Documents

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 ...

Policy document | 05-08-2025

MEB 5: Package leaflet of pharmaceutical products

This policy document explains the policy regarding the package leaflet of pharmaceutical products in the Netherlands. Download ...

Policy document | 22-07-2025

Request form for permission to carry out tests with additives for animal feed: explanatory notes for completing the electronic application form

Form | 02-06-2025

License holder registry

The license holder registry contains data about the location where the marketing authorisation holder may perform certain ...

Publication | 01-06-2025

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 ...

Policy document | 28-05-2025

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), ...

Publication | 19-05-2025

Presentations & documents MEB Science Day 2025

Publication | 19-05-2025

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 ...

Publication | 14-05-2025

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 ...

Policy document | 17-04-2025

Question and answer document pertaining to variations for medicines for human use

Policy document | 06-02-2025