Government response: consultation on changes to the Human Medicines Regulations to support the rollout of COVID-19 and flu vaccines

The government hosted a public consultation from 28 August to 18 September on changes to the Human Medicines Regulations to support the rollout of COVID-19 vaccines. This is the formal government response to that consultation.

The amendments consulted on will:

strengthen existing regulations that allow for the temporary licencing of medicines and vaccines, on an exceptional basis, pending the grant of a full licence
extend the current immunity from civil liability to companies producing the vaccine, rather than just healthcare workers and manufacturers. This will protect them from legal liability in civil cases but does not give them blanket immunity from civil liability
allow a wider range of trained personnel to administer COVID-19 or flu vaccines
ensure that the vaccines and treatments used in response to certain specific types of public health threat, such as a COVID-19 vaccine, can be promoted as part of national vaccination or treatment campaigns
make short-term provisions to facilitate the swift and safe transfer of COVID-19 and flu vaccines under NHS or armed services' authorised arrangements by providing an exemption from the need for a wholesale dealer's licence

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