Medical and Regulatory Law Specialist Barristers | England, Wales, UK | London, Manchester & Regional
MHRA LAW, MHRA Prosecutions
We represent individuals and organisations that face prosecution by the Medicines & Healthcare products Regulatory Agency (MHRA) for breach of regulations in England and Wales.
We are Defence Counsel for Defendants Facing MHRA Prosecution of Offences or investigations.
The MHRA has powers of:
Enforcement: Investigates products that do not comply with regulations, oversees recalls, and enforces criminal offences related to counterfeit, unlicensed, or illegally supplied medicines.
Licensing and Authorisation: Grants approval for clinical trials and issues marketing authorisations (licences) for new medicinal products.
Medical Device Registration: Requires manufacturers to register medical devices with the MHRA before they can be placed on the UK market.
Reclassification: Oversees changes to the legal status of medicines, including Prescription Only Medicines, Pharmacy medicines, and General Sales List products.
Legal Framework
The Medicines Act 1968 (as amended by the Humand Medicines Regulations 2012) sets out various offences for failures to adhere to MHRA regulations. Sentencing: Imprisonment can be up to two years – imposed in Crown Court. Fines can be imposed and will vary depending on the offence, and the court in which the case is determined (Magistrates Court (around £400 for some offences); or Crown Court (much higher fines)).
Human Medicines Regulations 2012 – sets out the law for drugs licensing, manufacturing, supplying, and advertising.
Medical Devices Regulations 2002 – sets the law relating to the advertising of medicines, and the marking and registration of medicines.
Medicines and Medical Devices Act 2021 – An Act enabling changes to be made to legislation following the UK leaving the European Union.
For more details of how we can assist you in relation to an MHRA-related legal matter or an MHRA prosecution matter, contact us on 0845 652 0451.
Further Information and Case Law Relating to MHRA Law and Guidance
Medis Pharma Ltd v NHS Resolution [2025] EWHC 2616 (Admin) – tangential reference to MHRA guidance. The application was refused primarily because it was not established that the Claimant could deliver medicines safely and effectively, particularly in maintaining the required temperature controls throughout the delivery process. (21 October 2025)
Alexander Barristers Chambers
Telephone: 0845 652 0451
CONTACT FORM: Message Us
ALEXANDER CHAMBERS MENU
Alexander Barristers Chambers
Telephone: 0845 652 0451