is on the label of the goods; or

is on the package in which the goods are contained; or

is on any material included with the package in which the goods are contained.

anthroposophic pharmacopoeia means:

a publication specified under paragraph 3AB(3)(a), as that publication is in force from time to time; or

a part of a publication specified under paragraph 3AB(3)(b), as that part is in force from time to time.

anthroposophic preparation has the meaning given by subsection 3AB(1).

anthroposophic standard has the meaning given by subsection 3AB(2).

application audit assessment fee means a fee payable under subsection 41LA(3).

assessment fee means:

a conformity assessment fee; or

an application audit assessment fee;

payable under Part 4-10.

Australian conformity assessment body means an Australian corporation that is the subject of a conformity assessment body determination made under the regulations.

Australian conformity assessment body certificate means a certificate that is issued by an Australian conformity assessment body and that is of a kind mentioned in section 41FIA.

Australian corporation means a corporation that is registered under Part 2A.2 of the Corporations Act 2001.

Australia-UK Mutual Recognition Agreement means the Agreement on Mutual Recognition in Relation to Conformity Assessment, Certificates And Markings between the Government of Australia and the Government of the United Kingdom of Great Britain and Northern Ireland, as in force from time to time.

authorised person means:

in relation to any provision of this Act or the regulations, a person authorised by the Secretary to exercise powers under that provision; or

(b) in relation to a provision of Customs Act 1901).Part 6-2 or 6-2A, a member of the Australian Federal Police, or a Customs officer exercising powers in a Customs place (within the meaning of section 183UA of the

batch means a quantity of a product that is: uniform in composition, method of manufacture and probability of chemical or microbial contamination; and made in one cycle of manufacture and, in the case of a product that is sterilised or freeze dried, sterilised or freeze dried in one cycle.

uniform in composition, method of manufacture and probability of chemical or microbial contamination; and

made in one cycle of manufacture and, in the case of a product that is sterilised or freeze dried, sterilised or freeze dried in one cycle.

bioburden means the quantity and characteristics of microorganisms present in the goods or to which the goods may be exposed in a manufacturing environment.

biological has the meaning given by section 32A.

biological number of a biological means:

the number assigned to the biological under subsection 32DB(2), 32DCB(2), 32DF(2) or 32DN(5); or

if, in accordance with regulations made for the purposes of paragraph 9A(4)(ca), a different number is assigned to the biological—that different number.

British Pharmacopoeia means the edition of the publication of that name, including any additions or amendments, that was in effect for the purposes of this Act immediately before the commencement of Schedule 4 to the Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the British Pharmacopoeia Commission or any replacement body.

certification-related activities, when used in relation to an Australian conformity assessment body, means activities that consist of, or relate to, the issue of certificates as mentioned in section 41FIA.

civil penalty provision has the meaning given by section 42YA.

Class 1 biological means a biological, other than an export only biological, included in a class of biologicals that is: a class prescribed by the regulations for the purposes of section 32AA; and a class referred to in those regulations as Class 1 biologicals.

a class prescribed by the regulations for the purposes of section 32AA; and

a class referred to in those regulations as Class 1 biologicals.

commercial quantity of a kind of vaping goods means the quantity of that kind of vaping goods prescribed by the regulations.

Commonwealth authority includes:

a body corporate, or an unincorporated body, established for a public purpose by or under an Act; and

a tribunal or authority established by or in accordance with an Act.

Commonwealth officer includes:

a Minister; and

a person holding:

an office established by or under an Act; or

an appointment made under an Act; or

an appointment made by the Governor-General or a Minister but not under an Act; and

a person who is a member or officer of a Commonwealth authority; and

a person who is in the service or employment of the Commonwealth, or of a Commonwealth authority, or is employed or engaged under an Act or regulations made under an Act.

composite pack has the meaning given by subsection 7B(2).

Comptroller-General of Customs means the person who is the Comptroller-General of Customs in accordance with subsection 11(3) or 14(2) of the Australian Border Force Act 2015.

conformity assessment body determination has the meaning given by section 41EWA.

conformity assessment certificate means a certificate issued under section 41EE.

conformity assessment document means:

a conformity assessment certificate; or

an Australian conformity assessment body certificate; or

an overseas regulator conformity assessment document.

conformity assessment fee means a fee payable under subsection 41LA(1).

conformity assessment procedures has the meaning given by section 41DA.

conformity assessment standard means a conformity assessment standard specified in an order under section 41DC.

container means the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion.

corporation means a body corporate that is: a foreign corporation; or a trading corporation formed within the limits of the Commonwealth or a financial corporation so formed.

a foreign corporation; or

a trading corporation formed within the limits of the Commonwealth or a financial corporation so formed.

corresponding State law means a State law declared by the regulations to correspond to this Act or the regulations, including such a law as amended from time to time.

counterfeit has the meaning given by section 42E.

current Poisons Standard has the meaning given by section 52A.

Customs officer means an officer of Customs within the meaning of the Customs Act 1901.

data processing device means any article or material (for example, a disc) from which information is capable of being reproduced with or without the aid of any other article or device.

default standard means any of the following: (a) a standard referred to in paragraph (b) of the definition of standard in this subsection; a standard referred to in paragraph (c) of that definition; a standard referred to in paragraph (d) of that definition.

(a) a standard referred to in paragraph (b) of the definition of standard in this subsection;

a standard referred to in paragraph (c) of that definition;

a standard referred to in paragraph (d) of that definition.

device number means any combination of numbers, symbols and letters assigned to the device under section 41FL.

directions for use includes information on: appropriate doses of the goods; and the method of administration or use of the goods; and the frequency and duration of treatment for each indication of the goods; and the use of the goods by persons of particular ages or by persons having particular medical conditions.

appropriate doses of the goods; and

the method of administration or use of the goods; and

the frequency and duration of treatment for each indication of the goods; and

the use of the goods by persons of particular ages or by persons having particular medical conditions.

EC/EFTA attestation of conformity means an attestation of conformity (within the meaning of the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement) issued by an EC/EFTA conformity assessment body that is approved by the Secretary in writing.

EC/EFTA conformity assessment body means a Conformity Assessment Body designated in one of the following Sectoral Annexes to the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement: Sectoral Annex (Medical Devices); Sectoral Annex (Medicinal Products GMP Inspection and Batch Certification).

Sectoral Annex (Medical Devices);

Sectoral Annex (Medicinal Products GMP Inspection and Batch Certification).

EC Mutual Recognition Agreement means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Community, as in force from time to time.

EFTA Mutual Recognition Agreement means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Free Trade Association, as in force from time to time.

essential principles has the meaning given by section 41CA.

ethics committee means a committee: constituted and operating as an ethics committee in accordance with guidelines issued by the CEO of the National Health and Medical Research Council as in force from time to time; and (b) which has notified its existence to the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992.

constituted and operating as an ethics committee in accordance with guidelines issued by the CEO of the National Health and Medical Research Council as in force from time to time; and

(b) which has notified its existence to the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992.

European Pharmacopoeia means the English edition of the publication of that name, including any additions or amendments, that was in effect immediately before the commencement of this definition and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the Council of Europe or any replacement body.

evidential burden means the burden of adducing or pointing to evidence that suggests a reasonable possibility that the matter exists or does not exist.

exempt device means a medical device that is of a kind that is exempted from Division 3 of Part 4-11 by the regulations.

exempt goods means therapeutic goods that are exempted from the operation of that Part (except section 31A and sections 31C to 31F) by the regulations.

exempt goods means therapeutic goods that are exempted from the operation of that Part by the regulations.

exempt person means a person exempted from the operation of Part 3-3 in relation to those goods by the regulations.

export only biological means a biological that is: manufactured in Australia for export only; or imported into Australia for export only.

manufactured in Australia for export only; or

imported into Australia for export only.

export only medicine means a medicine that: is manufactured in Australia for export only, or imported into Australia for export only; and is listable goods only because it is so manufactured or imported (and not for any other reason).

is manufactured in Australia for export only, or imported into Australia for export only; and

is listable goods only because it is so manufactured or imported (and not for any other reason).

Federal Court means the Federal Court of Australia.

financial corporation means a financial corporation within the meaning of paragraph 51(xx) of the Constitution.

first Poisons Standard has the meaning given by section 52A.

foreign corporation means a foreign corporation within the meaning of paragraph 51(xx) of the Constitution.

gazetted kits group means a group of kits identified in an order in force under subsection 16(3A).

gazetted therapeutic goods group has the meaning given by subsection 16(2).

Gene Technology Regulator has the same meaning as in the Gene Technology Act 2000.

genetically modified organism has the same meaning as in the Gene Technology Act 2000.

GM product has the same meaning as in the Gene Technology Act 2000.

grouped therapeutic goods means therapeutic goods included in: a gazetted therapeutic goods group; or a gazetted kits group.

a gazetted therapeutic goods group; or

a gazetted kits group.

healthcare facility means:

a public hospital; or

a private hospital; or

any other facility prescribed by regulations made for the purposes of this paragraph.

health practitioner means a person who, under a law of a State or internal Territory, is registered or licensed to practice in any of the following health professions: Aboriginal and Torres Strait Islander health practice; dental (not including the professions of dental therapist, dental hygienist, dental prosthetist or oral health therapist); medical; medical radiation practice; nursing; midwifery; occupational therapy; optometry; pharmacy; physiotherapy; podiatry; psychology.

Aboriginal and Torres Strait Islander health practice;

dental (not including the professions of dental therapist, dental hygienist, dental prosthetist or oral health therapist);

medical;

medical radiation practice;

nursing;

midwifery;

occupational therapy;

optometry;

pharmacy;

physiotherapy;

podiatry;

psychology.

homoeopathic pharmacopoeia means:

a publication specified under paragraph 3AA(3)(a), as that publication is in force from time to time; or

a part of a publication specified under paragraph 3AA(3)(b), as that part is in force from time to time.

homoeopathic preparation has the meaning given by subsection 3AA(1).

homoeopathic standard has the meaning given by subsection 3AA(2).

hospital has the meaning given by subsection 121-5(5) of the Private Health Insurance Act 2007.

included in the Register:

in relation to a biological—means included in the Register under Part 3-2A; and

in relation to a medical device to which Chapter 4 applies—means included in the Register under Chapter 4.

indications means the specific therapeutic uses of the goods.

international instrument means:

any treaty, convention, protocol, agreement or other instrument that is binding in international law; and

a part of such a treaty, convention, protocol, agreement or other instrument.

issuing officer means:

a magistrate; or

a registrar or other officer of a court of a State or Territory who is authorised under a law of the State or Territory to issue search warrants.

kind, in relation to a medical device, has the meaning given by section 41BE.

label means a display of printed information: on or attached to the goods; or on or attached to a container or primary pack in which the goods are supplied; or supplied with such a container or pack.

on or attached to the goods; or

on or attached to a container or primary pack in which the goods are supplied; or

supplied with such a container or pack.

licence means a licence under Part 3-3.

listable goods means therapeutic goods that are required under the regulations to be included in the part of the Register relating to listed goods.

listed goods means therapeutic goods that are included in the Part of the Register for goods known as listed goods.

listing number means any combination of numbers, symbols and letters assigned to the goods under section 27.

major interest holder of a body corporate means a person who: is in a position to cast, or control the casting of, more than one-fifth of the maximum number of votes that might be cast at a general meeting of the body corporate; or holds more than one-fifth of the issued share capital of the body corporate (excluding any part of that issued share capital that carries no right to participate beyond a specified amount in a distribution of either profits or capital).

is in a position to cast, or control the casting of, more than one-fifth of the maximum number of votes that might be cast at a general meeting of the body corporate; or

holds more than one-fifth of the issued share capital of the body corporate (excluding any part of that issued share capital that carries no right to participate beyond a specified amount in a distribution of either profits or capital).

manufacture, in relation to therapeutic goods, or vaping goods, that are not medical devices, means:

to produce the goods; or

to engage in any part of the process of producing the goods or of bringing the goods to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the goods or of any component or ingredient of the goods as part of that process.

manufacturer, of a medical device, has the meaning given by section 41BG.

manufacturing principles means the principles for the time being having effect under section 36.

manufacturing site means premises: that are for use in the manufacture of a particular kind of therapeutic goods; and at which the same persons have control of the management of the production of the goods and the procedures for quality control.

that are for use in the manufacture of a particular kind of therapeutic goods; and

at which the same persons have control of the management of the production of the goods and the procedures for quality control.

manufacturing site authorisation means an authorisation referred to in subsection 38(2B) or 40B(4).

medical device has the meaning given by section 41BD.

medical device classification means a classification specified in the regulations made for the purposes of section 41DB.

medical device standard means a medical device standard, specified in an order under section 41CB, that is applicable to that kind of medical device.

medical practitioner means a person who is registered or licensed as a medical practitioner under a law of a State or an internal Territory that provides for the registration or licensing of medical practitioners.

medicine means therapeutic goods (other than biologicals) that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human.

member of EFTA means a country declared by the Minister under section 3A to be a member of the European Free Trade Association.

member of the European Community means a country declared by the Minister under section 3A to be a member of the European Community.

mother substance means any of the following: an animal; a plant; an alga; a fungus; a micro-organism; a mineral; a mineral compound; a chemical; a product obtained from any of the things mentioned in paragraphs (a) to (h).

an animal;

a plant;

an alga;

a fungus;

a micro-organism;

a mineral;

a mineral compound;

a chemical;

a product obtained from any of the things mentioned in paragraphs (a) to (h).

Mutual Recognition Convention means the Convention for the Mutual Recognition of Inspections in respect of the Manufacture of Pharmaceutical Products done at Geneva on 8 October 1970.

national emergency declaration has the same meaning as in the National Emergency Declaration Act 2020.

non-EC/EFTA attestation of conformity, for a non-EC/EFTA MRA, means an attestation of conformity issued, after the non-EC/EFTA MRA has come into force, by a conformity assessment body that is designated in the non-EC/EFTA MRA and approved by the Secretary in writing for the non-EC/EFTA MRA.

non-EC/EFTA MRA means an international instrument that Australia is bound by, or is a party to, if:

a purpose of the instrument is the recognition of attestations of conformity; and

the instrument satisfies the requirements (if any) set out in regulations made for the purposes of this paragraph;

but does not include:

the EC Mutual Recognition Agreement; or

the EFTA Mutual Recognition Agreement.

nurse practitioner means a person who is registered, or authorised (however described) to practise, as a nurse practitioner by or under a law of a State or an internal Territory that provides for the registration of nurse practitioners, or the authorisation of persons to practise as nurse practitioners.

oath includes affirmation.

overseas regulator has the meaning given by section 41BIB.

overseas regulator conformity assessment document means a certificate or other document that is issued by an overseas regulator after that regulator is satisfied that requirements, comparable to the conformity assessment procedures, have been applied to a medical device by the manufacturer of the device.

passed preliminary assessment:

when used in relation to a section 23 application for registration—has the meaning given by subsection 23B(3); and

when used in relation to a section 23 application for listing under section 26AE—has the meaning given by subsection 23B(3); and

when used in relation to a section 26BD application—has the meaning given by subsection 26BD(4); and

when used in relation to a section 32DD application—has the meaning given by subsection 32DDA(3); and

when used in relation to a section 41FC application—has the meaning given by subsection 41FDB(3).

period of a shortage of a medicine in Australia has the meaning given by section 30EIA.

personal information has the same meaning as in the Privacy Act 1988.

pharmacist means a person who is registered as a pharmacist under a law of a State or an internal Territory that provides for the registration of pharmacists.

poison means an ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury and includes any ingredient, compound, material or preparation referred to in a schedule to the current Poisons Standard.

premises includes:

a structure, building, aircraft, vehicle or vessel; and

a place (whether enclosed or built upon or not); and

a part of a thing referred to in paragraph (a) or (b).

presentation means the way in which the goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods.

primary pack means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers.

private hospital means a hospital in respect of which there is in force a statement under subsection 121-5(8) of the Private Health Insurance Act 2007 that the hospital is a private hospital.

product information means information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods.

protected information, in relation to therapeutic goods, has the meaning given by section 25A.

public hospital means a hospital in respect of which there is in force a statement under subsection 121-5(8) of the Private Health Insurance Act 2007 that the hospital is a public hospital.

quality includes the composition, strength, potency, stability, sterility, purity, bioburden, design, construction and performance characteristics of the goods.

refurbishment has the meaning given by the regulations.

Register means the Australian Register of Therapeutic Goods maintained under section 9A.

registered goods means:

therapeutic goods included in the part of the Register for goods known as registered goods; or

therapeutic goods included in the part of the Register for goods known as provisionally registered goods.

registration number means any combination of numbers, symbols and letters assigned to the goods under section 27.

related body corporate has the same meaning as in the Corporations Act 2001.

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 information has the meaning given by section 26AF.

restricted medicine means:

a medicine specified in an instrument under subsection (2A); or

a medicine included in a class of medicine specified in an instrument under subsection (2B).

scheduling has the meaning given by section 52A.

Secretary means the Secretary of the Department.

shortage of a medicine in Australia has the meaning given by section 30EI.

sponsor, in relation to therapeutic goods, means:

a person who exports, or arranges the exportation of, the goods from Australia; or

a person who imports, or arranges the importation of, the goods into Australia; or

a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere);

but does not include a person who:

exports, imports or manufactures the goods; or

arranges the exportation, importation or manufacture of the goods;

on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia.

standard means any of the following: a standard that is constituted by the matters specified in an order under section 10 that is applicable to the goods; if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1) in relation to the goods) in the British Pharmacopoeia—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2) in relation to the goods) in those monographs, as interpreted in accordance with the General Notices section of the British Pharmacopoeia; if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1) in relation to the goods) in the European Pharmacopoeia—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2) in relation to the goods) in those monographs, as interpreted in accordance with the General Notices section of the European Pharmacopoeia; if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1) in relation to the goods) in the United States Pharmacopeia-National Formulary—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2) in relation to the goods) in those monographs, as interpreted in accordance with the General Notices section of the United States Pharmacopeia-National Formulary; a homoeopathic standard; an anthroposophic standard.

a standard that is constituted by the matters specified in an order under section 10 that is applicable to the goods;

if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1) in relation to the goods) in the British Pharmacopoeia—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2) in relation to the goods) in those monographs, as interpreted in accordance with the General Notices section of the British Pharmacopoeia;

if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1) in relation to the goods) in the European Pharmacopoeia—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2) in relation to the goods) in those monographs, as interpreted in accordance with the General Notices section of the European Pharmacopoeia;

if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1) in relation to the goods) in the United States Pharmacopeia-National Formulary—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2) in relation to the goods) in those monographs, as interpreted in accordance with the General Notices section of the United States Pharmacopeia-National Formulary;

a homoeopathic standard;

an anthroposophic standard.

State includes the Australian Capital Territory and the Northern Territory.

State law means a law of a State, of the Australian Capital Territory or of the Northern Territory.

supply includes:

supply by way of sale, exchange, gift, lease, loan, hire or hire-purchase; and

supply, whether free of charge or otherwise, by way of sample or advertisement; and

supply, whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods or vaping goods in persons; and

supply by way of administration to, or application in the treatment of, a person.

system or procedure pack has the meaning given by section 41BF.

tamper: therapeutic goods are tampered with if:

they are interfered with in a way that affects, or could affect, the quality, safety or efficacy of the goods; and

the interference has the potential to cause, or is done for the purpose of causing, injury or harm to any person.

therapeutic goods means 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: for therapeutic use; or for use as an ingredient or component in the manufacture of therapeutic goods; or for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii); or determined to be therapeutic goods under subsection 7AAA(1);

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:

for therapeutic use; or

for use as an ingredient or component in the manufacture of therapeutic goods; or

for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or

included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii); or

determined to be therapeutic goods under subsection 7AAA(1);

and includes biologicals, medical devices and goods declared to be therapeutic goods under an order in force under section 7, but does not include: goods declared not to be therapeutic goods under an order in force under section 7; or goods in respect of which such an order is in force, being an order that declares the goods not to be therapeutic goods when used, advertised, or presented for supply in the way specified in the order where the goods are used, advertised, or presented for supply in that way; or (e) goods (other than goods declared to be therapeutic goods under an order in force under Food Standards Australia New Zealand Act 1991); orsection 7 and goods determined to be therapeutic goods under subsection 7AAA(1)) for which there is a standard (within the meaning of subsection 4(1) of the goods (other than goods declared to be therapeutic goods under an order in force under section 7 and goods determined to be therapeutic goods under subsection 7AAA(1)) which, in Australia or New Zealand, 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) (excluded goods); or goods covered by a determination under subsection 7AA(2) (excluded goods), if the goods are used, advertised, or presented for supply in the way specified in the determination.

goods declared not to be therapeutic goods under an order in force under section 7; or

goods in respect of which such an order is in force, being an order that declares the goods not to be therapeutic goods when used, advertised, or presented for supply in the way specified in the order where the goods are used, advertised, or presented for supply in that way; or

(e) goods (other than goods declared to be therapeutic goods under an order in force under Food Standards Australia New Zealand Act 1991); orsection 7 and goods determined to be therapeutic goods under subsection 7AAA(1)) for which there is a standard (within the meaning of subsection 4(1) of the

goods (other than goods declared to be therapeutic goods under an order in force under section 7 and goods determined to be therapeutic goods under subsection 7AAA(1)) which, in Australia or New Zealand, 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) (excluded goods); or

goods covered by a determination under subsection 7AA(2) (excluded goods), if the goods are used, advertised, or presented for supply in the way specified in the determination.

Therapeutic Goods Advertising Code means the code in force under section 42BAA.

therapeutic use means use in or in connection with: preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or influencing, inhibiting or modifying a physiological process in persons; or testing the susceptibility of persons to a disease or ailment; or influencing, controlling or preventing conception in persons; or testing for pregnancy in persons; or the replacement or modification of parts of the anatomy in persons.

preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or

influencing, inhibiting or modifying a physiological process in persons; or

testing the susceptibility of persons to a disease or ailment; or

influencing, controlling or preventing conception in persons; or

testing for pregnancy in persons; or

the replacement or modification of parts of the anatomy in persons.

trading corporation means a trading corporation within the meaning of paragraph 51(xx) of the Constitution.

unique device identifier of a medical device means any combination of numbers, symbols and letters given to the device to enable identification of the device (whether or not that combination also allows identification of information relating to the device).

unit of vaping goods has the meaning prescribed by the regulations.

United States Pharmacopeia-National Formulary means the English edition of the publication of that name, including any additions or amendments, that was in effect immediately before the commencement of this definition and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the United States Pharmacopeial Convention or any replacement body.

vaping accessory has the meaning given by section 41P.

vaping device has the meaning given by section 41P.

vaping goods has the meaning given by section 41P.

vaping substance has the meaning given by section 41P.

working day, for a person, means any day except:

Saturday or Sunday; or

a day that is a public holiday in the State or Territory in which the person is located.

if it states or suggests that the goods have ingredients, components or characteristics that they do not have; or

if a name applied to the goods is the same as the name applied to other therapeutic goods that are supplied in Australia where those other goods contain additional or different therapeutically active ingredients; or

if the label of the goods does not declare the presence of a therapeutically active ingredient; or

if the therapeutic goods are medicine included in a class of medicine prescribed by the regulations for the purposes of this paragraph—if the medicine’s label does not contain the advisory statements specified under subsection (5A) in relation to the medicine; or

if a form of presentation of the goods may lead to unsafe use of the goods or suggests a purpose that is not in accordance with conditions applicable to the supply of the goods in Australia; or

in prescribed cases.

an offence against the regulations; and

(b) an offence against Crimes Act 1914, or section 11.1, 11.4 or 11.5 of the Criminal Code, in relation to an offence against this Act or the regulations; andsection 6 of the

(c) an offence against Criminal Code in relation to this Act or the regulations.section 136.1, 137.1 or 137.2 of the

the corresponding State law confers a function or power on the officer or authority; and

the circumstances in which the function or power is conferred give rise to an obligation on the officer or authority to perform the function or to exercise the power.

a reference in this Act to therapeutic goods that are registered includes a reference to a medicine that is provisionally registered; and

a reference in this Act to the registration of therapeutic goods includes a reference to the provisional registration of a medicine.

manufactured from a mother substance; and

manufactured in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia.

Homoeopathic standard

there are therapeutic goods that are a homoeopathic preparation; and

the goods are the subject of one or more monographs (other than a monograph exempt under subsection (4)) in the homoeopathic pharmacopoeia describing the manufacturing procedure that the preparation was manufactured in accordance with;

then there is a homoeopathic standard, in relation to the goods, that is constituted by the statements (other than statements exempt under subsection (5)) in those monographs, as interpreted in accordance with any interpretation sections of that homoeopathic pharmacopoeia.

Specifying publications

publications;

parts of publications.

Exempting entire monographs

manufactured from a mother substance; and

manufactured in accordance with a manufacturing procedure described in an anthroposophic pharmacopoeia.

Anthroposophic standard

there are therapeutic goods that are an anthroposophic preparation; and

the goods are the subject of one or more monographs (other than a monograph exempt under subsection (4)) in the anthroposophic pharmacopoeia describing the manufacturing procedure that the preparation was manufactured in accordance with;

then there is an anthroposophic standard, in relation to the goods, that is constituted by the statements (other than statements exempt under subsection (5)) in those monographs, as interpreted in accordance with any interpretation sections of that anthroposophic pharmacopoeia.

Specifying publications

publications;

parts of publications.

Exempting entire monographs

the European Community; or

the European Free Trade Association.

provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are:

used in Australia, whether produced in Australia or elsewhere; or

exported from Australia;

to provide a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and ensure the safe handling, of poisons in Australia;

provide for a scheme allowing pharmacists to substitute certain medicine for other medicine if the Minister has declared there is a serious scarcity of the other medicine;

provide for the establishment and maintenance of a national system of controls relating to the regulation of vaping goods that are:

imported into Australia; or

manufactured in Australia; or

supplied in Australia, whether manufactured in Australia or elsewhere; or

exported from Australia.

things done by corporations; and

things done by natural persons or corporations in so far as those things are done:

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; or

under a law of the Commonwealth relating to the provision of pharmaceutical or repatriation benefits; or

in relation to the Commonwealth or in relation to an authority of the Commonwealth.

a Commonwealth officer; or

a Commonwealth authority.

the conferral or imposition, or the authorisation, would contravene any constitutional doctrines restricting the duties that may be imposed on Commonwealth officers or Commonwealth authorities; or

the authorisation would otherwise exceed the legislative power of the Commonwealth.

is consistent with subsections (1) to (3); and

is capable of operating concurrently with this Act.

imposing the duty is within the legislative powers of the State concerned; and

imposing the duty by the corresponding State law is consistent with the constitutional doctrines restricting the duties that may be imposed on a Commonwealth officer or Commonwealth authority.

Commonwealth legislative power sufficient to support duty but State legislative powers are not

is within the legislative powers of the Commonwealth; and

is consistent with the constitutional doctrines restricting the duties that may be imposed on a Commonwealth officer or Commonwealth authority.

contravene any constitutional doctrine restricting the duties that may be imposed on a Commonwealth officer or Commonwealth authority; or

otherwise exceed the legislative power of the Commonwealth.

applies only for the purposes of the application of the provisions of this Act or another law of the Commonwealth (with or without modification) as a law of a State by a provision of a corresponding State law; and

does not apply for those purposes if the corresponding State law otherwise provides.

is within the legislative powers of the State; and

is consistent with the constitutional doctrines restricting the duties that may be imposed on a Commonwealth officer or Commonwealth authority.

contravene any constitutional doctrine restricting the duties that may be imposed on a Commonwealth officer or Commonwealth authority; or

otherwise exceed the legislative powers of the State.

contravene any constitutional doctrine restricting the duties that may be imposed on a Commonwealth officer or Commonwealth authority; or

otherwise exceed the legislative powers of both the State and the Commonwealth;

the corresponding State law is taken instead to confer on the officer or authority a power to do that thing at the discretion of the officer or authority.

the function of including goods in the Register; or

the power to include goods in the Register;

the officer or authority may include the goods in the Register in accordance with the corresponding State law.

in the part of the Register for goods known as registered goods; or

in the part of the Register for goods known as provisionally registered goods; or

in the part of the Register for goods known as listed goods; or

in the part of the Register for biologicals included under Part 3-2A; or

in the part of the Register for medical devices included under Chapter 4.

the law under which the decision was made provides for review by the Administrative Review Tribunal; and

the decision is declared by the regulations to be a reviewable decision for the purposes of this section.

are or are not therapeutic goods; or

when used, advertised, or presented for supply in a particular way, are or are not therapeutic goods;

the Secretary may, by legislative instrument, make an order declaring that the classes of goods, or the classes of goods when used, advertised, or presented for supply in that way, are or are not, for the purposes of this Act, therapeutic goods.

are therapeutic goods; or

when used, advertised, or presented for supply in a particular way, are therapeutic goods;

the Secretary must disregard paragraphs (e) and (f) of the definition of therapeutic goods in subsection 3(1).

is a declaration that classes of goods are not therapeutic goods; and

applies wholly or partly to goods that, apart from this section, would be medical devices;

the goods are not medical devices, or are not medical devices when used, advertised, or presented for supply in the way specified in the declaration.

are therapeutic goods; or

when used, advertised, or presented for supply in a particular way, are therapeutic goods.

must have regard to the following matters:

whether it is likely that the specified goods, if not regulated under this Act, might harm the health of members of the public;

whether it is appropriate in all the circumstances to apply the national system of controls relating to the quality, safety, efficacy and performance of therapeutic goods established by this Act to regulate the specified goods;

whether the kinds of risks from the specified goods to which members of the public might be exposed could be more appropriately dealt with under another regulatory scheme; and

may have regard to any other relevant matter.

whether it is likely that the specified goods, if not regulated under this Act, might harm the health of members of the public;

whether it is appropriate in all the circumstances to apply the national system of controls relating to the quality, safety, efficacy and performance of therapeutic goods established by this Act to regulate the specified goods;

whether the kinds of risks from the specified goods to which members of the public might be exposed could be more appropriately dealt with under another regulatory scheme.

an officer of the Department, of another Department or of an authority of the Commonwealth;

an officer of:

a Department of State of a State; or

a Department or administrative unit of the Public Service of a Territory; or

an authority of a State or of a Territory;

being a Department, unit or authority that has functions relating to health matters or law enforcement matters.

the package and each of the goods are for use as a unit; and

the package and the goods do not constitute a composite pack; and

at least one of the goods is therapeutic goods; and

each item of the therapeutic goods consists of goods that are:

registered or listed; or

exempt goods in relation to Part 3-2; or

included in the Register under Part 3-2A; or

exempt under subsection 32CA(2) or section 32CB.

the therapeutic goods are of 2 or more kinds; and

the package does not contain any medical devices; and

the therapeutic goods are for administration as a single treatment or as a single course of treatment; and

it is necessary that the therapeutic goods be combined before administration or that they be administered in a particular sequence.

therapeutic goods; or

goods in relation to which the Secretary is considering making a declaration under section 7; or

goods in relation to which the Minister is considering making a determination under subsection 7AAA(1) (goods that are therapeutic goods); or

goods in relation to which the Minister is considering making a determination under section 7AA (excluded goods);

request the person to give to an officer of the Department identified in the notice, within such reasonable period as is specified in the notice, information required by the notice concerning the composition, indications, directions for use or labelling of the goods or concerning advertising material relating to the goods.

in writing; or

in accordance with specified software requirements:

on a specified kind of data processing device; or

by way of a specified kind of electronic transmission.

the evaluation of therapeutic goods for registration; or

the evaluation of a biological, other than a Class 1 biological or an export only biological, for inclusion in the Register under Part 3-2A; or

the inspection of manufacturers of therapeutic goods; or

other functions under this Act or the regulations.

a part for goods to be known as registered goods; and

a part for goods to be known as provisionally registered goods; and

a part for goods to be known as listed goods; and

a part for biologicals included in the Register under Part 3-2A; and

a part for medical devices included in the Register under Chapter 4.

the therapeutic goods, or the classes of therapeutic goods, that are required to be included in each part of the Register; and

the ways in which goods that are included in one part of the Register may be transferred, or may be required to be transferred, to another part of the Register; and

the ways in which goods that have been assigned a registration or listing number may be assigned a different registration or listing number; and

the ways in which a biological that has been assigned a number under subsection 32DB(2), 32DCB(2), 32DF(2) or 32DN(5) may be assigned a different number (which may be any combination of numbers and either or both of letters and symbols); and

the ways in which medical devices that have been assigned a device number may be assigned a different device number.

on a data processing device; or

by way of electronic transmission.

following a request by a person in relation to whom therapeutic goods are entered on the Register; or

on the Secretary’s own initiative;

vary the entry in the Register in relation to the goods if the entry contains information that is incomplete or incorrect.

a medicine is included in the part of the Register for goods known as provisionally registered goods; and

it appears to the Secretary that the quality, safety or efficacy of the medicine is unacceptable in relation to a class of persons;

the Secretary may, on the Secretary’s own initiative, vary the entry in the Register in relation to the medicine:

to reduce the class of persons for whom the medicine is suitable or to change the directions for use; or

to add a warning, or precaution, that does not include any comparison of the medicine with any other medicine by reference to quality, safety or efficacy.

a medicine is included in the part of the Register for goods known as provisionally registered goods; and

the Secretary makes a decision under subsection 29(9) to extend the provisional registration period for the medicine;

the Secretary may, on the Secretary’s own initiative, vary the entry in the Register in relation to the medicine to reduce the class of persons for whom the medicine is suitable or to change the directions for use.

give the person in relation to whom the medicine is registered written notice of the proposed variation and of the reasons for the proposed variation; and

give the person a reasonable opportunity to make a submission to the Secretary in relation to the proposed variation; and

if the person makes a submission in accordance with paragraph (b)—take the submission into account before making a decision whether or not to make the variation.

the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary information included in the entry in the Register that relates to the goods; and

the only effect of the variation would be:

to reduce the class of persons for whom the goods are suitable; or

to add a warning, or precaution, that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;

the Secretary must vary the entry in accordance with the request.

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; and

the variation is of a kind specified in the regulations; and

the conditions (if any) specified in the regulations are satisfied;

the Secretary must vary the entry in accordance with the request.

the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary information included in the entry in the Register that relates to the goods; and

subsection (2) does not apply to the request; and

subsection (2C) does not apply to the request; and

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;

the Secretary may vary the entry in accordance with the request.

(3AA) If:

the person in relation to whom a biological is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the biological; and

the only effect of the variation would be:

to reduce the class of persons for whom the biological is suitable; or

to add a warning, or precaution, that does not include any comparison of the biological with any other therapeutic goods by reference to quality, safety or efficacy;

the Secretary must vary the entry in accordance with the request.

(3AC) If:

the person in relation to whom a biological is included in the Register has requested the Secretary to vary the entry in the Register that relates to the biological; and

the variation is of a kind specified in the regulations; and

the conditions (if any) specified in the regulations are satisfied;

the Secretary must vary the entry in accordance with the request.

the person in relation to whom a biological is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the biological; and

subsection (3AA) does not apply to the request; and

subsection (3AC) does not apply to the request; and

the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the biological for the purposes for which it is to be used;

the Secretary may vary the entry in accordance with the request.

a particular biological ceases to be a biological because of a determination under subsection 32A(3); and

the biological is included in the Register under Part 3-2A;

the Secretary must move the entry relating to the biological from the part of the Register for biologicals to whichever other part of the Register is applicable.

the person in relation to whom a kind of medical device is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the kind of medical device; and

the only effect of the variation would be:

to reduce the class of persons for whom the kind of medical device is suitable; or

to add a warning, restriction or precaution, that does not include any comparison of the kind of medical device with any other therapeutic goods by reference to quality, safety or performance;

the Secretary must vary the entry in accordance with the request.

(3CB) If:

the person in relation to whom a kind of medical device is included in the Register has requested the Secretary to vary the entry in the Register that relates to the kind of medical device; and

the variation is of a kind specified in the regulations; and

the conditions (if any) specified in the regulations are satisfied;

the Secretary must vary the entry in accordance with the request.

the person in relation to whom a kind of medical device is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the kind of medical device; and

subsection (3C) does not apply to the request; and

subsection (3CB) does not apply to the request; and

the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or performance of the kind of medical device for the purposes for which it is to be used;

the Secretary may vary the entry in accordance with the request.

particular therapeutic goods cease to be medical devices because of a declaration under subsection 41BD(3); and

those goods are included in the Register under Chapter 4 as a kind of medical device;

the Secretary must move the entry relating to the goods from the part of the Register for medical devices to whichever other part of the Register is applicable.

Form and manner of requests

approve a form for particular kinds of requests under this section; and

approve the manner of making particular kinds of requests under this section.

the Secretary has approved a form for, and the manner of making, a kind of request under this section; and

either:

the kind of request is one under subsection (3) and which, under the regulations, must be decided within 175 or 255 working days; or

the kind of request is one prescribed by the regulations for the purposes of this subparagraph;

then a request of that kind is not effective unless:

the request is in accordance with that form; and

the request contains the information required by that form; and

the request is made in that manner; and

any prescribed application fee has been paid; and

the request is accompanied by information that is:

of a kind determined under subsection (8); and

in a form approved, in writing, by the Secretary.

there is an entry on the Register in relation to goods; and

the Secretary is satisfied that the goods are not therapeutic goods.

inform the person in writing that the Secretary proposes the removal and set out the reasons for it; and

invite the person to make written submissions to the Secretary in relation to the proposed removal within the period specified in the notice (being not less than 20 working days after the day the notice is given).

the person makes a statement; and

the statement is made in or in connection with a request under section 9D for the variation of an entry in the Register in relation to therapeutic goods; and

the statement is false or misleading in a material particular; and

either:

the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or

the use of the goods, if the goods were used, would result in, or would be likely to result in, harm or injury to any person.

the person makes a statement; and

the statement is made in or in connection with a request under section 9D for the variation of an entry in the Register in relation to therapeutic goods; and

the statement is false or misleading in a material particular.

the person makes a statement; and

the statement is made in or in connection with a request under section 9D for the variation of an entry in the Register in relation to therapeutic goods; and

the statement is false or misleading in a material particular.

the import into Australia of the therapeutic goods or vaping goods;

the export from Australia of the therapeutic goods or vaping goods;

the manufacture in Australia of the therapeutic goods or vaping goods;

the supply in Australia of the therapeutic goods or vaping goods.

the import into Australia of all or specified therapeutic goods or vaping goods that contain that ingredient or component;

the export from Australia of all or specified therapeutic goods or vaping goods that contain that ingredient or component;

the manufacture in Australia of all or specified therapeutic goods or vaping goods that contain that ingredient or component;

the supply in Australia of all or specified therapeutic goods or vaping goods that contain that ingredient or component.

the Minister causes to be published on the Department’s website a notice setting out details of:

the international agreement; and

the Minister’s satisfaction mentioned in subsection (2) or (4); and

the proposed prohibition; and

a period of 30 days has passed since the notice was published.

Commencement of regulations containing prohibition

make provision in relation to a matter by conferring on the Minister or Secretary a power to make a decision of an administrative character;

refer to the Minister or Secretary being satisfied of one or more specified matters;

make provision for and in relation to the Minister or Secretary delegating powers to an SES employee, or acting SES employee, in the Department.

the person:

imports into Australia therapeutic goods or vaping goods; or

exports from Australia therapeutic goods or vaping goods; or

manufactures in Australia therapeutic goods or vaping goods; or

supplies in Australia therapeutic goods or vaping goods; and

the import, export, manufacture or supply contravenes:

an absolute prohibition in force for the purposes of subsection 9K(1) or (3); or

one or more conditions of a prohibition in force for the purposes of subsection 9K(1) or (3).

Civil penalty

the person:

imports into Australia therapeutic goods or vaping goods; or

exports from Australia therapeutic goods or vaping goods; or

manufactures in Australia therapeutic goods or vaping goods; or

supplies in Australia therapeutic goods or vaping goods; and

the import, export, manufacture or supply contravenes:

an absolute prohibition in force for the purposes of subsection 9K(1) or (3); or

one or more conditions of a prohibition in force for the purposes of subsection 9K(1) or (3).

for an individual—300 penalty units; and

for a body corporate—3,000 penalty units.