Regulator Profile

MHRA

Medicines and Healthcare products Regulatory Agency

Enforcement Regulator

3

Areas of regulation

44

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

• Children Act 1989 Act 1989
• Children and Families Act 2014 Act 2014
• Dentists Act 1984 Act 1984
• Health Act 1999 Act 1999
• Housing Act 2004 (HMO licensing) Act 2004
• Human Tissue Act 2004 Act 2004
• Medical Act 1983 Act 1983
• Medicines Act 1968 Act 1968
• Medicines and Medical Devices Act 2021 Act 2021
• Mental Capacity Act 2005 Act 2005
• Police Act 1997 Act 1997
• Safeguarding Vulnerable Groups Act 2006 Act 2006

Secondary legislation

• Blood Safety and Quality Regulations 2005 UK Statutory Instrument 2005
• Care Quality Commission (Registration) Regulations 2009 UK Statutory Instrument 2009
• Childcare (Early Years Register) Regulations 2008 UK Statutory Instrument 2008
• Childcare (General Childcare Register) Regulations 2008 UK Statutory Instrument 2008
• Fire Safety (England) Regulations 2022, Regulation 9 - Information to residents UK Statutory Instrument 2022
• General Product Safety Regulations 2005 UK Statutory Instrument 2005
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 UK Statutory Instrument 2014
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 5 UK Statutory Instrument 2014
• Health Professions Order 2001 UK Statutory Instrument 2002
• Human Medicines Regulations 2012 UK Statutory Instrument 2012
• ... and 22 more statutory instruments