MAA: marketing authorisation application
A marketing authorisation application (MAA) is the dossier submitted to EMA or a national authority for permission to market a medicine in the EU.
The content of an MAA is set by Article 8(3) of Directive 2001/83/EC and Annex I, with Article 6 of Regulation (EC) No 726/2004 applying the same requirements to centralised applications. The dossier follows the Common Technical Document: Module 1 holds the regional administrative information, including the application form, product information and the environmental risk assessment, Module 2 the summaries, Module 3 quality, Module 4 non-clinical and Module 5 clinical data. The legal basis determines which modules must be complete. A full application under Article 8(3) carries the applicant's own data; abridged applications under Article 10 rely on a reference product, and Article 10a on published literature.
The route depends on the product and the markets. The centralised procedure is mandatory for biotechnology products, orphan medicines, advanced therapies and new active substances in several therapeutic areas, and optional for other innovations. Everything else goes through a national procedure, a decentralised procedure or mutual recognition. Choosing the route fixes the timetable, the fees, the assessing authority and the language requirements for the product information. Before submission, applicants typically request a pre-submission meeting or eligibility confirmation, check the invented name, book a slot with the reference member state or EMA, and confirm that the electronic application form and eCTD sequence pass technical validation.
The assessment then runs through validation, assessment, questions, clock-stops and opinion. The product information, the risk management plan, the paediatric investigation plan compliance and the GMP status of every manufacturing site are examined alongside the scientific data, and any of them can delay the decision. Once granted, the authorisation carries conditions and obligations that the dossier itself defined, so the MAA is also the baseline for every later variation.
What goes wrong: a legal basis that does not match the data, so the application is reclassified or refused at validation; a reference product whose data exclusivity has not expired; missing GMP certificates or an inspection that cannot be scheduled in time; product information that has not been checked against the current QRD template; and responses to questions that open new issues. Fees are often underestimated because each concerned member state and each national authority charges separately.
Timing
The statutory assessment time is 210 active days in the centralised, decentralised and national procedures, with clock-stops at the lists of questions and outstanding issues that add several months in practice. The centralised procedure adds up to 67 days for the Commission decision after the CHMP opinion. In a DCP or MRP, national authorisations follow within 30 days of the procedure closing. Pre-submission steps such as eligibility requests, slot bookings and name checks have their own deadlines, often months ahead.
Used in
Regulatory teams compare routes, timelines and fees before choosing where and how to file in the market expansion workflow.
Related terms
- Centralised procedure: single EU marketing authorisation via EMAThe centralised procedure grants one marketing authorisation valid across the EU and EEA after a single EMA assessment and a Commission decision.
- DCP: decentralised procedureThe decentralised procedure (DCP) authorises a medicine in several EU/EEA Member States at once when it is not yet authorised in any of them.
- National procedure: authorisation in a single Member StateA national procedure authorises a medicine in one EU Member State only, assessed by that country's competent authority under Directive 2001/83/EC.
- eCTD: electronic Common Technical DocumentThe electronic Common Technical Document (eCTD) is the electronic format for regulatory dossiers, organised in the five-module structure defined by ICH M4.
- eAF: electronic application formThe electronic application form (eAF) is the mandatory EU form for marketing authorisation, variation and renewal applications in every procedure type.
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