Documents - Marketing authorisation medicines for human use

47 documents Marketing authorisation medicines for human use

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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 ...

Policy document | 30-03-2022

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 | 30-03-2022

Question and answer document concerning changes not covered by the Variation Regulation 1234/2008 (as amended by Regulation 712/2012)

Policy document | 31-01-2022

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A marketing authorisation holder may decide to have their marketing authorisation withdrawn for various reasons.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 | 01-01-2022

Pictograms from the Positive list for medicine packages

The MEB makes the following set of pictograms, including the established accompanying text, available for use on the medicine ...

Policy document | 16-12-2021

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 | 16-12-2021

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 | 16-12-2021

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