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Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance article 26 CELEX: 02014R0536-20221205 Language requirements
The language of the application dossier, or parts thereof, shall be determined by the Member State concerned.
Member States, in applying the first paragraph, shall consider accepting, for the documentation not addressed to the subject, a commonly understood language in the medical field. |