Guidance for requesting review of regulation 5G, 5K or 5L decisions

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Version 1.1, January 2017

20 January 2017

Introduction

The purpose of this document is to provide:

  • information about the reconsideration by the Minister for Health (or a delegate of the Minister) of decisions made by the Secretary of the Department of Health or their delegate (the Secretary) which includes officers of the Australian Self Medication Industry (ASMI) and Complementary Medicines Australia (CMA) with the appropriate delegation under regulation 5M of the Therapeutic Goods Regulations 1990 (the TG Regulations); and
  • guidance on how to request a review of a decision of the Secretary by the Minister for Health (the Minister) under regulation 5M of the TG Regulations.

Note:

The Minister may either personally undertake a request for review of the Secretary's decision or delegate to an officer of the TGA with the appropriate delegation

Under regulation 5M, an applicant or approval holder who is dissatisfied with a decision of the Secretary made under the regulation 5G, 5K or 5L of the TG Regulations may request the Minister, in writing, to reconsider the Secretary's decision.

There is no timeframe prescribed in the TG Regulations within which the Minister (or the Minister's delegate) must make a decision upon reconsideration under regulation 5M.

Submitting a request for review of a decision of the Secretary under regulation 5M does not incur a fee.

Subject to the Administrative Appeals Tribunal Act 1975 (the AAT Act), if a person is dissatisfied with a decision of the Minister under regulation 5M, an application may be made to the Administrative Appeals Tribunal (AAT) for a review of the Minister's decision by the AAT.

Submitting an application to the AAT for review of the Minister's decision under regulation 5M may incur a fee. Refer to the Administrative Appeals Tribunal section in this document.

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