Medicinal Products & Devices Regulation

Medicinal product and device law governs every stage of the process, from development to distribution. This includes:

• securing marketing authorisations and licences
  
• following strict rules on labelling, advertising and promotion
  
• meeting good manufacturing and distribution practice
  
• monitoring product safety through pharmacovigilance
  
• ensuring devices are correctly classified and compliant under UK and EU rules

Many clients come to us for help with:

• deciding whether a product should be treated as a medicine or device
  
• ensuring advertising and promotional material complies with the law
  
• responding to MHRA concerns about unlicensed medicines or off-label promotion
  
• managing product recalls in a way that meets regulatory expectations
  
• resolving problems with high-risk products such as controlled drugs or weight-loss medicines
  
• addressing cross-border supply concerns when products are sold internationally

The MHRA and other regulators can open investigations following complaints, safety alerts, or inspections. These often focus on:

• the supply of unlicensed or counterfeit medicines
  
• failures in record keeping or distribution standards
  
• inappropriate promotion of prescription-only medicines
  
• device failures and patient safety risks
  

Our team steps in quickly to guide you through the process, challenge unfair findings, and defend you robustly where needed.

Our work includes:

• advising on the classification of borderline products
  
• supporting pharmacies investigated over the supply of Saxenda
  
• guiding healthcare businesses through urgent product recalls

Compliance is not optional. Failures can lead to:

• restrictions on your ability to supply or sell products
  
• financial penalties or criminal prosecution
  
• reputational damage with patients and commissioners
  
• GPhC investigations that affect your registration