The long-awaited Veterinary Medicines Regulations have been published, and will come into force on 30 October. To help users of animal medicines understand and comply with the complex issues, the National Office of Animal Health is producing a condensed, easily understood summary which will be distributed in January to all veterinary practices, shrink-wrapped with the industry reference manual – the 2006 edition of the NOAH Compendium of Data Sheets for Animal Medicines. “The new Regulations are sensible and clear – and much more user-friendly than the original 1968 Medicines Act and the 100 subsequent amendments to the Act,” says NOAH chief executive Phil Sketchley. “In particular, we welcome the decision to have two tiers of Prescription-Only Medicine (POM) classification. “The new classification POM-VPS embraces recognition that farmers, as professional animal keepers, need access to medicines such as anthelmintics, ectoparasiticides, teat dips, and minerals from a wide choice of distribution routes – suitably qualified persons employed by animal health merchants, and pharmacists, as well as veterinary surgeons. The new regulations also permit the marketing authorisation owners to continue to communicate with these audiences to educate them about disease awareness, product usage and availability. “The education of farmers through responsible advertising of POM-V and POM-VPS medicines, and of POM-VPS medicines to horse owners, is important to raise awareness of disease control measures and to stress the role played by the responsible use of medicines in good animal husbandry practice,” he added. “NOAH has a well established and strict code of practice on promotion, to ensure advertising and promotion is undertaken in a responsible manner.” The animal medicines industry was also greatly encouraged by the decisions to make abuse of the Cascade a criminal offence and to extend the Cascade to permit use of products authorised in other EU member states and third countries, for specific conditions when licensed veterinary medicines are not available in the UK. “The Regulations have both cleared up the confusion about what is an unauthorised medicine and made it illegal not only to administer or sell, but also to possess such medicines,” said Mr Sketchley. “An unauthorised medicine is one which does not have a marketing authorisation for animal use in the UK, or which has not been prescribed properly in the UK. “From now on, it will also be a criminal offence to advertise or promote a human medicine to the veterinary profession where there is a suitable veterinary medicine. Of course a human medicine may be prescribed if there is no suitable veterinary licensed medicine available, something NOAH fully supports, but wholesalers of other human medicines may not promote them directly to the vet or encourage them to choose such a product. “This is the resolution of one of the greatest concerns of the animal medicine industry,” Mr Sketchley added. “We have always warned against the use of human medicines to treat animals when those medicines have not been evaluated for safety, efficacy and quality in the target animal species.” Other issues encompassed by the new Regulations include:
• More comprehensive record keeping
• Better controls to ensure the Regulations are enforced
• A Small Animal Exemption Scheme to bring new products for minor pet species
• More public information about animal medicines
• Pharmacovigilance and packaging
27 October 2005 Notes for Editors1. For further information contact Phil Sketchley or Alison Glennon at NOAH on 020 8367 3131, or by email noah@noah.co.uk or look at the NOAH website www.noah.co.uk 2. The Veterinary Regulations 2005 have been drawn up to implement the EU Veterinary Medicines Directive – but the Veterinary Medicines Directorate have taken the opportunity to totally overhaul the legislation governing animal medicines in the UK, taking into account the Independent Review of Veterinary Dispensing (Marsh Report) and those parts of the Competition Commission report not implemented through the separate Order from the Department of Trade and Industry. Now animal medicines will be controlled by a single set of Regulations, which will be updated and replaced every year. 3. With effect from 30 October 2005, all animal medicines are reclassified into one of four new categories: • POM-V (Prescription Only Medicine – Veterinarian) (all current POMs, MFS and a few P products) – must be prescribed by a veterinary surgeon, and can be dispensed by any veterinary surgeon or pharmacist • POM-VPS (Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person) (all current livestock PMLs, MFSX, and a few P products) – must be prescribed by a veterinary surgeon, pharmacist or SQP, and can be dispensed by any of those persons • NFA-VPS (Non-Food Animal medicine – Veterinarian, Pharmacist, Suitably Qualified Person) (all current companion animal PMLs, and a few P products) – must be supplied by a veterinary surgeon, pharmacist or SQP • AVM-GSL (Authorised Veterinary Medicine – General Sales List) (all current GSL products including, for the moment, livestock GSLs) – can be supplied by anyone 4. The National Office of Animal Health was formed on 1 January 1986 to represent the UK companies which research, develop, manufacture and market licensed animal health products. The association has 32 corporate members and 13 associate members. In 2004 NOAH's members accounted for well over 90% of the £420 million UK animal health market. | 