Review of the Veterinary Medicines Regulations 2013

Overview

This consultation sets out proposals to amend and supplement the Veterinary Medicines Regulations 2013 (VMR), as they apply in Great Britain. The VMR set out the controls on the marketing, manufacture, distribution, possession and administration of veterinary medicines in Great Britain. They are therefore a critical tool to help protect animal health, public health and the environment, by assuring the safety, quality and efficacy of medicines administered to animals.

We have only made minor changes to the VMR since they came into force on 1 October 2013. Since then, there have been significant advances in the veterinary medicines industry. The VMR need to be updated to reflect changes and technical advances in the veterinary medicines industry, including the supply chain, as well as to future-proof the regulatory regime. The proposed changes on which we are consulting intend to reduce regulatory burden where possible and tighten controls where necessary, resulting in a balanced and proportionate regulation.

In addition, the Veterinary Medicines Directorate’s (VMD’s) fees and fee structure set out in the VMR have not changed since 2013. The VMD is required to achieve full cost recovery for its regulatory services, in line with HM Treasury’s guidance. A revised fee structure and updated fees are proposed as part of the update to the VMR.

We will amend and supplement the VMR using the powers in Part 3 of the Medicines and Medical Devices Act 2021. This consultation is conducted in line with the consultation requirement in section 45(1) of the Act. A summary of our assessment of the package of proposals included in the consultation document against the three factors set out in section 10 of the Act is provided in Annex C.

We are consulting on the proposed changes to give stakeholders the opportunity to share their views to enable us to make proportionate and appropriate regulation. Annex B highlights areas that are most relevant to different business types.

Territorial extent: This consultation relates to the regulation of veterinary medicines in England, Scotland and Wales only. Further to the Windsor Framework, the legislation relating to veterinary medicines in Northern Ireland is separate to that in Great Britain.

Please note, the consultation document is amended with regard to the numbering of questions in Annex A.

Why your views matter

We welcome your views on the proposed changes, as to whether they will achieve the intended objectives. We also seek information on the time and cost of familiarising your business with the new requirements, and the impact of the proposed changes on you, your business and wider aspects (such as social or environmental impacts). We are looking for the positive and negative impacts, as well as direct and indirect costs. We will use the information received to update and improve the pre-consultation impact assessment that is provided with the consultation.

Our preferred way of receiving responses is through the Citizen Space platform.

If you are unable to use Citizen Space, you can download the consultation documents and return your response via email to vmr@vmd.gov.uk.

You can also access the consultation documents by visiting the VMD’s new engagement website, VMD Connect, where you will also find details about several focussed Q&A sessions on the consultation that will be held later in February and March.