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Reviewable initial decisions under the Therapeutic Goods Act & Regulations
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Version 1.1, November 2016
8 November 2016
Therapeutic Goods Act 1989
Under section 60 a person whose interests are affected can seek a review of the following decisions of the Secretary or a delegate of the Secretary:
- under the definition of therapeutic devices in subsection 3(1), under subsection 7(1) (declaration of therapeutic goods) and under 41BD(3) (definition of medical device);
- subsection 7C(3) (decisions by computers);
- section 9C or 9D (inspection and variation of entries in the ARTG);
- section 9F (removal of entries from the Australian Register of Therapeutic Goods (ARTG))
- refusing to grant a consent under section 14 or 14A (standards);
- under Part 3-2 (registration and listing of therapeutic goods);
- under Part 3-2A (biologicals);
- under Part 3-3 (manufacturing of therapeutic goods);
- under Part 4-4 (conformity assessment certificates);
- under Part 4-5 (including medical devices in the ARTG), other than: a decision under section 41FH (selecting applications for auditing); or a decision about which aspects of the matters referred to in paragraphs 41FI(1) (a) and (b) to consider in auditing an application under Subdivision C of Division 1 of Part 4-5; or under Part 4-6 (suspension and cancellation of medical device from ARTG);
- under Part 4-7 (exempting medical devices from inclusion in the ARTG);
- under Part 4-8 (obtaining information in relation to medical devices);
- under Part 4-9 (public notification and recovery of medical devices);
- refusing to grant, or imposing conditions on a grant of, a consent for the purposes of section 41MA or 41MAA (non-compliance with essential principles); and
- section 42DF, 42DH or 42DI (in relation to restricted representations)
Therapeutic Goods Regulations 1990
Under regulation 48 a person whose interests are affected can seek a review of the following decisions of the Secretary or a delegate of the Secretary:
- subregulation 9(1) (orders about advertisements etc.);
- subregulation 10A(7) (cancellation where registration or listing transferred without notice);
- subregulation 10C(3), (4), (5) or (6) (assignment of registration or listing numbers);
- subregulation 10F(7) (cancellation of medical device where change of name without notice);
- subregulation 10H(9) (cancellation of biological where change of name without notice);
- subregulation 16J(3) (orphan drugs refusal);
- subregulation 22(8) (cancellation where licence transferred);
- subregulation 43AAH(4)(b) (refuse to waive the charge for the financial year)
- regulation 45 (waiver or reduction of fees); and
- regulation 45AA (payment of fees by instalments)
Under regulation 5M an applicant or approved holder who is dissatisfied can seek a review of the following decisions:
- regulation 5G (the granting of an advertising approval);
- regulation 5K (variation of conditions applying to such an approval); and
- regulation 5L (withdrawal of advertising approval)
Therapeutic Goods (Medical Devices) Regulation 2002
Under regulation 10.7 a person whose interests are affected can seek a review of the following decisions of the Secretary or a delegate of the Secretary:
- subregulation 4.10(2) (suspension/revocation of conformity assessment certificate where failure to advise Secretary);
- paragraph 9.4(2)(a) (conformity assessment fee - abridged assessment); and
- subregulation 9.5(1) (payment of assessment fee by instalments)
Version history
Version | Description of change | Author | Effective date |
---|---|---|---|
V1.0 | Original publication | Office of Regulatory Integrity | 7/09/2012 |
V1.1 | Update | Regulatory Pricing & Decision Review Section | 1/11/2016 |