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The Approval Process

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Appeals

REVIEW OF A DECISION OF THE SECRETARY TO APPROVE OR REFUSE TO APPROVE AN ADVERTISEMENT.

(In accordance with Part 2, Division 2 of the Therapeutic Goods Regulations).

A n applicant or approval holder (as defined in the Therapeutic Goods Regulations), who is dissatisfied with a decision of the Secretary to approve, disapprove, vary the conditions of approval or withdraw approval may, within 30 days of notification of the Secretary's decision, request, in writing, the Minister for Health and Aged Care to review the decision.

Requests should be headed “REVIEW UNDER REGULATION 5M OF THE THERAPEUTIC GOODS REGULATIONS” and sent to the following address:

Attn: The Assistant Minister for Health
        Parliament House
        Canberra ACT 2600

At the same time as writing to the Assistant Minister, a copy of the request must be forwarded to the Therapeutic Goods Advertising Code Council (TGACC), addressed to:

Attn: The Secretariat
        Therapeutic Goods Advertising Code Council
        Level 13 Macquarie House
        167 Macquarie Street
        Sydney NSW 2000
        Phone: 02 8667 3026 or 02 8667 3025

The Executive Officer must notify the complainant, the respective Advertising Services Manager and the Secretary of receipt or the request and the date of the meeting of the TGACC at which the matter will be considered.

The TGACC, at the conclusion of its deliberations may recommend to the Assistant Minister, that the Secretary's decision be:

  1. confirmed or;
  2. revoked and substituted with another decision [including a decision to impose conditions].

The TGACC will advise the Assistant Minister, in writing, of the recommendation within 5 working days following its deliberation.

As soon as practicable after receiving the TGACC recommendation the Assistant Minister must take into account this recommendation and then make his or her decision to confirm, revoke or substitute the Secretary's decision. The Assistant Minister will then notify, in writing, the applicant or approval holder and the TGACC, outlining the decision and rationale for that decision and any conditions that apply and if the Assistant Minister does not accept a recommendation of the TGACC or CRP, the Assistant Minister must notify the applicant or approval holder of the fact.

Until the Minister makes a decision, the decision of the Secretary is not affected.

The Assistant Minister either may deal with the review personally or send it to be dealt with by one of the Minister's delegates with the Commonwealth Department of Health and Aged Care. If the applicant or approval holder is dissatisfied with the result of the review then, subject to the Administrative Appeals Tribunal Act 1975 , the applicant or approval holder may appeal to the Administrative Appeals Tribunal (AAT) for review of the Assistant Minister's / delegate's decision.