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 ...

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

Current effective version

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...

AdoptedReference Number: EMA/CHMP/509951/2006, Rev.1Summary:

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.

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...

Reference Number: EMA/647097/2015

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...

Draft: consultation closedConsultation dates: 27/07/2015 to 30/09/2015Reference Number: EMA/CHMP/509951/2006 Rev. 1Summary:

This draft guideline has been updated in order to reflect the experiences accumulated with conditional marketing authorisations and is therefore released for repeated public consultation.

Document history

Draft 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 f...

Draft: consultation closedReference Number: EMEA/509951/2006