MHRA authorisation for medicines and medical devices

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).

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.

You need this licence to sell or supply medicines to anyone other than the patient who will use them, including when a pharmacy supplies other than directly to the public. Apply through the MHRA process licensing (PCL) portal and name a Responsible Person. The MHRA inspects your site for Good Distribution Practice before it grants the licence.

A new application costs £2,159 plus a £4,136 inspection fee. A reduced £992 application fee applies if you handle only general sales list medicines, if you are a registered retail pharmacy whose wholesaling is no more than 15% of turnover in licensed products, or if your wholesaling is no more than £35,000 of that turnover. Once licensed, you pay an annual periodic fee of £346, or £206 at the reduced rate.

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.

You need a manufacturer's licence to make, assemble or import human medicines. There are separate licence types for licensed products, unlicensed 'specials', investigational medicinal products for clinical trials and exempt advanced therapy products. If you are applying for a marketing authorisation, you need the manufacturer's licence first.

Complete the MHRA application form and email it with the supporting documents to pcl@mhra.gov.uk. The MHRA invoices you for the standard £4,209 application fee and inspects your site for GMP before granting the licence; inspections are charged at £5,251 a day. Once licensed, you pay an annual periodic fee of £561. If you withdraw before the inspection, 90% of the application fee is refunded; after it, 50%.

Good Manufacturing Practice (GMP)

Your manufacturing facility must comply with Good Manufacturing Practice standards. MHRA conducts inspections to verify compliance. Main 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