Documents - Marketing authorisation medicines for human use
46 documents Marketing authorisation medicines for human use
Parallel import comparison form
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 ...
MEB 42: Renewal of medicinal products for human use authorised through the national procedure
The MEB decides whether to renew the marketing authorisation for each product authorised through the national procedure.
MEB 45: National implementation of additional risk minimisation measures
An important element of a risk management plan (RMP) is a clear description of the necessary measures in order to minimise the ...
Question and answer document concerning changes not covered by the Variation Regulation 1234/2008 (as amended by Regulation 712/2012)
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A marketing authorisation holder may decide to have their marketing authorisation withdrawn for various reasons.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 ...