6February 2001
The UK licensing system for animalmedicines exists to protect the public, their pets and farm animals. TheNational Office of Animal Health wants more people to know about the workcompanies must undertake in order for an animal medicine to get the marketingauthorisation needed to get onto the market. It welcomes the move made by theVeterinary Medicines Directorate with its publication Veterinary Medicines - Do You Need a Marketing Authorisation?
Companies cannot offer an animalmedicine for sale through any outlet unless they have convinced the governmentthat it is safe, of high quality and that it works. The marketing authorisation number, which all products carry,designated Vm or historically PL, is effectively the products guarantee.NOAHs advice is to look for this numberwhen buying a medicine and to check and follow all the other valuableinformation on the label.
But some products being sold are,through ignorance or by design, making medicinal claims without having beenthrough the very stringent approval procedures. The VMDs new guide aims to setout exactly what is a medicine and what is not, so there will be no excuses forcompanies to break the law. There are some areas where further clarification isneeded, says the association, but the idea behind the guidance is one that NOAHstrongly supports.
A product is medicinal bypresentation if it is put onto the market indicating or recommending that ittreats or prevents disease. This recommendation could be on the label, in aleaflet, in an advertisement or even by word of mouth. The booklet sets outsome words and phrases that are understood to imply a product is medicinal, andsome that do not, to help avoid confusion. Anyproduct medicinal by presentation must have a marketing authorisation.
A product is medicinal byfunction if it is endowed with properties for treating or preventing diseasein animals, or if it may be administered to animals with a view to restoring,correcting or modifying a physiological function. The VMD may ask to seeexactly what is in a product, to see if it is covered by these criteria. Again,a product medicinal by function musthave a marketing authorisation.
But NOAH adds that support for afair approval system must not be seen as an invitation for unnecessaryregulation. There must be a balance between control and availability oflicensed animal medicines. Animal medicines keep pets healthy. They help ensurethat Britains consumers are eating healthy food from healthy farm animals. Toover-regulate is counterproductive and may only serve to drive important,strictly assessed products from the market.
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Notes for Editors
1. Forfurther information please contact Roger Cook or Alison Glennon, 020 8367 3131,or visit the NOAH website, www.noah.co.uk.
2. TheNational Office of Animal Health was formed on 1 January 1986 to represent theUK companies which research, develop, manufacture and market licensed animalhealth products. The association has 34 corporate members and 12 associatemembers. In 1999 NOAH's members accounted for around 95% of the 366 million UKanimal health market, with additional valuable exports.
3. TheVMD booklet Veterinary Medicines - Do You Need a Marketing Authorisation? isavailable from the Veterinary Medicines Directorate, Woodham Lane, New Haw,Addlestone, Surrey KT15 3LS. Forfurther information regarding authorised products contact the LicensingAdministration Branch of the VMD (Tel 01932 338432) and for information onunauthorised products contact the Licensing Policy Branch of the VMD (Tel 01932338308).