Regulator Profile

MHRA

Medicines and Healthcare products Regulatory Agency

Enforcement Regulator

3

Areas of regulation

15

Laws enforced

UK-wide

Quick links

Visit official website Email MHRA Call 020 3080 6000

Clinical Trials Medical Devices Medicines

What MHRA does

Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.

Legal framework

Legislation that MHRA enforces.

Primary legislation

• Medicines Act 1968 Act 1968
• Misuse of Drugs Act 1971 Act 1971
• Medicines and Medical Devices Act 2021 Act 2021

Secondary legislation

• Medical Devices Regulations 2002 UK Statutory Instrument 2002
• Medicines for Human Use (Clinical Trials) Regulations 2004 UK Statutory Instrument 2004
• Blood Safety and Quality Regulations 2005 UK Statutory Instrument 2005
• General Product Safety Regulations 2005 UK Statutory Instrument 2005
• Human Medicines Regulations 2012 UK Statutory Instrument 2012
• Medical Devices (Amendment ) (EU Exit) Regulations 2019 UK Statutory Instrument 2019
• Market Surveillance (Northern Ireland) Regulations 2021 UK Statutory Instrument 2021
• Medical Devices (Northern Ireland Protocol) Regulations 2021 UK Statutory Instrument 2021
• Medical Devices (Amendment) (Great Britain) Regulations 2023 UK Statutory Instrument 2023
• Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 UK Statutory Instrument 2024
• ... and 2 more statutory instruments