The European Medicines Agency reminds applicants and marketing-authorisation holders that they need to submit translations of product information in Croatian for opinions as of April 2013.


This concerns applications for initial marketing authorisations and extensions adopted by the Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP), to prepare for the accession of Croatia to the European Union on 1 July 2013.


The Agency also reminds companies to check the applicable requirements for submission of translations in Croatian in the framework of post-authorisation procedures. This is detailed in the revised practical guidance on the extension of Commission decision annexes in the new accession country language.


Posted on the EMA website on 19 March 2013