Healthcare & Social Care

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.

UK-wide
Guide summary

You need MHRA authorisation to sell, make or distribute medicines and medical devices in the UK. Check which licence you need based on your business activity. Apply before 1 January 2025 when new UK-wide rules start.

  • Check which MHRA authorisation you need for your business
  • Apply for Marketing Authorisation to sell medicines (210 days)
  • Get a Wholesale Dealer Licence to distribute medicines (90 days)
  • Apply for a Manufacturer's Licence to make medicines (90 days)
  • Register medical devices before selling (£261 fee per application)
  • Use UKCA marking for Great Britain from 1 January 2025
  • CE marks accepted until 30 June 2028 or 2030
  • Non-UK device makers need a UK Responsible Person
  • Manufacturers must follow Good Manufacturing Practice
  • Distributors must follow Good Distribution Practice
On this page
UK-wide

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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

  1. Identify your products: Determine whether you're dealing with medicines, medical devices, or both
  2. Classify your products: For medical devices, determine the risk class
  3. Determine authorisation needs: List all licences and registrations required
  4. Prepare quality systems: Implement GMP (medicines) or QMS (devices) as appropriate
  5. Submit applications: Apply via MHRA portals with required documentation
  6. Prepare for inspection: MHRA will inspect manufacturing facilities
  7. Implement PMS: Set up post-market surveillance systems before launch