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Documents - Marketing authorisation medicines for human use

46 documents Marketing authorisation medicines for human use

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  1. 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

  2. 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

  3. Declaration Member State of origin parallel import

    Form | 01-01-2017

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

    Form | 01-01-2017

  5. Application for parallel import marketing authorisation

    Form | 01-01-2017

  6. Braille declaration

    Form | 01-01-2017

  7. Classification overview legal status of supply NSAIDs

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

    Policy document | 24-11-2016

  8. MEB 41: MEB policy concerning marketing authorisations without Dutch translations of the product information and/or mock-ups

    The MEB is aware of the fact that medicinal products are not always marketed immediately after authorisation. Following the ...

    Policy document | 18-10-2016

  9. Declaration accompanying a duplex marketing authorisation regarding the technical aspects of the readability of the patient information leaflet for pharmaceutical products for human use

    Directive | 01-09-2015

  10. Form to request withdrawal of a parallel import marketing authorisation

    Form | 12-06-2015

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