EMEA Facilitates Proposal to Establish a Harmonised Format for IMP Batch Release Certification

GMP News
28 June 2007
 

EMEA Facilitates Proposal to Establish a Harmonised Format
for IMP Batch Release Certification

 
In order to facilitate the free movement of investigational medicinal products (IMPs) used in clinical trials taking place in more than one Member State a harmonised format for the contents of the certificate was proposed. EMEA is consulting on behalf of the European Commission on this proposal to establish a harmonised format for the batch release certification referred to in article 13.3 of Directive 2001/20/EC.

According to the directive a batch of investigational medicinal product shall not have to undergo further checks in relation to the provisions of article 13.3(a), (b) or (c) of the same directive when it moves between Member States accompanied by batch certification signed by the Qualified Person. The proposal is intended therefore to facilitate the free movement of IMPs.

The explanatory note on the front of the draft document provides further details. It is proposed that the format, once agreed, be included within Volume 10 of Eudralex.

The complete document is available at the EMEA website.

Comments should be sent to GMP@emea.europa.eu by 31 August 2007.
 

Learn more about the important interfaces between GMP and GCP - in the ECA Education Course "The Management of Clinical Trials - GMP meets GCP" in Berlin, Germany, from 15-16 November 2007.

 
Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
 

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