Documents - Marketing authorisation medicines for human use
45 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 ...
Declaration Member State of origin parallel import
Declaration for information intended for healthcare professionals of parallel imported products
Application for parallel import marketing authorisation
Classification overview legal status of supply NSAIDs
The MEB has determined a classification system for OTC anti-inflammatories (NSAIDs).
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 ...