Named-patient import into the UK: what it is, what it is not, and what a first-time NHS request actually looks like.

A named-patient import is the legitimate way for a UK prescriber to obtain an unlicensed medicine from abroad for one identified patient. It is not a bulk-supply route, it is not a back-door around marketing authorisation, and it is not the same thing as a UK Specials manufacture. It is a narrow, regulated, paperwork-heavy pathway — and it works reliably when the desk knows what it is asking for.

What a named-patient import actually is.

In UK regulatory language, a named-patient import is the supply of an unlicensed medicinal product — meaning a product that does not hold a UK Marketing Authorisation — to meet the special clinical needs of one individually identified patient, on the written request of that patient's prescriber. The medicine is sourced from outside the UK. A UK entity holding the correct licence imports it. The prescriber's clinical justification is the gating document.

Three words in that definition matter more than they look.

• Unlicensed. The product does not hold a UK Marketing Authorisation. It may be fully authorised in the EU, the US, or elsewhere — but in the UK, for this indication or strength, it is unlicensed.
• Named. The prescriber is prescribing for a specific patient, identified in the clinical notes. Not for a ward, not for a formulary gap, not for the next quarter. A named individual with a clinical need.
• Imported. The product crosses the UK border. This is what distinguishes a named-patient import from a UK-manufactured Special, which is compounded inside the UK by a licensed Specials manufacturer.

Strip any one of those three out and the route is something else.

The legal basis: Regulation 167 of the Human Medicines Regulations 2012.

The statutory basis is Regulation 167 of the Human Medicines Regulations 2012, which carries forward the UK's long-standing allowance for supply of unlicensed relevant medicinal products to meet special clinical needs. The same regulation is the basis for UK Specials — the operational difference is not the regulation, it is whether the product is imported or manufactured in the UK under a Specials licence.

Two credentials sit on top of Regulation 167.

The importer's licence.

A UK entity importing an unlicensed medicine from abroad must hold either a Wholesale Dealer's Licence (Human), abbreviated WDA(H), with the appropriate authorisation to import unlicensed medicines, or a Manufacturer's Specials Licence (MS) that covers importation. Hospital pharmacies in larger trusts sometimes hold a WDA(H) directly and import for their own use. More often, a specialist unlicensed-medicines wholesaler — sometimes called a specials importer — does the importing on the trust's behalf, then supplies the trust pharmacy under the wholesaler-to-hospital route.

The MHRA import notification.

Before importation, the importer must submit an import notification to the MHRA. This is handled through the MHRA Portal. The notification captures the product, the source country, the manufacturer, the intended quantity for the named patient, the importer's details, the prescriber's details and the clinical rationale for why an unlicensed product is being sought where a licensed one is not considered suitable.

MHRA has a 28-day window within which it may object to the proposed import. If MHRA does not object within that window, the importer may proceed. In genuine emergencies — typically life-threatening clinical scenarios with no clinical alternative — the MHRA can be approached for immediate clearance, and the 28-day clock effectively collapses. Emergency handling is not the default; it is exactly what the word suggests.

When the route is the right one.

A named-patient import is the right answer to a specific, narrow set of clinical situations. The route exists because UK licensing, by definition, cannot cover every molecule, every strength, every patient sub-population. It is worth being precise about when the pathway fits, because using it outside that envelope is where procurement gets into trouble.

The common reasons NHS trusts use the route:

• Paediatric formulations. A licensed adult product exists in a 500 mg strength; the paediatrician needs a 50 mg or liquid presentation that is routinely manufactured in India or elsewhere but has no UK SKU. The paediatric pack exists; it just isn't UK-licensed.
• EU- or US-licensed drugs not yet UK-licensed. Post-Brexit divergence has widened this gap. A drug holding an EMA authorisation but no MHRA authorisation, still prescribed by a UK consultant with a European training background, is a candidate.
• National shortages of a UK-licensed line. Oncology cytotoxics, specialist injectables, anaesthesia lines — when the UK-licensed pack is on back-order for weeks, named-patient import of an overseas equivalent keeps chemotherapy lists running.
• Orphan indications. A molecule used for a rare condition where the UK market was never commercially attractive to a marketing-authorisation holder.
• Low-volume tropical or specialist lines. Travel medicine, tropical-disease treatment, occasional infectious-disease lines where the UK simply does not hold a licensed pack.

What the route is not for: routine supply to a formulary gap. If a trust needs a regular monthly supply of a molecule with no UK licence, the correct answer is usually a Specials manufacture route, a parallel-import arrangement, or a commercial MA application — not repeated named-patient imports.

The paperwork chain, in order.

The administrative choreography is the thing most first-time importers underestimate. The sequence below is the standard flow for a non-emergency named-patient import; the emergency path compresses the same steps rather than skipping them.

1. Prescriber writes the clinical rationale. A letter or structured prescription identifying the patient (by hospital number), the diagnosis (ICD-10 code where applicable), the dosing regimen, the treatment duration, and the reason a UK-licensed alternative is not clinically suitable. “Not available in the UK” is not enough on its own if a licensed alternative exists.
2. Importer receives the request. The UK importer — either the trust pharmacy's own WDA(H) operation or a contracted specials importer — takes the prescriber's rationale and confirms the sourcing plan: which overseas manufacturer, which country of origin, expected batch expiry.
3. MHRA import notification submitted. Via the MHRA Portal, with the product details, source country, manufacturer, quantity for the named patient, importer and prescriber details, and the clinical rationale.
4. 28-day review window. MHRA may raise an objection within 28 days. In emergencies, the importer can request expedited handling.
5. Purchase order to the overseas supplier. Once the notification has cleared (or been expedited), the importer places a PO with the overseas manufacturer or the manufacturer's export arm.
6. Supplier-side documentation pack. On our side as an Indian supplier, this is a standard paper trail: WHO-GMP certificate for the manufacturing site, CDSCO Certificate of Pharmaceutical Product (CoPP) in WHO format, batch-specific Certificate of Analysis signed by the manufacturer's QC head, manufacturing licence copy, Certificate of Origin, and for cold-chain lines the pre-shipment thermal validation and temperature logger setup.
7. Dispatch, customs, logger read-out. The consignment leaves India, clears UK customs, and is received by the importer. Cold-chain logger data is read and archived before the carton is opened.
8. Importer release to the trust. The importer's Responsible Person signs the consignment in, and the medicine is supplied to the trust pharmacy for dispensing to the named patient.
9. Pharmacovigilance. Any adverse event is reported via the importer to the MHRA Yellow Card scheme, with the report routed back to the manufacturer's QA for trend analysis.

There are typically ten to fifteen documents in a complete file. A missing one stops the clock.

How it differs from Specials and parallel import.

Three adjacent routes are regularly confused with named-patient import. A procurement desk that can tell them apart saves itself a week.

UK Specials manufacture.

A UK Specials manufacturer holds a Manufacturer's Specials Licence (MS) and compounds or packages unlicensed medicinal products inside the UK to meet an individual patient's special clinical needs. Same Regulation 167 statutory basis as named-patient import; different operational reality. The medicine is not imported — it is made to order in a UK facility. Used heavily for paediatric liquid formulations, reconstitutions and bespoke strengths where an overseas pack doesn't exist or can't arrive in time.

Parallel import.

A parallel import is a fully UK-licensed medicine, sourced from a lower-price EU market (where that remains permissible under UK rules) and re-presented for UK sale by a holder of a parallel import licence. It is not an unlicensed-medicines route at all — the product is licensed in the UK through an equivalent MA. Parallel import is a commercial pricing mechanism, not a clinical-access pathway.

Commercial Marketing Authorisation.

If a molecule is going to be used regularly in the UK, the right long-term answer is an MA. The named-patient route is explicitly not a substitute for an MA — MHRA will notice if a trust is using named-patient imports as a de-facto ongoing supply route, and the correct conversation in that case is with a specials manufacturer or with a prospective MA holder.

Realistic timelines: standard and emergency.

Two honest numbers matter to procurement.

• Standard named-patient import, complete file, stock-on-hand molecule: typically 1–3 weeks from a cleared MHRA notification to the consignment landing at the UK importer's warehouse. Door-to-door, from prescriber signature to pharmacy dispensing, the realistic figure is closer to 7–12 working days once the 28-day MHRA clock has run (or been expedited).
• Emergency life-threatening single-patient supply: 48–72 hours is achievable when every party prioritises the case. MHRA expediting, a supplier with stock on hand, cold-chain capacity on the same day's flight out of Mumbai or Delhi, and an importer whose Responsible Person is available to sign the consignment in. It is not a promise — it is a pattern we have seen work repeatedly when the clinical brief justifies it.

Made-to-order batches, unusual strengths, or manufacturer lead time on a product that isn't currently in stock move the window to four to eight weeks. Knowing which of those three categories a request falls into is the first thing to establish on day one, because it shapes every downstream promise.

Five procurement pitfalls to avoid.

Patterns we see regularly on first-time named-patient import requests. None of them are regulatory showstoppers; all of them cost days.

1. Dispatching before the 28-day MHRA window has cleared. On non-emergency imports, the importer must either wait out the window or secure an explicit earlier go-ahead. A consignment that lands before the notification is complete is a regulatory problem, not a paperwork one.
2. Prescriber rationale that is too thin. “Not available in the UK” is insufficient if a UK-licensed alternative in fact exists. The clinical justification needs to address the alternative: why this strength, this presentation, this molecule, for this patient, where the licensed option is clinically unsuitable.
3. Confusing named-patient import with a UK Special. A Specials manufacturer does not necessarily handle named-patient imports, and vice versa. Check the licence. A supplier that holds an MS for UK manufacture may not be the right partner for sourcing an overseas unlicensed pack.
4. Using the route for bulk or ongoing supply. Named-patient is per-patient, per-course, quantity-bounded. A desk that finds itself placing the same named-patient order every quarter should be looking at a Specials manufacture arrangement or an MA conversation instead.
5. Generic product CoA instead of batch-specific CoA. The manufacturer's standard product-specification sheet is not the same as the lot's QC data. The importer's Responsible Person will ask for the batch sheet. Get it from the supplier before the consignment ships, not after.

FAQ

What is a named-patient import in the UK?

A named-patient import is the supply of an unlicensed medicinal product from abroad to meet the special clinical needs of one identified UK patient, on the written request of that patient's prescriber. The statutory basis is Regulation 167 of the Human Medicines Regulations 2012, and the route requires a UK importer holding either a Wholesale Dealer's Licence (WDA(H)) with unlicensed-medicine authorisation or a Manufacturer's Specials Licence that covers importation.

What is the difference between a named-patient import and a UK Special?

Both sit under Regulation 167, so the legal basis is identical. The difference is operational: a UK Special is compounded, packaged or manufactured inside the UK by a Specials manufacturer holding an MS licence, while a named-patient import is sourced from a manufacturer abroad and imported by a UK WDA(H) holder. A trust that needs a bespoke paediatric liquid tends to use a Specials manufacturer; a trust sourcing a specific oncology pack from an Indian WHO-GMP facility is using the named-patient import route.

How long does a named-patient import take?

For a standard, stock-on-hand molecule with a complete file, 1–3 weeks from cleared MHRA import notification to consignment arrival is typical. Emergency single-patient supply for life-threatening cases has been moved in 48–72 hours when every party prioritises. Made-to-order batches, unusual strengths or manufacturer lead-time products move the window to four to eight weeks. The 28-day MHRA review window is the single biggest variable on non-emergency cases.

Does M Care hold a UK WDA(H) or specials importer licence?

No. M Care is the Indian-side manufacturer-linked supplier. The UK importer must hold the appropriate licence — a WDA(H) with unlicensed-medicine authorisation or an MS licence covering importation. We supply product and the complete manufacturer-side documentation pack (WHO-GMP certificate, CDSCO CoPP, batch-specific CoA, Certificate of Origin, cold-chain logger data) into the UK importer's chain. If a trust does not already have a specials importer partner, we can introduce one.