Legal requirements for placing a veterinary medicine on the market

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 the VMR.

The VMR is available on Legislation.gov.uk.

Requirement for a Marketing Authorisation (MA)

The VMR require that any person who places a veterinary medicine on the market does so in accordance with an MA.

Definition of Veterinary Medicine

A Veterinary Medicine is 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 a veterinary medicine if 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 product as 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 manufacturer’s 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 a MA granted by the Secretarythe SoS before of State before it can be placed on the market unless it is covered by Schedule 6 to the VMR Exemptions 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 they’re 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, 74.8 KB, 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 an MA.

UK based websites advertising a non-UK authorised veterinary 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 the Medicinal words and phrases (PDF, 241 KB, 6 pages)

False and misleading claims

The VMR do 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 a veterinary medicine are 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 an MA granted by the SoS before it can be placed on the market. This requirement does not apply to products marketed under Schedule 6 to the VMR.

ComplyingSpecific withtopics

Feeding legalstuffs requirementsintended -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 an MA if medicinal claims are made or if they contain certain ingredients that exert a pharmacological effect on the target animal.

Biocides, insecticides and repellents

The following require an MA:

• a veterinary product administered to an animal, which contains a substance that kill insects or external parasites, such as pyrethrins, pyrethroids or organophosphate compounds, as they are medicinal by presentationfunction
• a veterinary product claiming to have, or which has, the function of, control of internal parasites
• a veterinary product administered to an animal, claiming to treat or prevent a disease caused by a viral, bacterial or fungal infection

The following do not require an MA:

• a product containing a repellent, such as diethyltoluamide or ethylhexanediol, provided they claim only to repel external insects
• a product applied only to housing or bedding
• a topical disinfectant applied to intact skin provided they do not claim to treat or prevent disease

The marketing of these products are covered by legislation on biocides. For further guidanceinformation onrefer whetherto the Chemicals Regulation Directorate, email Biocides@hse.gsi.gov.uk or enquiries@hse.gov.uk.

Shampoos

A shampoo for animals will be considered medicinal if it contains an insecticide or an ingredient which has a pharmacological effect or is presented as an insecticidal shampoo. Reference to skin conditions such as seborrhoea and dermatitis are medicinal and should not be made in connection with an unauthorised shampoo.

Cosmetic products

Cosmetic products for animals are subject to the general definition of veterinary medicines. Products that do not make specific typemedicinal claims and are used for cosmetic purposes only, such as colouring shampoos and hoof oils, are not considered to be veterinary medicines as long as they do not contain any pharmacologically active ingredients.

Teat and udder products

A product applied internally to teats and udders for the prevention of mastitis is considered to be a veterinary medicinemedicine.

A orproduct applied topically to disinfect teats and udders and for which no medicinal claims are made, does not require an MA. These are regarded as biocidal products and dealt with by the Health and Safety Executive (HSE) under the Biocidal Products Regulations.

Disinfectants

A product requireslabelled as a marketingdisinfectant authorisation,which referdoes not claim to treat or prevent disease does not require an MA. However, disinfectants may be regarded as biocidal products and can be dealt with by the guidanceHSE [Advertisingunder non-medicinalthe Biocidal Products Regulations.

Herbal products

Herbal products are treated like any other products. They require an MA if they are medicinal by presentation or function. For example, a product containing pyrethrum, pyrethrins or alkaloids, such as digoxin from Digitalis sp., would be considered medicinal by function.

Homeopathic remedies

A new homeopathic veterinary products].remedy placed on the market must either be registered under the homeopathic registration scheme or have a full MA. A homeopathic product on the market prior to 1 January 1994 may remain on the market provided no medicinal claims are made.

Diagnostic tools (testing kits)

Any substance, or combination of substances administered to animals with a view to making a medical diagnosis is a veterinary medicine and therefore requires an MA.

The withdrawal of fluid or tissue for diagnostic purposes and laboratory diagnostic tests are not considered medicinal.

Colostrum

Manufactured colostrum, including that from cows that have been treated to ensure the colostrum will contain particular antibodies, require an MA.

A colostrum or colostrum based product containing pure colostrum, provided that no reference is made to disease, immunoglobulin, antibodies, IgA, IgG or immunity, does not require an MA.

Products excluded from the scope of the Regulations

The VMR do not apply to:

• a veterinary medicinal product based on radio-active isotopes

• a product intended for administration in the course of a procedure licensed under the Animals (Scientific Procedures) Act 1986, except that, if the animals are to be put into the human food chain, the only products that may be administered to the animals are:

  • authorised veterinary medicinal products administered in accordance with their marketing authorisation; or
  • products administered in accordance with an animal test certificate granted under VMR paragraph 9 of Schedule 4.

Reporting non-compliance

Use our online reporting forms to:

• report any suspected breach of the VMR
• Report an animal product that is marketed as a medicine

The VMD’s Enforcement Section coordinates reports of suspected breaches of the VMR. The information and intelligence we receive is analysed and may be shared with our enforcement partners with the aim of protecting public health, animal health and the environment, and to promote animal welfare by assuring the safety, quality and efficacy of veterinary medicines.

Anonymous reporting

You can submit an anonymous report to us through:

• the online reporting form and selecting the anonymous option
• our telephone Hotline on 01932 338 338

Please be aware that if you use this option and there is not enough information in your report, we may be limited on the action we can take regarding your concern.

We do not disclose where reports originate.

Other Legislation

If a product does not fall within the definition of a veterinary medicine care should be taken to ensure that it meets the requirements of any legislation which might be relevant, such as:

• The Food and Environment Protection Act as amended
• The Control of Pesticides Regulations as amended
• The Biocidal Products Regulations as amended
• The Animal Feed (England) Regulations as amended

FurtherContact and further guidance

LinkFor tofurther Linkinformation toregarding [Advertisingany non-medicinalof veterinarythe products]above topics contact the Enforcement Section, enforcement@vmd.gov.uk 

For information relating to authorised veterinary products see the Product Information Database or email your enquiry to postmaster@vmd.gov.uk.

For information on authorisation routes and how to apply for a marketing authorisation refer to the guidance; Marketing authorisations for veterinary medicines.

For information on advertising; Advertise veterinary medicines legally.

For information on the retail of veterinary medicine; Retail of veterinary medicines.