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24 March 2006

EMEA:
GMP Information for QP Compliance with the requirements of the Marketing Authorisation

A batch of medicinal product that does not comply with the requirements of the marketing authorisation cannot lawfully be released for sale. From time to time a Qualified Person (QP) can be faced with a batch of product that does not fully comply with all the details described in the authorised marketing authorisation dossier. The competent authorities have been considering whether or not a QP is able to certify such batches, as required in Art. 55(3)/51(3) of Directive 2001/82(3)/EC, thereby allowing them to be released for sale. A reflection paper is hereby published, which is intended to clarify, in the circumstances described, whether a batch complies with the requirements of the marketing authorisation or not. The paper describes certain conditions that must be met. It is hoped that this paper will be helpful in dealing with a large proportion of cases where there has been some uncertainty in the past. Cases of non-compliance outside the scope of this paper must continue to be dealt with by following the relevant national procedures.

The European Commission has signalled its possible future support for a corresponding amendment to Annex 16 of the GMP Guide (Certification by a Qualified Person and Batch Release). This will partly depend on feedback from the industry on the practical implementation of the details in this reflection paper. EMEA is presently considering, together with the Commission, how this feedback should be collected and further information on this will be provided in the coming months.

Read the reflection paper for further information.

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