Documents - Marketing authorisation medicines for human use
45 documents Marketing authorisation medicines for human use
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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 ...
Question and answer document pertaining to variations for medicines for human use
MEB 42: Renewal of medicinal products for human use authorised through the national procedure
The MEB decides whether to renew the marketing authorisation for each product authorised through the national procedure.
MEB 39: Policy for assigning RVG numbers
This document describes the Medicines Evaluation Board policy for assigning RVG numbers. This policy is based on the definitions ...
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 ...