The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.
In this section
|General requirements for all applications||Particular application types|
Steps involved in obtaining an EU marketing authorisation
Submission of eligibility request
|18 to 7 months before submission of marketing authorisation application (MAA)|
To find out whether a product can be evaluated under the centralised procedure, applicants should always submit an eligibility request using the specific form and accompanied by a justification.
More information: pre-authorisation guidance - section 2: Steps prior to submitting the application
Notification of intention to submit an application
|7 months before submission of MAA|
Applicants should consider the date of submission carefully, referring to the published submission dates.
To notify the Agency of the intended submission date, they should email the pre-submission request form (intent to submit MA) to email@example.com. The selected scope of request should be: 'Centralised Procedure – Intent to submit a MAA'.
More information: pre-authorisation guidance – section 2: Steps prior to submitting the application
Appointment of rapporteurs
|7 months before submission of MAA|
The Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC) appoints (co-)rapporteurs to conduct the scientific assessment.
For advanced therapy medicinal products, (co-)rapporteurs are also appointed from members of the Committee for Advanced Therapies (CAT), who will lead the assessment.
More information: Pre-authorisation - section 2: Steps prior to submitting the application
|6 to 7 months before submission of MAA|
Pre-submission meetings are the best opportunity for applicants to obtain procedural and regulatory advice from the Agency:
Successful pre-submission meetings along with the information in the guidance should enable applicants to submit applications in line with legal and regulatory requirements. This speeds up the validation process.
More information: Pre-authorisation guidance – section 2: Steps prior to submitting the application
Submission and validation of the application
Applicants should use the electronic common technical document (eCTD) format and submit the application through the eSubmission gateway or web client.
If the Agency needs additional information to complete its validation of the application, it will ask the applicant to supply this by a deadline.
|Up to 210 active days of assessment|
The CHMP evaluates MAA submitted through the centralised procedure. The PRAC provides input on aspects related to risk management and the CAT on advanced therapy medicines.
More information: Pre-authorisation guidance – section 5: Assessment of the application
CHMP scientific opinion
After the evaluation, the CHMP must issue a scientific opinion on whether the medicine may be authorised or not.
EMA sends this opinion to the European Commission, which issues the marketing authorisation. The Agency then publishes a summary of the committee's opinion.
More information: Pending European Commission decisions
European Commission decision
|Within 67 days of receipt of CHMP opinion|
When a new marketing authorisation application is refused, the Agency publishes a refusal EPAR, including a question and answer document and an assessment report.
More information: What we publish on medicines and when
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- Pre-authorisation guidance
- Guidance documents
- Templates for assessors
- Submission dates
- Post-opinion guidance
- Post-authorisation guidance
Related EU legislation
- Eudralex Volume 1 – Pharmaceutical Legislation Medicinal Products for Human Use
- EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use