Every year, thousands of patients across the world require medicines that are not licensed in their country. The medicine exists. It is manufactured to the highest quality standards. It works. But it does not hold a marketing authorisation in the country where the patient is being treated.

This situation is more common than most people realise, and there is a legal, well-established route to supply it. It is called named patient supply, and understanding how it works is essential for hospital pharmacists, procurement managers, and healthcare institutions operating in complex or international environments.

This guide explains what named patient medicines are, when this supply route applies, how the regulatory framework operates in the UK, and how to source these medicines compliantly.

What Is a Named Patient Medicine?

A named patient medicine is an unlicensed medicinal product that is supplied to a specific, identified patient when no suitable licensed alternative is available. The term "named patient" means exactly that: the supply is made for a particular patient, under the responsibility of a registered prescriber, rather than as a general stock product.

In the UK, named patient supply is governed by Regulation 167 of the Human Medicines Regulations 2012. This regulation allows licensed wholesalers to source and supply medicines that do not hold a UK Marketing Authorisation (MA), provided that the supply is:

  • Initiated by a registered healthcare professional (a doctor, dentist, or nurse prescriber)
  • For the treatment of an individual patient under their care
  • Based on an unsolicited request from the prescriber
  • In response to a genuine clinical need that cannot be met by a licensed product

It is important to understand that named patient supply is not a loophole. It is a carefully regulated pathway with clear legal obligations on both the prescriber and the supplier.

When Does Named Patient Supply Apply?

Named patient supply typically applies in four situations:

1. The medicine is not licensed in the UK

Some medicines are licensed and approved in other countries but have never received a UK Marketing Authorisation. This can happen for commercial reasons, or because the manufacturer has not sought UK approval. A prescriber may have clinical evidence that this product is the best treatment for their patient, and named patient supply provides the legal route to access it.

2. The licensed UK version is unavailable

Drug shortages are a persistent problem. When a licensed UK medicine is out of stock, a named patient import of the same product manufactured abroad may be the fastest available solution. This is increasingly common for injectable medicines, specialist oncology drugs, and critical care products.

3. The patient requires a different formulation

A licensed medicine may exist in tablet form, but a particular patient may require a liquid, or a different dosage strength. If no licensed alternative exists in the required formulation, named patient supply can facilitate access.

4. International supply for unregistered medicines

Outside the UK, hospitals and health ministries frequently face situations where a medicine used routinely in Europe or the US is simply not registered in their country. Named patient or compassionate use frameworks provide the legal route to import and supply these medicines under special regulatory provisions.

Euro Biom regularly supports named patient and early-access supply into regions where medicine access is constrained, including pharmaceutical supply to Saudi Arabia, supply to the United Arab Emirates, and pharmaceutical supply to Nigeria. Each jurisdiction operates its own named patient, emergency use, or compassionate access framework, and we work directly with hospital procurement teams, ministries of health, and local importers to route MHRA-compliant supply through the correct regulatory channel.

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the supply of unlicensed medicines. The key piece of legislation is the Human Medicines Regulations 2012, specifically:

  • Regulation 167, Permits the supply of unlicensed medicines on a named patient basis when a licensed alternative is unavailable or unsuitable
  • Regulation 174, Governs supply under hospital exemptions for specials manufactured by or for a specific patient

Separately, the importation of medicines from outside the UK (or outside the European Economic Area) requires a Special Import Licence (SIL) from the MHRA. This licence is issued on a case-by-case basis and is specific to each importation.

Key point: The responsibility for named patient supply sits primarily with the prescriber, who must satisfy themselves that the product is appropriate for their patient. However, the wholesale distributor plays a critical role in ensuring the product is sourced from a verified manufacturer, accompanied by the correct documentation, and handled in accordance with Good Distribution Practice (GDP).

Who Can Supply Named Patient Medicines?

Only organisations holding an MHRA Wholesale Dealer Authorisation (WDA) are permitted to supply named patient medicines in the UK. The WDA specifies the categories of product the holder can deal in and the geographical scope of their operations.

This is not an area where informal or unregulated supply routes are acceptable. Sourcing unlicensed medicines through channels that do not hold appropriate regulatory authorisation creates significant patient safety and legal risk.

When selecting a named patient supplier, procurement teams should verify:

  • That the supplier holds a current MHRA WDA (verifiable via the MHRA's public register)
  • That the supplier operates under Good Distribution Practice (GDP) guidelines
  • That the supplier can provide a full documentation package for each supply, including certificates of analysis, manufacturer details, and where required, import licence copies
  • That the supplier has experience with the specific type of product or import route required

The Supply Process: From Enquiry to Delivery

While every named patient case is different, the process broadly follows these steps:

  1. Clinical decision: The prescriber determines that a licensed alternative is not available or suitable and identifies the unlicensed product required.
  2. Enquiry to licensed wholesaler: The hospital pharmacy or procurement team contacts an MHRA-licensed wholesaler with the product details (name, strength, formulation, quantity, and patient identifier).
  3. Supplier sourcing: The wholesaler identifies a verified source for the product, either from a UK-licensed manufacturer of specials or from an overseas manufacturer.
  4. Documentation: The wholesaler prepares or obtains the required regulatory documentation, including any import licence applications where the product is being imported from outside the UK.
  5. Quality check: The product is received and checked against agreed specifications. Cold chain integrity is verified where applicable.
  6. Delivery: The product is delivered to the hospital or institution with a full documentation package accompanying the shipment.

Timelines depend on the product and source. In urgent situations, supply can sometimes be arranged within 24 to 72 hours. Standard cases typically take 5 to 10 working days from the point of confirmed enquiry.

Common Challenges in Named Patient Supply

Named patient supply is not without complexity. The most common challenges procurement teams encounter are:

Manufacturer verification

When sourcing products from overseas manufacturers, confirming that the manufacturer operates to GMP (Good Manufacturing Practice) standards recognised by the MHRA is essential. Not all international manufacturers meet this standard, and using a supplier without the networks to verify this creates risk.

Import documentation

The import process involves regulatory documentation that varies by country of origin and product type. Special Import Licence applications, certificates of analysis, and shipping documentation must be correctly prepared. Errors can cause delays or, in the worst case, customs seizures.

Cold chain management

Many unlicensed medicines, particularly biologics and certain injectables, require temperature-controlled storage and transport. Maintaining cold chain integrity across international shipments requires specialist logistics expertise.

Urgency versus compliance

The clinical need is often urgent. Balancing speed of supply with the need for full regulatory compliance is the core operational challenge in named patient supply, and it requires a supplier with established systems and relationships rather than an ad hoc approach.

International Named Patient Supply

Outside the UK, the landscape becomes more complex. Each country has its own regulatory framework governing the import and use of unlicensed medicines. Some common mechanisms include:

  • Special import licences, required in many countries for medicines not holding a local marketing authorisation
  • Compassionate use programmes, for patients who require access to medicines still in clinical trials or not yet approved locally
  • Emergency use authorisations, in crisis situations, expedited regulatory pathways may allow faster supply
  • Ministerial authorisation, in some markets, particularly across Sub-Saharan Africa and the Middle East, health ministry approval is required for each importation

For international institutions, working with a UK-based MHRA-licensed wholesaler provides a significant advantage. The MHRA licence and the UK's reputation for pharmaceutical quality standards is recognised and trusted by regulatory bodies in most markets. A shipment accompanied by the correct MHRA-authorised documentation carries credibility with customs and health ministry officials worldwide.

How Euro Biom Supports Named Patient Supply

Euro Biom holds an MHRA Wholesale Dealer Authorisation and operates specifically in the complex, urgent, and non-routine medicine supply space. Named patient and unlicensed medicine supply is not a secondary service for us, it is a core part of what we do.

We support hospitals, pharmacies, health ministries, and NGOs with:

  • Fast sourcing of named patient products from verified UK and international manufacturers
  • Full documentation packages for each supply, including certificates of analysis and import documentation
  • Special Import Licence management where required
  • Cold chain compliant shipping for temperature-sensitive products
  • International export to hospitals and institutions in Africa, the Middle East, Central Asia, and beyond

If you are dealing with a named patient supply situation and need guidance on what is possible, our team is available to discuss your case.

Ready to discuss a supply requirement? Contact us at work@eurobiom.co.uk or use our enquiry form. We respond to all enquiries within one working day.

Frequently Asked Questions

What is a named patient medicine?
A named patient medicine is an unlicensed medicinal product supplied to a specific, identified patient when no licensed alternative is available or suitable. It is supplied under the responsibility of a prescribing clinician and must be sourced through an MHRA-licensed Wholesale Dealer Authorisation holder.
Is named patient supply legal in the UK?
Yes. Named patient supply is legal in the UK under Regulation 167 of the Human Medicines Regulations 2012. It must be initiated by a registered prescriber and sourced through an MHRA-licensed wholesaler. It is a well-established, regulated pathway, not a workaround.
Who can supply named patient medicines?
Only organisations holding a current MHRA Wholesale Dealer Authorisation (WDA) are permitted to supply named patient medicines. Procurement teams should always verify a supplier's WDA status via the MHRA public register before placing an order.
How long does named patient supply take?
Timelines vary depending on whether the product is sourced in the UK or internationally, and whether import documentation is required. In urgent cases, supply can be arranged within 24 to 72 hours. Standard cases typically take 5 to 10 working days from confirmed enquiry.
Does Euro Biom handle named patient supply for international hospitals?
Yes. Euro Biom supplies named patient and unlicensed medicines to hospitals, health ministries, and NGOs across Africa, the Middle East, Central Asia, and other regions. We manage the full documentation package for every international shipment, including import documentation relevant to the destination country.

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