Veterinary pre-authorisation guidance

Guidance is available for marketing authorisation applicants for centrally authorised veterinary medicines in the form of questions and answers (Q&As) from the European Medicines Agency (EMA). 

These Q&As provide an overview of EMA's advice on issues that are typically addressed in discussions or meetings with applicants before submitting a marketing authorisation application and throughout the assessment.


Guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)

Guidance for marketing authorisation applicants under Regulation (EU) 2019/6. This applies for procedures submitted on or after 28 January 2022.

Guidance under Directive 2001/82/EC and Regulation (EU) 726/2004

Guidance for marketing authorisation applicants on applications submitted on or before 27 January 2022 to be concluded in accordance with Directive 2001/82/EC and Regulation (EU) 726/2004.

Pre-submission meetings

EMA emphasises the importance of pre-submission meetings, around seven months prior to the anticipated date of submission of the application.

These are a vital opportunity for applicants to obtain procedural, regulatory and legal advice from the Agency.

EMA's pre-authorisation guidance and successful pre-submission meetings should enable applicants to submit applications that conform with regulatory requirements and can be validated speedily.

Pre-submission meetings also enable applicants to establish contact with the Agency staff who will be involved with the application.

To request a pre-submission meeting, use the request form below.

How useful was this page?

Add your rating