MHRA Consultation on the ongoing supply and deployment of vaccines across the UK - outcomes

Introduction

Between 5 September and 28 November 2025, the UK government hosted a public consultation on amending regulations to support the supply and deployment of vaccines across the UK. These proposals build upon the successes of vaccination programmes during the COVID-19 pandemic, with the intention of developing a vaccination system that is fit for the future.

The need for consultation

The government used several COVID-19/flu-era legal flexibilities in the Human Medicines Regulations 2012 (HMRs) to help deliver vaccination programmes at scale, and some of those provisions are time-limited and due to lapse on 1 April 2026. 

Outcomes

• Regulation 3A: keep relabelling flexibilities, but let large-scale “assembly/prep” powers lapse
  • R3A (1) & (2) (pandemic-scale final assembly/preparation) will lapse on 1 April 2026, reflecting a move away from mass vaccination-centre operations for COVID-19.
  • R3A (3) & (4) (labelling/shelf-life relabelling linked to thawing; packaging leaflet adjustments) will be made permanent and expanded beyond COVID-19 to any vaccine against an infectious disease caused by a virus or bacteria—framed as future-proofing, including for vaccines requiring frozen/ultra-low-temperature supply chains (for example, mRNA-related logistics).
• Regulation 19: allow vaccine movement between NHS providers only in tightly defined “exceptional” cases
  • R19 (movement of vaccines between NHS service providers without a wholesale dealer’s licence) will become permanent and expanded in scope to any vaccine against an infectious disease caused by a virus or bacteria.
    • Crucially, government clarifies R19 should be used only when strict preconditions are met, including: an urgent public health need for a patient to receive that vaccine on that occasion, no alternative way for the patient to receive it without undue delay, no suitable alternative product without undue delay, plus requirements to keep vaccines in original packaging and stored/transported per marketing authorisation.
    • It explicitly notes that reducing wastage alone is not enough to justify using R19; it’s intended for clinically essential transfers tied to urgent public health need.
• Regulation 247A is replaced: new permanent “extended workforce” mechanism via Vaccine Group Directions
  • The temporary workforce mechanism (R247A) will lapse on 1 April 2026 and be replaced by a new permanent provision, regulation 235A.
  • The new approach is built around Vaccine Group Directions (VGDs), designed to keep the benefits of deploying trained non-registered staff while strengthening governance and clarity. A key operational distinction: under a VGD, a registered professional can make the clinical decision/consent step while delegating administration-related tasks to others (including trained non-registered staff), which is not permitted under a PGD.
  • Notable change from the consultation: the government decided not to include a blanket age condition in the legislation. Instead, any age limits would be set within specific VGDs on a programme/vaccine basis where clinically needed.
• Regulation 233 and Regulation 3: expand community pharmacy outreach vaccination and enable off-site preparation
  • R233 (community pharmacies vaccinating off registered premises) will be expanded to cover any vaccine against an infectious disease caused by a virus or bacteria, to support wider outreach vaccination services.
  • Regulation 3 will be amended to include pharmacists so they can continue to prepare/assemble vaccines when delivering off-site services (aligned with conditions that already apply to doctors/dentists/nurses/midwives).
  • The response also corrects an error in the consultation document: pharmacy technicians were not permitted under R3A(1) in the way implied, and the government says it will not add a new derogation on that basis.
• Schedule 17: broaden occupational health vaccination scope and workforce, including private OHS providers
  • Schedule 17 will be expanded so occupational health vaccinators can support all vaccinations/immunisations offered under an occupational health scheme (OHS), not just COVID-19/flu.

It will also:

• • • align who counts as an occupational health vaccinator with the relevant professions list in part 4 of schedule 16, and
    • extend the framework to include private OHS providers, to increase capacity and parity with NHS/local authority schemes.

What happens next

The UK government says it will lay the amendments using the affirmative procedure, meaning they must be actively approved by both Houses of Parliament before taking effect.