Marketing authorisation application in the EU explained
An EU marketing authorisation application seeks permission to market a medicine. Learn the centralised process, dossier requirements and assessment times.
A marketing authorisation application (MAA) asks a European regulatory authority for permission to market a medicine in the EU. In the centralised procedure, EMA assesses the application and the European Commission decides whether to grant authorisation. EMA's CHMP gives the scientific opinion. The application is not the authorisation itself. See EMA's definition of an MAA and its EU authorisation process.
EMA's published guidance gives a standard assessment timetable of up to 210 active days, or 150 active days for accelerated assessment. Applicant-response clock stops are excluded. EMA describes a separate Commission decision phase within 67 days of receiving the CHMP opinion. None of these figures guarantees a submission-to-approval date. Sources: standard assessment, accelerated assessment and Commission decision.
Which medicines use the centralised procedure?
This guide covers human medicines. Not every EU marketing authorisation application goes to EMA. A centralised application has one evaluation and, if successful, an authorisation valid throughout the EU, Iceland, Liechtenstein and Norway. The Commission grants or refuses authorisation following EMA's scientific recommendation. A positive CHMP opinion alone does not permit marketing. See EMA's route overview.
Centralised assessment is mandatory for specified biotechnology-derived medicines, advanced therapies and designated orphan medicines. It also covers medicines with qualifying new active substances for specified disease areas, including cancer, diabetes and viral diseases. An indication alone does not establish mandatory scope. Optional access can cover qualifying new active substances, significant innovation or Union-level patient interest. Check the full EMA eligibility criteria for the product concerned.
EMA says applicants should always submit an eligibility request, including for products within mandatory scope or with automatic access. The applicant or marketing-authorisation holder must be established in the EEA. Centralised eligibility does not establish eligibility for accelerated assessment or conditional authorisation. These are separate decisions under EMA's pre-authorisation guidance.
Other routes lead to national authorisations. The decentralised procedure involves parallel applications in several Member States where the medicine is not yet authorised. Mutual recognition uses an existing Member State authorisation. These distinctions come from the Commission's Notice to Applicants, Chapter 1, rather than the centralised timetable below.
Preparing the application dossier
The Common Technical Document (CTD) organises the dossier into five modules. It is a document structure, not an authorisation route. The ICH CTD framework sets out their contents:
| Module | Contents |
|---|---|
| 1 | Region-specific administrative and prescribing information |
| 2 | Summaries and overviews |
| 3 | Quality |
| 4 | Nonclinical study reports |
| 5 | Clinical study reports |
The shared structure does not make regional requirements interchangeable. Module 1 is region-specific, so a CTD prepared for another market is not automatically an EU-ready submission. Nor does the format provide a worldwide authorisation. See ICH's explanation of the regional module.
Centralised applications use the electronic CTD, or eCTD, and are submitted in English through EMA's eSubmission Gateway or Web Client. Specified editable working documents sit outside the eCTD structure. Check EMA's submission guidance for the applicable technical instructions rather than relying on an old dossier's settings.
Pre-submission planning and validation
EMA publishes planning milestones well before scientific assessment starts. Its step-by-step guidance gives the following schedule:
- Submit the eligibility request 18 to 7 months before submission.
- Notify EMA of the intention to submit 7 months before submission.
- Hold the recommended pre-submission meeting 6 to 7 months before submission.
- Reconfirm the submission date 2 to 3 months before submission.
These are planning milestones, not assessment deadlines. They do not mean every application must begin exactly 18 months before submission. Use them to plan engagement with EMA separately from the scientific review timetable.
After submission, technical validation checks the electronic submission. Regulatory and administrative validation checks essential content before assessment begins. EMA can request Validation Supplementary Information. Unresolved deficiencies can delay the start, suspend validation or lead to negative validation. Technical acceptance alone does not start the assessment clock. See EMA's validation guidance.
The centralised procedure timeline
The process runs from eligibility and planning through submission, validation, CHMP assessment, a scientific opinion and the Commission decision. Within assessment, applicant questions create pauses that affect elapsed time. EMA's evaluation guide describes these standard milestones:
| Assessment point | What happens |
|---|---|
| Day 120 | CHMP issues its list of questions |
| First clock stop | The applicant prepares responses |
| Day 180 | CHMP may issue a list of outstanding issues |
| Further clock stop, if needed | The applicant addresses outstanding issues |
| By day 210 | CHMP adopts its scientific opinion |
These are active assessment days. EMA describes the first clock stop as usually three months and the second as usually one month, subject to agreement. Those durations are not fixed for every application. Validation, response preparation and possible re-examination can extend elapsed time. See EMA's explanation of assessment and clock stops.
The Commission decision follows the opinion. EMA's published process describes this phase as within 67 days of receiving the CHMP opinion. Adding 210 and 67 days does not give a guaranteed approval date: clock stops and validation sit outside those figures.
Accelerated assessment and conditional marketing authorisation
Accelerated assessment changes the review timetable. Conditional marketing authorisation concerns the evidence available at authorisation and the obligations that follow. They can be combined, but each has its own eligibility test. See EMA's guidance on accelerated assessment and conditional marketing authorisation.
Accelerated assessment reduces the timetable from 210 to 150 active days, excluding clock stops. It is intended for medicines of major public-health interest, particularly therapeutic innovation, subject to CHMP acceptance. It does not independently reduce evidence requirements or predict a positive decision. EMA advises requesting it at least 2 to 3 months before submission through IRIS. It strongly recommends a pre-submission meeting 6 to 7 months beforehand. See EMA's accelerated-assessment guidance.
Conditional authorisation permits less comprehensive clinical data than normally required for eligible medicines. Its scope includes seriously debilitating or life-threatening diseases, including orphan medicines, and public-health emergencies. All four criteria must be met:
- The benefit-risk balance is positive.
- The applicant is likely to provide comprehensive clinical data after authorisation.
- The medicine addresses an unmet medical need.
- Immediate availability offers benefits that outweigh the risks from outstanding data.
In emergencies, less comprehensive pharmaceutical and nonclinical data may also be accepted. That exception does not apply to every conditional application. See EMA's conditional-authorisation criteria.
A conditional authorisation lasts one year and is renewable annually. The holder must meet specific obligations within defined timelines, potentially completing studies or collecting further data. Conditions appear in the European public assessment report (EPAR). Conversion to standard authorisation is possible after obligations are fulfilled and full data confirm favourable benefit-risk. It is not automatic after one year. Conditional authorisation also differs from exceptional circumstances, where full data cannot be obtained even after authorisation. See EMA's guidance on conditions and conversion.
UK and US applications remain separate
This is an EU submission guide. Since 1 January 2025, MHRA regulates through UK-wide marketing authorisations, and Commission Union authorisations are no longer valid for Northern Ireland. An EU centralised authorisation does not permit UK marketing. See MHRA's UK-wide licensing guidance.
US applications also remain separate: an FDA new drug application proposes approval of a new pharmaceutical, while a biologics licence application requests permission to introduce a biological product into interstate commerce.
RegAffairs AI's answer on EU marketing authorisation applications explains the centralised process with links to official sources.