Human Medicines Regulations 2012

The Human Medicines Regulations 2012 in the United Kingdom were created, under statutory authority of the European Communities Act 1972 and the Medicines Act 1968 in 2012. The body responsible for their upkeep is the Medicines and Healthcare products Regulatory Agency. The regulations partially repealed the Medicines Act 1968 in line with EU legislation.[1][2][3][4]

Human Medicines Regulations 2012
Statutory Instrument
Citation2012 No. 1916
Territorial extent United Kingdom
Dates
Made19 July 2012
Laid before Parliament24 July 2012
Commencement14 August 2012 (2012-08-14)
Revoked ()
Other legislation
AmendsMedicines Act 1968
TransposesDirective 2010/84/EU
Amended byThe Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020
Status: Current legislation
Text of statute as originally enacted

Amendments

In October 2020, the regulations were amended to expand the workforce eligible to administer COVID-19 vaccines, so enabling additional healthcare professionals to vaccinate the public. This was a temporary provision, but in January 2022 it was announced that this would be made permanent as would the provision for community pharmacy contractors to provide COVID-19 and flu vaccines “away from their normal registered premises”.[5]

Regulation 174

Regulation 174 provides an exemption to the requirement for authorisation of Regulation 46, allowing for the sale or supply of any medicinal product to be temporarily authorised by the licensing authority (MHRA) in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation.[6]

References
  1. "How will the new Human Medicines Regulations affect your practice?". Royal Pharmaceutical Society. 3 August 2012.
  2. Medicines, Ethics and Practice 39: The professional guide for pharmacists. Royal Pharmaceutical Society of Great Britain. 18 July 2015. p. 25.
  3. Appelbe, Gordon E.; Wingfield, Joy (2013). Dale and Appelbe's Pharmacy and Medicines Law (10 ed.). Pharmaceutical Press. p. 22. ISBN 9780853699897.
  4. "Legislation covering medicines". Department of Health (N.I.). 18 August 2015. Retrieved 18 December 2020. Please note that the Human Medicines Regulations 2012 repealed aspects of the Medicines Act 1968 as follows...
  5. "Law to be changed permanently to allow pharmacies to provide vaccinations off-premises". Pharmaceutical Journal. 26 January 2022. Retrieved 20 March 2022.
  6. Dodds-Smith, Ian; Townsend, Ewan (2017). "Unlicencsed Medicinal Products in the UK" (PDF). arnoldporter.com. Thomson Reuters Practical Law. Retrieved 19 December 2020. Regulation 174 contains an exemption for the sale or supply of products that are authorised by the MHRA on a temporary basis in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents, or nuclear radiation, which may cause harm to human beings.


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