Marketing authorisation (veterinary medicines)
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
Steps involved in obtaining an EU marketing authorisation
Submission of eligibility request |
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| 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: |
Notification of intention to submit an application |
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| 4 months before submission of MAA |
Applicants should consider the date of submission carefully, referring to the published and the guidance below:
To notify the Agency of the intended submission date, they should email the
More information: Veterinary pre-submission Q&A |
Appointment of rapporteurs |
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| 4 months before submission of MAA |
The Committee for Medicinal Products for Veterinary Use (CVMP) appoints (co-)rapporteurs to conduct the scientific assessment.
More information: |
Pre-submission |
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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: Veterinary pre-submission Q&A |
Submission and validation of the application |
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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: |
Scientific evaluation |
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| Up to 210 active days of assessment |
The CVMP evaluates MAA submitted through the centralised procedure. |
CVMP scientific opinion |
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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 |
European Commission decision |
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| 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. |