Enforcement policy for animal medicines
This enforcement policy sets out the general principles and approach taken by the VMD.
This Enforcement Policy sets out the general principles and approach that the Veterinary Medicines Directorate (VMD) will take to enforce the Veterinary Medicines Regulations (Statutory instrument 2013 No. 2033, as amended).
The Secretary of State owns the powers provided by the Veterinary Medicines Regulations (VMR), which include powers of entry and powers of an inspector.
It is however the responsibility of the VMD to ensure these regulations are enforced in accordance with our Privacy Notice and the Regulators’ Code.
Aim
We aim to protect public health, animal health and the environment, and to promote animal welfare by assuring the safety, quality and efficacy of veterinary medicines. In accordance with the VMR the definition of a veterinary medicine is:
-
Any substance or combination of substances presented as having properties for treating or preventing diseases 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
We meet our aims through proportionate risk-based regulation, providing high quality services to stakeholders and enforcement partners.
We receive information (raw, unverified and unevaluated data) and intelligence (processed, evaluated and perspective data) from a range of sources such as the pharmaceutical industry, veterinarians, general public and other stakeholders. This data is analysed and we may share it with our enforcement partners in accordance with our Privacy Notice.
Purpose and method of enforcement
‘Enforcement’ refers to any action taken by us in relation to suspected offences under the VMR.
The purpose of enforcement is to secure compliance with the requirements of the VMR.
In keeping with Defra’s approach to better regulation and enforcement, we recognise that the best way to achieve compliance is to ensure that those carrying out regulated or unregulated activities understand their responsibilities.
We therefore seek to work with businesses and individuals to assist them in complying with the regulations through the provision of advice and guidance.
However, where necessary we will use more formal means of enforcement against a business or an individual to secure compliance, which include:
- issuing advisory and warning letters
- serving enforcement notices
- removing non-compliant listings and / or adverts from online marketplaces, websites and social media platforms
- variation, suspension or revocation of authorisations relating to authorised products and premises
- removal of veterinary practice registration
- seizure and destruction of products
- and ultimately prosecution
Principles of enforcement
This Enforcement Policy embraces the key principles of proportionality, consistency, and transparency.
Proportionality
All our enforcement action is risk-based. The enforcement action we take will be proportionate to the assessed risks associated with an illegal activity. Where we consider the risks to be low or there is no history of non-compliance, enforcement action may generally be delivered through advice.
However where the risks are considered greater, for example when dealing with an incident involving food-producing animals or antibiotics, or where similar non-compliance has previously been identified, and continues, more formal action will be considered.
Consistency
We aim to be consistent in our approach when dealing with non-compliance. Therefore, comparable non-compliances will be dealt with in a similar way.
Transparency
Offences are clearly specified in the VMR (regulation 43) and, where appropriate, the final paragraph of the Schedules to the VMR).
It is important that stakeholders, businesses and individuals understand what is expected of them, and the consequences of any non-compliance.
Therefore, through routine engagement and publication of guidance and advice, we expect stakeholders, businesses, and individuals to be aware of the relevant requirements of the VMR.
Enforcement action
Advisory and Warning letters
Advisory and warning letters are the initial steps within our enforcement process.
Letters are prepared on a case-by-case basis and aim to inform the recipient of the necessary requirements to achieve compliance with the VMR.
We will send an advisory letter where we have reason to believe an offence may have been committed, with the intention to inform and educate the recipient.
We will send a warning letter where we have evidence an offence has been committed, with the intention to ensure this activity stops.
Removal of non-compliant posts online
We assess listings and posts placed on online marketplaces and websites to ensure that they comply with the VMR. We also encourage stakeholders to report any offending content they find to us so we can investigate them further.
In cases where non-compliance is identified we seek to remove offending posts, websites, and social media content by working with the platforms hosting the material.
We work with such platforms to ensure they are aware of the requirements of the VMR, with our primary aim being to prevent any non-compliant listings from appearing in the first place.
Improvement Notices
The VMR gives inspectors the powers to serve an improvement notice on any person or business they believe is not complying with the regulations.
Depending on the seriousness of the risk, the notice may prohibit or restrict the person on whom it is served from carrying out an activity from a specific date, or require them to take measures to comply from a specific date. This will generally be at least 14 days, however in some cases an immediate stop may be required.
Immediate action or restriction with less than 14 days to comply
There may be instances where an inspector believes a person or business is failing to comply with the VMR and that the non-compliance poses a serious risk to animal or human health or of damage to the environment. In these cases they may serve an improvement notice that prohibits or restricts one or more activity until the non-compliance is reduced or rectified to a satisfactory level.
The notice will clearly set out:
- the activity which is to be prohibited or restricted
- the reasons why such prohibition or restriction is considered appropriate
- the time and date at which the prohibition or restriction is to take effect, which may be immediately
Once evidence has been provided to demonstrate that the measures specified in the notice have been taken to secure compliance, and the inspector is satisfied, the inspector will revoke the notice and inform the recipient.
Minimum of 14 days to comply
Where an inspector has assessed that immediate action is not required as outlined above, the notice will clearly set out:
- the inspector’s grounds for believing an offence has taken place
- an explanation of what the offence is
- the exact nature of the offence
- the measures that need to be taken to comply
This notice will give at least 14 days within which required corrective action must be taken to ensure compliance.
Failure to comply with an improvement notice is a further offence.
A person may appeal against being served an improvement notice to a magistrates’ court or, in Scotland to the sheriff, within 28 days or the period specified in the improvement notice, whichever ends the earlier.
The improvement notice sets out the appeals procedure.
In the case of a business authorised by us to carry out an activity, this may result in a compulsory variation, suspension, or in the most serious of cases, revocation of that business’s authorisation. For a vet practice, that may result in the revocation of the practice’s registration and removal from the register.
In this instance we will write to the business explaining the decision and outline the processes to be followed to appeal to an appointed person.
Seizure Notices
The VMR gives inspectors the power to seize veterinary medicines, anything purporting to be a veterinary medicine, any additives to which Schedule 5 applies and any intermediate feedingstuff or feedingstuffs which are not authorised in the UK, or which are not stored, manufactured or supplied correctly.
They have powers to seize computers and associated equipment, as well as documentation.
The inspector must serve a seizure notice on the person appearing to be responsible for item(s) they wish to seized which sets out details of:
- products / items they are seizing, and
- grounds for the seizure
If inspectors are not able to remove seized items immediately, they may serve a notice on the person prohibiting the products’ movement from the premises until the product is collected.
If a person believes that the items were not liable for seizure, they must notify us within 28 days of the date of seizure, setting out the grounds in full.
Prosecution
Where there is a significant risk to human or animal health or the environment or where a business or individual continues an illegal activity that has already been brought to their attention, the case may be considered for prosecution.
Investigations into such illegal activities are carried out by our enforcement officers or by officers from Defra Counter Fraud and Investigations (CFI) on our behalf. All investigations will be carried out in accordance with relevant investigative procedures.
Following an investigation and where there is sufficient evidence of an offence, the case may be referred to the Crown Prosecution Service or the Procurator Fiscal in Scotland.
A person prosecuted and found guilty of an offence under the VMR (regulation 44) is liable:
-
on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding six months or both; or
-
on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both
We may also look to work with our enforcement partners to prosecute under other regulations if further offences are identified.
Publication of Enforcement Action
We may publicise on GOV.UK enforcement notices, suspension and revocation of authorisations and approvals, and outcomes of prosecutions.
Further information
Refer to our Veterinary medicines guidance collection.
Contact
To report any illegal activities relating to animal medicines go to Report illegal animal medicine