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

To ask His Majesty's Government what criteria the Veterinary Products Committee uses to recommend whether an application to vary the marketing authorisation of a prescription-only veterinary medicine to allow over-the-counter sale be granted.

The VPC review VMD’s assessment and conclusion (they may question the assessors if necessary) and provide an opinion as to whether they agree (or not) with the VMD’s conclusion to grant (or not) the lower distribution category.

The VMD consider the VPC’s advice and make a final decision as to whether an application to vary the marketing authorisation of a prescription-only veterinary medicine to allow over-the-counter sale is granted.

The criteria for the VMD’s decision are that:

• the non-prescription category must be legally permitted, and
• the benefit-risk balance must remain favourable, i.e. any potential increased risks to animal health, public health or the environment, due to increased availability and absence of veterinary point of supply advice, can be suitability mitigated.