Marketing Authorization (EU)
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A Marketing Authorization is the EU approval required before a medicinal product may be placed on the market, granted through one of four routes: the centralised procedure — a single EMA-recommended authorization valid across the EU — or the national, mutual recognition, or decentralised procedures, which route approval through individual member-state authorities rather than a single EU-wide decision.
The centralised procedure is mandatory for certain product categories — including most biotechnology products, orphan medicinal products, and new active substances for specified serious diseases — and optional for other innovative products; it results in a single authorization valid in all EU member states, plus EEA states via separate arrangements, rather than a patchwork of national approvals.
The decentralised procedure lets a company seek simultaneous authorization in several member states when the product has not yet been authorized anywhere in the EU, with one member state acting as Reference Member State; the mutual recognition procedure extends an authorization already granted in one member state to additional member states. National procedures apply only within a single member state.
- —Centralised procedure yields one EMA-recommended authorization valid EU-wide
- —Centralised route is mandatory for biotech products, orphan drugs, and specified new active substances
- —Decentralised procedure authorizes in multiple member states simultaneously via a Reference Member State
- —Mutual recognition extends an existing single-state authorization to further member states
- —National procedures apply within one member state only
Regulation (EC) No 726/2004 (centralised procedure); Directive 2001/83/EC (national, mutual recognition, and decentralised procedures)
Frequently asked questions
What is Marketing Authorization (EU)?
A Marketing Authorization is the EU approval required before a medicinal product may be placed on the market, granted through one of four routes: the centralised procedure — a single EMA-recommended authorization valid across the EU — or the national, mutual recognition, or decentralised procedures, which route approval through individual member-state authorities rather than a single EU-wide decision.
Which regulations cover Marketing Authorization (EU)?
Regulation (EC) No 726/2004 (centralised procedure); Directive 2001/83/EC (national, mutual recognition, and decentralised procedures)