The Greek pharmaceutical and medical devices legislation is based on the relevant EU legislation, with a few national adjustments.
In each of the following sections, you will find all original legislative texts, and, where available, an English translation.
If you are interested in receiving a full translation of the texts in English, please contact us at medworkinfo@medwork.gr
- Greek Pharmacovigilance Legislation
- Cypriot Pharmacovigilance Legislation
- Greek Materiovigilance Legislation
- Questions and Answers regarding the local implementation of Regulation (EU) No 536/2014 (CTR) in Greece(Version 1.1/01-07-2022)Circular regarding the management and reporting of safety issues in the context of conducting clinical trials(Version 12976/05-02-2019)Common/frequently asked questions about Pharmacovigilance of medicines for human use and Materiovigilance(Version 1.1/12-03-2018)National Organization for Medicines - Yellow CardThe "Yellow Card", is used to collect information on adverse drug reactions. Healthcare professionals and patients can use it to report adverse drug reactions to the National Organization for Medicines (EOF). It can be sent via fax or regular mail. Alternatively, adverse drug reactions may be reported electronically via EOF's site. For more information visit: https://www.eof.gr/web/guest/yellowgeneral.Ministerial Decision 3a/90023, published in Government Gazette issue 2485/B/03-10-2013Transposition of Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 into Greek law, amending Directive 2001/83/EC as regards pharmacovigilance. It applies in conjunction with the "Ministerial Decision No. 3a / G.P.",32221/29-04-2013.National Organization for Medicines Circular 70473/01-10-2013Requirement to add: (a) specific text regarding ADR reporting in SmPC and PIL; (b) a black triangle in SmPC and PIL; and (c) specific text in educational material that is part of RMPs in order to promote ADR reporting by HCPs and consumers.Ministerial Decision 3a/32221, published in Government Gazette issue 1049/B/29-4-2013Transposition of EU Directive 2001/83/EC into Greek law, concerning the production and the marketing of medicinal products for human use, as applicable and as amended by the EU Directive 2011/62 regarding the prevention of falsified medicines in the legal supply chain (L 174/01-07-2011).
- Pharmaceutical Services - Ministry of Health Announcement 03-02-2016Announcement regarding submission through Common European Submission Platform (CESP)Pharmaceutical services - Ministry of Health Circular - RMPs 02-01-2015Local requirements regarding the submission of Risk Management Plans (RMP) and Risk Minimisation Measures (RMM)Pharmaceutical services - Ministry of Health Circular - Local contact person 02-01-2015Requirements for local QPPV/RPPVPharmaceutical Services - Ministry of Health Announcement 25-10-2013Announcement regarding "Dear Health Care Professional (DHPC)" communicationsLegislation on medicinal products for human useLegislation on medicinal products for human use (quality control, supply and prices) from 2001 to 2004 (No. 3)/452 2004
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EURegulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EECGuidelines on a Medical Device Vigilance System_revision January 13EU Guidelines on a Medical Device Vigilance System _MEDDEV 2.12-1 revision 8/January 2013Summary of the Obligations for manufacturers and operators of Medical Devices (Version 1.0/April 2010)For further information regarding legislation on medical devices please visit: National Organisation for Medicine's website