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30 April 2007

EMEA and European Commission Publish Document to describe the Issue and Update of GMP Certificates

The European Medicines Agency EMEA and EU Commission's DG Enterprise and Industry Directorate have developed a document which describes the issue and update of GMP Certificates. The paper is part of the Compilation of Community Procedures on Inspections and Exchange of Information. The document is intended to give interpretation on aspects of responsibilities of the issue, renewal and update of GMP certificates. The issue of GMP certificates following an inspection of a manufacturer of IMPs is not defined. However, Member States may choose to do so.

GMP certificates are for the purpose of confirming to a manufacturer (whether for active substances or medicinal products) the overall conclusion of an inspection with respect to compliance with GMP. In some cases, particularly outside of the EEA, they may be used by applicants to support regulatory submissions. GMP certificates issued by EEA authorities are recognised within the framework of WHO and fulfil obligations under the Mutual Recognition Agreements. However, within the EEA they do not replace confirmation of the holding of a manufacturing authorisation.

For active substances, the supporting document in regulatory submissions is the declaration by the Qualified Person of the manufacturing authorisation holder that uses the active substance as a starting material.

Wolfgang Schmitt
On behalf of the European QP Association

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