The Pharma Legal Handbook: Greece

Greece is a European Union member state with a pharmaceutical regulatory framework administered by the National Organization for Medicines (EOF). Greece has been subject to significant pharmaceutical pricing reforms, with mandatory rebates, clawbacks, and reference pricing mechanisms that have substantially reduced the net prices companies receive in the market.

The Greek reimbursement system, administered by EOPYY, operates a positive list for reimbursable products with co-payment requirements that vary by product category and patient group. The system of mandatory rebates based on sales volume and the quarterly reconciliation process are features that market access and finance teams need to understand in detail.

The Pharma Legal Handbook: Greece provides comprehensive guidance on pharmaceutical regulation in Greece, covering EOF product authorisation, pricing and mandatory rebate mechanisms, EOPYY reimbursement pathways, clinical trial requirements, pharmacovigilance obligations, manufacturing standards, marketing rules, parallel imports, and intellectual property protection.