In Greece, pharmacovigilance (PV) activities are regulated and supervised by the National Organization for Medicines (EOF – Εθνικός Οργανισμός Φαρμάκων). The requirements are aligned with EU legislation, but Greece also has national-level obligations that marketing authorization holders (MAHs) must follow.

Key Requirements in Greece

1. Local Pharmacovigilance Contact Person (LCPPV)
   • In addition to the EU-mandated QPPV, MAHs operating in Greece must appoint a local pharmacovigilance contact person.
   • This person must:
     • Be resident in Greece.
     • Hold a degree in medicine, pharmacy, biology, chemistry, or a related science.
     • Have at least 2 years’ PV experience.
     • Be independent of promotional/marketing activities.
   • Their role is to liaise directly with EOF in Greek, ensure timely reporting, and support local safety measures.
2. Adverse Event Reporting
   • Adverse reactions must be reported to EOF via the Greek Yellow Card system (Κίτρινη Κάρτα).
   • Healthcare professionals and patients can submit reports directly, but MAHs must collect and forward all suspected ADRs.
   • Timelines are the standard EU ones:
     • 15 days for serious ADRs.
     • 90 days for non-serious ADRs.
3. Pharmacovigilance System Documentation
   • MAHs must maintain a Pharmacovigilance System Master File (PSMF).
   • The local PV contact should have knowledge of the PSMF and facilitate EOF inspections.
4. Periodic Safety Update Reports (PSURs)
   • Submitted in line with EU schedules, but EOF can request additional national data if needed.
5. Risk Management Plans (RMPs)
   • RMPs are required for new medicines and must be kept updated.
   • MAHs must ensure that risk minimisation measures are effectively implemented in Greece (e.g. educational materials in Greek).
6. Language Requirements
   • Safety communications, patient information, and educational materials must be available in Greek.
   • The local PV contact ensures translations are accurate and consistent.
7. Inspections and Compliance
   • EOF conducts pharmacovigilance inspections to verify compliance with national and EU law.
   • Companies must have SOPs, a functioning PV system, and be ready to present data or the PSMF on request.

Recent / Upcoming Changes

• Regulation (EU) 2025/1466 : This is an implementing regulation amending the EU’s pharmacovigilance implementing rules. It was published in July 2025 and will affect several PV activities, including how the PSMF is handled, signal management, etc. Member states (thus also Greece) will be obliged to comply. EUR-Lex+1
• Falsified Medicines / Safety Features: Greece has introduced ministerial decisions (e.g. Δ3(α) 6030 as of February 2025) to more strictly enforce packaging safety features, unique codes, authenticity checks etc. These relate somewhat peripherally to pharmacovigilance (in that safety, tampering, quality issues are in scope) but also to drug safety more broadly.

Key Takeaways

• Much of pharmacovigilance legislation in Greece is derived from EU law, which is implemented via national legislation and overseen by Greek authorities
• Local PV Contact is mandatory – In addition to the EU QPPV, every MAH must appoint a Greek-based pharmacovigilance contact person (LCPPV) with scientific background, ≥2 years PV experience, and independence from marketing.
• Language requirement – All safety communications and PV documents for healthcare professionals and patients must be in Greek.
• EOF inspections – EOF actively audits PV systems; companies must have SOPs, trained staff, and compliance mechanisms in place.
• National focus – Greece emphasizes local patient reporting and may request additional national safety measures beyond EU requirements.

In short: Greece follows EU PV law but adds stricter local obligations, especially the requirement for a Greek-resident PV contact and Greek-language compliance.

Authored By : Hassene Mokaadi
Senior Project Manager, Baupharma.