| Short Title: | Human Medicines Regulations 2012 |
| Status: | Current |
| Type: | Statutory Instrument |
| Year: | 2012 |
| Citation: | SI 2012/1916 |
| Territorial Extent: | United Kingdom |
| Eu Directives: | Directive 2010/84/EU |
| Amendments: | Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 |
| Si Made Date: | 19 July 2012 |
| Si Laid Date: | 24 July 2012 |
| Amends: | Medicines Act 1968 |
| Original Text: | https://www.legislation.gov.uk/uksi/2012/1916/pdfs/uksi_20121916_en.pdf |
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 The regulations partially repealed the Medicines Act 1968 in line with EU legislation.[1] [2] [3] [4]
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 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]