Library / regulatory-reference
Greece: National Organisation for Medicines (EOF)
Audience: administrators-policy, researchers-scientists ยท Review state: published
The national authority
The National Organisation for Medicines, known by its Greek initials EOF, is Greece's national regulatory authority for medicines and medical devices, operating under the Ministry of Health.
Greece's market sits inside the European single market, and the organization's decisions operate in a system marked by tight pharmaceutical-spending controls introduced over years of fiscal adjustment.
How products enter the market
Medicines require marketing authorization through national or European procedures after evaluation of quality, safety and efficacy, and establishments are licensed and inspected by the organization.
Post-market work includes safety monitoring within the European alert network and recalls, with pricing and reimbursement decisions made in a closely controlled framework.
Regional and international role
The organization is an active member of the European regulatory network, contributing to shared scientific work.
Its experience managing pharmaceutical expenditure under external fiscal pressure is a reference case for cost-containment policy in Europe.
Using this profile
The organization publishes regulations, registers and alerts in Greek, with English material, through its official portal, which is the primary source for current rules and listed in this profile's internal reference record.
For cross-country comparison: Greece illustrates the cost-pressured regulator: European-network authorization combined with some of Europe's tightest spending controls.
Limitations
Educational profile of a national regulatory system, current as of drafting. It simplifies routes and classes and is not legal, regulatory, or clinical advice. Filing and compliance decisions must be confirmed against the authority's current published rules and, where needed, professional regulatory counsel.