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    EMA

    EMA procedures: which route to choose for European market access

    The MA procedure shapes geographic scope, timelines and launch strategy. A comparison of European routes and their eligibility criteria.

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    Accessing the European market requires a Marketing Authorisation (MA). Four main procedures coexist, framed by the EMA and the competent national authorities (FAMHP in Belgium, ANSM in France, BfArM in Germany, etc.). Choosing a procedure is a strategic trade-off between geographic coverage, timelines, costs and product positioning.

    1. Centralised procedure (EMA)

    Handled by the EMA and the CHMP, it leads to a single MA valid across the 27 EU member states as well as Iceland, Liechtenstein and Norway.

    It is mandatory for biotechnology products, orphan medicines, advanced therapies (ATMPs), oncology, HIV antivirals, diabetes and autoimmune diseases, among others.

    2. Decentralised procedure (DCP)

    Used when the product has never been authorised in the EU. The company files simultaneously in several member states, with a Reference Member State (RMS) leading the assessment jointly with Concerned Member States (CMS).

    Well-suited to so-called 'mature' medicines (generics, hybrids, well-known products), with predictable timelines (210 net days).

    3. Mutual Recognition Procedure (MRP)

    Applicable when a national MA already exists in a member state. The Reference Member State shares its assessment dossier with Concerned Member States, which recognise the decision unless there is a major public-health ground.

    Often used to progressively extend a national MA to other EU countries.

    4. National procedure

    Limited to a single member state. Useful for products distributed locally, some legacy portfolios, or as a market-testing approach before extension.

    In Belgium, the FAMHP is the competent authority; timelines remain close to those of the DCP.

    5. How to choose?

    • Product type: biotech / ATMP / orphan → mandatory centralised.
    • Geographic ambition: pan-European launch → centralised or DCP.
    • Product history: existing national MA → mutual recognition.
    • Resources and timeline: plan for scientific advice and pre-submission meetings.

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    SiraGroup vous accompagne du cadrage stratégique jusqu'au dépôt et au suivi post-AMM, entre Europe / EMA et espace UEMOA.

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