Documents - Marketing authorisation medicines for human use
46 documents Marketing authorisation medicines for human use
Question and answer document pertaining to variations for medicines for human use
Withdrawal of marketing authorisation at the request of the marketing authorisation holder
A marketing authorisation holder may decide to have their marketing authorisation withdrawn for various reasons. After completing ...
Pictograms from the Positive list for medicine packages
The MEB makes the following set of pictograms, including the established accompanying text, available for use on the medicine ...
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 5: Package leaflet of pharmaceutical products
This policy document explains the policy regarding the package leaflet of pharmaceutical products in the Netherlands. Download ...
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 ...
MEB 43: Two-round assessment policy for national procedures
Limiting the number of assessment rounds ensures that the (legally) stipulated time within which the MEB must make a decision ...
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 ...
Declaration for the package leaflet of parallel imported products
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 ...