Documents - Marketing authorisation medicines for human use
46 documents Marketing authorisation medicines for human use
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Terms and conditions for package fee and reduced fee for copy DCP application - human products
The term package fee entails that a group of products (each with an individual RVG number) is only billed once at the tariff ...
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Parallel import comparison form
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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 ...
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GS-list 21
The list of active substances in products that may qualify for sale general sale (GS list) was updated by the MEB on 20 October ...
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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.
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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 ...
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Question and answer document concerning changes not covered by the Variation Regulation 1234/2008 (as amended by Regulation 712/2012)
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Question and answer document pertaining to variations for medicines for human use
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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A marketing authorisation holder may decide to have their marketing authorisation withdrawn for various reasons.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 ...
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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 ...