Documents - Marketing authorisation medicines for human use
47 documents Marketing authorisation medicines for human use
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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 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A marketing authorisation holder may decide to have their marketing authorisation withdrawn for various reasons.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 ...
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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 ...
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MEB 5: Package leaflet of pharmaceutical products
This policy document explains the policy regarding the package leaflet of pharmaceutical products in the Netherlands. Download ...
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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 ...
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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 ...