To inwardly digest:-
LEGISLATIVE FRAMEWORK
1. Directive 2001/82/EC as amended by Directive 2004/28/EC, prohibits the advertisement of veterinary medicinal products that are available only on veterinary prescription, or contain psychotropic drugs or narcotics, to the general public.
REQUIREMENTS UNDER UK LEGISLATION
2. The Veterinary Medicines Regulations 2005 have implemented the Directive’s requirements to allow the advertisement of products that contain psychotropic drugs or narcotics to:
• veterinary surgeons only.
3. The Regulations allow the advertisement of products distributed under the POM - V (Prescription Only Medicine - Veterinarian) category to:
• veterinary surgeons,
• pharmacists,
• professional keepers of animals
Professional keepers of animals are those whose primary means of earning a living is through keeping animals, for example farmers.
4. The Regulations allow the advertisement of products distributed under the POM-VPS (Prescription Only Medicine - Veterinarian, Pharmacist, Suitably Qualified Person) category to:
• veterinary surgeons,
• pharmacists,
• suitably qualified persons (SQP’s),
• other veterinary healthcare professionals,
• professional keepers of animals,
• owners or keepers of horses.
The term “other veterinary healthcare professionals” includes veterinary nurses.
5. The provisions in the Regulations include an exemption for price lists of veterinary medicinal products and so the displaying of POM-V and POM-VPS price lists in veterinary surgeries,
as required by the Supply of Relevant Veterinary Medicinal Products Order 2005 (SI 2751/2005) is permitted.
6. As a rule of thumb it is accepted that specialist journals and other media will be read by people other than the target audience. Provided the advertisement is aimed primarily at a group who are allowed to receive such advertising then it may continue to be published.
7. The publication of informative and educational information by marketing authorisation holders is acceptable, provided there is no specific promotion of a product, other than the linkage permitted by a strap line to say the information ‘had been provided by [company] manufacturers of product [brand name]’. Thus it would be possible to provide information to the public about a disease, its symptoms and how to prevent or treat it without the material being classified as advertising.
8. It is an offence under the Regulations to advertise a veterinary medicinal product if the advertisement is misleading or contains any medicinal claim that is not in the summary of product characteristics (SPC).
ADVERTISING HUMAN PRODUCTS FOR ADMINISTRATION UNDER THE CASCADE
9. It is an offence to advertise a human medicine for administration to animals. This includes sending a price list of, or including, human medicines to a veterinary surgeon or veterinary practice.
10. However, wholesale dealers are permitted to send information, including price lists, about human medicines, when requested by a veterinary surgeon who wishes to use the medicines under the veterinary prescribing cascade. When providing any such information, wholesale dealers may only provide information on the type of products requested by the veterinary surgeon, and must clearly state on the information sent that the product is not an authorised veterinary medicinal product and may only be administered by a veterinary surgeon under the prescribing cascade. The information given may only relate to products that can legally be administered under the cascade and so, for example, may not include information on human medicines which are generic copies of an authorised veterinary medicinal product. It is an offence to supply a medicinal product authorised for human use for administration to an animal, other than in accordance with a prescription from a veterinary surgeon for administration under the prescribing cascade.
STATUTORY DEFENCE
11. Under the Regulations, it is considered a defence for a person whose business it is to publish or arrange for the publication of advertisements, to prove that he received the advertisement in the course of ordinary business and did not know, or have reason to suspect that its publication would be an offence.
OTHER AUTHORISED PRODUCTS
12. There are no restrictions on the advertising of products which are distributed under the NFA - VPS (Non-Food Animal - Veterinarian, Pharmacist, Suitably Qualified Person) or AVM - GSL (Authorised Veterinary Medicine - General Sales List) categories. Lists of authorised products in their distribution categories will be available on the VMD web site at
www.vmd.gov.uk after the Regulations come into force on 30 October 2005 and they will be updated regularly.
