Submission dates (veterinary medicines)
VeterinaryRegulatory and procedural guidanceMedicines
Recommended submission dates and guidance are available from the European Medicines Agency (EMA) to help marketing authorisation applicants for veterinary medicines plan when to submit their application. This aims to ensure that the assessment process is as efficient as possible.
Appropriately timed applications help ensure that the assessment process is as efficient as possible for all parties involved, including marketing authorisation applicants, marketing authorisation holders (MAHs), EMA and the members and experts of its Committee for Veterinary Medicinal Products (CVMP).
EMA advises applicants to consider the date of submission very carefully, particularly for full applications, and to observe the joint guidance from EMA and Heads of Medicines Agencies below:
The use of electronic Application Forms (eAF) is mandatory for all application procedures (authorisations and variation requiring assessment). It is also mandatory for applicants to use the eSubmission Gateway / Web Client for all veterinary procedural submissions to the Agency. For more information, including links to guidance on registration with the system, see:
Deadlines and timetables
Timetables are published as a generic calendar and serve to inform applicants, MAHs, EMA, CVMP members and assessment teams. The full list of recommended submission dates is available below: