For any company bringing a medicine to Europe, one of the earliest and most consequential decisions is procedural rather than scientific: which marketing authorisation route to take. The choice shapes your timelines, your budget, the number of markets you can reach and the authority you will answer to. Selecting the wrong route can add months of avoidable delay, so it deserves careful thought long before a dossier is compiled.
The centralised procedure
The centralised procedure, governed by Regulation (EC) No 726/2004, results in a single marketing authorisation valid simultaneously across all EU Member States and the EEA countries (Norway, Iceland and Liechtenstein). A single application is submitted to the European Medicines Agency (EMA), assessed by the Committee for Medicinal Products for Human Use (CHMP), which issues its opinion within 210 active days, excluding clock-stops for company responses. The European Commission then adopts a binding decision, generally within around two months of the opinion.
The route is mandatory for defined categories, including:
- medicines derived from biotechnological processes;
- advanced therapy medicinal products (ATMPs);
- orphan medicinal products;
- products containing a new active substance for indications such as cancer, neurodegenerative disorders, diabetes, HIV/AIDS, auto-immune diseases and viral diseases.
For other innovative products it is optional. The trade-off is clear: pan-European reach and a single point of contact, in exchange for a rigorous, high-visibility assessment.
The decentralised and mutual recognition procedures
Where a product falls outside the mandatory centralised scope but is intended for several national markets, two related routes apply. Both rely on one country, the Reference Member State (RMS), performing the scientific assessment on behalf of the Concerned Member States (CMS).
- Decentralised procedure (DCP) — used when the product is not yet authorised anywhere. Applications are submitted in parallel and the CMS agree the RMS assessment, typically by day 210.
- Mutual recognition procedure (MRP) — used when a national authorisation already exists in one Member State and recognition is sought in others.
Disagreements are handled by the Coordination Group (CMDh); an unresolved potential serious risk to public health can be referred to the CHMP for arbitration.
The national procedure
A purely national authorisation, granted by a single competent authority — in Greece, the National Organisation for Medicines (EOF) — remains available for products intended for one market only. It is often the pragmatic choice for locally focused generics or long-established products where a wider footprint is not commercially justified.
Making the right choice
The optimal route depends on several interacting factors:
- whether the product falls within the mandatory centralised scope;
- the number and priority of markets targeted, now and in future;
- product type, competitive timing and lifecycle strategy;
- practical considerations such as the United Kingdom now operating a separate system following its departure from the EU.
A route chosen for a first launch also sets the framework for every subsequent variation and renewal, so it should be viewed as a long-term commitment rather than a one-off administrative step.
How PQRA helps
PQRA advises pharmaceutical companies and healthcare innovators on selecting and executing the right regulatory strategy for the Greek and EU markets. We assess your product against the mandatory centralised criteria, model the timeline and cost implications of each route, and manage submissions end to end — from EOF national applications to EMA centralised dossiers — keeping lifecycle maintenance coherent across every market you enter.
To discuss the best authorisation route for your product, get in touch with our regulatory team.
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