Guidance for requesting reconsideration of an initial decision

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Version 2.1, January 2017

20 January 2017

Introduction

The purpose of this document is to provide:

Under section 60 of the Therapeutic Goods Act, a person whose interests are affected by an initial decision made under the Act may, by notice in writing given to the Minister, request the Minister to reconsider the initial decision.

Under regulation 48 of the Therapeutic Goods Regulations, a person whose interests are affected by an initial decision made under the Regulations may, by notice in writing given to the Minister, request the Minister to reconsider the initial decision.

Under regulation 10.7 of the Medical Devices Regulations, a person whose interests are affected by an initial decision made under the Medical Devices Regulations may, by notice in writing given to the Minister, request the Minister to reconsider the initial decision.

Submitting a request for reconsideration of an initial decision does not incur a fee.

Subject to the Administrative Appeals Tribunal Act 1975 (the AAT Act), if a person is dissatisfied with a reconsideration decision made by the Minister, 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 a decision upon reconsideration may incur a fee. Refer to the Administrative Appeals Tribunal section in this document.

Reviewable initial decisions

Only 'reviewable' initial decisions can be reconsidered by the Minister.

An initial decision made by the Secretary that is not specifically identified as a 'reviewable' initial decision, cannot be reconsidered under section 60 of the Therapeutic Goods Act, regulation 48 of the Therapeutic Goods Regulations or regulation 10.7 of the Medical Devices Regulations. A summary of reviewable initial decisions under the Act and Regulations are published on the TGA website.

The following are some examples which are not considered to be an initial decision:

  • TGA advice to an applicant that an application made by the applicant was 'not effective' because the application fee had not been paid
  • a proposal by the TGA to cancel an entry on the Australian Register of Therapeutic Goods (ARTG) (though the decision to cancel is an initial decision)
  • informing an applicant that an application had not been made in accordance with statutory requirements (including that the information necessary to allow the application to be evaluated, had not been provided).

These examples are not initial decisions because no 'decision' has been made by the Secretary by exercising their discretion under the Therapeutic Goods Act, the Therapeutic Goods Regulations or the Medical Devices Regulations. The outcome, such as, 'the application is not effective' is the outcome of ensuring compliance with legislation has occurred (i.e. the operation of the Therapeutic Goods Act itself).

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