Marketing authorisation

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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

 

 Steps involved in obtaining an EU marketing authorisation

 

Submission of eligibility request

Up 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: 

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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 vet.applications@ema.europa.eu. The selected scope of request should be: 'Centralised Procedure – Intent to submit a MAA'.

 

More information: Veterinary pre-submission Q&A

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Appointment of rapporteurs

7 months before submission of MAA

The Committee for Medicinal Products for Veterinary Use (CVMP) appoints (co-)rapporteurs to conduct the scientific assessment. 

 

More information: 

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Pre-submission 

 

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: Veterinary pre-submission Q&A

 

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Submission and validation of the application

Applicants submit the application to the Agency.

 

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:

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Scientific evaluation

Up to 210 active days of assessment

The CVMP evaluates MAA submitted through the centralised procedure.

 

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CVMP scientific opinion

After the evaluation, the CVMP 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

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European Commission decision

Within 67 days of receipt of CVMP opinion

Commission decisions are published in the Community Register of medicinal products for veterinary 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.

 

 

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Contact point

Veterinary applications team
European Medicines Agency
Tel. +44 (0)20 3660 6000
Fax +44 (0)20 3660 5545
E-mail: vet.applications@ema.europa.eu