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A marketing authorisation holder may decide to have their marketing authorisation withdrawn for various reasons.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

Vaccine in short for Spikevax (Moderna) to prevent COVID-19

Publication | 23-12-2021

Vaccine in short for Comirnaty (BioNTech/Pfizer) to prevent COVID-19

Publication | 23-12-2021

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

License holder registry

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

Publication | 17-09-2021

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 | 23-08-2021

Explanatory statement for applications for an exemption for tests with veterinary medicinal products

Publication | 08-07-2021

Vaccine in short for the Janssen vaccine to prevent COVID-19

Publication | 18-05-2021