Scientific advice for veterinary medicines

The European Medicines Agency can give scientific advice to companies on the appropriate tests and studies in the development of veterinary medicines. This is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines.

Added on June 2024
'Parallel scientific advice with the United States' section

For veterinary medicines, EMA's Committee for Medicinal Products for Veterinary Use (CVMP) provides scientific advice at the recommendation of the veterinary Scientific Advice Working Party (SAWP-V).

To find information on fees payable for scientific advice go to:

• Fees payable to the European Medicines Agency

Guidance and deadlines

EMA provides guidance to help medicine developer submit their applications for scientific advice and a template to present their scientific questions.

European Medicines Agency guidance for companies requesting scientific advice (veterinary)

Reference Number: EMA/CVMP/11887/2020

Scientific advice request template

Reference Number: EMA/CVMP/SAWP/11888/2020Summary:

Scientific advice request template (veterinary)

Applicants can find the submission deadlines in the following document:

Veterinary Scientific Advice procedure - submission deadlines 2024

Reference Number: EMA/CVMP/SAWP/492656/2023

Apply using IRIS platform

Medicine developers should use EMA's secure online IRIS platform to request scientific advice from EMA:

• IRIS platform

The platform provides a single space for applicants and EMA to:

• submit requests, 
• communicate and share information,
• Deliver documents concerning a scientific advice procedure.

Prior to use the platform to apply for scientific advice, medicine developers need to complete the registration steps:

Quick interactive guide to IRIS registration process

Summary:

Quick interactive guide to IRIS registration process: This presentation is interactive. Please follow the instructions and click on the appropriate icon to be directed to the relevant section.

Further guidance on how to register and make regulatory submissions using IRIS is available on the platform's homepage and in the videos under the expandable panels below (click on the title of each panel to access them).

Register for access to IRIS

Request scientific advice for veterinary medicines using IRIS

Parallel scientific advice with the United States

EMA and the United States’ Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) offer parallel scientific advice procedures to developers of veterinary medicines who intend to apply for authorisation of their products in both regions.

This joint programme enables applicants to exchange views on scientific issues with both authorities simultaneously during the development phase of a new veterinary medicine.

Parallel scientific advice procedures can:

• provide a deeper understanding of regulatory decisions;
• optimise product development;
• avoid unnecessary testing replication or unnecessary diverse testing methodologies.

These procedures are based on the confidentiality arrangement between the European Commission, EMA and FDA-CVM.

From June 2024, the programme includes more defined timelines, an additional meeting between the medicine developer and both authorities, and preliminary written feedback to the medicine developer.

For more information, including on the related timetable, see:

General principles EMA-FDA parallel scientific advice (animal drug products)

EMA and FDA-CVM parallel scientific advice timetable