Worksharing of variations (veterinary medicines)

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The worksharing procedure enables marketing authorisation holders for veterinary medicines to combine the same variations affecting different medicines into a single application, irrespective of the authorisation route of the medicines. Guidance is available from the European Medicines Agency (EMA) on this procedure in the form of questions and answers.

Worksharing only applies for Variations requiring assessment (veterinary medicines)

This guidance applies under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), which is applicable from 28 January 2022. 

Applicants should use the eSubmission Gateway / Web Client for all variations requiring assessment submitted to EMA. For more information, including links to guidance on registration with the system see the Veterinary eSubmission website.

Separate guidance is also available on Variations: guidance under Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012.

Questions and answers

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