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Australian regulatory guidelines for OTC medicines (ARGOM) (Nov 2012)

Version 1.4

9 November 2012

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7. Review of decisions

The current Australian Regulatory Guidelines for Over-the-counter Medicines (ARGOM) is being reviewed and updated by the TGA.

Selected chapters have been removed and replaced with references to the appendices. This document will remain as the guidance document until it can be fully replaced by the updated ARGOM, i.e. chapters such as Chapter 2, 3, 7, 8, 10 and 11 will remain in effect until such time it is replaced.

The Medicines Evaluation Committee - 'opportunity to be heard'

Where an application is under evaluation by the MEC and it appears that rejection is to be recommended, the committee has established a procedure whereby the sponsor is invited to appear at a committee meeting and present a submission in support of the application.

This is not a formal appeal mechanism but is simply a means of ensuring that you have an opportunity to personally present a case to the committee. It has no bearing on any subsequent right of appeal to the Minister or Administrative Appeals Tribunal if the application is rejected.

If your application is formally rejected by the TGA you will be sent a letter from the Delegate of the Secretary informing you of the decision and setting out the reasons for the rejection. If you wish to have this decision reviewed, a number of procedures are available (section 60 of the Act refers).

Reconsideration by the Minister

In the first instance you may write to the Minister, within 90 (calendar) days of receiving the rejection letter, requesting a reconsideration of the decision to reject the application. Directions on how to proceed will be given in the rejection letter. The decision is generally reviewed by a delegate of the Minister, usually a senior officer of the TGA other than the officer who made the initial decision.

After the decision has been reviewed, you will be given a statement of the outcome and, if the decision is confirmed, advice on further options available to you. The delegate of the Minister may confirm the initial decision or revoke it and substitute another decision in its place. If you do not receive notice of the review of the decision within 60 (calendar) days of your request it is taken that the initial decision is confirmed.

The Administrative Appeals Tribunal

If you are dissatisfied with the results of the reconsideration you may then make an appeal to the Administrative Appeals Tribunal for a review of the decision.

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