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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. Guidance on the substantiation of Claims made on Animal Nutrition

    Policy document | 01-01-2025

  4. License holder registry

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

    Publication | 01-01-2025

  5. MEB 49: Compassionate Use Programme

    Medicinal products can only be marketed if a marketing authorisation has been granted. In cases of compassionate use, medicinal ...

    Policy document | 19-12-2024

  6. Terms of Use for internet trade in veterinary medicinal products

    Policy document | 16-12-2024

  7. Product types and fees, veterinary

    Publication | 12-12-2024

  8. 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

  9. 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

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

    Directive | 18-10-2024

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