Legal requirements for placing a veterinary medicine on the market
Placing a veterinary medicine on the market, including non-medicinal products, how to obtain advice and report non-compliance.
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.
It is an offence to place a veterinary medicine on the market unless that product has been granted 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 Secretary 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 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.
Complying with legal requirements - medicinal by presentation or function
For further guidance on whether a specific type of veterinary medicine or product requires a marketing authorisation, refer to the guidance Advertising non-medicinal veterinary products.
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
Further guidance
Advertising non-medicinal veterinary products
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.
Updates to this page
-
Guidance amended to remove references to non-medicinal veterinary products following the publishing of separate and enhanced guidance for this topic.
-
Updated to remove section for Obtaining advice.
-
Added revised Medicinal Words and Phrases document.
-
First published.