Variations requiring assessment (veterinary medicines)

Guidance is available from the European Medicines Agency (EMA) on variations for centrally authorised veterinary medicines requiring assessment under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6). This includes information on the documents that marketing authorisation holders will need to submit as part of the variation procedure.

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) applies from 28 January 2022. For guidance applicable under Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012, see Variations: guidance under Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012.

Marketing authorisation holders (MAH) should use the eSubmission Gateway/Web Client for all variations not requiring assessment  submitted to the Agency. For more information, including links to guidance on registration with the system see the Veterinary eSubmission website.

Separate guidance is also available on variations not requiring assessment.

Guidance

Guidance on variations requiring assessment is available below. This includes information on the documents that marketing authorisation holders will need to submit for each variation type.

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