Regulator profile
MHRA
Medicines and Healthcare products Regulatory Agency
Enforcement Regulator3 areas of regulation · 18 laws enforced · UK-wide
What MHRA does
Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.
Contact MHRA
Types of regulation
Clinical Trials
Medical Devices
Medicines
Legal framework
Legislation that MHRA directly 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
- Misuse of Drugs Regulations 2001 UK Statutory Instrument 2001
- 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
- The Education (National Curriculum) (Key Stages 1 and 2 Assessment Arrangements) (England) (Coronavirus) (Amendment) Order 2021 UK Statutory Instrument 2021
- The Health Protection (Coronavirus, International Travel and Operator Liability) (England) (Amendment) (No. 23) Regulations 2021 UK Statutory Instrument 2021
- The Market Surveillance (Northern Ireland) Regulations 2021 UK Statutory Instrument 2021
- ... and 5 more statutory instruments
Related legislation
Legislation connected to MHRA's remit but not directly enforced — establishing Acts, amendments, referenced legislation, and context.
Administered / monitored
-
The Tobacco and Related Products Regulations 2016
UK Statutory Instrument 2016
Referenced in enforcement
-
Ionising Radiation (Medical Exposure) Regulations 2017
UK Statutory Instrument 2017
Coverage area
UK-wide