FOREIGN THEORY AND PRACTICE

DIRECTIVE 2001/20/EC RELATING TO THE IMPLEMENTATION OF GOOD CLINICAL PRACTICE IN THE CONDUCT OF CLINICAL TRIALS ON MEDICINAL PRODUCTS FOR HUMAN USE

Abstract

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 (hereinafter: Directive) was published in the Official Journal of the European Union no. 121 of 1 May 2001. The Directive entered into force on the date of its publication in the EU Official Journal. The EU Member States had the deadline to adopt the laws and other regulations until 1 May 2003, and meet the implementation deadline of 1 May 2004. Based on the provisions of the Directive, Serbia adopted the first Law on Medicinal Products and Medical Devices in mid-2004 - LoMPMD 2004, Official Gazette of RS, no. 84/2004, despite not being an EU member state. Truth be told, some of the provisions of the Directive later underwent slight amendments under Regulation no. 1901/2006 of 27 December 2006 and Regulation no. 596/2009 of 18 July 2009. In accordance with the Directive, the effective Law on Medicinal Products and Medical Devices was passed - LoMPMD 2010, Official Gazette of RS, 30/2010, 107/2012, 105/2017-other law, 113/2017-other law.

UDK: (031.1)(4-672EEZ):338.266 2001/20EZ:128.34:348.131:616-093/898:543.615.2/3 Ilijić, mr Slobodan DIRECTIVE 2001/20/EC RELATING TO THE IMPLEMENTATION OF GOOD CLINICAL PRACTICE IN THE CONDUCT OF CLINICAL TRIALS ON MEDICINAL PRODUCTS FOR HUMAN USE Page: 113-119
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