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Uniform recall procedure for therapeutic goods (URPTG), 2004 edition
K. Follow-up action
The follow-up action consists of a check on the effectiveness of the recall and an investigation of the reason for the recall and remedial action taken to prevent a recurrence of the problem.
Check on effectiveness of recall action
The Australian Recall Co-ordinator examines the reports received from the sponsor and an assessment made of the effectiveness of recall action. Recall records may be inspected by TGA and in some cases the records may be audited by the ACCC in the company of TGA.
Investigation of the reasons for recall and initiation of remedial action
On completion of a recall, the sponsor is requested to provide details of the remedial action proposed to prevent a recurrence of the problem which gave rise to the recall (Section H). Where the nature of the problem and appropriate remedial action are not apparent, investigation and in some cases Good Manufacturing Practice audits may be necessary.
It is required under the Therapeutic Goods Act 1989 that therapeutic goods made overseas for supply in Australia shall be subject to levels of good manufacturing practice equivalent to those expected for similar products manufactured in Australia.
Appropriate follow-up action will be taken by the Therapeutic Goods Administration where indicated; this might include, for example, review of the product by the relevant Product Regulator of the Therapeutic Goods Administration.
Where a recall is initiated following a report submitted by a party from outside the Commonwealth or the State/Territory health authorities, the reporter is to be provided, on request, with an outline of the results of investigations and a summary of the recall.