Interpretation
2 Interpretation
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:
that is recommended by its manufacturer for:
dermal application; or
application to the mucous membranes of a person or an animal:
to kill micro organisms; or
to prevent the growth of micro organisms to a level that causes or may cause clinical infection; and
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.
The Australian Approved Names List includes:
Australian Approved Names—Chemicals List; and
Australian Approved Names—Biological Lists; and
the Herbal Substances AAN List.
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.
Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.
biological medicine means:
a medicine (other than an antibiotic) that is:
a vaccine, a peptide, a protein or polysaccharide‑based; and
derived from a human, animal or other organism, or produced through recombinant technology or biotechnology; and
of a kind specified in item 1 of Part 1 of Schedule 10; or
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):
that:
has been subjected to only minimal manipulation; and
is only for homologous use; and
is not mentioned in Schedule 16 as a Class 1, 3 or 4 biological; or
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):
that is not a Class 1, 2 or 4 biological; or
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.
Defence clinical governance committee means a committee established by the Defence Department to perform functions concerned with clinical governance in relation to therapeutic goods.
Defence Department means the Department administered by the Minister administering Part III of the Defence Act 1903, and includes the Australian Defence Force.
Defence medical practitioner means a medical practitioner engaged by the Defence Department.
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:
that is recommended by its manufacturer for application to an inanimate object to kill micro organisms; and
that is not represented by the manufacturer to be suitable for internal use.
disposable therapeutic vape means a therapeutic good:
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
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
that is pre‑filled with a therapeutic vaping substance; and
that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.
engagement by the Defence Department means engagement by the Defence Department to perform duties for the Defence Department, whether as an employee, a contractor or in another capacity.
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:
comprises, contains or is derived from human stool; and
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):
has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and
has the same pharmaceutical form; and
is bioequivalent; and
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):
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
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:
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
prepared according to the practices of homoeopathic pharmacy using the methods of:
serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or
serial trituration in lactose.
homologous use: see regulation 3B.
hospital grade disinfectant means a disinfectant that is represented to be suitable for therapeutic use:
in premises used for:
the investigation or treatment of a disease, ailment or injury; or
procedures that are carried out involving the penetration of the human skin; or
in connection with:
the business of beauty therapy or hairdressing; or
the practice of podiatry;
but does not include:
an antibacterial clothes preparation; or
a sanitary fluid; or
a sanitary powder; or
a sanitiser.
household grade disinfectant means a disinfectant that is not:
an antibacterial clothes preparation; or
a hospital grade disinfectant; or
a sanitary fluid; or
a sanitary powder; or
a sanitiser.
immediate family of a person means:
a spouse, de facto partner, child, parent, grandparent, grandchild or sibling of the person; or
a child, parent, grandparent, grandchild or sibling of a spouse or de facto partner of the 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:
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
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
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:
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
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:
an evaluation of the 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
a monograph contained in a default standard; and
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:
that is:
a Class 1 IVD medical device; or
a Class 2 IVD medical device; or
a Class 3 IVD medical device; or
a Class 4 IVD medical device; and
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:
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:
has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and
has the same pharmaceutical form; and
is bioequivalent; and
has the same safety and efficacy properties; or
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:
either:
the application requires an independent evaluation of the efficacy of the medicine; or
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
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:
is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and
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:
the new medicine is a changed form of a medicine (the existing medicine) listed under section 26AE of the Act; and
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
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:
is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and
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:
the new medicine is a changed form of a medicine (the existing medicine) listed under section 26AE of the Act; and
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
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:
is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and
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:
the new medicine is a changed form of a medicine (the existing medicine) listed under section 26AE of the Act; and
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
the change is of a kind specified in the changes table as an L(A)CN (section 23) level change.
master file means a technical master file or a plasma master file.
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 I of Annex A to the Minamata Convention that contain mercury, but does not include:
products essential for civil protection and military uses; or
products for research, calibration of instrumentation, or for use as reference standards; or
if no feasible mercury‑free alternative for replacement is available—the following:
switches and relays;
cold cathode fluorescent lamps and external electrode fluorescent lamps for electronic displays;
measuring devices; or
products used in traditional or religious practices; or
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.
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:
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
has an indication in common with that other medicine; and
does not have the same dosage form as that other medicine.
new indications medicine means a prescription medicine that:
has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and
does not have the same indications as that other medicine.
new prescription medicine means a prescription medicine that contains:
a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or
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.
nicotine pouch means a therapeutic good of a kind specified in item 1 of the table in Schedule 1 to the Therapeutic Goods (Determined Goods) Determination 2024 that:
is in the form of a pouch, sachet or other similar article; and
is designed or intended to:
deliver nicotine by absorption into a person’s bloodstream by being placed in the person’s mouth; and
remain intact (or relatively intact) in the person’s mouth during usage and to be removed from the person’s mouth after usage.
nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:
a standard applicable to the biological; or
any manufacturing requirements under the Act for the biological.
non‑Minamata mercury means any of the following:
mercury to be used for laboratory‑scale research or as a reference standard;
naturally occurring trace quantities of mercury present in:
products such as non‑mercury metals, ores or mineral products (including coal); or
products derived from the products mentioned in subparagraph (i);
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.
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.
overseas medical practitioner means a person who is registered or licensed to practise medicine under a law of a foreign country that provides for the registration or licensing of persons to practise medicine.
pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.
plasma master file means a plasma master file mentioned in clauses 2 to 5 of Schedule 5A.
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:
the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or
the application requires an independent evaluation of one of the following:
the safety of the medicine;
the quality of the medicine;
the efficacy of the medicine.
RCM4 application means an application made under section 23 of the Act to register a complementary medicine, if:
the application requires an independent evaluation of 2 of the following:
the safety of the medicine;
the quality of the medicine;
the efficacy of the medicine; or
the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or
the application is for a medicine that is registered and is for one or more of the following:
an extension of indications of the medicine;
new directions for use of the medicine;
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:
either:
the application requires an independent evaluation of the safety, quality and efficacy of the medicine; or
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
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:
the new medicine is a changed form of a registered complementary medicine (the existing medicine); and
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
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:
the new medicine is a changed form of a registered complementary medicine (the existing medicine); and
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
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:
the new medicine is a changed form of a registered complementary medicine (the existing medicine); and
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
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:
the new medicine is a changed form of a registered complementary medicine (the existing medicine); and
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
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.
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:
generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or
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:
kills bacterial spores; and
has the potential to act as a sterilising agent after prolonged contact with an inanimate object.
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.
technical master file means a technical master file mentioned in clauses 2 to 5 of Schedule 5A.
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).
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 therapeutic vaping device; or
a therapeutic vaping device accessory; or
a therapeutic vaping substance; or
a therapeutic vaping substance accessory.
therapeutic vaping kit means a kit, covered by subsection 7B(1) of the Act, that:
contains one or more therapeutic vaping substances or therapeutic vaping substance accessories; and
does not contain any other goods.
therapeutic vaping pack means a primary pack that:
contains at least one therapeutic vaping substance or therapeutic vaping substance accessory; and
contains at least one therapeutic vaping device or therapeutic vaping device accessory; and
does not contain any other therapeutic 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 vaping accessory that:
is designed or intended for use in, or with, a therapeutic vaping device; and
contains a therapeutic vaping substance.
trade name, for therapeutic goods of a particular kind, means the commercial name:
given to goods of that kind by the manufacturer; and
under which the goods are supplied.
traditional use, for a designated active ingredient, means use of the designated active ingredient that:
is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and
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.
virucide means a chemical agent that renders a virus non‑infective.
For the definitions of the following terms, see subsection 3(1) of the Act:
• medicine
• poison
• product information
• Secretary.
This Act’s bill:Explanatory statement
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