Marketing authorisation

  • Email
  • Help

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. 

United Kingdom’s (UK) withdrawal from the EU

EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the European Economic Area (EEA). For more information, see UK’s withdrawal from the EU.

In this section

General requirements for all applicationsParticular 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

Arrow

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 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

Arrow

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

Arrow

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

 

Arrow

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:

Arrow

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

Arrow

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

Arrow

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

 

How helpful is this page?

Average rating:

 Based on 100 ratings

Add your rating:

See all ratings
8 ratings
4 ratings
2 ratings
13 ratings
73 ratings
    

Tell us more

Related content

Related EU legislation

Related documents

Contact point:

General questions:
Send a question to EMA

Application questions:
Product and application business support
Email: pa-bus@ema.europa.eu