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

To ask His Majesty's Government, further to the Written Answer by Lord Benyon on 13 July (HL9237), what is the process for members of the Veterinary Products Committee to question the Veterinary Medicines Directorate’s assessors following receipt of the assessment report; what criteria the Veterinary Medicines Directorate uses to determine whether any potential increased risks to (1) animal health, (2) public health, or (3) the environment, can be suitability mitigated; and what criteria the Veterinary Medicines Directorate uses to assess the potential benefits of allowing over-the-counter sale, especially when the non-prescription category is already established.

If a product is referred to the Veterinary Products Committee (VPC) for advice, the VPC will be provided with a briefing document. Relevant scientific assessors will attend the VPC meeting and respond to questions by VPC members as directed by the VPC Chair.

Legislation and published guidance set out the information (including data, scientific studies and risk assessments) that applicants must provide for a new marketing authorisation or change to an existing marketing authorisation. Each part of the dossier is supplemented by a critical overall summary prepared by an appropriate scientific expert commissioned by the applicant. The VMD assess the data package against the same guidance. Every year a sample of VMD assessment reports is reviewed by the VPC to score the VMD’s assessment of the application against criteria in the areas of: quality, efficacy and target species safety, safety to the user and consumers, environmental safety and overall benefit risk.

If a non-prescription category is already established, another product will normally be allowed to have the same distribution category provided it contains the same active substance, is the same pharmaceutical presentation, and for the same species. Should information become available at any stage post-authorisation that potentially impacts the benefit-risk balance, the VMD can review the marketing authorisation(s) and require changes and/or suspend a product (or group of products) to protect animal health, public health and the environment.