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  1. MEB 21: Statement of ‘abbreviated indications’ on OTC medicinal product packaging

    Directive 2001/83/EC discusses European regulations on labelling. In accordance with Article 54(n), the outer packaging of ...

    Policy document | 17-04-2025

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

    Policy document | 06-02-2025

  3. 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

  4. 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

  5. Quarterly overview of companies in the starting materials (API) register

    Publication | 01-01-2025

  6. Guidance on the substantiation of Claims made on Animal Nutrition

    Policy document | 01-01-2025

  7. 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

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

    Policy document | 16-12-2024

  9. Product types and fees, veterinary

    Publication | 12-12-2024

  10. 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

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