Documents - Marketing authorisation medicines for human use
53 documents Marketing authorisation medicines for human use
Product types and fees
The list of product types indicates the various product types handled by the MEB. The choice of the product type determines the ...
MEB 14: Parallel importation: marketing authorisation and maintenance
Parallel import is the importation – and subsequent marketing in the Netherlands – of a medicinal product authorised elsewhere in ...
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 ...
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 ...
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 ...
MEB 44: Direct Healthcare Professional Communications (DHPCs)
This document is based on the Guideline on Good Pharmacovigilance Practices (GVP) Module XV – Safety communication, and is aimed ...
GS-list 15
The list of active substances in products that may qualify for sale general sale (GS list) was updated by the MEB on 30 May 2018. ...