Guideline on the scientific application and the practical arrangements necessary to implement Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No ...

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberEMA/CHMP/509951/2006, Rev.1
Published07/03/2016
KeywordsConditional marketing authorisation
DescriptionThis guideline has been developed in order to provide advice on the scientific application and the practical arrangements necessary to implement the legal provisions on the conditional marketing authorisation, taking into account the experience gained so far.

Document history

Revision 1
Current version

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

In operation: 01/06/2016-present

Published: 07/03/2016

Published: 27/07/2015

First version PDF iconDraft guideline Published: 05/12/2006

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