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Guidance for requesting reconsideration of an initial decision

Version 2.1, January 2017

20 January 2017

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Administrative Appeals Tribunal

Introduction

The Administrative Appeals Tribunal (AAT) is a Commonwealth administrative body that reviews a wide range of decisions made by Australian Government ministers, departments, agencies and some other tribunals. The AAT takes a fresh look at a decision and, based on all the evidence before the AAT, decides the 'best or preferable decision' in the circumstances.

Notification of a decision upon reconsideration

Under the Therapeutic Goods Act, the Therapeutic Goods Regulations and the Medical Devices Regulations, where written notice of the decision by the Minister upon reconsideration is given to a person whose interests are affected and that person is dissatisfied with the Minister's decision, they can, subject to the Administrative Appeals Tribunal Act 1975 (the AAT Act), make an application to the AAT for review of the Minister's decision.

Application for review of a decision

Under the AAT Act, an application to the AAT for review of a decision upon reconsideration must be made in writing within 28 days commencing on the day on which the decision upon reconsideration is made, otherwise an extension of time must be sought from the AAT.

Applicants should complete the AAT online form Application for Review of Decision (Organisation) and submit the form via email to <> or by regular mail to 'Administrative Appeals Tribunal, GPO Box 9955 in your capital city' or by facsimile. For more information or assistance, refer to the AAT website or contact the AAT on 1800 228 333.

Submitting an application to the AAT for review of a decision upon reconsideration may incur a fee. Further information about AAT application fees is available on the AAT website).

The AAT notifies the Minister as the person on whose behalf the decision upon reconsideration was made (the respondent) that an application has been received requesting review of a decision upon reconsideration made by the respondent. The respondent must then lodge a statement of reasons for the decision upon reconsideration and all documents relevant to the AAT's review of the decision upon reconsideration within 28 days of receiving the notice. These documents are referred to as 'Tribunal Documents' ('T Documents').

Note:

After an application for review of a decision upon reconsideration is made to the AAT, the TGA is unable to alter the decision upon reconsideration by variation of the decision upon reconsideration, setting aside the decision upon reconsideration or setting aside a decision upon reconsideration and making a new decision upon reconsideration in substitution for the decision upon reconsideration set aside unless the applicant and the Tribunal consent to the making of the alteration. Such an agreement refers to consent orders under section 42C of the AAT Act.

Shortly after the T Documents are lodged, a conference is conducted by an AAT member or Conference Registrar with both parties present. The conference aims to identify issues in dispute, to negotiate a settlement of the case or, if settlement is not possible, to prepare a matter for hearing. Normally a timetable is set by the AAT for the parties to file any additional evidence in support of their case.

Once both parties have filed their evidence, it is possible that if the parties and the AAT agree, the matter can proceed to mediation. However, this is a voluntary process to be agreed by both parties. At mediation, the parties can negotiate a settlement of their case with the help of the neutral third party (the AAT). The mediator does not decide the dispute or tell the parties what to do, but helps the parties to reach an agreement. If an agreement is not reached after mediation (or alternatively if mediation is not undertaken and the matter is not resolved after a conference) the matter proceeds to a hearing. At the hearing, parties and witnesses will appear before an AAT member or members to present their case. AAT hearings are usually open to the public. At the end of the hearing, the AAT will either give its review decision immediately or will reserve its review decision, which will be provided at a later date. The review decision may be published.

Section 60A - new information on review - discretion to remit

Where a decision upon reconsideration is made by the Minister in relation to an initial decision made under section 25, section 32DF, section 32DG or section 41EC of the Therapeutic Goods Act and a person whose interests are affected by the Minister's decision applies to the AAT for review of that decision and lodges 'initial new' or 'later new' information (or both) in support of that application, the AAT may if the AAT thinks fit, remit the matter to the Secretary for a fresh (initial) decision.

Note:

A person whose interests are affected by a decision upon reconsideration made by the Minister in relation to an initial decision made by the Secretary under section 25, section 32DF, section 32DG or section 41EC of the Act, is under the Act, obliged to pay the applicable evaluation fee or conformity assessment fee as if it is a new application, before the application can be considered.

Under the Therapeutic Goods Act, 'initial new' information means information that was in existence at the time the Secretary made the initial decision under section 25, section 32DF, section 32DG or section 41EC of the Therapeutic Goods Act, or at the time the Minister made the decision upon reconsideration but was not made available to the Secretary for the purpose of making the initial decision or was not made available to the Minister for the purpose of making the decision upon reconsideration and is information that is relevant to the making of either of those decisions.

Under the Therapeutic Goods Act, 'later new' information means information that was in existence at the time the Minister made the decision upon reconsideration in relation to an initial decision made by the Secretary under section 25, section 32DF, section 32DG or section 41EC of the Act, but was not made available to the Minister for the purpose of making the decision upon reconsideration and is information that is relevant to the making of that decision.

If the AAT decides to remit the matter to the Secretary and the person whose interests are affected has paid a further evaluation or conformity assessment fee as required under the Therapeutic Goods Act, the Secretary must make a fresh (initial) decision under section 25, section 32DF, section 32DG or section 41EC taking into account the 'initial new' or 'later new' information, as if a fresh application had been made.

If the AAT decides not to remit the matter to the Secretary, where a person whose interests are affected by a decision upon reconsideration made by the Minister applies to the AAT for review of that decision upon reconsideration and lodges 'initial new' or 'later new' information (or both) in support of that application, the AAT cannot consider any 'initial new' information not considered by the Minister or 'later new' information except where the 'initial new' or 'later new' information lodged indicates that the quality, safety or efficacy of the therapeutic goods is unacceptable.

The AAT cannot remit the matter to the Secretary for a fresh (initial) decision where a person lodges only 'initial new' information (not 'later new' information) to the AAT in support of their application, which was not already considered by the Minister.

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