Documents - Marketing authorisation medicines for human use

46 documents Marketing authorisation medicines for human use

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Product types and fees

The list of product types indicates the various product types handled by the MEB. The choice of the product type determines the ...

Publication | 16-09-2021

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 ...

Policy document | 06-04-2021

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 ...

Policy document | 10-03-2021

GS-list 18

The list of active substances in products that may qualify for sale general sale (GS list) was updated by the MEB on 22 October ...

Policy document | 22-10-2020

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 | 01-09-2020

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 ...

Policy document | 01-08-2020

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A marketing authorisation holder may decide to have their marketing authorisation withdrawn for various reasons.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 ...

Form | 01-08-2020

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 | 27-05-2020

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 ...

Policy document | 23-03-2020

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 | 23-03-2020