Documents - Marketing authorisation medicines for human use
50 documents Marketing authorisation medicines for human use
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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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Template briefing book national scientific advice
Use this template briefing book to submit relevant information when requesting national scientific advice.
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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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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 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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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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MEB 21: Statement of ‘abbreviated indications’ on OTC medicinal product packaging
Directive 2001/83/EC discusses European regulations on labelling. In accordance with Article 54(n), the outer packaging of ...
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Question and answer document pertaining to variations for medicines for human use
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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 ...