Unauthorised (borderline) Products
Part 1, Regulation 2 of the Veterinary Medicines Regulations (VMR) defines a "Veterinary medicinal product" as:
any substance or combination of substances presented as having properties for treating or preventing disease in animals; or
any substance or combination of substances that may be used in, or administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
Conversely veterinary products may be considered non-medicinal if they fulfil the following two requirements:
The product is not medicinal by function;
The product is not medicinal by presentation.
Medicinal by Function
A product is medicinal by function if it possesses recognised properties for treating or preventing disease in animals or if it may be administered to animals with a view to restoring, correcting or modifying a physiological function.
Products may also be considered medicinal by function due to their route of administration. For example a vitamin supplement administered by injection would be considered medicinal by function.
All products that are medicinal by function must be authorised under the VMR before they can be placed on the market.
Medicinal by Presentation
A product is medicinal by presentation if it indicates or recommends it is for treating or preventing disease, or for restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic effect. This may be by way of product labelling, leaflets, advertisements or by testimonials, or by other forms of literature, relating to the product issued before, during, or after the sale.
In the absence of express indications or recommendations such as those described above, a product is also medicinal by presentation if it gives the averagely informed person the impression that the product treats or prevents disease.
All products which are medicinal by presentation must be authorised under the VMR before they can be placed on the market.
A non-medicinal product should be presented for health maintenance purposes or to maintain or support the healthy function of a physiological system. Non-medicinal products should not be associated with diseases or adverse conditions.
Reference expressed or implied to the treatment or prevention of a specific disease, or adverse condition, or to improving the condition of the animal treated may be considered a medicinal claim. Such a reference, for example to the treatment or prevention of scours, mastitis, colic, foot rot, laminitis, eczema, and also to stress related to nervous conditions such as hyperactivity, or any other condition that is not the normal state of a healthy animal, would amount to a medicinal claim.
For further information please see VMGN 01 - Controls of Veterinary Medicines or contact the Enforcement Team - email@example.com.
Reporting unauthorised (borderline) products
To report a possible offence relating to the marketing of an unauthorised veterinary product which may be medicinal by function or by presentation, please complete an Unauthorised Product Complaint form.