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

• Application guidance (veterinary medicines)
• Compliance: marketing authorisation
• Environmental risk assessment of veterinary medicines
• Guidance documents
• Product-information requirements for veterinary medicines
• Veterinary pre-authorisation guidance
• Submission dates (veterinary medicines)
• Assessment templates and guidance (veterinary medicines)

Steps involved in obtaining an EU marketing authorisation

1. Eligibility request and intention to submit an application

   4 months before submission of MAA

   
   To find out whether a product can be evaluated under the centralised procedure, applicants should always submit an eligibility request using the IRIS platform, accompanied by a justification and a draft SPC document.

2. Appointment of rapporteurs

   4 months before submission of MAA

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

3. Pre-submission

   
   Companies that consider that a pre-submission meeting would be useful should complete the pre-submission meeting request form and submit it via the IRIS portal, (instructions are included in the form):

   • Veterinary medicines marketing authorisation application pre-submission interaction request form

4. 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.

5. Scientific evaluation

   Up to 210 active days of assessment

   
   The CVMP evaluates MAA submitted through the centralised procedure.

6. 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.

7. 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 the public assessment report on the Veterinary Medicines Information website.

   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:

• Veterinary pre-submission Q&A
• VET eSubmission
• Pending European Commission decisions
• Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur (according to Article 62 (1) of Regulation (EC) No 726/2004)
• Veterinary medicines marketing authorisation application pre-submission interaction request form

Page update history

See update history

19 August 2026

Steps involved in obtaining an EU marketing authorisation updated to reflect the migration of veterinary regulatory business services from ServiceNow to the IRIS platform.