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DRAFT: Uniform Recall Procedure for Therapeutic Goods

Consultation document

27 October 2015

Book pagination

Note: This information is part of the Consultation: Revised edition of the Uniform Recall Procedure for Therapeutic Goods

The Uniform Recall Procedure for Therapeutic Goods (URPTG) is prepared by the Therapeutic Goods Administration (TGA) for sponsors and other responsible entities undertaking market action because of an issue with therapeutic goods.

Follow this procedure to find out:

  • if your market action is a recall action or non-recall action
  • how to conduct a recall action.

The therapeutic goods industry and Commonwealth, state and territory health authorities have agreed to this procedure and the roles of the various participants.

The recall procedure applies to all therapeutic goods including:

  • goods in the ARTG
  • exempt therapeutic goods
  • cancelled or illegally supplied therapeutic goods.

This procedure is also applicable when the TGA orders an appropriate responsible entity (sponsor, supplier, importer) to conduct a mandatory recall. Civil and criminal penalties apply if you do not comply with a mandatory recall.

A collaborative process

Undertaking recall actions of therapeutic goods requires collaboration between many different participants:

Providing assistance

If you require assistance with the recall procedure, contact the Australian Recall Coordinator.

Documented procedures

Sponsors and manufacturers are expected to:

  • have their own documented recall action procedure that describes how a recall action will be initiated and carried out and is consistent with the URPTG
  • train relevant staff in this procedure.

The recall procedure

The Uniform Recall Procedure for Therapeutic Goods consists of thirteen steps.

The steps in the Recall Procedure

  1. Step 1 - Taking responsibility for a market action
  2. Step 2 - Immediate recall actions
  3. Step 3 - Nominating recall contacts
  4. Step 4 - Obtaining information
  5. Step 5 - Conducting a risk analysis
  6. Step 6 - Analysing the type, class and level of recall
  7. Step 7 - Developing a recall strategy
  8. Step 8 - Drafting your communication
  9. Step 9 - Contacting us
  10. Step 10 - Action by the TGA
  11. Step 11 - Implementing the communication and recall strategies
  12. Step 12 - Reporting on recall actions
  13. Step 13 - Reviewing the recall action

Version history

Version Description of change Author Effective date
V1.0 Publication for consultation Therapeutic Goods Administration 27 October 2015

Book pagination