Healthcare & Social Care Healthcare and medical devices UK-wide

MHRA licensing for medicines and medical devices

MHRA licensing requirements for manufacturing, distributing, and importing medicines and medical devices in the UK.

Guide summary

If you manufacture, distribute, import or supply medicines or medical devices in the UK, you must get the right MHRA licence. You need a Manufacturer's Licence (MIA) to make medicines, a Wholesale Dealer's Licence (WDA) to distribute them, and Clinical Trial Authorisation (CTA) for trials. Medical devices must be registered with MHRA and have UKCA or CE marking. You must also set up a pharmacovigilance system to monitor medicine safety.

  • Apply for a Manufacturer's Licence (MIA) to make medicines in the UK
  • Pay £4,209 for standard MIA application; annual fee £561
  • Apply for a Wholesale Dealer's Licence (WDA) to distribute medicines
  • Pay £346 annual fee for standard WDA; £206 for reduced
  • Get Clinical Trial Authorisation (CTA) before starting a trial; fee £4,656
  • Register all medical devices on UK market with MHRA at £300 per category
  • Have a Qualified Person (QP) for manufacturing and Responsible Person (RP) for distribution
  • Set up a pharmacovigilance system with a Qualified Person for Pharmacovigilance (QPPV)
  • Report serious adverse drug reactions within 15 calendar days
  • Non-compliance may lead to criminal prosecution
On this page

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Medical device compliance checklist

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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.

Healthcare & Social Care Requirement

Good Manufacturing Practice (GMP) compliance is mandatory

All manufacturers must comply with Good Manufacturing Practice (GMP) as detailed in the EU GMP Guidelines (still applicable in UK). Key requirements include:

  • Quality Management System covering all manufacturing activities
  • Qualified Person (QP) responsible for batch release
  • Appropriate premises, equipment, and personnel
  • Written procedures and batch documentation
  • Regular self-inspection and quality audits

MHRA conducts pre-licence inspections and ongoing inspections (typically every 2-3 years) to verify GMP compliance. Inspection fees are £5,251 per day.

Who this applies to: All manufacturers holding or applying for MIA or MIA(IMP) licences
Enforcement:
Non-compliance can result in licence suspension, licence revocation, or prosecution. Manufacturing without a licence carries unlimited fines and up to 2 years imprisonment.
GMP guidance (opens in a new tab)

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.

Healthcare & Social Care Requirement

Good Distribution Practice (GDP) compliance is mandatory

All wholesale dealers must comply with Good Distribution Practice (GDP). Key requirements include:

  • Responsible Person (RP) - typically a registered pharmacist
  • Appropriate premises with controlled temperature/humidity
  • Quality Management System and documented procedures
  • Supplier and customer due diligence
  • Falsified Medicines Directive (FMD) compliance
  • Cold chain management for temperature-sensitive products

MHRA conducts GDP inspections to verify compliance. Non-compliance can result in licence suspension or revocation.

Who this applies to: All wholesale dealers holding or applying for WDA licences
Enforcement:
Operating without a WDA where required is a criminal offence carrying unlimited fines and up to 2 years imprisonment.
GDP guidance (opens in a new tab)

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