Documents - Marketing authorisation medicines for human use

49 documents Marketing authorisation medicines for human use

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  1. Questions and answers about Compassionate Use Programme

    In the MEB49 policy document, we set out the policy for the Compassionate Use Programme (CUP). We have provided answers to ...

    Question and answer

  2. Questions and answers about the timeslot tool

    For a number of procedures for human medicines (including herbal medicines and homeopathic medicines), the MEB has a tool ...

    Question and answer

  3. 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

  4. MEB 13: Nomenclature of pharmaceutical products

    This document describes the requirements which the marketing authorisation holder has to fulfil when submitting a proposal for a ...

    Policy document | 01-11-2024

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

    Directive | 18-10-2024

  6. 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

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

    Directive | 18-10-2024

  8. 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

  9. 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

  10. 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