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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 ...
MEB 8: Guideline on the excipients in the label and the package leaflet of medicinal products for human use
Overview of proposed withdrawals
At the request of the marketing authorisation holder, the Medicines Evaluation Board (MEB) can withdraw the 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 ...
The MEB: Good medicines used better (short version)
The MEB: Good medicines used better (long version)
MEB 45: National implementation of additional risk minimisation measures
An important element of a risk management plan (RMP) is a clear description of the necessary measures in order to minimise the ...