The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)

My Lords, I am glad to introduce these regulations, which will take effect from 31 March 2026. This statutory instrument is technical, relating to the preparation and administration of vaccines. In autumn 2020, in response to the Covid-19 pandemic, multiple temporary amendments were made to the Human Medicines Regulations 2012 to support the rollout of the Covid-19 and influenza vaccination programmes. Three of these amendments were extended in 2022 and 2024 following public consultation, and are due to lapse on 1 April 2026. These regulations look to retain several provisions within those amendments—which have been utilised in the Covid-19 and influenza programmes for five years—as permanent legislation and expand them to other vaccines. They are designed to build on the benefits that the amendments have provided to date, as well as on the wider lessons learned during the pandemic and in recent polio and MMR vaccine catch-up programmes. I will briefly set out what each of these regulations does, and what amendments this instrument will make to them. Regulation 3A(1) and (2) of the 2012 regulations enable trained healthcare professionals, or staff under the supervision of trained healthcare professionals, to conduct the final stage of assembly and preparation of Covid-19 vaccines without additional marketing authorisations or a manufacturer’s licence being required. This enabled bulk assembly of Covid-19 vaccines during the pandemic. Given that we are no longer in a pandemic and have taken a more targeted approach to recent Covid-19 vaccination campaigns, this instrument allows these provisions to lapse from 1 April 2026. Regulation 3A(3) and (4) permit holders of a wholesale dealer’s licence who do not hold a manufacturer’s licence to relabel Covid-19 vaccines to reflect changes in shelf life resulting from product thawing. This instrument retains these provisions as permanent legislation and expands them to include any vaccine against an infectious disease, which will helpfully support flexibilities in the supply chain now and in the future. Regulation 19 allows Covid-19 and influenza vaccines to be moved between different NHS service providers at the end of the supply chain, without the need for a wholesale dealer’s licence. This instrument retains these provisions as permanent legislation and expands them to include any vaccine against an infectious disease, with relevant safeguards in place to regulate its use.