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

  • 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 Card
    The "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/03-10-2013
    Transposition 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 70473/01-10-2013
    Requirement 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/29-4-2013
    Transposition 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).