Transcription of Practical guidance on the application form for centralised ...
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Practical guidance on the application form for centralised ...
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 25 February 2021 EMA/233564/2014 - Rev. 3 Procedure Management and Business Support Division European Medicines Agency Practical guidance on the application form for centralised type IA and IB variations This document is intended as guidance to facilitate the completion of the latest version of the application form for type IA and IB variations to be submitted in the centralised Procedure and should be read in conjunction with Changes introduced in of the variation form - guidance for applicants.
For Type IB grouped applications a justification for grouping should be provided. This justification is not needed for IA grouped applications. If the product information is updated, the sections of the SmPC should be specified along with a description of the change. In case there are
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