GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices Pharmaceuticals European Legislation • Directive 2001/83/EC ( “Directive” ) on the Community code relating to pharmaceutical products for human use, as amended and in force. National Legislation • Legislative Decree 96/1973 (Government Gazette A’ 172/3/8.8.1973) on the trading of pharmaceutical and cosmetic products. • Law 1316/1983 (Government Gazette A’ 3/11/11.1.83) on the establishment, organisa- tion and competence of the National Organi- zation for Medicines (EOF, as per its Greek acronym). • Joint Ministerial Decision DYG 3a/32221/2013( “JM Decision” ) (Govern- ment Gazette Β’ 1049/29.04.2013) on the implementation of Directive 2001/83/EC of the European Parliament and the European Council on the Community Code relating to pharmaceutical products for human use. Medical Devices European Legislation • Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017 on medical devices ( “MDR” ). • Regulation (EU) 2017/746 of the European Parliament and Council of 5 April 2017 on in vitro diagnostic medical devices ( “IVDR” ). National Legislation • Joint Ministerial Decision DY8d/130648/2009 on “Medical Devices” (Government Gazette Β’ 2198/02.10.2009), for the harmonisation
of national legislation with the provisions of Directive 93/42/EEC “on Medical Devices” , as amended by Directives 98/79/EC, 2000/70/ EC, 2001/104/EC, 2007/47/EC and Regula- tion (EC) 1882/2003. • Joint Ministerial Decision DY8d/130644/2009 on “Active Implantable Medical Devices” (Government Gazette Β’ 2197/2.10.2009), for the harmonisation of national legislation with the provisions of Directive 90/385/EEC “on the approximation of the laws of the Member States relating to Active Implantable Medical Devices” , as amended by Directives 93/42/ EEC, 93/68/EC, 2007/47/EC and Regulation (EC) 1882/2003. • Joint Ministerial Decision DY8d/3607/892/2001 on “In Vitro Diagnos- tic Medical Devices” (Government Gazette Β’ 1060/10.8.2001), for the harmonisation of national legislation with the provisions of Directive 98/79/EC of the European Parlia- ment and of the of 27 October 199 “on In Vitro Diagnostic Medical Devices” . Regulatory Bodies The competent national authority with regu- latory oversight over pharmaceutical prod- ucts and medical devices is EOF, established by Law 1316/1983 (Government Gazette A’ 3/11/11.1.83) as an entity of public law. Within the framework of its mission, EOF is responsible for: • receiving and approving applications for mar- keting authorisations; • receiving and approving applications for clini- cal trials and monitoring clinical trials; • approving and monitoring manufacturing facilities in order to ensure compliance with Good Manufacturing Practices (GMP);
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