Documents - Marketing authorisation medicines for human use
49 documents Marketing authorisation medicines for human use
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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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Questions and answers about Compassionate Use Programme
In the MEB49 policy document, we set out the policy for the Compassionate Use Programme (CUP). We have provided answers to ...
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Questions and answers about the timeslot tool
For a number of procedures for human medicines (including herbal medicines and homeopathic medicines), the MEB has a tool ...
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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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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 ...
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Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I) - Duplex with supplementary conditions
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MEB 16: Duplex marketing authorisation
A duplex marketing authorisation is a marketing authorisation for a product of which the dossier is identical to that of a ...
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Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I)
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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 ...