Legal terms for veterinary medicines, marketing of non-medicinal products including medicinal words and phrases, how to complain (formally VMGN 1).
The Veterinary Medicines Regulations (VMR) 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.
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.
Administration of products
The VMR prohibit the administration of a veterinary medicine unless:
- it is the subject of an MA
- it has been registered under the scheme for homeopathic remedies, or has been notified to the VMD for inclusion on the “grandfather rights” list
- it is exempt from the requirements of an MA under the small pet animal exemption scheme
- it has been imported by a vet or his agent for the purpose of administration under the cascade
Further restrictions apply in the case of food-producing animals.
Exceptions are provided for products administered for research purposes in accordance with a certificate granted by the Secretary of State (SoS) or administered in accordance with the provisions of the VMR (including the cascade).
Definition of Veterinary Medicinal Product (VMP)
A VMP 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
This means that a product may be a VMP if it is:
- medicinal by presentation; in that it gives the averagely well-informed person the impression that the product treats or prevents disease
- medicinal by function
Medicinal by presentation
A product is medicinal by presentation if it gives the averagely well informed person the impression that the product treats or prevents disease, or they gain that impression.
This means that if a person placing the product on the market, or the manufacturer, or a connected third party, expressly indicates or recommends the product for treating or preventing disease, the product is 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.
European and 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 SoS or the European Medicines Agency (EMA) 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:.
Diseases and adverse conditions
If a product refers, expressed or implied, 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 medicinal claims.
For example, medicinal claims include a reference to the treatment or prevention of scours, mastitis, colic, footrot, laminitis, eczema, or to stress related to nervous conditions such as hyperactivity, or any other condition which is not the normal state of a healthy animal.
References to the nutritional maintenance of a healthy animal, healthy digestive system or healthy respiratory system would not normally be regarded as medicinal claims.
The term disease is defined as follows in Ballières’s veterinary dictionary (Blood & Studdert, Baillère Tindall, 1988):
disease traditionally defined as a finite abnormality of structure or function with an identifiable pathological or clinicopathological basis, and with a recognizable syndrome of clinical signs. It’s cause is more often than not unknown.
This definition has long since been widened to embrace subclinical diseases in which there is no tangible clinical syndrome but which are identifiable by chemical, haematological, biophysical, microbiological or immunological means. Today the definition is used more widely still to include failure to produce at expected levels in the presence of normal levels of nutritional supply and environmental quality. It is to be expected that the detection of residues of disqualifying chemicals in foods of animal origin will also come to be included within the scope of disease.
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 (eg 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 (eg. on packaging or other marketing material) are not sufficient to prevent a product from being considered medicinal by presentation if they:
- declare the product not to be a VMP
- declare that any claims made are not intended to present the product as medicinal
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.
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 VMP, 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.
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 VMP are dealt with by local Trading Standards Officers under the Trade Descriptions Act 1968.
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.
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 or the EMA before it can be placed on the market. This requirement does not apply to products marketed under Schedule 6 to the VMR.
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.
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 which contain substances that kill insects or external parasites (eg. pyrethrins, pyrethroids or organophosphate compounds) as they are medicinal by function
- a veterinary product claiming to have, or which has, the function of, control of internal parasites
- a veterinary product 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 (eg. 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
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 for animals are subject to the general definition of veterinary medicines. Products that do not make specific medicinal 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 will be considered to be medicinal.
A product 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.
A product labelled as a disinfectant which does 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 HSE under the Biocidal Products Regulations.
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.
A new homeopathic veterinary remedy to be 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 VMP and therefore requires an MA.
The withdrawal of fluid or tissue for diagnostic purposes and laboratory diagnostic tests are not considered medicinal.
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 or immunity, does not require an MA.
Further information on the importation of bovine colostrum and colostrum based products can be found on the European Union Law website (EUR-Lex) or by contacting the Specialist Service Centre for Imports on telephone number 01245 398298 or e-mail AHITChelmsford@animalhealth.gsi.gov.uk.
Products excluded from the scope of the Regulations
The VMR do not apply to:
- inactivated immunological VMPs that are manufactured from pathogens or antigens obtained from an animal and used for the treatment of that animal or other animals on the same site
- veterinary medicines based on radioactive isotopes
If you are in any doubt as to whether a specific product requires an MA you will be able to obtain confirmation from the VMD through a formal process. There is a fee for this procedure, the details can be found on the Fees for the provision of advice relating to marketing authorisations page.
It is not mandatory to seek formal confirmation of a product’s status before it is placed on the UK market. However, should a product be placed on the market without an MA and it is deemed to be a veterinary medicine, enforcement action will be taken which could result in the product being seized without compensation.
How to apply
Eachshould be signed by the applicant or in the case of a corporate body by a proper officer and be accompanied by the supporting information referred to in the application form.
Applications may be submitted electronically by email to: firstname.lastname@example.org or in duplicate hard copy to the Enforcement team.
All relevant information submitted in support of such applications is treated as commercially confidential.
Each application will be acknowledged and validated to check that all necessary information has been supplied within 10 calendar days of receipt.
Once the application has passed validation it will be considered by VMD staff. You will be informed within 30 calendar days of the VMD’s view on whether an MA is required, or will be asked to provide further information.
You will be sent a formal letter confirming whether an MA is required or not. This decision is only valid based on the documentation submitted as part of the application. Small changes to any of the information provided could invalidate the decision.
On receipt of a valid application, the VMD will send an invoice to the applicant for each product in the application.
Marketing and administration in exceptional circumstances
The VMR provide that, where the health situation so requires, the SoS may authorise the marketing or administration to animals of a VMP authorised in a country other than the UK.
Exemption from prescription requirement for certain food animal products
Veterinary medicines for food-producing animals would normally be required to be available only on prescription (either POM-V or POM-VPS). However, a product for a food- producing species may be exempted from this requirement if it meets all of the following criteria:
- the administration of a VMP is restricted to formulations requiring no particular knowledge or skill in using the products
- the VMP does not present a direct or indirect risk, even if administered incorrectly, to the animal or animals treated, to the person administering the product or to the environment
- the summary of product characteristics (SPC) of the VMP does not contain any warnings of potential serious side effects deriving from its correct use
- neither the VMP nor any other product containing the same active substance has previously been the subject of frequent serious adverse event reporting
- the SPC does not refer to contra-indications related to other VMP commonly used without prescription
- the VMP is not subject to special storage conditions
- there is no risk for consumer safety as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly
- there is no risk to human or animal health as regards the development of resistance to antimicrobials or anthelmintic substances even where the veterinary medicinal products containing those substances are used incorrectly
The VMR provide for enforcement activities. They include provision for the appointment of enforcement officers and powers to carry out enforcement activities including powers of entry, inspection of premises, examination of records and documents, taking of samples and seizure of products. The VMR require MA holders to allow authorised enforcement officers to carry out their duties and exercise their powers as appropriate.
Report an animal product that is marketed as a medicine. Complete an unauthorised product complaint form and email to email@example.com.
If a product does not fall within the definition of a VMP 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
For further information regarding unauthorised products contact the Unauthorised Products team, email: firstname.lastname@example.org or Tel: 01932 338308 / 338410