Practical guidance on the extension of Commission Decision Annexes in the new Accession Country language
EMA, Practical guidance on the extension of Commission Decision Annexes in the new Accession Country language, 28 June 2013 EMA/9826/2011 Rev. 2 Patient Health Protection.
This Guidance outlines practical considerations concerning the phasing-in of Commission Decisions concerning CAPs in Croatia.
Marketing Authorisation Holders are legally obliged to provide translations of the product information in the new official language as of the date of accession. In order to facilitate the phasing-in of Commission Decisions related to the EU centralised procedure, a voluntary pre-accession checking procedure for Annex I, II, III and IV, if applicable, has been set up in cooperation with the National Competent Authorities (NCA) of the new MS. See information on our web-site under the European Union enlargement page.
This Guidance 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 PostAuthorisation Guidance Documents published on the EMA Website.
Applicants/MAHs are advised to systematically discuss the best approach for their product(s) with their Product Team Leader/Project Manager, especially for Regulatory Procedures which will finalise before or around enlargement.
