GovWire

Legislation

The Veterinary Medicines Regulations 2013 (legislation.gov.uk) (VMR), as amended, set out the UK controls on veterinary medicines, including their manufacture, advertising, marketing, supply and administration.

It is the responsibility of anyone engaged in these activities to comply with theVMR.

TheVMRis available onLegislation.gov.uk.

Requirement for a Marketing Authorisation (MA)

TheVMRrequire that any person who places a veterinary medicine on the market does so inaccordance with anMA.

Definition of Veterinary Medicine

AVeterinary Medicineis legally defined as:

• any substance or combination of substances presented as having properties for treating or preventing disease in animals
• 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
• any substance or combination of substances that may be used for the purpose of euthanising an animal

This means that a product may be aveterinary medicineif it is:

• medicinal by presentation; in that product information, such as product labels or marketing material, gives the averagely well-informed person the impression that the product treats or prevents disease
• medicinal by function; in that it contains a substance that would have a medicinal effect

Medicinal by presentation

A product is medicinal by presentation if its appearance gives the averagely well informed person the impression that the product treats or prevents disease, or they gain that impression.

Principally, if a person placing a product on the market, or the manufacturer, or a connected third party, expressly indicates or recommends the product for treating or preventing disease, this would render the productas medicinal by presentation. This includes product labels, leaflets, websites and social media advertisements or oral recommendations, and any other forms of literature relating to the product issued before, during or after the sale.

UK case law has established that:

• the concept of presentation of a product must be broadly understood
• the presentation will be that of the manufacturer but is not limited to the terms or manner in which the manufacturer chooses to package, describe or classify the product
• when considering whether a product is medicinal by presentation, regard should be given to the warnings, express indications and recommendations on the packaging but they are not conclusive of the position
• the external form of the product may be relevant to establishing the manufacturers intention but may also be material to the impression gained by the averagely well informed person
• the method of administration is an aspect of the presentation
• if a product is not only used externally but is used internally this may be relevant to its presentation and function

A product which is medicinal by presentation must have aMAgranted by theSoSbefore it can be placed on the market unless it is covered by Schedule 6 to theVMRExemptions for small pet animals.

Medicinal words and phrases

If a product claims it will treat, prevent or control a disease it is medicinal by presentation. Certain words are considered medicinal as theyre normally associated with authorised medicines. The whole presentation of the product, including the packaging, will determine whether the words used make the product appear medicinal.

For guidance on marketing non-medicinal products:Digital media checklist(PDF,91.4KB,1 page).

Diseases and adverse conditions

If a product label refers, explicitly or implicitly, to the treatment or prevention of a disease or adverse condition, or to improving the state of health of the animal treated, it is making a medicinal claim.

References to the nutritional maintenance of a healthy animal, healthy digestive system or healthy respiratory system would not normally be regarded as medicinal claims.

Complying with legal requirements - medicinal by presentation: issues of difficulty

The following is guidance on particular points of difficulty and is not a definitive account of legal requirements.

Marketing and other promotional material

Claims made by a third party, such as magazine reviews or articles published by independent analysts, will be regarded as those of the company marketing the product where evidence confirms that the third party has a connection to the marketing company via solicitation, endorsement, sponsorship or funding.

Disclaimers

Disclaimers, for example on packaging or other marketing material, are not sufficient to prevent a product from being considered medicinal by presentation.

Reference to studies

References in marketing material to studies may cause a product to be considered medicinal if the study indicates that the product, or one of its ingredients, may have a medicinal effect or purpose.

Customer testimonials

If customer testimonials are used in connection with the marketing of a product and report results containing medicinal claims, the claims will be regarded as those of the company marketing the product.

Websites and social media

Websites and social media sites, including any chat room or forum, are considered in the same way as any other form of advertising and should not make medicinal claims for products that do not hold anMA.

UK based websites advertising a non-UK authorisedveterinary medicine, intended for sale and administration outside the UK, must clearly indicate that the products will not be sold to UK customers.

For guidance on what internet marketing material to check see themedicinal words and phrases(PDF,131KB,5 pages).

False and misleading claims

TheVMRdo not cover any claim made for an unauthorised veterinary medicine that is thought to be misleading or false but does not imply a medicinal effect.

False or misleading advertising claims about a product that is not aveterinary medicineare dealt with by local Trading Standards Officers.

Product form

The form in which a product is presented and the instructions for administration will be considered when deciding if a product is medicinal by presentation. For example, a vitamin supplement administered by injection may be considered to be medicinal by the nature of its presentation.

Packaging presentation

The appearance and design of packaging and its similarity to that of authorised medicines will be considered when deciding if a product is medicinal by presentation.

Medicinal by function

A product is medicinal by function if it is used or administered to animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action or making a medical diagnosis. Risk to health is a factor that must be taken into account when classifying a product as medicinal by function.

A product which is medicinal by function must have anMAgranted by theSoSbefore it can be placed on the market. This requirement does not apply to products marketed under Schedule 6 to theVMR.

Specific topics

Feeding stuffs intended for particular nutritional purposes

The Animal Feed (England) Regulations are enforced by local Trading Standards Officers.

Your local office (contact your local council for details) will be able to provide individual advice on these Regulations.

The Animal Feed (England) Regulations apply in England only, separate but parallel legislation is in force in Scotland, Wales and Northern Ireland.

Nutraceuticals

A nutraceutical product is a food or naturally occurring food supplement marketed as having a beneficial effect on health and is treated like any other product. They require anMA

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