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: |
Notification of intention to submit an application |
|---|
| 4 months before submission of MAA |
Applicants should consider the date of submission carefully. To notify the Agency of the intended submission date, please submit a Pre-submission request form to the European Medicines Agency for veterinary medicinal product in accordance with Regulation (EU) 2019/6 via Service Now by selecting Veterinary Regulatory > Pre-Submission-Vets. The selected scope of request should be: 'Centralised Procedure – Intent to submit a MAA'. More information: Veterinary pre-submission Q&A |
Appointment of rapporteurs |
|---|
| 4 months before submission of MAA |
The Committee for Veterinary Medicinal Products (CVMP) appoints (co-)rapporteurs to conduct the scientific assessment. More information: |
Pre-submission |
|---|
Companies that consider that a pre-submission meeting would be useful should complete the request form and submit it via EMA’s Veterinary Regulatory Service Now (instructions are included in the 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 |
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: |
Scientific evaluation |
|---|
| Up to 210 active days of assessment |
The CVMP evaluates MAA submitted through the centralised procedure. |
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 |
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. |