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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.
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