Medicines and Medical Devices Act 2021 – Stakeholder Call For Evidence

Overview

The Veterinary Medicines Directorate is conducting a review of the UK’s veterinary medicines regulatory framework, and we are seeking views from stakeholders across the veterinary sector to inform recommendations about whether future reform of the regulations is needed.

The review is a statutory obligation under the Medicines and Medical Devices Act 2021 and is being conducted in accordance with Part 6, Regulation 48 of the Act, which requires the government to assess the operation and impact of the legislation at least once every five years.

The focus of the review is the legislation that govern the development, authorisation, supply, and oversight of medicines and medical devices in the UK. These include:

1. Human Medicines Regulations 2012 (HMRs): which set out the regime for the manufacture, authorisation, supply, and pharmacovigilance of medicines.
2. Medical Devices Regulations 2002 (MDRs): which provide the regulatory framework for medical devices, including requirements for safety, performance, and conformity assessment.
3. The Medicines for Human Use (Clinical Trials) Regulations 2004: which govern the conduct of clinical trials of medicinal products.
4. Medicines and Medical Devices (Fees) Regulations: which outline the fees payable to the MHRA in relation to regulatory services.
5. The Veterinary Medicines Regulations 2013 (as amended) (VMR): which set out the controls on the marketing, manufacture, supply, possession and administration of veterinary medicines and medicated feed.

The objectives of the legislation are to:

• Provide a clear legislative framework for veterinary medicines and medicated feed
• Ensure this framework is fit for purpose to protect animal health, public health and the environment by assuring the quality, safety and efficacy of veterinary medicines
• Give the regulator oversight to ensure the requirements are met and action can be taken when they are not
• Give the regulator the power to charge fees

The UK veterinary medicines regulations were originally derived from EU legislation which was transposed into UK law. The Medicines and Medical Devices Act, passed in 2021, provides the primary powers that enable the UK to update and amend this legislation.

Purpose

The purpose of this review is to evaluate whether the legislation is operating as intended now, if it continues to effectively protect animal and public health and the environment, and avoids imposing unnecessary or excessive regulatory burdens. The review is also looking at the structure of the legislation and whether restructure or consolidation would make the regulations clearer or easier to implement.

Audience

Anyone may respond to this call for evidence. Those who may have a particular interest include:

• Veterinary medicines marketing authorisation holders, manufacturers and wholesale distributors.
• Vet surgeons, vet nurses, vet pharmacists and suitable qualified persons (SQPs).
• Farmers and other professional keepers of animals, and feed business operators.
• Pet owners.

How to respond

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

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

The call for evidence will run for 4 weeks. This call for evidence opens on 1 September 2025 and closes at 23:59 on 26 September 2025. Any responses received after this date will not be analysed.

Confidentiality and data protection

This Review complies with data protection legislation including the Data Protection Act 2018 (DPA) and the UK General Data Protection Regulation (UK GDPR). Personal data will be kept for no longer than necessary to fulfil our purpose in processing it.  Any personal information will be anonymised.

Information from this review, including personal information, may be disclosed in accordance with the access to information regimes. These are primarily the Freedom of Information Act 2000 (FOIA), the DPA, the UK GDPR and the Environmental Information Regulations 2004.

The VMD will process your personal data in accordance with the DPA and UK GDPR and in most circumstances, this will mean that your personal data will not be disclosed to third parties. The lawful basis for processing personal data is article 6(1)(e) UK GDPR. Further information on how personal data is handled, including data subject rights, is available in the VMD privacy notice.

Why your views matter

We would value your views and experiences on the Veterinary Medicines Regulations 2013 (as amended) which are relevant to you or your organisation. Please provide us with unbiased responses and where possible, specific examples.

The deadline for completing the questionnaire is 26 September 2025.

If you have any questions relating to this review and the completion of the survey, please email: legislation@vmd.gov.uk, with “MMD Act Review” in the subject line.