Policy paper

Veterinary Medicines Directorate enforcement strategy

Updated 5 December 2016

This policy paper was withdrawn on 17 August 2022

Replaced by Enforcement policy for animal medicines - GOV.UK)

This Enforcement Strategy sets out the general principles and approach that the Veterinary Medicines Directorate (VMD) will take to enforce the Veterinary Medicines Regulations (VMR). The Secretary of State owns the powers provided by the VMR but it is for the VMD to ensure the regulations are enforced.

1. Introduction

The VMD is an Executive Agency of the Department for Environment, Food and Rural Affairs (Defra). The aim of the VMD is to protect public health, animal health, the environment and promote animal welfare by assuring the safety, quality and efficacy of veterinary medicines. We will meet this aim through proportionate risk based regulation, providing high quality services to relevant interest groups and utilising clear agreements with service providers.

2. The Purpose and Method of Enforcement

“Enforcement” refers to action taken by us in relation to breaches of 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, by guidance and advice, that those carrying out regulated activities understand their responsibilities. We therefore seek to work with businesses and individuals to assist them in complying with the legislation through the provision of advice and guidance. However, where necessary we will use more formal means of enforcement to secure compliance. We use a range of enforcement tools to secure compliance with the legislation. This includes advisory and warning letters, the issue of improvement and seizure notices, destruction of products, variation, suspension or revocation of authorisations or approvals, and ultimately prosecution. Enforcement action may be taken against a business or an individual.

3. The Principles of Enforcement

This enforcement strategy embraces the key principles of proportionality, consistency, transparency and targeting.

3.1 Proportionality

The enforcement action we take will be graduated and proportionate to the assessed risks associated with an activity. Where the risks are considered to be low or there is no history of non-compliance enforcement will generally be through advice. However, where the risks are greater or similar non-compliance has previously been noted, more formal action may be taken.

3.2 Consistency

We aim to be consistent in our approach when dealing with non-compliance. Therefore similar non-compliances will be dealt with in a similar fashion.

3.3 Targeting

Enforcement actions are directed at those businesses and individuals who are most likely to fail to comply with the VMR. Targeting involves risk assessment and the concentration of enforcement effort on those with the highest risk and/or lowest compliance.

4. Enforcement Action

4.1 Non-compliances

N.B Non-compliances are also referred to as deficiencies within the work of the VMD.

We will generally deal with non-compliances depending on the perceived risk, i.e. the potential to do harm, which includes risk to human and animal health or to the environment:

4.2 Advisory/Warning letters

Advisory and warning letters are the initial steps on our enforcement process. Letters are prepared on a case by case basis to ensure the reader is aware of the necessary requirements to achieve compliance with the VMR.

4.3 Improvement Notices

The VMR give inspectors the powers to serve improvement notices on any person they believe is not complying with the legislation.

The notices will clearly set out:

• how that person or business is failing to comply with the VMR
• the exact nature of the failure
• the measures that need to be taken to comply

All improvement notices will give at least fourteen days within which required measures must be taken to ensure compliance. A person who is aggrieved by an improvement notice may appeal 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. Failure to comply with an improvement notice is an offence. In the case of a business authorised or approved by the VMD 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 or approval. We will write to the business explaining the decision, the options for appeal, and outline the processes to be followed to appeal to an appointed person.

4.4 Seizure Notices

The VMR give inspectors the powers to seize veterinary medicines, anything purporting to be a veterinary medicine, additives, premixtures or feedingstuffs to which Schedule 5 applies, that may have been illegally imported, supplied, marketed or administered. Computers and associated equipment may also be seized. The inspector must serve on the person appearing to be in charge of the seized product a seizure notice which sets out details of:

• products / items that have been seized, and
• grounds for the seizure

If inspectors are not able to remove seized products immediately, they may mark the products accordingly, and serve a notice on the person appearing to be in charge of the products prohibiting the products movement from the premises until they are collected. Any person who removes products identified under such a notice is guilty of an offence. A person who is aggrieved by a seizure notice may, within 28 days of seizure, notify any claim that the product was not liable to seizure to the Secretary of State at the address specified in the seizure notice, setting out the grounds in full. Inspectors will draw this information to the attention of the person at the time the notice is served.

4.5 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 will normally be considered for prosecution.

Investigation into such illegal activities are carried out by officers from Defra Investigation Services (DIS), on behalf of the VMD. 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 will be referred to Crown Prosecution Service or Procurator Fiscal.

A person prosecuted and found guilty of an offence under the VMR 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.

4.6 Publication of Enforcement Action

We will publicise all improvement notices, seizure notices, suspension and revocation of authorisations and approvals, and outcome of prosecutions.

This information can be found on GOV.UK illegal animal medicines . The information will remain on GOV.UK for one year.