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