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1. Our Regulatory Activities
Our regulatory activities are underpinned by a range of powers set out in Veterinary Medicines Regulations 2013 (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 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 and are required to undertake at least 5 days learning and/or development annually. Good regulatory practice is built into our work and is supported by documented policies and procedures, as part of our ISO 9001:2015 accredited Quality 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 who are involved in delivering our priorities or who are affected by our work – our stakeholders. This includes:
- holding annual ‘open’ meetings and other webinars and workshops
- publishing information on our website (which has a ‘sign up to alerts’ function) and on social media
- meeting with individual companies on request
- regular meetings with stakeholder representative groups
- having an exhibition stand at several industry events
- consulting prior to any changes to our legislation
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.
3.4 Rights to appeal
The VMR includes a right to appeal a regulatory decision we’ve taken, such as about a marketing authorization or variation, clinical trial application, or authorization/approval 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 annual 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 Authorizations
When authorizing new veterinary medicines, assessing any changes to those authorizations 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.
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.
We take a risk-based approach to enforcement as set out in our Enforcement Strategy. 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.
We routinely publish the outcomes of our inspection, enforcement and surveillance activity which is collated in our MAVIS Hub (Marketing Authorizations Veterinary Information Service) or published elsewhere on our website.
5. Making available clear information, guidance, and advice
5.1 Published guidance
We use different channels in our communications programs as appropriate. We use media and stakeholder channels to raise awareness, and our web and direct channels to increase understanding and engagement.
Our guidance and published information are focused on assisting 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 are available online in accordance with our Accessibility Statement and adhere to government guidelines to publish guidance 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’ authorizations.
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 make a request for it under the Freedom of Information Act.
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 9001:2015 and ISO 27001 standards for quality and information security, respectively.
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