Australian regulatory guidelines for complementary medicines (ARGCM)
Version 6.0, October 2016
Mechanism for review of decisions made under the Act
Section 60 reviews
Initial decisions made under a provision of the Act by the Secretary of the Department of Health, or a delegate of the Secretary, can be reviewed under section 60 of the Act. This means that if a person’s interests are affected by the decision, they may seek reconsideration by the Minister. If a decision can be reviewed by the Minister, details of the appeal rights will usually accompany the decision. Appeals must be lodged within 90 days of decisions.
Examples of appealable decisions include:
- a refusal to register or list goods on the ARTG
- the variation or addition of conditions applying to a registration or listing
- suspension or cancellation of a registration or a listing
- revocation or suspension of a manufacturing licence.
An appeal letter should be clearly marked ‘Request for reconsideration under section 60 of the Therapeutic Goods Act 1989’ and sent to:
The Minister for Health
CANBERRA ACT 2600
The request should include supportive information for the Minister to consider. Under subsection 60(3A) of the Act, the Minister is not able to consider any information provided after the request is submitted. This is unless the additional information is provided in response to a request from the Minister or it is information that indicates that the quality, safety or efficacy of the relevant therapeutic goods is unacceptable. Information provided in support of your request should include:
- a copy of the decision to be reconsidered
- a specific description and reasons why parts of the decision are believed to be incorrect or in relation to which you object
- describe how your interests are affected by the decision.
The Assistant Minister may either personally deal with the request or send it to be dealt with by one of the Minister’s delegates within the Department.
The Administrative Appeals Tribunal (AAT)
If not satisfied with the outcome of a section 60 appeal, an application may be made to the Administrative Appeals Tribunal (AAT) for review. Applications to the AAT must be made within 28 calendar days of the Minister’s decision regarding a section 60 appeal.
Whereas the AAT provides a merit review process, affected parties may appeal at any time to the Federal Court on the grounds of the legality of a decision.