Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) In this Act, unless the contrary intention appears:
"accessory" , in relation to a medical device covered by paragraph 41BD(1)(a), (aa) or (ab), means a thing that the manufacturer of the thing specifically intended to be used together with the device to enable or assist the device to be used as the manufacturer of the device intended.
"actual or potential tampering" has the meaning given by section 42U.
"advertise" , in relation to therapeutic goods or vaping goods, includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:
(a) is on the label of the goods; or
(b) is on the package in which the goods are contained; or
(c) is on any material included with the package in which the goods are contained.
"anthroposophic pharmacopoeia" means:
(a) a publication specified under paragraph 3AB(3)(a), as that publication is in force from time to time; or
(b) 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) a conformity assessment fee; or
(b) 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.
Note: The Agreement could in 2020 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).
"authorised person" means:
(a) 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 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 Customs Act 1901 ).
"batch" means a quantity of a product that is:
(a) uniform in composition, method of manufacture and probability of chemical or microbial contamination; and
(b) 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" , in relation to therapeutic goods, 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:
(a) the number assigned to the biological under subsection 32DB(2), 32DCB(2), 32DF(2) or 32DN(5); or
(b) 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) a class prescribed by the regulations for the purposes of section 32AA; and
(b) 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) a body corporate, or an unincorporated body, established for a public purpose by or under an Act; and
(b) a tribunal or authority established by or in accordance with an Act.
"Commonwealth officer" includes:
(a) a Minister; and
(b) a person holding:
(i) an office established by or under an Act; or
(ii) an appointment made under an Act; or
(iii) an appointment made by the Governor - General or a Minister but not under an Act; and
(c) a person who is a member or officer of a Commonwealth authority; and
(d) 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) a conformity assessment certificate; or
(b) an Australian conformity assessment body certificate; or
(c) 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" , in relation to therapeutic goods, 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) a foreign corporation; or
(b) 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;
(b) a standard referred to in paragraph (c) of that definition;
(c) a standard referred to in paragraph (d) of that definition.
"device number" , in relation to a medical device, means any combination of numbers, symbols and letters assigned to the device under section 41FL.
"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.
"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:
(a) Sectoral Annex (Medical Devices);
(b) 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:
(a) 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" , in relation to a matter, 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" , in relation to a provision of Part 3 - 2, 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" , in relation to a provision of Part 3 - 3, means therapeutic goods that are exempted from the operation of that Part by the regulations.
"exempt person" , in relation to therapeutic goods, 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:
(a) manufactured in Australia for export only; or
(b) imported into Australia for export only.
"export only medicine" means a medicine that:
(a) is manufactured in Australia for export only, or imported into Australia for export only; and
(b) is listable goods only because it is so manufactured or imported (and not for any other reason).
"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) a gazetted therapeutic goods group; or
(c) a gazetted kits group.
"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:
(a) Aboriginal and Torres Strait Islander health practice;
(b) dental (not including the professions of dental therapist, dental hygienist, dental prosthetist or oral health therapist);
(c) medical;
(d) medical radiation practice;
(e) nursing;
(f) midwifery;
(g) occupational therapy;
(h) optometry;
(i) pharmacy;
(j) physiotherapy;
(k) podiatry;
(l) psychology.
"homoeopathic pharmacopoeia" means:
(a) a publication specified under paragraph 3AA(3)(a), as that publication is in force from time to time; or
(b) 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).
"included in the Register" :
(a) in relation to a biological--means included in the Register under Part 3 - 2A; and
(b) in relation to a medical device to which Chapter 4 applies--means included in the Register under Chapter 4.
"indications" , in relation to therapeutic goods, means the specific therapeutic uses of the goods.
"international instrument" means:
(a) any treaty, convention, protocol, agreement or other instrument that is binding in international law; and
(b) a part of such a treaty, convention, protocol, agreement or other instrument.
"issuing officer" means:
(a) a magistrate; or
(b) 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" , in relation to therapeutic goods, means a display of printed information:
(a) on or attached to the goods; or
(b) on or attached to a container or primary pack in which the goods are supplied; or
(c) 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" , in relation to listed goods, 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:
(a) 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
(b) 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:
(a) to produce the goods; or
(b) 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:
(a) that are for use in the manufacture of a particular kind of therapeutic goods; and
(b) 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" , in relation to a kind of medical device, 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:
(a) an animal;
(b) a plant;
(c) an alga;
(d) a fungus;
(e) a micro - organism;
(f) a mineral;
(g) a mineral compound;
(h) a chemical;
(i) 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) a purpose of the instrument is the recognition of attestations of conformity; and
(b) the instrument satisfies the requirements (if any) set out in regulations made for the purposes of this paragraph;
but does not include:
(c) the EC Mutual Recognition Agreement; or
(d) 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" :
(a) when used in relation to a section 23 application for registration--has the meaning given by subsection 23B(3); and
(b) when used in relation to a section 23 application for listing under section 26AE--has the meaning given by subsection 23B(3); and
(ba) when used in relation to a section 26BD application--has the meaning given by subsection 26BD(4); and
(c) when used in relation to a section 32DD application--has the meaning given by subsection 32DDA(3); and
(d) 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) a structure, building, aircraft, vehicle or vessel; and
(b) a place (whether enclosed or built upon or not); and
(c) a part of a thing referred to in paragraph (a) or (b).
"presentation" , in relation to therapeutic goods, 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" , in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers.
"product information" , in relation to therapeutic goods, 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.
"quality" , in relation to therapeutic goods, 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:
(a) therapeutic goods included in the part of the Register for goods known as registered goods; or
(b) therapeutic goods included in the part of the Register for goods known as provisionally registered goods.
Note: Subsection (8) provides that a reference in this Act to therapeutic goods that are registered, or to the registration of therapeutic goods, includes a reference to a medicine that is provisionally registered under section 29.
"registration number" , in relation to registered goods, 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 medicine" has the meaning given by section 30EH.
"restricted information" has the meaning given by section 26AF.
"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).
"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) a person who exports, or arranges the exportation of, the goods from Australia; or
(b) a person who imports, or arranges the importation of, the goods into Australia; or
(c) 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:
(d) exports, imports or manufactures the goods; or
(e) 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" , in relation to therapeutic goods, means any of the following:
(a) a standard that is constituted by the matters specified in an order under section 10 that is applicable to the goods;
(b) 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;
(c) 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;
(d) 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;
(e) a homoeopathic standard;
(f) an anthroposophic standard.
Note: See also section 13.
"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:
(a) supply by way of sale, exchange, gift, lease, loan, hire or hire - purchase; and
(b) supply, whether free of charge or otherwise, by way of sample or advertisement; and
(c) 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
(d) 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:
(a) they are interfered with in a way that affects, or could affect, the quality, safety or efficacy of the goods; and
(b) 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:
(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:
(i) for therapeutic use; or
(ii) for use as an ingredient or component in the manufacture of therapeutic goods; or
(iii) for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or
(b) 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
(ba) 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:
(c) goods declared not to be therapeutic goods under an order in force under section 7; or
(d) 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 section 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 Food Standards Australia New Zealand Act 1991 ); or
(f) 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
(g) goods covered by a determination under subsection 7AA(1) (excluded goods); or
(h) 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:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or
(b) influencing, inhibiting or modifying a physiological process in persons; or
(c) testing the susceptibility of persons to a disease or ailment; or
(d) influencing, controlling or preventing conception in persons; or
(e) testing for pregnancy in persons; or
(f) 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:
(a) Saturday or Sunday; or
(b) a day that is a public holiday in the State or Territory in which the person is located.
(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.
(2A) The Minister may, by legislative instrument, specify medicines for the purposes of paragraph (a) of the definition of restricted medicine in subsection (1).
(2B) The Minister may, by legislative instrument, specify classes of medicine for the purposes of paragraph (b) of the definition of restricted medicine in subsection (1).
(3) The Secretary must, at least once in each year, cause to be published in the Gazette or on the Department's website a list of the names of all persons, other than members of the Australian Federal Police, who are, at the time of publication, authorised persons.
(4) The provisions of this Act are in addition to, and not in substitution for, the provisions of any other Act that relate to therapeutic goods.
(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, without limiting the previous words in this subsection, the presentation of therapeutic goods is unacceptable:
(a) if it states or suggests that the goods have ingredients, components or characteristics that they do not have; or
(b) 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
(c) if the label of the goods does not declare the presence of a therapeutically active ingredient; or
(ca) 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
(d) 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
(e) in prescribed cases.
(5A) The Minister may, by legislative instrument, specify advisory statements in relation to medicine for the purposes of paragraph (5)(ca).
(5B) For the purposes of subsection (5A), the Minister may specify different advisory statements for different medicines or different classes of medicine.
(6) A reference in this Act to an annual registration charge, an annual listing charge, an annual charge for inclusion in the Register, an annual licensing charge or an annual conformity assessment body determination charge is a reference to such a charge imposed under the Therapeutic Goods (Charges) Act 1989 .
(7) A reference to an offence against this Act includes a reference to:
(a) an offence against the regulations; and
(b) an offence against section 6 of the 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; and
(c) an offence against section 136.1, 137.1 or 137.2 of the Criminal Code in relation to this Act or the regulations.
(7A) For the purposes of this Act, a corresponding State law imposes a duty on a Commonwealth officer or Commonwealth authority if:
(a) the corresponding State law confers a function or power on the officer or authority; and
(b) 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.
(8) To avoid doubt:
(a) a reference in this Act to therapeutic goods that are registered includes a reference to a medicine that is provisionally registered; and
(b) a reference in this Act to the registration of therapeutic goods includes a reference to the provisional registration of a medicine.
Note: Subsection 29(2) deals with the provisional registration of a medicine.