European Medicines Agency - Human regulatory

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.

General requirements for all applications	Particular application types
Steps involved in obtaining an EU marketing authorisation Pre-authorisation guidance Fees Product information Pharmacovigilance Compliance	Biosimilars Generic and hybrid applications Orphan medicines Paediatric medicines Advanced therapy medicinal products Medicines for use outside the EU (Article 58)

Submission of eligibility request
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
Applicants should consider the date of submission carefully, referring to the published submission dates and the guidance below: Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines To notify the Agency of the intended submission date, they should email the pre-submission request form (intent to submit MA) to pa-bus@ema.europa.eu. 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
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

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

Pre-submission meetings
Pre-submission meetings are the best opportunity for applicants to obtain procedural and regulatory advice from the Agency: Marketing authorisation application pre-submission meeting request form 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

Pre-submission meetings

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:

Marketing authorisation application pre-submission meeting request form

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

Re-confirmation of communicated submission date
Applicants should re-confirm the submission date initially communicated to EMA, or inform EMA of any delays or cancellations, following the guidance below: Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines If the planned submission date is changed, applicants must inform EMA by re-sending the completed pre-submission request form to pa-bus@ema.europa.eu, selecting 'notification of change' as the scope of the request and stating the new intended submission date in the corresponding field. Holding successful pre-submission meetings and following this guidance should enable applicants to submit applications in line with legal and regulatory requirements, speeding up the validation process. More information: Pre-authorisation guidance – section 2: Steps prior to submitting the application

Re-confirmation of communicated submission date

2-3 months before submission of MAA

Applicants should re-confirm the submission date initially communicated to EMA, or inform EMA of any delays or cancellations, following the guidance below:

Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines

If the planned submission date is changed, applicants must inform EMA by re-sending the completed pre-submission request form to pa-bus@ema.europa.eu, selecting 'notification of change' as the scope of the request and stating the new intended submission date in the corresponding field.

Holding successful pre-submission meetings and following this guidance should enable applicants to submit applications in line with legal and regulatory requirements, speeding 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.

More information:

What is eSubmission?
Pre-authorisation guidance section 4: Submission, valiadation and fees

Scientific evaluation
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

Scientific evaluation

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

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

Commission decisions are published in the Community Register of medicinal products for human use and EMA publishes a European public assessment report (EPAR).

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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Marketing authorisation

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In this section

Steps involved in obtaining an EU marketing authorisation

Submission of eligibility request

Notification of intention to submit an application

Appointment of rapporteurs

Pre-submission meetings

Re-confirmation of communicated submission date

Submission and validation of the application

Scientific evaluation

CHMP scientific opinion

European Commission decision

Related content

Related EU legislation

Related documents

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