The Human Medicines Regulations 2012 in the

United Kingdom The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a country in Europe, off the north-western coast of the continental mainland. It comprises England, Scotland, Wales and North ...

were created, under statutory authority of the European Communities Act 1972 and the

Medicines Act 1968 The Medicines Act 1968 is an Act of Parliament of the United Kingdom, more properly: An Act to make new provision with respect to medicinal products and related matters, and for purposes connected therewith. It governs the control of medicines for ...

in 2012. The body responsible for their upkeep is the

Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...

. The regulations partially repealed the

in line with EU legislation.

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”.

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.

References

External links

* National Health Service Pharmaceutics Life sciences industry Pharmacy 2012 establishments in the United Kingdom Department of Health and Social Care Medical regulation in the United Kingdom Biotechnology Statutory Instruments of the United Kingdom Health law in the United Kingdom {{UK-law-stub