Documents - Marketing authorisation medicines for human use

46 documents Marketing authorisation medicines for human use

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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. 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

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

    Directive | 18-06-2018

  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. Declaration regarding the technical aspects of the readability of the patient information leaflet for pharmaceutical products for human use

    Form | 01-01-2018