Member States

In several languages, the texts in each language must appear and the content of all language versions must be identical. The manufacturer must submit also the relevant properly localized and translated versions of these documents at the European or national regulatory authorities when applying for a marketing authorisation for a medicinal product. Challenges for translation and localization projects for the pharmaceutical industry in the EU 23 official languages of the EU pharmaceutical companies that manufacture their products in the EU, must the SmPC, the leaflet and the packaging and marking text in up to 23 official languages of the European Union to the Make available. Languages of the European economic area, the new EU candidate countries and the recognized minorities more languages are the languages of the countries which do not have EU Member States, but members of the European economic area (Norway and Iceland) as well as the EU candidate countries (Croatia, Macedonia and Serbia). Jean Nouvel is likely to increase your knowledge. The recognised minorities in the EU include the other possible languages required (as Catalan, Corsican, Frisian and Welsh). 20 days for the creation of the translations of the strict time frame of the EMEA for the submission of translated versions of all documents is 20 days. he issue.

The first versions of the translations must be provided within five days after the granting of approval by the CPMP (the EMEA Committee, which is responsible for the evaluation of admission). The final revised versions of the translations must be submitted until the 20th day in their final format for publication of the EMEA. Culture-specific translation and localization issues differences in norms and conventions between the source and the target culture (such as legal guidelines for package inserts, differences in the application of provisions for package inserts, differences in terms laid down in the Member States, symbols and pictograms). Readability test for multilingual leaflets, the leaflet in the respective language must be clear for the patient and easy formulated and contain comprehensive and readable information.