Corporate report

How the Veterinary Medicines Directorate meets the Regulators’ Code

Updated 2 September 2025

1. Our Regulatory Activities

Our regulatory activities are underpinned by a range of powers set out in Veterinary Medicines Regulations 2013 (as amended) (VMR).

The VMR sets out the controls on the manufacture, authorisation, marketing, distribution and post-authorisation surveillance of veterinary medicines. The regulations are periodically amended and supplemented after consultation with interested groups to ensure that they are up-to-date and fit for purpose.

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2. Supporting those we regulate to comply and grow

2.1 Costs to the industry

We are legally obliged to recover the full economic costs of the regulatory work we carry out, in accordance with HM Treasury rules on fees and charges. Our fees are set in the VMR. We monitor and regularly revise the fees for each service we provide to ensure, as far as possible, that they reflect the cost of the work we undertake. We consult publicly on proposed changes to the VMR and produce impact assessments which consider the impact our fees have on those we charge.

We seek opportunities to improve our efficiency and service delivery, reduce regulatory burden, and to detect improper veterinary medicines sales and associated unfair competition to the industry.

2.2 Quality and staff competence

We recruit staff with the appropriate specialist skills, qualifications and experience, and all staff are required to comply with an annual Learning and Development Plan, which includes mandatory training in such topics as: Civil Service Expectations, and Security and Data Protection.

Good regulatory practice is built into our work and is supported by documented policies and procedures, as part of our ISO 9001 certified Quality Management System and ISO 27001 certified Information Security Management System.

3. Providing ways to engage and listen

3.1 Information sharing and engagement

Our information sharing and engagement plans ensure that we take a consistent, co-ordinated and comprehensive approach to communicating to, and engaging effectively with, those we regulate and those operational delivery partners that assist us in delivering our priorities - our stakeholders. This includes:

• holding regular open and other webinars and workshops
• publishing information on GOV.UK (which has a ‘sign up to alerts’ function) and on social media
• meeting with individual companies on request
• regular meetings with stakeholder representative groups
• giving presentations or holding workshops at industry-led events
• having an exhibition stand at industry events
• consulting prior to any changes to our legislation
• directly emailing quarterly VMD Bulletins to stakeholders

3.2 Service standards

Our Service Standards sets out what users of our services and other stakeholders can expect from us. It also explains what can be done if a user feels that we have not met these standards.

3.3 Inspection outcomes

Our inspection procedure includes a closing-meeting that is specifically intended to give businesses the opportunity to discuss any non-compliances and ways these can be corrected. We include relevant guidance in our inspection reports and inspectors continue to provide advice post-inspection, when needed.

3.4 Rights to appeal

The VMR includes a right to appeal a regulatory decision we’ve taken, such as about a marketing authorisation or variation, clinical trial application, or authorisation of premises. Improvement Notices served on a business for serious non-compliance includes clear guidance on the grounds and procedure for appeal.

We also publish our Complaints Procedure for concerns about our service or the way we operate.

3.5 Customer satisfaction

We conduct Customer Satisfaction surveys to assess our performance and invite suggestions on ways we can improve our service. We carefully consider and publish survey results and take action, where required.

We provide feedback forms following every company meeting or inspection – feedback is reviewed by our senior leaders. If required we follow up comments with a business to discuss any specific points they have, which we consider when reviewing our policies.

4. Basing regulatory activities on risk

4.1 Marketing Authorisations

When authorising new veterinary medicines, assessing any changes to those authorisations and conducting periodic reviews of new and emerging safety information, we do so on the basis of a structured benefit:risk evaluation. The outcome of this evaluation forms the basis of our regulatory decisions.

4.2 Inspections

We conduct risk-based inspections of those businesses we regulate, which considers the inherent risk of a business and its compliance history. We have agreements with other regulators that enable them to undertake inspections on our behalf; and we also work with some operational delivery partners to enable us to apply earned recognition which extends the inspection interval of compliant businesses that are also inspected by that trusted partner.

4.3 Enforcement

We take a risk-based approach to enforcement as set out in our Enforcement Policy. Our enforcement action is graduated and proportionate and where we consider the risks to be low or there is no history of non-compliance, enforcement will generally be through advice.

4.4 Our risk governance

Our Audit and Risk Assurance Committee supports and advises our Management Board on issues of risk, control, governance and assurance and other related matters, and assists internal audit’s role and status within the agency.

4.5 Reporting

We routinely publish the outcomes of our enforcement and surveillance activity on GOV.UK.

5. Making available clear information, guidance, and advice

5.1 Published guidance

We use different channels in our communications programmes as appropriate. We use media and stakeholder channels to raise awareness, and our web and direct channels to increase understanding and engagement.

We publish a series of guidance and information to assist those businesses we regulate to understand and meet their responsibilities. In keeping with the government’s ‘digital by default’ strategy, all the material we produce is available online in accordance with our Accessibility Statement and adhere to government guidelines to publish content in plain English, clearly, and concisely - in both electronic and hard copy formats.

Scientific guidance, Best Practice and one-to-one contacts are available to assist applicants in conducting, generating and compiling scientific data required in support of applications for veterinary medicines’ authorisations.

We aim to achieve compliance with the VMR through advice and education. We will work with those businesses who approach us asking for help, even where it transpires that they may have inadvertently broken the law.

6. Ensuring our approach is transparent

We routinely publish as much information about our activities and decision-making processes as we can. If the information you want is not routinely published, you can contact us to request it.

We publish our Corporate Priorities and our performance against Published Standards on our About Us page.

We are externally audited by the Comptroller and Auditor-General (C&AG) on our economy, efficiency, and the effectiveness of how we use our resources. The outcome of these audits is reported in our Annual Report & Accounts annually. We are also independently audited against ISO 9001 and ISO 27001 standards for quality and information security, respectively.

7. Contact us

If you would like more information email postmaster@vmd.gov.uk.