Question to the Department for Environment, Food and Rural Affairs:

To ask His Majesty's Government what process the Veterinary Medicines Directorate uses to determine whether to grant an application to vary the marketing authorisation of a prescription-only veterinary medicine to allow over-the-counter sale.

Veterinary medicine approvals are assessed against statutory criteria for safety, quality and efficacy, as set down in the Veterinary Medicines Regulation. We assess the risks of providing products over-the-counter against the benefits and this is taken to the VPC for independent consideration.