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Documents - Marketing authorisation medicines for human use

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  1. 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

  2. Previous versions of the Dutch QRD-template

    Form | 01-01-2018

  3. Parallel import dossier structure

    Publication | 01-01-2018

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

    Form | 01-01-2018

  5. Application for the inclusion of QR code in national procedures

    Form | 01-01-2018

  6. MEB 47: Assessment criteria for combination packages

    In policy document MEB 47 the MEB has described terms and conditions to assess applications for combination packages of medicinal ...

    Directive | 19-12-2017

  7. MEB 27: MEB commentary on the ‘Guideline on Summary of Product Characteristics’

    This document serves as a commentary on the ‘Guideline on Summary of Product Characteristics’. Download this policy document in ...

    Policy document | 23-08-2017

  8. Declaration Member State of origin parallel import

    Form | 01-01-2017

  9. Declaration for information intended for healthcare professionals of parallel imported products

    Form | 01-01-2017

  10. Application for parallel import marketing authorisation

    Form | 01-01-2017

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