15.05.2015

EMA releases revision 18 of the Dossier requirements for Centrally Authorised Products

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The European Medicines Agency (EMA) has released a new revision 18 of the "Dossier requirements for Centrally Authorised Products (CAPs)".

Revision 18, dated 08 May 2015 can be downloaded from EMA and contains the following notable changes:

  • France accepts now submissions for CAPs via CESP - no separate CD is required any longer
  • CHMP Co-opted Member Jean-Lois Robert (Luxembourg): Separate submission is no longer required
  • All Committee Members: For members where a separate submission is not required, the corresponding dossier delivery address has been removed and replaced by "N/A" for clarity.

Revision 18 contains no updates regarding Member States using the Common Repository (background: usage of the Common Repository for CAPs will become mandatory for all National Competent Authorites on 1st July 2015).


[Source: EMA]

 

 

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