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Question and answer document concerning changes not covered by the Variation Regulation 1234/2008 (as amended by Regulation 712/2012)

Policy document | 05-10-2018

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 ...

Publication | 01-10-2018

MEB 8: Guideline on the excipients in the label and the package leaflet of medicinal products for human use

Policy document | 11-09-2018

Overview of proposed withdrawals

At the request of the marketing authorisation holder, the Medicines Evaluation Board (MEB) can withdraw the marketing ...

Publication | 02-07-2018

Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I)

Directive | 18-06-2018

Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I) - Duplex with supplementary conditions

Directive | 18-06-2018

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 ...

Policy document | 18-06-2018

The MEB: Good medicines used better (short version)

Video | 13-06-2018

The MEB: Good medicines used better (long version)

Video | 13-06-2018

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 ...

Policy document | 11-06-2018