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Information about cancellations requested by the sponsor - regulatory actions

25 July 2014

Effect of cancellation

Once the cancellation takes effect, the goods can no longer be imported, manufactured or exported from Australia by the sponsor unless the goods are otherwise exempt or approved under the Therapeutic Goods Act 1989 (the Act).

Revocation of a cancellation at the sponsor's request

Under the following sections of the Act, the person at whose request therapeutic goods were cancelled can, within 90 days of the day on which the goods were cancelled, request the Secretary to revoke that decision:

  • listed and registered therapeutic goods: section 30A
  • biologicals: section 32GD
  • medical devices: section 41GLA.

The Secretary can publish particulars of any decisions under sections 30A, 32GD and 41GLA of the Act to revoke a sponsor-initiated cancellation. Information about the revocation of a cancellation is shown in the database under 'Decision status'.

Review of a cancellation by delegate of Minister

Under section 60 of the Act, a person whose interests are affected by a decision of the Secretary to cancel the entry of therapeutic goods in the Australian Register of Therapeutic Goods (ARTG), can, within 90 days, request an internal review of the decision by the Minister for Health. Such a person can also seek a review by the Administrative Appeals Tribunal (AAT) of the decision by the Minister on the internal review.

The Secretary is required by the Act to publish particulars of any decision by the delegate of the Minister that revokes a decision to cancel a product from the ARTG. Information about any such reviews of a cancellation in the table are shown in the database under 'Decision status'.

Records of individual decisions

The database contains records of regulatory decisions that the Secretary is required under the Act to publish. In the event that a product is reinstated to the ARTG because of a decision by a delegate of the Minister to revoke the cancellation decision, the information about both the initial and review decision are required to remain available to the public. It is for this reason that particulars about both decisions will remain in the database.

If the cancellation decision is revoked by a delegate of the Secretary under section 30A, 32GD or 41GLA of the Act at the request of the relevant sponsor, information about both the cancellation decision and revocation decision will remain in the database.

To find out whether a product is currently authorised for supply in Australia, check the ARTG.