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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A marketing authorisation holder may decide to have their marketing authorisation withdrawn for various reasons.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 ...
Vaccine in short for Spikevax (Moderna) to prevent COVID-19
Vaccine in short for Comirnaty (BioNTech/Pfizer) to prevent COVID-19
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 ...
License holder registry
The license holder registry contains data about the location where the marketing authorisation holder may perform certain ...
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 ...