Our Fraud and Regulatory team has specialist expertise in pharmaceutical regulation and we advise wholesalers, NHS Trusts, registered pharmacies and dispensing doctors on all regulatory matters related to the supply and trade of medicine.
We provide comprehensive legal support to those subject to investigation by the Medicine and Healthcare products Regulatory Agency (MHRA) and the Royal Pharmaceutical Society of Great Britain (RPSGB). For further information on the professional regulation of pharmacists and pharmacy technicians by the RPSGB, please refer to our Pharmacists page.
The Medicine and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health. It is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.
The MHRA issues licences to manufacturers or wholesalers of medicine, and regulates medical devices through notified bodies. All license holders are inspected regularly to ensure compliance with the licence conditions.
If the MHRA suspects any illegal activity relating to medicines it has the power to investigate breaches and bring criminal prosecutions. It also has recourse to civil penalties, including:
- Refusal to grant a licence or a variation
- Proposal to vary a licence to disallow unacceptable practice
- Proposal to suspend the licence for a stated period
- Proposal to revoke the licence
- Notification of immediate suspension of the licence for a stated period
- Action to remove a Responsible Person from the licence
If you have received a negative inspection report and are under threat of adverse licensing action, or even criminal prosecution, please contact us immediately. We are fully experienced in dealing with regulatory issues and have successfully defended MHRA prosecutions for our clients.
We provide professional, pragmatic advice to clients throughout the UK on matters including:
- Investigations by the MHRA
- Criminal Prosecutions by the MHRA and/or RPSGB
- Representations to the MHRA
- Investigations by the RPSGB Investigation Committee
- High Court Injunctions
- Hearings before a RPSGB Fitness to Practise Committee
- High Court Judicial Reviews
- High Court appeals of RPSGB decisions