GREECE Law and Practice Contributed by: Angela Livgieri and Danai Panopoulou, ALG Manousakis Law Firm
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation Pharmaceuticals European legislation • Directive 2001/83/EC (“Directive”) on the Commu- nity 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, as amended and in force. • Law 1316/1983 (Government Gazette A’ 3/11/11.1.83) on the establishment, organisation and competence of the National Organisation for Medicines (EOF, as per its Greek acronym), as amended and in force. • Joint Ministerial Decision DYG 3a/32221/2013 (“JM Decision”) (Government Gazette Β’ 1049/29.04.2013) on the implementation of Direc- tive 2001/83/EC of the European Parliament and the European Council on the Community Code relating to pharmaceutical products for human use, as amended and in force. • Joint Ministerial Decision D3 (α) 52922/2025 (Government Gazette 230/Β/22-1-2026) on the simplification and rationalization of procedures for contract execution and financial management of clinical trials with medicinal products, non-inter- ventional studies with medicinal products, clinical research with medical devices, clinical perfor- mance studies with in vitro diagnostic products, and research projects without medicinal products, medical devices, or in vitro diagnostic products. Medical Devices European legislation • Regulation (EU) 2017/745 of the European Par- liament and Council of 5 April 2017 on medical devices (“MDR”). • Regulation (EU) 2017/746 of the European Parlia- ment and Council of 5 April 2017 on in vitro diag- nostic 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 Regulation (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 Direc- tive 90/385/EEC “on the approximation of the laws of the Member States relating to Active Implant- able 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 Diagnostic Medical Devices” (Government Gazette Β’ 1060/10.8.2001), for the harmonisation of national legislation with the provisions of Direc- tive 98/79/EC of the European Parliament and of the Council of 27 October 1998 “on In Vitro Diag- nostic Medical Devices”. • Joint Ministerial Decision D3 (α) 52922/2025 (Government Gazette 230/Β/22-1-2026) on the simplification and rationalization of procedures for contract execution and financial management of clinical trials with medicinal products, non-inter- ventional studies with medicinal products, clinical research with medical devices, clinical perfor- mance studies with in vitro diagnostic products, and research projects without medicinal products, medical devices, or in vitro diagnostic products. Regulatory Bodies The competent national authority with regulatory oversight over pharmaceutical products and medi- cal 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 respon- sible for: • receiving and approving applications for marketing authorisations; • receiving and approving applications for clinical trials and monitoring clinical trials;
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