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VMD Consultation on the Draft Veterinary Medicines Regulations
CFG 09/05 rev.

Letter to Ms. Jennifer Prescott, Veterinary Medicines Directorate on 5th May 2005

Foodaware members welcome the streamlining of the UK legislation, its incorporation of the EU requirements and the attempts to clarify and simplify it in line with the principles of good regulation. As the streamlined regulations run to 115 pages, and the total consultation to significantly more than that, we comment only in general terms.

Advertising

In line with other advertising legislation, the Regulations require that advertisements must not be misleading and that any claims must be included in the product characteristics. We particularly welcome the ban on advertising prescription only medicines to the general public, but consider it important that they be given sufficient information with any medication intended for domestic animals and pets to treat them appropriately.

Food producing Animals

Regulation 8.2 makes it an offence to administer a veterinary medicinal product to a food producing animal unless it is prescribed in accordance with Schedule 3 or administered in accordance with Schedule 4. We support the requirement that all products for food producing animals should be classified as POM-V or POM-VPM so that they are subject to veterinary control. It will be important for vets and other suppliers, farm assurance inspectors and enforcement authorities to check that any medication prescribed for food producing animals is used in accordance with the data sheet, recorded in the farm records and that relevant withdrawal periods are complied with. On farm record-keeping has not in the past been adequate. We would like the VMD to liaise with Defra and the Food Standards Agency once the new regulations are in place, to ensure that new arrangements are implemented and that there is sufficient emphasis on enforcement of the new regime.

Classification

We note the VMD’s intention to reclassify medicines to make clear which may be prescribed only by vets; those which will be available from vets, pharmacists and merchants for the wholesale trade and those which will be permitted on general sale. Recognising that there are increasing numbers of para-professionals and veterinary nurses working in veterinary teams and as part of the supply chain, Foodaware members consider that the definition of Suitably Qualified Professionals should be wide enough to encompass veterinary nurses. This should help to keep the costs of medication down, while allowing different types of medicine to be administered by appropriately qualified personnel.

Members are particularly interested in how currently authorised medicines will be reclassified and wish to ensure that there will be sufficient consultation on this work as it progresses. We are concerned that there should be no weakening of existing controls on active ingredients and that the safety assessments are robust. It is important that the arrangements for fast-tracking amendments to existing data sheets should not be used to lessen public protections and that the level of scrutiny is adequate to protect users and their animals, as well as the wider public.

There is particular concern about the classification of antibiotics because of the growing problem of resistance in bacteria, animals and humans. In human medicine controls on excess use are to some extent achieved through the use of prescriptions issued by doctors and supply through pharmacies. Veterinarians are both prescribing and supplying these products (an indeed other medicines) and there is potential commercial pressure to oversupply. Members consider that the use of antibiotics in animals should be reduced as far as possible and the level of use by individual suppliers should be monitored.

Internet sales of medicines including veterinary medicines should be brought within the scope of the reclassification exercise. Members of Foodaware recognise the difficulties in controlling such sales, but are concerned about the potential for abuse in this area.

Specialist Producers

The high profile campaign by bee-keepers to be allowed to prescribe relevant treatments without any supervision and involvement by vets (who may not have a specialist knowledge of bee diseases) reflects their economic concerns. Whatever solution is found to sustain the health of the bee population in the UK, it must not be at the expense of food safety and the quality of the final product. Veterinary and other residues have been found in honey in the past. The use of medication, which can leave unacceptable residues in a food often marketed for its health giving properties, is a problem and needs control.

Foodaware is content for this response to be made publicly available.

Susan Knox
Chairperson

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