Documents - Marketing authorisation medicines for human use
50 documents Marketing authorisation medicines for human use
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 6: Labelling of pharmaceutical products
The presentation of the primary and secondary packaging of a medicinal product are determining factors in the recognition of a ...
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 ...
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 ...
Declaration for the package leaflet of parallel imported products
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 ...
GS-list 16
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. ...
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 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 ...