Documents
205 documents
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Request form for permission to carry out tests with additives for animal feed: explanatory notes for completing the electronic application form
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License holder registry
The license holder registry contains data about the location where the marketing authorisation holder may perform certain ...
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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 Science Policy 2025 - 2029 (ENG)
This science policy is a further elaboration of the strategic directions set out in the Strategic Business Plan 2024-2028 (SBP), ...
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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 ...