Cancellations

Database for cancellations

The TGA maintains a database listing all cancellations from the Australian Register of Therapeutic Goods (ARTG) based on the different circumstances in which the cancellation occurs and the kind of therapeutic goods involved.

Cancellations and suspensions

About cancellations

Medicines

• Complementary medicines: Cancellations from the ARTG 
  Following a review by the TGA, complementary medicines can be cancelled from the ARTG by the Secretary
• Registered medicines: Cancellations from the ARTG 
  Following a review by the TGA, registered medicines, including both prescription and over-the counter medicines, can be cancelled from the ARTG by the Secretary

Medical devices

• Medical devices and IVDs: Cancellations from the ARTG
  Following a review by the TGA, medical device entries (including IVDs) can be cancelled from the ARTG by the Secretary
• Medical devices and IVDs: Cancellations of certain devices within an entry
  The Secretary can cancel some devices covered by an ARTG entry

Sponsor-initiated cancellations

• Cancellations requested by the sponsor - regulatory actions
  Therapeutic goods can be cancelled at the request of the sponsor
• Cancellations by sponsors dataset

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

Effect of cancellation

Once cancelled, the therapeutic good can no longer be imported, manufactured or exported from Australia by the sponsor, unless they are otherwise exempt or approved under the Therapeutic Goods Act 1989 (the Act).

Review of a cancellation by a delegate of the 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 from the ARTG, can, within 90 days, request an internal review of the decision by the Minister for Health. 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 under the Act to publish particulars of any decision by the delegate of the Minister that overturns a decision to cancel a product from the ARTG. Information about any such reviews of a cancellation is shown in the relevant 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 details about both decisions will remain in the Cancellations and suspensions database.