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Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020
Statutory Instrument
Citation	SI 2020/1125
Introduced by	Matt Hancock, Secretary of State for Health and Social Care
Territorial extent	England
Dates
Made	15 October 2020
Laid before Parliament	16 October 2020
Commencement	Subject to paragraph (3) 6 November 2020; (3) This regulation and regulations 2 17 October 2020
Revoked
Other legislation
Amends	Human Medicines Regulations 2012
Status: Current legislation
Text of the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 as in force today (including any amendments) within the United Kingdom, from legislation.gov.uk.

The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (SI 2020/1125) is a statutory instrument (SI) that was laid before Parliament on 16 October 2020 to make provision for the strengthening of existing regulations that allow for the temporary authorisation of the supply of unlicensed medicines, including vaccines, in response to certain public health threats, and for the expansion of the workforce able to administer the COVID-19 vaccines and influenza vaccines. Certain amendments within the instrument, regulations 3, 12 and 3, allowing for the administration of vaccines by a wider range of medically trained people such as an "occupational health vaccinator" are time-limited to 1 April 2022.^[1]

The statutory instrument also makes provision for temporary authorisations where the existing partial immunity (for registered healthcare professionals) from civil liability is extended to pharmaceutical companies in relation to temporarily authorised medicinal products.^[2]

Regulation 174A

A new regulation (174A) has been added to Regulation 174 of the Human Medicines Regulations 2012 which will provide temporary authorisation^[3] for the promotion of medicinal products, including COVID-19 vaccines, in limited forms of advertisements where permitted in campaigns "relating to the suspected or confirmed spread of pathogenic agents".^[4] The existing regulations under the Human Medicines Regulations 2012 for the disapplication of certain advertising restrictions for unlicensed vaccines are expanded by these regulations to permit temporary authorisation of any medicinal products for the purposes of any campaign approved by ministers.^[5]

Temporary authorisation of vaccine BNT162b2

On 2 December 2020, a temporary authorisation was issued under Regulation 174 of the Human Medicines Regulations 2012 (as amended by Regulation 174A)^[6] for the implementation of the first COVID-19 vaccine, the Pfizer/BioNTech (BNT162b2), to be used in the United Kingdom.^[7]^[8] The authorisation was subject to a number of conditions which fall under Regulation 174A(1) of these amending regulations. The temporary authorisation meant that a new COVID-19 vaccine could be approved by the MHRA without having to wait for the usual approval of the European Medicines Agency.^[9]

References

^ "Explanatory Note" (PDF). legislation.gov.uk. 15 October 2020. p. 12. Retrieved 13 December 2020. These arrangements are time limited to 1st April 2022 (regulations 3, 12 and 32).
^ "Explanatory Memorandum: The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020" (PDF).
^ Parkinson, Stephen (4 December 2020). "Regulation and Uptake of the COVID-19 Vaccine". kingsleynapley.co.uk. Kingsley Napley. Retrieved 13 December 2020. With the 2020 Regulations, the government has amended Regulation 174 by inserting Regulation 174A...
^ "COVID-19: Human Medicine Regulations amended to support vaccine rollout". uk.practicallaw.thomsonreuters.com. Thomson Reuters Practical Law. 19 October 2020. Retrieved 13 December 2020. ...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.
^ "Government response: consultation on changes to the Human Medicines Regulations to support the rollout of COVID-19 and flu vaccines". gov.uk. Department of Health & Social Care. 16 October 2020. Retrieved 13 December 2020. These amendments on the easement of advertising restrictions are not limited to unlicensed vaccines only, but are intended to apply to all the public health purposes that would justify temporary authorisation of the distribution of an unlicensed vaccine or other treatment listed in regulation 174.
^ "Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine" (PDF). Medicines & Healthcare Products Regulatory Agency (MHRA). 2 December 2020. Retrieved 18 December 2020.
^ "UK medicines regulator gives approval for first UK COVID-19 vaccine". Gov.uk. 2 December 2020. Retrieved 18 December 2020.
^ Roberts, Michelle (2 December 2020). "Covid-19: Pfizer/BioNTech vaccine judged safe for use in UK". BBC News. Retrieved 18 December 2020.
^ Mahase, Elisabeth (2020). "Midwives and paramedics can deliver flu and covid vaccines after new laws come into force". BMJ. 371: m4044. doi:10.1136/bmj.m4044. PMID 33067245.