Uniform recall procedure for therapeutic goods (URPTG), 2004 edition
B. Stages of recall procedure
|Recall stage||See section|
Notification to the Co-ordinator Crisis management
This should be to the Australian Recall Co-ordinator.
Information Required to Assess Recall
Information on product, problem and distribution is required, (see also - The Medicine Problem Report Form, Medical Device Incident Report Form and Human Blood and Tissues Report Form at Appendices I, II and III).
Assessment of Recall
Liaison between sponsor and Australian Recall Co-ordinator to assess classification, level and strategy of recall.
Letters and advertisements are submitted by the sponsor to the Australian Recall Co-ordinator for approval before despatch.
Notification to the Federal Minister Responsible for Consumer Affairs
Where the recall is safety-related, there is a legal requirement to notify the Minister via the Product Safety Policy Unit, Australian Competition and Consumer Commission (ACCC).
Progress of Recall and Report
Progress reports are forwarded to the Australian Recall Co-ordinator.
The effectiveness of the recall is monitored by the Australian Recall Co-ordinator.