The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood products in the UK. If you manufacture, import, distribute, or supply these products, you likely need MHRA authorisation.
This guide covers licensing requirements for pharmaceutical and medical device businesses operating in the UK market.
Medicines manufacturing (MIA)
A Manufacturer's Licence (MIA) is required to manufacture medicines in the UK. This includes manufacturing finished products, active pharmaceutical ingredients (APIs), or carrying out partial manufacturing steps like packaging, labelling, or quality testing.
Medicines wholesale distribution (WDA)
A Wholesale Dealer's Licence (WDA) is required to procure, hold, and distribute medicines to other licensed entities such as pharmacies, hospitals, or other wholesalers.
Clinical trial authorisation
Before conducting clinical trials involving investigational medicinal products (IMPs) in the UK, you must obtain Clinical Trial Authorisation (CTA) from MHRA. You also need favourable opinion from a Research Ethics Committee.
Combined MHRA/Ethics approval pathway
The MHRA now offers a combined MHRA and Ethics Committee review option for clinical trial applications, reducing overall approval time. This integrates the regulatory and ethics approval processes.
For Phase 3 and 4 trials meeting certain criteria, the New Notification Scheme allows trials to proceed within 14 days if no objection received.
Medical device registration (UKCA marking)
All medical devices placed on the Great Britain market must be registered with MHRA. Post-Brexit, devices require UKCA marking (UK Conformity Assessed), though CE marked devices remain accepted during transition periods.
Pharmacovigilance requirements
All Marketing Authorisation Holders (MAHs) must have a pharmacovigilance system to monitor the safety of their medicines post-authorisation.
Penalties for non-compliance
MHRA online services
Legal basis
Primary legislation and key regulations