Documents - Marketing authorisation medicines for human use
48 documents Marketing authorisation medicines for human use
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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 ...
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Declaration accompanying a duplex marketing authorisation regarding the technical aspects of the readability of the patient information leaflet for pharmaceutical products for human use
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Form to request withdrawal of a parallel import marketing authorisation
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Manual parallel import dossier structure
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Schrijfadviezen voor de geneesmiddelenbijsluiter
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MEB 15: Replica marketing authorisation (only apply to existing marketing authorisations)
A replica marketing authorisation concerns a medicinal product which is exactly the same as the reference medicinal product, with ...
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Disinfectant products: Distinguishing between biocidal products and medicinal products (human and veterinary)
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Assessment report coagulated potato protein and hydrolysates, applicant AVEBE
A report on the assessment of the substantial equivalence of coagulated potato protein and hydrolysates by the company AVEBE with ...