EU Clinical Trials Regulation (CTR 536/2014)
CTR - Application Dossier (Ch IV)

EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.25_26_27: Application dossier and language requirements (Articles 25-27)

Article 25 sets the application dossier contents (Annex I). Article 26 sets language requirements (the Reporting Member State accepts English for Part I; Part II language is determined by each Member State concerned, with Member States permitted to accept English). Article 27 empowers the Commission to adopt delegated acts updating Annex I.

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