Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsIn these Regulations, unless the contrary intention appears:
"active ingredient" , for a medicine, means a therapeutically active component in the medicine's final formulation that is responsible for its physiological or pharmacological action.
"AHPRA number" , of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.
"analysis" includes examination and testing.
"antiseptic" means a substance:
(a) that is recommended by its manufacturer for:
(ii) application to the mucous membranes of a person or an animal:
(A) to kill micro organisms; or
(B) to prevent the growth of micro organisms to a level that causes or may cause clinical infection; and
(b) that is not represented to be suitable for internal use.
"Australian Approved Names List" means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.
Note 1: The Australian Approved Names List includes:
(a) Australian Approved Names--Chemicals List; and
(b) Australian Approved Names--Biological Lists; and
(c) the Herbal Substances AAN List.
Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.
"authorised officer" , in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.
Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.
(a) a medicine (other than an antibiotic) that is:
(i) a vaccine, a peptide, a protein or polysaccharide - based; and
(ii) derived from a human, animal or other organism, or produced through recombinant technology or biotechnology; and
(iii) of a kind specified in item 1 of Part 1 of Schedule 10; or
(b) a medicine that is a human blood product of a kind mentioned in Appendix A in Part 5 of the Poisons Standard.
"biologicals (priority applicant) determination" has the meaning given by subsection 32DEA(2) of the Act.
"C1 (section 9D) application" has the meaning given by Part 1 of Schedule 9.
"C1 (section 23) application" has the meaning given by Part 1 of Schedule 9.
"C2 (section 9D) application" has the meaning given by Part 1 of Schedule 9.
"C2 (section 23) application" has the meaning given by Part 1 of Schedule 9.
"C3 (section 9D) application" has the meaning given by Part 1 of Schedule 9.
"C3 (section 23) application" has the meaning given by Part 1 of Schedule 9.
"C4 (section 9D) application" has the meaning given by Part 1 of Schedule 9.
"C4 (section 23) application" has the meaning given by Part 1 of Schedule 9.
"changes table" means the table published on the Department's website for the purposes of this definition, as in force from time to time.
"Class 1 biological" means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.
"Class 1 IVD medical device" has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002 .
"Class 2 biological" means a biological (other than an export only biological):
(i) has been subjected to only minimal manipulation; and
(ii) is only for homologous use; and
(iii) is not mentioned in Schedule 16 as a Class 1, 3 or 4 biological; or
(b) that is mentioned in Schedule 16 as a Class 2 biological.
"Class 2 IVD medical device" has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002 .
"Class 3 biological" means a biological (other than an export only biological):
(a) that is not a Class 1, 2 or 4 biological; or
(b) that is mentioned in Schedule 16 as a Class 3 biological.
"Class 3 IVD medical device" has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002 .
"Class III medical device" has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002 .
"Class 4 biological" means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.
"Class 4 IVD medical device" has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002 .
"complementary medicine" means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.
"designated active ingredients" , for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.
"designated orphan drug" means a medicine in relation to which a designation under regulation 16J is in force.
"disinfectant" means a substance:
(a) that is recommended by its manufacturer for application to an inanimate object to kill micro organisms; and
(b) that is not represented by the manufacturer to be suitable for internal use.
"disposable therapeutic vape" means a therapeutic good:
(a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in this regulation; and
(b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and
(c) that is pre - filled with a therapeutic vaping substance; and
(d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.
"expiry date" , for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.
"faecal microbiota transplant product" means a thing that:
(a) comprises, contains or is derived from human stool; and
(b) is for introduction into a person for a therapeutic use.
"Finance Minister" means the Minister who administers the Public Governance, Performance and Accountability Act 2013.
"fungicide" means a chemical agent that kills a fungus or spores of a fungus.
"generic product" means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine ):
(a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and
(b) has the same pharmaceutical form; and
(d) has the same safety and efficacy properties.
"gene therapy" means the in vivo transfer of DNA or RNA into the cells of human recipients.
"herbal substance" means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):
(a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and
(b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.
"high level disinfectant" means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.
"homoeopathic preparation" means a preparation:
(a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and
(b) prepared according to the practices of homoeopathic pharmacy using the methods of:
(i) serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or
(ii) serial trituration in lactose.
"homologous use" : see regulation 3B.
"hospital grade disinfectant" means a disinfectant that is represented to be suitable for therapeutic use:
(i) the investigation or treatment of a disease, ailment or injury; or
(ii) procedures that are carried out involving the penetration of the human skin; or
(i) the business of beauty therapy or hairdressing; or
(ii) the practice of podiatry;
(c) an antibacterial clothes preparation; or
"household grade disinfectant" means a disinfectant that is not:
(a) an antibacterial clothes preparation; or
(b) a hospital grade disinfectant; or
"immediate family" , in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.
"IN1 application" means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:
(a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or
(i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and
(ii) the quality of the ingredient based on a monograph contained in a default standard.
"IN2 application" means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:
(a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and
(b) an independent evaluation of the quality of the ingredient.
"IN3 application" means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:
(a) an evaluation of the quality of an ingredient based on:
(i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or
(ii) a monograph contained in a default standard; and
(b) an independent evaluation of the safety of the ingredient.
"IN4 application" means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.
"independent evaluation" means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.
"in-house IVD medical device" has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002 .
"IVD device" means an IVD medical device:
(i) a Class 1 IVD medical device; or
(ii) a Class 2 IVD medical device; or
(iii) a Class 3 IVD medical device; or
(iv) a Class 4 IVD medical device; and
(b) that is not an in - house IVD medical device.
"IVD medical device" has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002 .
"joint replacement medical device" has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002 .
"L(A)1 application" means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).
"L(A)2 application" means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:
(a) the application is for a medicine that, in comparison to a medicine (the included medicine ) that is or was listed under section 26AE of the Act:
(i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and
(ii) has the same pharmaceutical form; and
(iv) has the same safety and efficacy properties; or
(b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.
"L(A)3 application" means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:
(i) the application requires an independent evaluation of the efficacy of the medicine; or
(ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and
(b) the application is not an L(A)1 application or an L(A)2 application.
"L(A)C1 (section 9D) request" means a request under subsection 9D(1), (2) or (3) of the Act for a variation that:
(a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and
(b) is of a kind specified in the changes table as an L(A)C1 (section 9D) level change.
"L(A)C1 (section 23) application" means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine ), if:
(a) the new medicine is a changed form of a medicine (the existing medicine ) listed under section 26AE of the Act; and
(b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3 - 2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
(c) the change is of a kind specified in the changes table as an L(A)C1 (section 23) level change.
"L(A)C2 (section 9D) request" means a request under subsection 9D(1), (2) or (3) of the Act for a variation that:
(a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and
(b) is of a kind specified in the changes table as an L(A)C2 (section 9D) level change.
"L(A)C2 (section 23) application" means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine ), if:
(a) the new medicine is a changed form of a medicine (the existing medicine ) listed under section 26AE of the Act; and
(b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3 - 2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
(c) the change is of a kind specified in the changes table as an L(A)C2 (section 23) level change.
"L(A)CN (section 9D) request" means a request under subsection 9D(1), (2) or (3) of the Act for a variation that:
(a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and
(b) is of a kind specified in the changes table as an L(A)CN (section 9D) level change.
"L(A)CN (section 23) application" means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine ), if:
(a) the new medicine is a changed form of a medicine (the existing medicine ) listed under section 26AE of the Act; and
(b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3 - 2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
(c) the change is of a kind specified in the changes table as an L(A)CN (section 23) level change.
"medicinal cannabis products" means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).
"mercury" means elemental mercury (Hg(0), CAS No. 7439 - 97 - 6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non - Minamata mercury.
"mercury-added products" means the products listed in Part 1 of Annex A to the Minamata Convention that contain mercury, but does not include:
(a) products essential for civil protection and military uses; or
(b) products for research, calibration of instrumentation, or for use as reference standards; or
(c) if no feasible mercury - free alternative for replacement is available--the following:
(ii) cold cathode fluorescent lamps and external electrode fluorescent lamps for electronic displays;
(d) products used in traditional or religious practices; or
(e) vaccines containing thiomersal as preservatives.
"Minamata Convention" means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.
Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).
"minimal manipulation" : see regulation 3B.
"mother tincture" means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.
"N1 application" has the meaning given by Part 1 of Schedule 9.
"N2 application" has the meaning given by Part 1 of Schedule 9.
"N3 application" has the meaning given by Part 1 of Schedule 9.
"N4 application" has the meaning given by Part 1 of Schedule 9.
"N5 application" has the meaning given by Part 1 of Schedule 9.
"new dosage form medicine" means a medicine that:
(a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and
(b) has an indication in common with that other medicine; and
(c) does not have the same dosage form as that other medicine.
"new indications medicine" means a prescription medicine that:
(a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and
(b) does not have the same indications as that other medicine.
"new prescription medicine" means a prescription medicine that contains:
(a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or
(b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.
"nonconforming biological" means a biological that is included in the Register under Part 3 - 2A of the Act but does not conform with:
(a) a standard applicable to the biological; or
(b) any manufacturing requirements under the Act for the biological.
"non-Minamata mercury" means any of the following:
(a) mercury to be used for laboratory - scale research or as a reference standard;
(b) naturally occurring trace quantities of mercury present in:
(i) products such as non - mercury metals, ores or mineral products (including coal); or
(ii) products derived from the products mentioned in subparagraph (i);
(c) unintentional trace quantities of mercury in chemical products.
"open shelf life" , for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.
Note: For container , see Act, subs 3(1).
"original cells or tissues" : see regulation 3B.
"OTC medicine" means therapeutic goods mentioned in Part 3 of Schedule 10.
"pharmaceutical benefit" means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans' Entitlements Act 1986 .
"Poisons Standard" has the same meaning as current Poisons Standard .
"Practice Guideline" has the meaning given by paragraph 12AB(2)(a).
"principal investigator" , in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.
"quarter" means a period of 3 months commencing on 1 January, 1 April, 1 July or 1 October in a year.
"RCM1 application" means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).
"RCM2 application" means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.
"RCM3 application" means an application made under section 23 of the Act to register a complementary medicine, if:
(a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or
(b) the application requires an independent evaluation of one of the following:
(i) the safety of the medicine;
(ii) the quality of the medicine;
(iii) the efficacy of the medicine.
"RCM4 application" means an application made under section 23 of the Act to register a complementary medicine, if:
(a) the application requires an independent evaluation of 2 of the following:
(i) the safety of the medicine;
(ii) the quality of the medicine;
(iii) the efficacy of the medicine; or
(b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or
(c) the application is for a medicine that is registered and is for one or more of the following:
(i) an extension of indications of the medicine;
(ii) new directions for use of the medicine;
(iii) an increase in the target population for the medicine.
"RCM5 application" means an application made under section 23 of the Act to register a complementary medicine, if:
(i) the application requires an independent evaluation of the safety, quality and efficacy of the medicine; or
(ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and
(b) the application is not an RCM1 application, an RCM2 application, an RCM3 application or an RCM4 application.
"RCMC1 (section 9D) request" means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.
"RCMC1 (section 23) application" means an application made under section 23 of the Act to register a complementary medicine (the new medicine ), if:
(a) the new medicine is a changed form of a registered complementary medicine (the existing medicine ); and
(b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3 - 2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
(c) the change is of a kind specified in the changes table as an RCMC1 (section 23) level change.
"RCMC2 (section 9D) request" means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.
"RCMC2 (section 23) application" means an application made under section 23 of the Act to register a complementary medicine (the new medicine ), if:
(a) the new medicine is a changed form of a registered complementary medicine (the existing medicine ); and
(b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3 - 2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
(c) the change is of a kind specified in the changes table as an RCMC2 (section 23) level change.
"RCMC3 (section 9D) request" means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.
"RCMC3 (section 23) application" means an application made under section 23 of the Act to register a complementary medicine (the new medicine ), if:
(a) the new medicine is a changed form of a registered complementary medicine (the existing medicine ); and
(b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3 - 2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
(c) the change is of a kind specified in the changes table as an RCMC3 (section 23) level change.
"RCMC4 (section 9D) request" means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.
"RCMC4 (section 23) application" means an application made under section 23 of the Act to register a complementary medicine (the new medicine ), if:
(a) the new medicine is a changed form of a registered complementary medicine (the existing medicine ); and
(b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3 - 2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
(c) the change is of a kind specified in the changes table as an RCMC4 (section 23) level change.
"Required Advisory Statements for Medicine Labels" means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.
"sample" includes part of a sample.
"serious" , in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:
(a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or
(b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.
"specialist" has the same meaning as in the Health Insurance Act 1973 .
"sporicide" means a chemical agent that:
(a) kills bacterial spores; and
(b) has the potential to act as a sterilising agent after prolonged contact with an inanimate object.
"Standard AS/NZS" means a joint Australian and New Zealand Standard published by, or on behalf of, Standards Australia and the body known as Standards New Zealand.
Note: Section 2B of the Acts Interpretation Act 1901 defines Standards Australia.
"sterilant" means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10 - 6 .
"submission" has the meaning given by subclause 1(2) in Part 1 of Schedule 9.
"TGA notifications process guidance document" means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process--requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).
Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration's website (http://www.tga.gov.au).
"the Act" means the Therapeutic Goods Act 1989 .
"Therapeutic Goods Administration" means that part of the Department known as the Therapeutic Goods Administration.
"therapeutic goods (priority applicant) determination" has the meaning given by subsection 25AAA(2) of the Act.
"therapeutic vaping device" has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002 .
"therapeutic vaping device accessory" has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002 .
"therapeutic vaping good" means:
(a) a therapeutic vaping device; or
(b) a therapeutic vaping device accessory; or
(c) a therapeutic vaping substance; or
(d) a therapeutic vaping substance accessory.
"therapeutic vaping kit" means a kit, covered by subsection 7B(1) of the Act, that:
(a) contains one or more therapeutic vaping substances or therapeutic vaping substance accessories; and
(b) does not contain any other goods.
"therapeutic vaping pack" means a primary pack that:
(a) contains 2 or more therapeutic vaping goods, including at least one therapeutic vaping device or therapeutic vaping device accessory; and
(b) does not contain any other goods.
"therapeutic vaping substance" means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.
"therapeutic vaping substance accessory" means a therapeutic good that is a cartridge, capsule, pod or other vessel:
(a) that contains a therapeutic vaping substance (whether or not the vessel is designed or intended to be refilled); and
(b) that is designed or intended for use in or with a therapeutic vaping device.
"trade name" , for therapeutic goods of a particular kind, means the commercial name:
(a) given to goods of that kind by the manufacturer; and
(b) under which the goods are supplied.
"traditional use" , for a designated active ingredient, means use of the designated active ingredient that:
(a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and
(b) accords with well - established procedures of preparation, application and dosage.
"tuberculocide" means a chemical agent that kills Mycobacterium tuberculosis and related acid - fast bacteria.
"turnover" of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).
"unused emergency biological" means a biological to which section 32CG of the Act applies.
"unused emergency goods" means goods to which section 30G of the Act applies.
(a) a device that generates or releases, or is designed or intended to generate or release, using a heating element and by electronic means, an aerosol, vapour or mist for direct inhalation by its user; or
(b) a device to which paragraph (a) would apply were the device not incomplete, damaged, temporarily or permanently inoperable, or unfinished.
Note 1: Examples of devices that are not vaping devices include the following:
Note 2: To avoid doubt, therapeutic vaping substance accessories and therapeutic vaping device accessories are not devices to which paragraph (b) applies.
"virucide" means a chemical agent that renders a virus non - infective.
Note: For the definitions of the following terms, see subsection 3(1) of the Act:
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