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EMA: Practical guidance on the extension of Commission decision annexes in the new accession country language

04.07.2013
This Guidance outlines practical considerations concerning the phasing-in of Commission Decisions concerning CAPs in Croatia.The document provides further details on the inclusion of the new language and new specimens into the operational aspects of the centralised procedure. For general guidance on the handling of new applications and post - authorisation procedures and more practical aspects of the submission requirements of Annexes, please refer to the respective Pre - Submission and Post - Authorisation Guidance Documents published on the EMA Website.