Regulation No. 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive No. 2001/20/EC, European Union (EU)
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Notes The notification by the European Union to the WTO under Article 63.2 of TRIPS states: 'Regulation No. 536/2014 regulates clinical trials in regards to authorization requirements and procedure, implementation as well as the creation of an electronic database for safety reporting. The Regulation further deals with the manufacture and import of investigational medicinal products and auxiliary medicinal products and their labelling.'
Article 99 under Chapter XIX of the Regulation states that it shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. The Regulation was published on May 24, 2014, and, accordingly, entered into force on June 16, 2014.
Available TextsMain text(s)Main text(s)GermanVerordnung (EU) Nr. 536/2014 des Europäischen Parlaments und des Rates vom 16. April 2014 über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie Nr. 2001/20/EGPDFHTMLFrenchRèglement n° 536/2014 du 16 avril 2014 relatif aux essais cliniques de médicaments à usage humain et abrogeant la Directive n° 2001/20/CEPDFHTMLEnglishRegulation No. 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive No. 2001/20/ECPDFHTMLPortugueseRegulamento (UE) n.° 536/2014 do Parlamento Europeu e do Conselho, de 16 de abril de 2014 , relativo aos ensaios clínicos de medicamentos para uso humano e que revoga a Diretiva n.° 2001/20/CEPDFHTMLItalianRegolamento (UE) n. 536/2014 del Parlamento europeo e del Consiglio, del 16 aprile 2014 , sulla sperimentazione clinica di medicinali per uso umano e che abroga la Direttiva n. 2001/20/CEPDFHTMLSpanishReglamento N° 536/2014 de 16 de abril de 2014 sobre los ensayos clínicos de medicamentos de uso humano, y por el que se deroga la Directiva N° 2001/20/CEPDFHTML LegislationImplements (1 text(s))Implements (1 text(s))