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

    Publication | 04-06-2019

  2. Assessment report novel food status L-fucose

    Report | 24-05-2019

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

    Form | 01-05-2019

  4. 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

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

    Policy document | 11-09-2018

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

    Video | 13-06-2018

  7. The MEB: Good medicines used better (long version)

    Video | 13-06-2018

  8. MEB 48: National informed consent application

    An Article 10c 'Informed Consent' application ( article 10c of Directive 2001/83/EC)  is an application for marketing ...

    Policy document | 02-03-2018

  9. Previous versions of the Dutch QRD-template

    Form | 01-01-2018

  10. Parallel import dossier structure

    Publication | 01-01-2018

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