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GS1 Recallnet Healthcare and the TGA

3 December 2013

The Therapeutic Goods Administration (TGA) wishes to clarify that it is not a requirement for sponsors of therapeutic goods in Australia to join GS1 Recallnet Healthcare to undertake recall actions. This clarification has been issued to address any industry confusion about GS1 Recallnet Healthcare and the way recalls of therapeutic goods will be undertaken in the future.

GS1 Recallnet Healthcare provides sponsors with an alternative method for notifying the TGA of recall actions and communicating with customers who have been supplied defective products.

The TGA has contributed to the development of GS1 Recallnet Healthcare through the provision of advice to GS1 Australia on the requirements and procedures outlined in the Uniform Recall Procedures for Therapeutic Goods (URPTG), which still apply.

Further, the TGA has agreed that a signed electronic copy of an approved recall letter can be distributed to customers through GS1 Recallnet Healthcare, subject to the ability to confirm receipt.

The TGA will continue to:

  • receive sponsors' notifications regarding proposed recall actions
  • classify proposed recall action
  • approve the recall strategy and correspondence
  • include the approved recall in the System for Australian Recall Actions
  • monitor the implementation and effectiveness of the recall action.

TGA's role in recalls of therapeutic goods

Recalls are undertaken to remove or mitigate the exposure of the public to potentially unsafe therapeutic products.

A recall action is a market action taken to resolve a problem with the safety, quality, efficacy or performance of a therapeutic good already being supplied in Australia. A recall action may also be undertaken for precautionary reasons.

It is a requirement for sponsors of therapeutic good to notify the TGA (the Recalls Unit via telephone 02 6232 8935 or email as soon as they become aware of a deficient or potentially deficient therapeutic good for which they are responsible.

Sponsors are also required to submit certain information to assure the TGA that any risks associated with the product are effectively mitigated. This includes provision of a risk assessment and, where relevant, the manufacturer's hazard assessment. The TGA reviews this material and the sponsor's proposed recall strategy and associated communication. A clinical assessment may also be undertaken. The TGA approves the proposed recall strategy and communication where it is considered to be acceptable.

The TGA also monitors the recall action process undertaken by sponsors to ensure that it is carried out effectively and in a timely manner and that appropriate corrective actions have been put in place to reduce the likelihood of the same issue recurring.