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|
|Reference number||EMA/CHMP/509951/2006, Rev.1|
|Keywords||Conditional marketing authorisation|
|Description||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.|
In operation: 01/06/2016-present
|First version||Draft guideline||Published: 05/12/2006|