§ Dr. MurrisonTo ask the Secretary of State for Environment, Food and Rural Affairs what discussions she has had with EU states concerning the mutual recognition of veterinary medicines. [108905]
§ Mr. MorleyThe main forum for discussion of issues concerning the mutual recognition of marketing authorisations for veterinary medicinal products is the Veterinary Mutual Recognition Facilitation Group (VMRFG). This meets monthly (except in August) and is attended by my officials and those from the other member states and the European Medicines Evaluation Agency (EMEA). The UK was instrumental in establishing the VMRFG in April 1997. In addition, there are a number of other EU fora at which issues relating to veterinary medicines are discussed and at which issues relating to mutual recognition may be raised.
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§ Dr. MurrisonTo ask the Secretary of State for Environment, Food and Rural Affairs what assessment she has made of the benefits of combining the Medicine Control Agency with the Veterinary Medicines Directorate, with reference to EU Directive 6565. [108906]
§ Mr. MorleyThe Department carried out a Review of its five science-based agencies, including the Veterinary Medicines Directorate (VMD), in 2002. It was published on 17 December 2002. Copies of the report are available on: www.defra.gov.uk/agency_review/index.asp
The Review explored a number of possible options on the organisational structure for VMD, including combining the Medicines Control Agency (now the Medicines and Healthcare Products Regulatory Agency (MHRA)) and VMD. Having taken account of the current assessment of business prospects, it concluded that there should be no organisational change for VMD. However, there should be a further reassessment of the option of a merger with MCA once the future role of the European Medicines Evaluation Agency in the EU's approval procedures is known.
§ Dr. MurrisonTo ask the Secretary of State for Environment, Food and Rural Affairs what assessment she has made of the cost to British industry of delays in the processing of authorisation applications by the Veterinary Medicines Directorate. [108904]
§ Mr. MorleyEuropean legislation requires member states to process applications for new marketing authorisations for veterinary medicinal products within 210 "clock" days of the submission of a valid application. "Clock days" are calendar days, including weekends and holidays but excluding any period where further information is requested and awaited from the applicant. In addition to this legal requirement, annual performance targets are agreed for the Veterinary Medicines Directorate (VMD) which, together with details of how they have been met, are published in the VMD Annual Report and Accounts. The Annual Report for 2001–02 illustrates that, during the period 1999 to 2002, the VMD met its target of determining 100 per cent. of valid applications for new UK marketing authorisations within 210 clock days in each successive year. Furthermore, during each of these years, the VMD has exceeded agreed performance targets of determining or referring to the Veterinary Products Committee (VPC) valid applications for new marketing authorisations within 120 clock days, achieving outturns of 92.2 per cent., 95.9 per cent. and 94 per cent. respectively. For 2002–03, the average time for determining or referring applications for new marketing authorisations to the VPC is 89.1 clock days. Applications are only referred to the VPC where the product is novel or where the VMD considers a marketing authorisation cannot be granted.
In the light of the VMD's performance in processing applications I do not consider an assessment of the cost to British industry of delays in the procedures to be appropriate.
§ Dr. MurrisonTo ask the Secretary of State for Environment, Food and Rural Affairs what assessment she has made of the impact on British industry of 41W disallowing alternative presentations of single products in the marketing authorisation of parent producers by the Veterinary Medicines Directorate. [108907]
§ Mr. MorleyThe Veterinary Medicines Directorate ceased to accept applications to include alternative presentations in single marketing authorisations in April 1997. The decision to do so was made to bring UK procedures into line with those of the other member states and procedural guidance produced by the European Commission. It was considered that the practice of allowing alternative presentations on marketing authorisations was not compatible with European harmonised procedures and could be detrimental to holders of UK marketing authorisations who wished to apply to have them recognised in other member states under the mutual recognition procedures. It was further considered that facilitating easier access to the markets in other member states through the mutual recognition procedures would counterbalance any resulting additional costs to British industry.