Decisions to withdraw medicines advertising approval

15 November 2017

Medicines advertisements in television, radio, newspapers, magazines and other specified media require approval prior to broadcast or publication.

Applications for advertising pre-approval are considered under Regulation 5G of the Therapeutic Goods Regulations 1990 (Regulations) with responsibility for deciding applications delegated to industry associations – the Australian Self-Medication Industry (ASMI) and Complementary Healthcare Council of Australia (CHC).

Regulation 5L of the Regulations allows for the withdrawal of advertising approval for the following reasons:

  • where the information provided with the application was false or incorrect
  • the person has contravened section42 C of the Therapeutic Goods Act 1989 (Act) in relation to the Advertisement
  • where there has been a breach of a condition of approval
  • because a change to the facts or circumstances existing when the advertisement was approved means that the advertisement no longer complies with the Therapeutic Goods Advertising Code (Code)
  • because a change to the Therapeutic Goods Advertising Code means that the advertisement no longer complies with the Code
  • after recommendation of the Complaints Resolution Panel (Panel) following a complaint to the Panel

Effect of withdrawal

Once advertising approval has been withdrawn, the advertisement can no longer be published or broadcast in specified media.

Review of withdrawal by a delegate of the Minister

Under regulation 5M of the Therapeutic Goods Regulations 1990, the applicant or approval holder who is dissatisfied with a decision of the Secretary that is made under regulation 5L can, within 30 days, request an internal review of the decision by the Minister for Health. The applicant or approval holder can also seek a review by the Administrative Appeals Tribunal (AAT) of the decision by the Minister on the internal review.

The decision made under regulation 5L remains in effect unless and until it is revoked or revoked and substituted by the Minister as a result of a request for reconsideration under regulation 5M of the Regulations or is set aside, varied or remitted by the AAT or is otherwise overturned or stayed.

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Notices of withdrawn advertising approvals

Below is a list of advertisements where advertising approval has been withdrawn following investigation by the TGA.

Displaying 1 - 1 of 1

Ease-a-cold Cough Cold & Flu Day & Night

ARTG No.: 194706

Date of effect: 11 Oct 2017

Sponsor: Pharmacare Laboratories Pty Ltd

Approval number: ASMI26278-0516

Because of a change to the facts or circumstances existing when the advertisement was approved, the advertisement no longer complies with the Therapeutic Goods Advertising Code.