Changes to Human Medicine Regulations to support the rollout of vaccines: one-year review
A report summarising the findings following a one-year review of the use of regulations 174A and 247A, implemented to support the rollout of COVID-19 and flu vaccines.
Documents
Details
The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 were laid in Parliament on 16 October 2020. The amendments made included the addition of:
- regulation 174A (R174A) that allows for conditions to be attached to the temporary authorisations of an unlicensed medicine, such as a COVID-19 vaccine
- regulation 247A (R247A) that allows for the expansion of the workforce legally able to administer a COVID-19 or influenza vaccine under an approved national protocol and allows vaccinations to happen on sites other than registered pharmacies, subject to the conditions set out in the protocol
These amendments followed a public consultation held from 28 August to 18 September 2020 on changes to the Human Medicines Regulations 2012 to support the rollout of COVID-19 vaccines and the upscaling of the influenza vaccination programme in the UK.
As a result of the responses received, the Department of Health and Social Care (DHSC) made key changes to the proposals set out in the original review. This included a commitment to formally review the operation of R174A and R247A following one year of use to evaluate whether there have been any adverse consequences for the market in medicines or for patient safety as a consequence of the operation of these regulations.
This is the formal government report of that review.