265 documents
License holder registry
The license holder registry contains data about the location where the marketing authorisation holder may perform certain ...
Product types and fees, veterinary
Question and answer document concerning changes not covered by the Variation Regulation 1234/2008 (as amended by Regulation 712/2012)
Letter to stakeholders regarding the implementation of safety features under the Falsified Medicines Directive 2011/62/EU
The delegated Regulation on the characteristics of the safety features and the new medicine verification system will apply as of ...
Overview of proposed withdrawals
At the request of the marketing authorisation holder, the Medicines Evaluation Board (MEB) can withdraw the marketing ...
Overview of approved compassionate use programmes
The MEB can give permission for bringing a medicinal product on the market that has not (yet) been granted a marketing ...
Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I)
Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I) - Duplex with supplementary conditions
MEB 16: Duplex marketing authorisation
A duplex marketing authorisation is a marketing authorisation for a product of which the dossier is identical to that of a ...