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Documents - Marketing authorisation medicines for human use

48 documents Marketing authorisation medicines for human use

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  1. Parallel import dossier structure

    Publication | 01-01-2018

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

    Form | 01-01-2018

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

    Form | 01-01-2018

  4. 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

  5. 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

  6. Declaration Member State of origin parallel import

    Form | 01-01-2017

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

    Form | 01-01-2017

  8. Application for parallel import marketing authorisation

    Form | 01-01-2017

  9. Braille declaration

    Form | 01-01-2017

  10. Classification overview legal status of supply NSAIDs

    The MEB has determined a classification system for OTC anti-inflammatories (NSAIDs).

    Policy document | 24-11-2016

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