Question to the Department for Environment, Food and Rural Affairs:
To ask His Majesty's Government what documents are provided by the Veterinary Medicines Directorate to the Veterinary Products Committee to enable them to assess whether an application to vary the marketing authorisation of a prescription-only veterinary medicine to allow over-the-counter sale can be granted.
The VMD provides the VPC with the assessment report (as peer-reviewed and agreed by the internal scientific review committee). The assessment report includes a benefit-risk assessment and conclusion as to whether the VMD consider that the variation to lower the distribution category should be granted.