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  1. List of patient-friendly terms for the package leaflet

    In order to optimise the readability of the package leaflet, the MEB has revised the list of patient-friendly terms. The list has ...

    Policy document | 28-06-2019

  2. Poster Renske ten Ham: Challenges in development and market authorisation of ATMP in Europe

    Publication | 04-06-2019

  3. Poster Tahira Nakchedi: Regulatory experience with non-clinical studies of cell-based therapy

    Publication | 04-06-2019

  4. Assessment report novel food status L-fucose

    Report | 24-05-2019

  5. 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 | 10-05-2019

  6. Declaration on modification of information in the printed SmPC and package leaflet pertaining to patented indications

    Form | 01-05-2019

  7. Letter to stakeholders regarding the implementation of safety features under the Falsified Medicines Directive 2011/62/EU

    The delegated Regulation on the characteristics of the safety features and the new medicine verification system will apply as of ...

    Publication | 01-10-2018

  8. MEB 8: Guideline on the excipients in the label and the package leaflet of medicinal products for human use

    Policy document | 11-09-2018

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

    Directive | 18-06-2018

  10. The MEB: Good medicines used better (short version)

    Video | 13-06-2018

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