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 a product not registered in the patient's own market that is supplied to a specific, identified patient when no suitable registered 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.

The term is used in two different ways, and the difference matters when you choose a supplier:

  • Outside the UK, named patient usually describes an import route in the patient's own country. The hospital or local importer obtains permission from its national regulator to import a medicine that is not registered there. Examples include Section 21 in South Africa and Ministry of Health import permits in the GCC. The medicine can be fully UK-licensed. This is the route Euro Biom supports.
  • Inside the UK, a medicine with no UK marketing authorisation can only reach a patient as an unlicensed "special" under Regulation 167 of the Human Medicines Regulations 2012, on a prescriber's unsolicited order, to meet the special needs of an individual patient. Euro Biom does not supply specials or any other unlicensed medicine.

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 import typically applies in four situations:

1. The medicine is not registered in the patient's country

Some medicines are licensed in the UK but have never been registered in the buyer's market. This can happen for commercial reasons, or because the manufacturer has not applied there. A prescriber may have clinical evidence that this product is the best treatment for their patient, and the national named patient route provides the legal way to import it.

2. The locally registered version is unavailable

Drug shortages are a persistent problem. When a registered medicine is out of stock nationally, a hospital may be able to import the UK-licensed equivalent under its regulator's shortage or named patient provisions. This is increasingly common for specialist oncology drugs and critical care products.

3. The patient requires a different formulation

A registered medicine may exist in tablet form, but a particular patient may require a liquid, or a different dosage strength. If a UK-licensed presentation exists in the required form, the buyer can ask its regulator for permission to import it.

4. International supply for medicines not yet locally registered

Outside the UK, hospitals and health ministries frequently face situations where a medicine licensed in the UK 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 supplies UK-licensed medicines for named-patient import and early access 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 supply UK-licensed product to hospital procurement teams, ministries of health and local importers, who use their own destination-country regulatory channel.

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates the supply of medicines. The key piece of legislation is the Human Medicines Regulations 2012. Regulation 167 allows an unlicensed medicine to be supplied in response to a prescriber's unsolicited order, to meet the special needs of an individual patient, and importing an unlicensed medicine into the UK needs a suitably licensed importer and prior notification to the MHRA.

Those activities belong to specials manufacturers and authorised importers. They fall outside Euro Biom's Wholesale Dealer Authorisation, which covers the procurement, supply and export of UK-licensed medicines.

Key point: Under any named patient route, the decision to use a medicine sits with the prescriber, who must be satisfied that the product is appropriate for their patient. When a UK-licensed medicine is exported under a buyer's import permit, the UK wholesaler's role is to source it through the UK licensed supply chain, supply the documents available for it, and handle it in line with Good Distribution Practice (GDP).

Who Can Supply Named Patient Medicines?

In the UK, wholesale dealing in medicines requires an MHRA Wholesale Dealer Authorisation (WDA). The WDA specifies the categories of product the holder can deal in, so a WDA alone does not mean a supplier can handle every medicine. Regulators overseas set their own rules on who may import.

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

When selecting a 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 licence covers the product you need
  • That the supplier can confirm at quotation which documents are available for each line, such as batch details and export documents

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 locally registered alternative is not available or suitable and identifies the product required.
  2. Import permission: The hospital or local importer applies to its national regulator for permission to import the product.
  3. 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).
  4. Supplier sourcing: The wholesaler identifies a verified UK-licensed source for the product.
  5. Documentation: The wholesaler prepares or obtains the required supply documentation for the UK-licensed product.
  6. Quality check: The contract storage site receives and checks the product against agreed specifications, and temperature records are reviewed where applicable.
  7. Shipment: The product is shipped to the buyer's importer or hospital by specialist carriers, with the export documents available for it.

Timelines depend on the product and source. Typical dispatch is within 24 to 72 hours of order confirmation, subject to availability. Transit times depend on carrier routing and customs clearance; we confirm an estimate with each quote.

Common Challenges in Named Patient Supply

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

Manufacturer verification

Buyers using intermediaries that source outside the UK-licensed supply chain take on a verification burden: confirming the manufacturer operates to GMP (Good Manufacturing Practice) standards recognised by the MHRA is essential, and not every overseas manufacturer meets this standard. Euro Biom sources only UK-licensed, MHRA-authorised medicines through the UK licensed supply chain, which reduces the manufacturer verification a buyer needs to carry out.

Import documentation

The import process involves regulatory documentation that varies by destination country. The buyer's import permit, batch documentation and shipping documents all need to match. Errors can cause delays or, in the worst case, customs seizures.

Cold chain management

Many of these medicines, particularly temperature-sensitive 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 regulatory compliance is the core operational challenge in named patient supply, and it requires a supplier with documented systems 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 medicines not registered in that market. 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 can be checked on the public MHRA register. A shipment accompanied by the correct MHRA-authorised documentation gives customs and health ministry officials a clear starting point for review.

How Euro Biom Supports Named Patient Supply

Euro Biom holds an MHRA Wholesale Dealer Authorisation, trades exclusively in UK-licensed medicines, and operates specifically in the complex, urgent, and non-routine medicine supply space. Supplying UK-licensed medicines for named-patient import 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:

  • Sourcing of UK-licensed products for named-patient import through the UK licensed supply chain
  • Documentation for each supply, including batch documentation
  • UK-side documentation to accompany the buyer's own destination-country import permit application
  • 2-8°C shipping arranged with specialist carriers
  • International export to hospitals and institutions in Africa, the Middle East, Central Asia, and beyond

If you have a named patient supply requirement for a UK-licensed product, our team is available to discuss the supply.

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

Frequently Asked Questions

What is a named patient medicine?
A named patient medicine is a medicinal product supplied for a specific, identified patient when no suitable alternative is registered in that patient's market. It is supplied under the responsibility of a prescribing clinician, through a licensed supply route.
Is named patient supply legal in the UK?
Yes. In the UK, an unlicensed medicine can be supplied to an individual patient as a special under Regulation 167 of the Human Medicines Regulations 2012, on a prescriber's unsolicited order. Euro Biom does not supply specials. For export, named patient means the import route in the buyer's own country, for a product that is UK-licensed.
Who can supply named patient medicines?
It depends on the country and the licence. In the UK, a wholesale supplier needs an MHRA Wholesale Dealer Authorisation (WDA), and the licence must cover the product. 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 the product, the UK licensed source and the destination-country import documentation required. Typical dispatch is within 24 to 72 hours of order confirmation, subject to availability. Transit times depend on carrier routing and customs clearance; we confirm an estimate with each quote.
Does Euro Biom handle named patient supply for international hospitals?
Yes. Euro Biom supplies UK-licensed medicines for named-patient import to hospitals, health ministries, and NGOs across Africa, the Middle East, Central Asia, and other regions. We supply the UK-side documentation package with each international shipment to support the buyer's destination-country import documentation.

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