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 (HL9238), what is the makeup of the Veterinary Medicines Directorate’s internal scientific review committee; what process and criteria the scientific review committee follows to develop its assessment report; and what documents are provided to the scientific review committee by Veterinary Medicines Directorate assessors.

The scientific review committee for pharmaceutical products is chaired by the Head of Pharmaceuticals. Membership includes all pharmaceutical assessors (quality, safety and efficacy), representatives from Regulatory Affairs, Pharmacovigilance, and other government bodies including the UK Health Security Agency, Health and Safety Executive, Food Standards Agency, Environment Agency, and the Department of Agriculture, Environment and Rural Affairs of Northern Ireland. Other agencies may also be invited on an ad hoc basis.

The documents for the formal review meeting include the assessment report, list of questions to be addressed by the applicant and an executive summary which highlights the main issues and the benefit-risk conclusion.

The scientific review committee provides a formal peer -review forum, where each application is summarised, and key issues raised and discussed. The operation of the committee is described in internal operating procedures. Formal minutes are produced. The committee output is to endorse the list of questions for the applicant, decide whether these are likely to be resolvable, agree the benefit-risk conclusion and decide whether or not further scientific advice from the Veterinary Products Committee should be sought.

Similar scientific committee and processes are in place for non-pharmaceutical products (immunological and biological products).