Amendments to regulations 3A, 19 and 247A of the Human Medicines Regulations 2012 to support the ongoing delivery of COVID-19 and influenza vaccination

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Consultation opened on 08 August 2023. Closing date 18 September 2023.

Summary

The UK government has launched a UK-wide consultation on proposals to amend Regulation 247A of the Human Medicines Regulations 2012 to allow the Health Service to continue maximising the use of unregistered staff for the COVID-19 and flu vaccine programmes when COVID-19 is declared to be endemic rather than a pandemic. The consultation also proposes to extend existing provisions in Regulations 3A and 19 of the Human Medicines Regulations to maintain existing flexibilities to support the continuing supply; distribution and administration of COVID-19 and Influenza for an additional 1-2 years as we transition out of the pandemic. The joint consultation will run for 6 weeks, and is facilitated by virtue of the primary powers contained in the Medicines and Medical Devices Act 2021 (MMDA).

Consultation description

In advance of the COVID-19 Vaccine programme, it was recognised that an expanded workforce would be required to deliver vaccines at the pace and scale required without significant impact on the delivery of wider health services. The R247A national protocol model has brought significant operational benefits to the COVID-19 and flu vaccination programmes, including the ability to reduce pressure on the use of registered healthcare professionals through expanding the trained vaccinator workforce to include non-registered staff working under agreed training and governance frameworks.  Being able to utilise this workforce has reduced pressures for general practice to deliver vaccinations and optimised use of professional resources in all four nations.

Regulations 3A and 19 of the Human Medicines Regulations have brought significant operational benefits to the COVID-19 and flu vaccination programmes across the UK. R3A has allowed the labelling of vaccines with a new shelf life after thawing and preparation, or reconstitution by the adding the recommended diluent. This has meant NHS teams have been able to use the skills and expertise of their staff in appropriate areas much more effectively, enabling safer systems of working, particularly at larger sites.  R19, has allowed COVID-19 and Influenza vaccines to be moved between premises at the end of the supply chain by NHS bodies and the medical services of Her Majesty’s Forces that do not hold wholesale dealer licences.  These provisions were enabled in response to situations that had arisen during previous vaccination campaigns where there were more vaccines than were needed in one healthcare organisation and too few in another separate healthcare organisation.

The consultation document can be accessed via the .gov.uk website.

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