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Documents - Marketing authorisation medicines for human use

46 documents Marketing authorisation medicines for human use

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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

Declaration Member State of origin parallel import

Form | 01-01-2017

Declaration for information intended for healthcare professionals of parallel imported products

Form | 01-01-2017

Application for parallel import marketing authorisation

Form | 01-01-2017

Braille declaration

Form | 01-01-2017

Classification overview legal status of supply NSAIDs

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

Policy document | 24-11-2016

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

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

Form to request withdrawal of a parallel import marketing authorisation

Form | 12-06-2015

Schrijfadviezen voor de geneesmiddelenbijsluiter

Policy document | 01-01-2015

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