Overview of amendments
On 31 March and 1 April 2026 a number of amendments to the Human Medicines Regulations (HMR) 2012 will come into force. These amendments are being introduced to support and improve vaccine deployment and supply across the UK.
In this video expert speakers from the Department of Health and Social Care (DHSC), NHS Specialist Pharmacy Service (SPS), the Medicines and Healthcare products Regulatory Agency (MHRA), NHS England (NHSE) and the UK Health Security Agency (UKHSA) outline the amendments to the regulations. The background to the legislative changes is explained by the DHSC.
Outline and speakers
The video contains the following short presentations. You can view all the presentations in the order they have been recorded, or you can navigate to the presentations you are interested in using the chapters function within the video.
Introduction
Jo Jenkins outlines the video content (see 00:00).
Background to the legislative changes
Harriet Fowler from the DHSC gives an overview of why the amendments have been introduced. She explains the journey from temporary regulatory amendments used during the COVID-19 pandemic to the new permanent amendments supporting all national vaccination programmes (see 00:42).
Regulation 3A – vaccine preparation
Tim Root explains the changes to Regulation 3A. He outlines how temporary provisions that allowed supervised staff to prepare COVID‑19 vaccines without additional licences will end on 31 March 2026. From 1 April, only the person administering a vaccine may carry out reconstitution or dilution. He also highlights that parts of the regulation allowing licensed wholesalers to relabel thawed, frozen‑stored vaccines will become permanent and have been expanded to cover all virus and bacterial vaccines. These amendments are helping future‑proof the supply chain (see 05:19)
Regulation 19 – vaccine handling and supply
Bernadette Sinclair-Jenkins from the MHRA explains the amendments to Regulation 19. These update the exemptions allowing certain NHS organisations to move vaccines without a wholesale dealer’s licence. She outlines the expanded scope and clearer definitions of distributing and receiving parties. The legislation update adds new conditions to ensure movements only occur in exceptional public health circumstances and with packaging and marketing authorisation compliant handling requirements (see10:05).
Regulation 233 – off site vaccination by community pharmacies
Marta Senger from NHSE and Stefan Politowicz from DHSC outline the legislative changes that allow community pharmacies to provide commissioned vaccination services away from their registered premises. The amendments enable pharmacists and pharmacy technicians to supply, prepare, and administer a wider range of vaccines off site under patient group directions or the new vaccine group directions (see 20:30).
Regulation 235A – introducing the new Vaccine Group Direction (VGD)
David Green from UKHSA talks about the new vaccine group direction and discusses how this differs from the now retired National Protocol for COVID‑19 and ‘flu vaccinations. He describes why a new legal mechanism is needed, who can carry out patient assessment and consent, and which tasks can be delegated to trained staff under supervision (see 28:52).
Schedule 17 – vaccination by occupational health services (OHS)
Jo Jenkins outlines updates to Schedule 17 of the Human Medicines Regulations relating to occupational health vaccination. She explains how the role of occupational health vaccinators is being expanded, widening the range of vaccines they can administer, and extending the permissions to both public and private occupational health providers (see 45:03).
Further information and resources
Jo Jenkins concludes the webinar and signposts to further resources (see 48:46).