Documents - Marketing authorisation medicines for human use

46 documents Marketing authorisation medicines for human use

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  1. 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 | 01-09-2023

  2. Parallel import comparison form

    Form | 17-11-2022

  3. 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 | 17-11-2022

  4. GS-list 21

    The list of active substances in products that may qualify for sale general sale (GS list) was updated by the MEB on 20 October ...

    Policy document | 20-10-2022

  5. MEB 42: Renewal of medicinal products for human use authorised through the national procedure

    The MEB decides whether to renew the marketing authorisation for each product authorised through the national procedure.

    Policy document | 03-08-2022

  6. 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

  7. 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

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

    Policy document | 31-01-2022

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    A marketing authorisation holder may decide to have their marketing authorisation withdrawn for various reasons.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

  10. 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