Documents - Marketing authorisation medicines for human use
51 documents Marketing authorisation medicines for human use
Explanation of the Interest Form - MEB-ZIN Parallel Procedures pilot
Accelerating patient access to reimbursable innovative medicines has been on the wish list of the government, patient ...
List of patient-friendly terms for the package leaflet
In order to optimise the readability of the package leaflet, the MEB has revised the list of patient-friendly terms. The list has ...
MEB 13: Nomenclature of pharmaceutical products
This document describes the requirements which the marketing authorisation holder has to fulfil when submitting a proposal for a ...
MEB 21: Statement of ‘abbreviated indications’ on OTC medicinal product packaging
Directive 2001/83/EC discusses European regulations on labelling. In accordance with Article 54(n), the outer packaging of ...
Declaration on modification of information in the printed SmPC and package leaflet pertaining to patented indications
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 ...
Scientific advice during the development of a medicinal product
The MEB can provide scientific advice and contributes with this advice to the development of medicines. See the leaflet for ...
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 ...