Documents - Marketing authorisation medicines for human use
47 documents Marketing authorisation medicines for human use
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Declaration regarding the technical aspects of the readability of the patient information leaflet for pharmaceutical products for human use
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Application for the inclusion of QR code in national procedures
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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 ...
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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 ...
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Declaration Member State of origin parallel import
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Declaration for information intended for healthcare professionals of parallel imported products
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Application for parallel import marketing authorisation
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Braille declaration
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Classification overview legal status of supply NSAIDs
The MEB has determined a classification system for OTC anti-inflammatories (NSAIDs).
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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 ...