Reviewable initial decisions under the Therapeutic Goods Act & Regulations

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