Last reviewed 16 August 2021

In September 2020, the Department of Health and Social Care (DHSC) hosted a consultation on changes to the Human Medicines Regulations to support the rollout of Covid-19 vaccines and an expanded flu vaccine programme in the UK.

The Government response to the more than 190,000 replies it received has been published and is available at

It is proceeding with the amendments to the Human Medicines Regulations (HMRs) proposed in the consultation, with three changes listed below, and will be laying legislation which brings these into force in the near future.

The three changes will:

  • ensure robust scrutiny of the impact of regulation 174A takes place by making it a requirement that the impact of this regulation will be formally reviewed after a year of any first use (Regulation 174A permits the attaching of conditions to the temporary authorisation of an unlicensed medicine or vaccine under regulation 174);

  • promote objectivity by changing the 'objective bystander' test that relates to loss of immunity from civil liability where conditions are breached to make this a person who has 'relevant expertise in the subject matter of the breach', in place of the original reference to pharmaceutical companies; and

  • create an additional level of reassurance in relation to the expanded workforce by making it clear that the new national protocol should include, where appropriate, the requirements for the supervision of an additional experienced vaccinator.

The draft Human Medicines (Coronavirus) (Amendment) Regulations can be found at