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Direct links to the current provisions in Therapeutic Goods Regulations 1990.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
These Regulations are the Therapeutic Goods Regulations 1990.
In 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.
analyst: see subregulation 24(1).
antiseptic means a substance:
(a) that is recommended by its manufacturer for:
(i) dermal application; or
(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.
biological medicine means:
(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):
(a) that:
(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 subsection 41P(1) of the Act; 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
(c) is bioequivalent; 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:
(a) in premises used for:
(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
(b) in connection with:
(i) the business of beauty therapy or hairdressing; or
(ii) the practice of podiatry;
but does not include: (c) an antibacterial clothes preparation; or (d) a sanitary fluid; or (e) a sanitary powder; or (f) a sanitiser.
household grade disinfectant means a disinfectant that is not:
(a) an antibacterial clothes preparation; or
(b) a hospital grade disinfectant; or
(c) a sanitary fluid; or
(d) a sanitary powder; or
(e) a sanitiser.
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
(b) an evaluation of:
(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:
(a) that is:
(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
(iii) is bioequivalent; 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:
(a) either:
(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
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