Veterinary pre-authorisation guidance

Guidance is available for marketing authorisation applicants for centrally authorised veterinary medicines in the form of questions and answers 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 and applicants before submitting a marketing authorisation application.

 

Guidance currently in place
 

Guidance for marketing authorisation applicants in the current legal framework (Directive 2001/82/EC and Regulation (EU) 726/2004)

Guidance under the Veterinary Medicinal Products Regulation

Guidance for marketing authorisation applicants that will apply under Regulation (EU) 2019/6, which becomes applicable on 28 January 2022

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.

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