Greece is a strategically located EU market in Southeast Europe, offering growing opportunities for pharmaceutical, medical device, and life sciences manufacturers with access to the European single market and increasing healthcare investments.
The National Organization for Medicines (EOF – Εθνικός Οργανισμός Φαρμάκων) is the competent authority in Greece responsible for regulating medicines, medical devices, in vitro diagnostics, clinical trials, pharmacovigilance, and vigilance. As an EU Member State, Greece fully implements centralized procedures via EMA for medicines and MDR/IVDR for medical devices, with EOF managing national procedures, decentralized/mutual recognition procedures, Greek language requirements, and local compliance oversight. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate Greece’s EU-harmonized framework efficiently, prepare compliant submissions (including Greek labelling), secure timely approvals, and achieve sustained compliance in this important Mediterranean EU market.
Get Greece Compliance Support
Expert CTD/eCTD dossier compilation, Module 1 Greece-specific adaptation, scientific/technical review, and quality assurance for EOF/EMA submissions.
Complete management of national, DCP, MRP, and centralized submissions via EOF and EMA, including validation, follow-up, and query handling.
Preparation and submission of CTAs/CTIS applications to EOF, ethics committee coordination, and regulatory support for clinical trials in Greece.
Greek QPPV/local contact person services, PSUR/PBRER submissions to EOF/EMA, adverse event reporting, signal detection, and RMP maintenance.
CE marking support, Notified Body liaison, conformity assessment, vigilance reporting, and EOF registration/oversight compliance in Greece.
PMS/PMSR implementation, trend reporting, FSCA notifications, vigilance compliance, and ongoing monitoring per EOF and EU requirements.
Greek labelling review, Blue Box/EEA requirements, mock-ups, readability testing, and EOF approval support.
Support for post-approval changes, renewals, line extensions, and full lifecycle compliance with EOF and EMA/EEA standards.
Strategic consulting, optimal pathway selection (centralized/national/DCP/MRP), EOF scientific advice preparation, and up-to-date Greek/EU regulatory intelligence.
Partner with Medwisdom for expert, efficient, and fully compliant regulatory support in Greece — from EOF/EMA submissions and MDR/IVDR compliance to pharmacovigilance, Greek labelling, and sustained EU market success.
Contact Our Greece Regulatory Experts