Guide
MHRA authorisation for medicines and medical devices
How to obtain MHRA authorisation for medicines and medical devices in the UK. Covers Marketing Authorisations, wholesale dealer licences, manufacturer licences, and medical device registration including UKCA vs CE marking.
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines and medical devices in the UK. If you manufacture, distribute, or sell these products, you need the appropriate MHRA authorisation.
From 1 January 2025: MHRA issues single authorisations covering all UK nations (England, Wales, Scotland, and Northern Ireland), simplifying the regulatory landscape.
Types of MHRA authorisations
The authorisation you need depends on your business activity.
Which authorisation do you need?
- Pharmaceutical manufacturer: Manufacturer's Licence + Marketing Authorisation for each product
- Medicine importer/distributor: Wholesale Dealer Licence
- Medical device manufacturer: Device registration + UKCA marking
- Medical device importer: Device registration as UK Responsible Person
- Clinical trial sponsor: Clinical Trial Authorisation + IMP manufacturing/distribution licences
Marketing Authorisation for medicines
To sell or supply a medicine in the UK, you need Marketing Authorisation from MHRA.
Which route is right for your medicine?
- Standard medicines: National Assessment Procedure (NAP) - 210 days
- Innovative medicines: Innovative Licensing and Access Pathway (ILAP) - faster with MHRA support
- Urgent unmet need: Conditional Marketing Authorisation - can be granted with less complete data
Wholesale Dealer Licence
To distribute medicines (including importing and exporting), you need a Wholesale Dealer Licence.
Note: If you deal with controlled drugs, you also need a Home Office controlled drugs licence in addition to your MHRA WDA.
Manufacturer's Licence
To manufacture medicines in the UK, you need a Manufacturer's Licence.
Good Manufacturing Practice (GMP)
Your manufacturing facility must comply with Good Manufacturing Practice standards. MHRA conducts inspections to verify compliance. Key requirements include:
- Quality Management System
- Qualified Person responsible for batch release
- Validated manufacturing processes
- Documentation and record-keeping
- Staff training and competency
Medical device registration
Medical devices must be registered with MHRA before being placed on the UK market.
Medical device classification
Devices are classified by risk level, which determines the regulatory pathway.
Understanding your device class
- Class I (low risk): Self-certification possible - you declare conformity
- Class I sterile/measuring: UK Approved Body assessment for sterility or measuring aspects only
- Class IIa, IIb, III: UK Approved Body must assess and certify before you can place on market
UKCA vs CE marking
Understanding which marking to use is critical for market access.
Post-market surveillance
Once your products are on the market, you have ongoing safety monitoring obligations.
Next steps
- Identify your products: Determine whether you're dealing with medicines, medical devices, or both
- Classify your products: For medical devices, determine the risk class
- Determine authorisation needs: List all licences and registrations required
- Prepare quality systems: Implement GMP (medicines) or QMS (devices) as appropriate
- Submit applications: Apply via MHRA portals with required documentation
- Prepare for inspection: MHRA will inspect manufacturing facilities
- Implement PMS: Set up post-market surveillance systems before launch