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)
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 Veterinary pre-submission meeting request form - in accordance with Regulation (EU) No 2019/6 and the guidance below: To notify the Agency of the intended submission date, please submit a Presubmission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application 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 |
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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. |