Contents
- active ingredient, for a medicine, means a therapeutically…
- AHPRA number, of a health practitioner, means the registra…
- analyst: see subregulation 24(1).
- antiseptic means a substance:
- Australian Approved Names List means the document entitled…
- authorised officer, in relation to a provision of these Re…
- biological medicine means:
- biologicals (priority applicant) determination has the mea…
- C1 (section 9D) application has the meaning given by Part…
- C1 (section 23) application has the meaning given by Part…
- C2 (section 9D) application has the meaning given by Part…
- C2 (section 23) application has the meaning given by Part…
- C3 (section 9D) application has the meaning given by Part…
- C3 (section 23) application has the meaning given by Part…
- C4 (section 9D) application has the meaning given by Part…
- C4 (section 23) application has the meaning given by Part…
- changes table means the table published on the Department’…
- Class 1 biological means a biological (other than an expor…
- Class 1 IVD medical device has the same meaning as in the…
- Class 2 biological means a biological (other than an expor…
- Class 2 IVD medical device has the same meaning as in the…
- Class 3 biological means a biological (other than an expor…
- Class 3 IVD medical device has the same meaning as in the…
- Class III medical device has the same meaning as in the Th…
- Class 4 biological means a biological (other than an expor…
- Class 4 IVD medical device has the same meaning as in the…
- complementary medicine means a therapeutic good consisting…
- Defence clinical governance committee means a committee es…
- Defence Department means the Department administered by th…
- Defence medical practitioner means a medical practitioner…
- designated active ingredients, for a complementary medicin…
- designated orphan drug means a medicine in relation to whi…
- disinfectant means a substance:
- disposable therapeutic vape means a therapeutic good:
- engagement by the Defence Department means engagement by t…
- expiry date, for therapeutic goods, means the date (expres…
- faecal microbiota transplant product means a thing that:
- Finance Minister means the Minister who administers the Pu…
- fungicide means a chemical agent that kills a fungus or sp…
- generic product means a medicine that, in comparison to a…
- gene therapy means the in vivo transfer of DNA or RNA into…
- herbal substance means all or part of a plant or substance…
- high level disinfectant means a disinfectant that kills al…
- homoeopathic preparation means a preparation:
- homologous use: see regulation 3B.
- hospital grade disinfectant means a disinfectant that is r…
- household grade disinfectant means a disinfectant that is…
- immediate family of a person means:
- IN1 application means an application made under subsection…
- IN2 application means an application made under subsection…
- IN3 application means an application made under subsection…
- IN4 application means an application made under subsection…
- independent evaluation means an evaluation that is not bas…
- in-house IVD medical device has the same meaning as in the…
- IVD device means an IVD medical device:
- IVD medical device has the same meaning as in the Therapeu…
- joint replacement medical device has the same meaning as i…
- L(A)1 application means an application made under section…
- L(A)2 application means an application made under section…
- L(A)3 application means an application made under section…
- L(A)C1 (section 9D) request means a request under subsecti…
- L(A)C1 (section 23) application means an application made…
- L(A)C2 (section 9D) request means a request under subsecti…
- L(A)C2 (section 23) application means an application made…
- L(A)CN (section 9D) request means a request under subsecti…
- L(A)CN (section 23) application means an application made…
- master file means a technical master file or a plasma mast…
- medicinal cannabis products means therapeutic goods that c…
- mercury means elemental mercury (Hg(0), CAS No. 7439-97-6)…
- mercury-added products means the products listed in Part I…
- Minamata Convention means the Minamata Convention on Mercu…
- minimal manipulation: see regulation 3B.
- mother tincture means a preparation prepared by the proces…
- N1 application has the meaning given by Part 1 of Schedule…
- N2 application has the meaning given by Part 1 of Schedule…
- N3 application has the meaning given by Part 1 of Schedule…
- N4 application has the meaning given by Part 1 of Schedule…
- N5 application has the meaning given by Part 1 of Schedule…
- new dosage form medicine means a medicine that:
- new indications medicine means a prescription medicine that:
- new prescription medicine means a prescription medicine th…
- nicotine pouch means a therapeutic good of a kind specifie…
- nonconforming biological means a biological that is includ…
- non-Minamata mercury means any of the following:
- open shelf life, for therapeutic goods, means the time, af…
- original cells or tissues: see regulation 3B.
- OTC medicine means therapeutic goods mentioned in Part 3 o…
- overseas medical practitioner means a person who is regist…
- pharmaceutical benefit means a Commonwealth pharmaceutical…
- plasma master file means a plasma master file mentioned in…
- Poisons Standard has the same meaning as current Poisons S…
- Practice Guideline has the meaning given by paragraph 12AB…
- principal investigator, in relation to a clinical trial of…
- quarter means a period of 3 months commencing on 1 January…
- RCM1 application means an application made under section 2…
- RCM2 application means an application made under section 2…
- RCM3 application means an application made under section 2…
- RCM4 application means an application made under section 2…
- RCM5 application means an application made under section 2…
- RCMC1 (section 9D) request means a request made under subs…
- RCMC1 (section 23) application means an application made u…
- RCMC2 (section 9D) request means a request made under subs…
- RCMC2 (section 23) application means an application made u…
- RCMC3 (section 9D) request means a request made under subs…
- RCMC3 (section 23) application means an application made u…
- RCMC4 (section 9D) request means a request made under subs…
- RCMC4 (section 23) application means an application made u…
- Required Advisory Statements for Medicine Labels means the…
- serious, in relation to a form of a disease, condition, ai…
- specialist has the same meaning as in the Health Insurance…
- sporicide means a chemical agent that:
- sterilant means a chemical agent that kills microbes with…
- submission has the meaning given by subclause 1(2) in Part…
- technical master file means a technical master file mentio…
- TGA notifications process guidance document means Version…
- the Act means the Therapeutic Goods Act 1989.
- Therapeutic Goods Administration means that part of the De…
- therapeutic goods (priority applicant) determination has t…
- therapeutic vaping device has the same meaning as in the T…
- therapeutic vaping device accessory has the same meaning a…
- therapeutic vaping good means:
- therapeutic vaping kit means a kit, covered by subsection…
- therapeutic vaping pack means a primary pack that:
- therapeutic vaping substance means a therapeutic good that…
- therapeutic vaping substance accessory means a vaping acce…
- trade name, for therapeutic goods of a particular kind, me…
- traditional use, for a designated active ingredient, means…
- tuberculocide means a chemical agent that kills Mycobacter…
- turnover of therapeutic goods, for Division 1 (other than…
- unused emergency biological means a biological to which se…
- unused emergency goods means goods to which section 30G of…
- virucide means a chemical agent that renders a virus non-i…
changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.
Sourced from the Federal Register of Legislation at legislation.gov.au, © Commonwealth of Australia, licensed under CC BY 4.0. Compilations may have been reformatted.