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Search results with tag "Post authorisation procedural advice"
The linguistic review process of product information in ...
www.ema.europa.eu3. The linguistic review process for post-authorisation procedures Detailed practical information regarding product information submission is available in the Agency Post-Authorisation Procedural Advice on the European Medicines Agency website. The same general principles as for the post-opinion linguistic review of New Applications apply, as
European Medicines Agency post-authorisation procedural ...
www.ema.europa.euEuropean Medicines Agency post-authorisation procedural advice for users of the centralised procedure EMEA-H-19984/03 Page 2/300 . Questions and answers are being updated continuously and will be marked by “NEW” or “Rev.” with