Documents - Marketing authorisation medicines for human use

46 documents Marketing authorisation medicines for human use

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  1. Parallel import comparison form

    Form | 08-02-2024

  2. Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I) - Duplex with supplementary conditions

    Directive | 15-12-2023

  3. 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 | 15-12-2023

  4. MEB 39: Policy for assigning RVG numbers

    This document describes the Medicines Evaluation Board policy for assigning RVG numbers. This policy is based on the definitions ...

    Policy document | 02-10-2023

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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