GNH USA
Named-Patient Supply — United Kingdom

GNH USA

Named-Patient Supply — United Kingdom

GNH USA arranges named-patient supply of unlicensed and Specials medicines into the UK, sourced worldwide and handled under MHRA requirements and WHO GDP.

Named-patient supply lets a clinician in the United Kingdom obtain a medicine that is not licensed for the local market when no suitable authorised product meets a particular patient's clinical needs. GNH USA — a US-based, WHO GDP-certified pharmaceutical distributor serving patients and healthcare providers worldwide — sources these unlicensed, orphan and hard-to-find medicines from regulator-approved markets and arranges their compliant supply into the UK, working alongside the prescriber who retains clinical responsibility.

For some patients, the medicine that would help most is simply not available as a licensed product in the United Kingdom. It may have been discontinued locally, it may be authorised only in another country, or it may treat a condition so rare that no UK marketing authorisation has ever been pursued. In those situations, the named-patient and unlicensed-medicines route gives clinicians a lawful way to obtain what an individual patient needs. GNH USA exists to make that route practical: we locate the product through trusted, regulator-approved channels worldwide, manage the quality and cold-chain handling that sensitive medicines demand, and present the documentation that lets a UK pharmacy or prescriber proceed with confidence. We supply to support a clinical decision that a UK prescriber has already made — we do not make that decision for them.

UK regulatory context

How unlicensed medicines work in the UK

In the United Kingdom, medicines are regulated by the MHRA. Where a patient has special clinical needs that an authorised product cannot meet, the law allows unlicensed medicines — often called 'Specials' — to be supplied. GNH USA operates within this framework rather than around it.

MHRA oversight

The Medicines and Healthcare products Regulatory Agency sets the requirements for supplying and importing unlicensed medicines in the UK.

Specials and unlicensed

An unlicensed medicine, or 'Special', may be supplied to meet the special clinical needs of an individual patient when no licensed equivalent is suitable.

Prescriber responsibility

An unlicensed medicine is supplied against the order of a prescriber who takes clinical responsibility for its use in that named patient.

Importation

Importing an unlicensed medicine into the UK is subject to MHRA requirements, including notification to the MHRA before importation.

No suitable alternative

Named-patient routes are intended for situations where an authorised UK product does not meet the patient's particular needs.

Documented supply

Each supply is supported by documentation so that the clinical and regulatory basis for use can be demonstrated.

Named-patient supply is not a way to bypass UK licensing — it is a recognised provision for individual patients whose needs cannot be met by an authorised medicine. The clinical decision rests with the prescriber, and the supply chain must satisfy the MHRA's expectations for quality, traceability and, where the product is imported, prior notification. GNH USA's role is to identify a suitable regulator-approved source, handle the product under WHO GDP-certified conditions, and deliver it with the documentation a UK healthcare provider needs.

Because GNH USA is based in the United States and ships internationally, we are not tied to a single regional supply network. That breadth matters for unlicensed medicines, where a product may only be obtainable from a specific approved market at a given time. We combine that global reach with the discipline expected of a WHO GDP-certified operation, so a medicine that has travelled across borders still arrives with intact quality, an unbroken temperature record where required, and a clear chain of documentation.

You can request a medicine at any time, or read more about our named-patient supply service and how we support clinicians and patients worldwide.

The process

From request to UK delivery

Every step is documented and audit-ready, so the clinical and regulatory trail is clear from the first enquiry to the bedside.
  1. Step 01

    Request

    A UK prescriber, pharmacy or caregiver tells us the medicine required and the clinical context.

  2. Step 02

    Verification

    We confirm the prescriber's order and the documentation needed for an unlicensed-medicine supply.

  3. Step 03

    Sourcing

    We identify a suitable, regulator-approved source for the product worldwide.

  4. Step 04

    Import and QA

    Importation is arranged subject to MHRA requirements, with internal quality checks before release.

  5. Step 05

    Delivery

    The medicine ships to the UK via validated, temperature-controlled lanes under WHO GDP.

Named-patient request

Request a UK named-patient medicine

Share the medicine and the clinical details. A prescriber's order and the relevant supporting documentation let us act faster. We respond within one business day and confirm what the UK named-patient and importation route requires before anything moves.
  • Sourced worldwide

    From regulator-approved markets to the patient or clinic in the UK.

  • MHRA-aligned

    Supply and importation handled subject to MHRA requirements.

  • WHO GDP cold-chain

    Temperature-sensitive medicines ship via validated, monitored lanes.

Request a medicine

FAQ

Frequently asked questions

What is named-patient supply in the United Kingdom?

It is the supply of an unlicensed medicine to meet the special clinical needs of an individual patient when no suitable licensed product is available. The medicine is supplied against the order of a prescriber who takes clinical responsibility for using it in that named patient.

What is a Special?

A Special is an unlicensed medicine prepared or imported to meet the special clinical needs of an individual patient. It does not hold a UK marketing authorisation, and it is intended for use where an authorised product cannot meet the patient's needs.

Is it legal to import an unlicensed medicine into the UK?

Yes, importing an unlicensed medicine is permitted but is subject to MHRA requirements, including notification to the MHRA before the medicine is imported. GNH USA arranges importation within this framework.

Who can request a named-patient medicine?

Requests are made in connection with a prescriber who takes clinical responsibility for the patient. Pharmacies, clinics and caregivers can also start an enquiry, and the supply proceeds on the basis of the prescriber's order.

How does GNH USA source these medicines?

GNH USA is a US-based, WHO GDP-certified distributor that sources unlicensed, orphan and hard-to-find medicines from regulator-approved markets worldwide, then arranges compliant, temperature-controlled delivery into the UK with full documentation.

How long does the process take?

Timelines depend on the medicine, its source and the documentation involved. We respond to enquiries within one business day and confirm the expected route once the request is verified.