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  1. License holder registry

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

    Publication | 01-12-2024

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

    Policy document | 12-11-2024

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

    Directive | 18-10-2024

  4. 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 | 18-10-2024

  5. Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I)

    Directive | 18-10-2024

  6. 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 | 01-10-2024

  7. Product types and fees, veterinary

    Publication | 04-09-2024

  8. MEB 37: Legal status of supply

    This document describes the policy of the Medicines Evaluation Board for awarding a legal status of supply.

    Policy document | 21-08-2024

  9. 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 | 18-07-2024

  10. Assessment report novel food status three ingredients derived from seeds of oilseed rape

    Report | 28-06-2024