B(3) Kits
7C Secretary may arrange for use of computer programs to make
The Secretary may arrange for the use of computer programs under their control.
7C(1) Secretary may arrange for use of computer programs to make
Decision made by computer program is taken to be Secretary's decision.
7C(2) Secretary may arrange for use of computer programs to make
Secretary may correct initial decision made by computer program.
7C(3) Secretary may arrange for use of computer programs to make
Secretary must make substituted decision within 60 days of initial decision.
7C(4) Secretary may arrange for use of computer programs to make
Must provide a substituted decision within the specified timeframe.
7D Form for product information for medicine
The Secretary may approve a form for product information in relation to medicine.
7D(1) Form for product information for medicine
Secretary may approve different forms for different medicines or classes of medicine.
7D(2) Form for product information for medicine
8 Power to obtain information with respect to therapeutic goods
Request for information about therapeutic goods
8(1) Power to obtain information with respect to therapeutic goods
within such reasonable period as is specified in the notice
Notice may require information to be given in writing or according to specified software requirements.
8(1A) Power to obtain information with respect to therapeutic goods
(a) in writing; or (b) in accordance with specified software requirements:
Must comply with notice given under section.
8(2) Power to obtain information with respect to therapeutic goods
A reasonable excuse is a valid reason for not applying subsection (2).
8(3) Power to obtain information with respect to therapeutic goods
Obligation to provide a reasonable excuse.
The defendant believes they have a reasonable excuse.
An offence under subsection (2) is an obligation.
8(4) Power to obtain information with respect to therapeutic goods
9 Arrangements with States etc.
The Minister may make arrangements with a State for the carrying out of certain functions on behalf of the Commonwealth.
9(1) Arrangements with States etc.
Payment of amounts to a State or Territory for performance of functions under an arrangement.
9(2) Arrangements with States etc.
9A Australian Register of Therapeutic Goods
Maintain a register of therapeutic goods.
9A(1) Australian Register of Therapeutic Goods
The Register is to be kept in such form as the Secretary determines.
9A(2) Australian Register of Therapeutic Goods
Classification of goods in the Australian Register of Therapeutic Goods
9A(3) Australian Register of Therapeutic Goods
9C Inspection of entries in Register
9C(1) Inspection of entries in Register
Must provide a copy of requested entry from computer database
9C(2) Inspection of entries in Register
Secretary may provide information in electronic format upon request.
9C(3) Inspection of entries in Register
9D Variation of entries in Register
Secretary may vary entry in Register under certain conditions.
9D(1) Variation of entries in Register
9D(1A) Variation of entries in Register
Variation of entries in Register is a class inclusion.
The Secretary may vary the entry in the Register on their own initiative.
9D(1B) Variation of entries in Register
Permission to vary the entry in the Register.
Secretary must give notice and opportunity to submit before making variation.
9D(1C) Variation of entries in Register
Notice given at least this far in advance
Secretary must give notice before making variation
Secretary must take submission into account
Submission made in accordance with paragraph (b)
Subsections (1A) and (1B) apply despite subsection 16(1).
9D(1D) Variation of entries in Register
Continues the obligation despite a condition.
Subsections (1A) and (1B) do not apply despite subsection 16(1).
Variation of entries in Register upon request
9D(2) Variation of entries in Register
Subsection (2) of section 16(1) applies despite subsection (2A)
9D(2A) Variation of entries in Register
Subsection (2) applies despite subsection (2A)
Secretary must vary entry in Register upon request.
9D(2C) Variation of entries in Register
the request was made at some point in time.
Request must be made within unspecified time frame.
(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;
the Secretary must vary the entry in accordance with the request.
the conditions (if any) specified in the regulations are satisfied;
Must satisfy conditions specified in regulations.
(b) the variation is of a kind specified in the regulations;
the request was made by a person who has registered or listed therapeutic goods.
Request must be made by person with registered or listed therapeutic goods.
Subsection (2C) applies despite subsection 16(1).
9D(2D) Variation of entries in Register
Subsection (2C) implies subsection 16(1).
Secretary may vary entry in Register upon request.
9D(3) Variation of entries in Register
Permits variation of entries in Register.
Specifies conditions for variation of entries in Register.
(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;
Combines conditions for variation of entries in Register.
9D(3A) Variation of entries in Register
Secretary must move entry from part of Register for biologicals to applicable part.
9D(3B) Variation of entries in Register
9D(3C) Variation of entries in Register
...the Secretary must vary the entry in accordance with the request.
Variation of entries is contained within variation upon request
(a) the person in relation to whom a kind of medical device is included in the Register has requested...
(c) the conditions (if any) specified in the regulations are satisfied;
(3CB) If...(a) the person in relation to whom a kind of medical device is included in the Register has requested...
Must add warning, restriction or precaution
(b) the only effect of the variation would be...(ii) to add a warning, restriction or precaution...
Variation of entries is a subclass of variation upon request
9D(3D) Variation of entries in Register
Allows for variation of entries in Register.
Must move entry from medical devices part to applicable part of Register
9D(4) Variation of entries in Register
Secretary may approve forms and manners for requests under this section.
9D(6) Variation of entries in Register
Limits the scope to specific temporal intervals.
Permits the Secretary to approve forms and manners.
Form, information, application fee, and prescribed documentation
Request for variation of entries in Register must comply with approved form and contain required information.
9D(7) Variation of entries in Register
Form and information are of a kind determined under subsection (8)
The Secretary may determine a kind of information for the purposes of subparagraph (7)(g)(i).
9D(8) Variation of entries in Register
The Secretary must publish a list of therapeutic goods on the Register at least once every 12 months.
9E Publication of list of goods on Register
The Secretary must publish a list of therapeutic goods on the Register.
9F Removal of entries from Register
Prohibition on removal of entries from Register if goods are therapeutic
9F(1) Removal of entries from Register
The provision applies during the existence of an entry on the Register related to goods that are not therapeutic goods.
Describes the temporal relationship between the provision and its application
(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.
The removal of entries from the Register is prohibited.
Prohibits removal of entries from Register
The provision applies everywhere where there is an entry on the Register related to goods that are not therapeutic goods.
Describes the spatial relationship between the provision and its application
(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.
Secretary may remove entry from Register
9F(2) Removal of entries from Register
Secretary must inform person of proposed removal and invite written submissions.
9F(3) Removal of entries from Register
Secretary must inform person of proposed removal.
Person may make written submissions to Secretary.
Secretary must consider submissions before giving notice.
9F(4) Removal of entries from Register
...until the Secretary has had regard to...
9F(5) Removal of entries from Register
Removal of entries from Register has effect on specified day
9F(6) Removal of entries from Register
Notice setting out particulars of removal
Secretary must publish notice after removing entry from Register.
9F(7) Removal of entries from Register
9G Criminal offences for false statements in requests for variation of
Making false statements in requests for variation of therapeutic goods entries is prohibited.
9G(1) Criminal offences for false statements in requests for variation of
9G(4) Criminal offences for false statements in requests for variation of
Prohibits making false statements in requests for variation of therapeutic goods entries.
Making false statements in requests for variation of therapeutic goods entries is an offence.
9G(5) Criminal offences for false statements in requests for variation of
9G(6) Criminal offences for false statements in requests for variation of
False statements in requests for variation of entries in Register
9H Civil penalty for false statements in requests for variation of
Regulations may prohibit imports, exports, manufacture, and supplies of certain goods.
9J Simplified outline of this Chapter
Regulations apply to imports, exports, manufacture, and supplies within a specific temporal interval.
Regulations prohibit imports, exports, manufacture, and supplies of certain goods.
9K Prohibition on import, export, manufacture or supply of
Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods
9K(1) Prohibition on import, export, manufacture or supply of
Prohibition applies during international agreements
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:
(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:
(b) the export from Australia of the therapeutic goods or vaping goods;
Prohibition ends when international agreements expire
Regulations must prohibit or restrict import, export, manufacture and supply of certain goods before an international agreement is made.
9K(2) Prohibition on import, export, manufacture or supply of
Regulations must be made before an international agreement is made.
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.
International agreements imply regulations that prohibit or restrict import, export, manufacture and supply of certain goods.
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.
Regulations must prohibit or restrict import, export, manufacture and supply of certain goods.
Regulations must prohibit or restrict certain goods.
International agreement requires parties to take steps to prohibit or restrict import, export, manufacture and supply of certain goods.
Regulations must diffuse to all parties to the agreement.
International agreements require parties to take steps to prohibit or restrict import, export, manufacture and supply of certain goods.
Regulations may prohibit import, export, manufacture or supply of therapeutic goods or vaping goods containing a specified ingredient or component.
9K(3) Prohibition on import, export, manufacture or supply of
Regulations must prohibit or restrict import, export, manufacture and supply of goods containing a specific ingredient or component.
9K(4) Prohibition on import, export, manufacture or supply of
The regulation must be made before a specific temporal interval.
Regulations must prohibit the specified activity.
Absolute or conditionally prescribed prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods.
9K(5) Prohibition on import, export, manufacture or supply of
(5) A prohibition referred to in subsection (1) or (3) may be absolute
(i) the international agreement; (ii) the Minister’s satisfaction; (iii) the proposed prohibition
Regulations containing a prohibition must be published and wait 30 days before implementation.
9K(6) Prohibition on import, export, manufacture or supply of
Notice must be published for at least 30 days before implementation
(b) a period of 30 days has passed since the notice was published
(6) Regulations containing a prohibition referred to in subsection (1) or (3)
Regulations must be published for public review
(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
Minister must cause publication of notice
Regulations containing prohibition must be implemented after publication
Regulations with prohibition must not start before the international agreement enters into force.
9K(7) Prohibition on import, export, manufacture or supply of
the day the international agreement enters into force for Australia.
Regulations with prohibition overlap with the international agreement.
(7) Regulations containing a prohibition referred to in subsection (1) or (3)
must not be expressed to commence on a day earlier than the day the international agreement enters into force for Australia.
Regulations with prohibition infer the international agreement.
Regulations with prohibition cannot start before the international agreement enters into force.
Regulations with prohibition diffuse to the international agreement.
Regulations with prohibition are until the international agreement enters into force.
Regulations may confer power on Minister or Secretary to make administrative decisions.
9K(8) Prohibition on import, export, manufacture or supply of
9L Offence and civil penalty
Import, export, manufacture or supply of therapeutic goods or vaping goods is prohibited.
9L(1) Offence and civil penalty
Prohibits the import, export, manufacture or supply of therapeutic goods or vaping goods.
Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
9L(2) Offence and civil penalty
Maximum civil penalty: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements
Temporal interval: Maximum civil penalty
(a) for an individual—300 penalty units; and (b) for a body corporate—3,000 penalty units.
(i) an absolute prohibition in force for the purposes of subsection 9K(1) or (3);
(ii) one or more conditions of a prohibition in force for the purposes of subsection 9K(1) or (3).
Customs Act 1901 applies to prohibited imports or exports if notified by Secretary.
9M Application of Customs Act 1901
9N Constitutional basis
Relies on Commonwealth's legislative power under paragraph 51(xxix) of the Constitution.
9N(1) Constitutional basis
...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3).
Prescribed for the purposes of subsection 9K(1) or (3)
...prescribed for the purposes of subsection 9K(1) or (3).
Relies on Commonwealth's legislative power
(1) This Chapter, and any other provision of this Act to the extent it relates to this Chapter, relies...
Recurring trace of subsection 9K(1) or (3)
9N(2) Constitutional basis
Conduct related to section 6 is permitted
Does not ban conduct related to section 6
Conduct related to section 6 is permitted but not a right
Does not grant a right to conduct related to section 6
Therapeutic Goods Act 1989