Documents - Marketing authorisation medicines for human use
46 documents Marketing authorisation medicines for human use
- Date
- Relevance
-
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A marketing authorisation holder may decide to have their marketing authorisation withdrawn for various reasons.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 ...