Navigating EOF Marketing Authorizations: What Sponsors Need to Know

Bringing a medicine to the Greek market starts with a marketing authorization — but the route you choose, and how well your dossier is prepared, can make the difference between a smooth approval and months of avoidable delay.

The Greek National Organisation for Medicines (EOF) is the competent authority for the authorization, pricing and supervision of medicinal products in Greece. For sponsors, understanding how EOF fits within the wider European system is the first step toward a predictable, on-time launch.

Four routes to authorization

Depending on the product and its commercial footprint, a marketing authorization in Greece can be obtained through one of four procedures:

• National procedure — for products marketed in Greece only, assessed directly by EOF.
• Mutual Recognition Procedure (MRP) — where an existing authorization in another EU member state is recognised by Greece.
• Decentralised Procedure (DCP) — a simultaneous application across several member states, with one acting as Reference Member State.
• Centralised Procedure — a single EMA authorization valid across the whole EU, mandatory for certain product classes such as biologics and orphan medicines.

Choosing the right route early is a strategic decision, not an administrative one. It affects timelines, cost, and how your product is positioned across markets.

The dossier: format matters

Submissions are made in electronic Common Technical Document (eCTD) format — the international standard for organising quality, non-clinical and clinical data. A well-structured, validated eCTD dossier reduces the risk of technical rejection and speeds up assessment. Common pitfalls include incomplete Module 1 regional information, inconsistent labelling, and missing lifecycle history.

Where time is really lost

In our experience, most delays do not come from the science — they come from preparation. Deficiency letters, clock-stops for missing documents, and last-minute labelling corrections are almost always avoidable with an early regulatory strategy and thorough pre-submission review.

How PQRA helps

PQRA supports sponsors across the full regulatory lifecycle: defining the optimal route, compiling and validating the eCTD dossier, managing the EOF liaison, and handling variations and renewals after approval. With more than 25 years of experience navigating the Greek and EU regulatory landscape, we help you reach the market faster and stay compliant once you are there.

Talk to our regulatory team →