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 ...
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This 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.
Keywords: Conditional marketing authorisation
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Guideline on the scientific application and the practical arrangements necessary to implement Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling... (PDF/340.02 KB)
Adopted
First published: 07/03/2016
Last updated: 07/03/2016
EMA/CHMP/509951/2006, Rev.1 -
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Overview of comments received on 'Guideline on the scientific application and the practical arrangements necessary to implement Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medici... (PDF/972.14 KB)
First published: 07/03/2016
Last updated: 07/03/2016
EMA/647097/2015 -
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Draft 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 with... (PDF/163.94 KB)
Draft: consultation closed
First published: 27/07/2015
Last updated: 27/07/2015
Consultation dates: 27/07/2015 to 30/09/2015
EMA/CHMP/509951/2006 Rev. 1