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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 | 10-05-2019

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

    Form | 01-05-2019

  3. 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

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

    Policy document | 11-09-2018

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

    Video | 13-06-2018

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

    Video | 13-06-2018

  7. 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

  8. Previous versions of the Dutch QRD-template

    Form | 01-01-2018

  9. Parallel import dossier structure

    Publication | 01-01-2018

  10. Request form for permission to carry out tests with additives for animal feed

    If you want to put animal feed on the market with an additive that has not (yet) been licensed, the additive has to be examined ...

    Form | 01-01-2018

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