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DRAFT: Uniform Recall Procedure for Therapeutic Goods
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:
- state and territory Recall Coordinators
- wholesalers and distributors
- health professionals
- ACCC (for goods that are also consumer goods).
If you require assistance with the recall procedure, contact the Australian Recall Coordinator.
- 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
- Step 1 - Taking responsibility for a market action
- Step 2 - Immediate recall actions
- Step 3 - Nominating recall contacts
- Step 4 - Obtaining information
- Step 5 - Conducting a risk analysis
- Step 6 - Analysing the type, class and level of recall
- Step 7 - Developing a recall strategy
- Step 8 - Drafting your communication
- Step 9 - Contacting us
- Step 10 - Action by the TGA
- Step 11 - Implementing the communication and recall strategies
- Step 12 - Reporting on recall actions
- Step 13 - Reviewing the recall action
|Version||Description of change||Author||Effective date|
|V1.0||Publication for consultation||Therapeutic Goods Administration||27 October 2015|