Named-patient import to the UK, from Indian WHO-GMP origin.
When the licensed UK product is out of stock, discontinued, or doesn't exist at the strength a patient needs, M Care is the manufacturer-side partner your MHRA Specials importer picks up the phone to. Single-vial shipments supported. Documentation prepared at source.
Regulation 167. Individual patient. Unlicensed medicinal product.
The UK named-patient route sits under regulation 167 of the Human Medicines Regulations 2012. It covers the supply of an unlicensed medicinal product to meet the special clinical needs of an individual patient, on the request of their prescriber. Separately, MHRA-licensed Specials manufacturers and importers hold the wholesale and specials authorisations that make the import itself legal.
Who the route serves
UK hospital pharmacies and NHS trust procurement teams during national stock-outs. Homecare pharmacies supplying complex patients at home. Paediatric hospitals where the commercial UK strength does not exist. Specialist teams prescribing a molecule registered elsewhere but not in the UK.
Where we sit in it
Manufacturer-side. We are not the UK importer and we are not the prescriber. We are the Indian WHO-GMP facility's commercial and regulatory arm. The UK Wholesale Dealer's Licence holder pulls product from us; the Responsible Person signs it in on arrival; the pharmacy dispenses to the named patient.
What the importer gets
A batch of product on the cold-chain validated pallet with every document the MHRA notification, the Responsible Person, and the dispensing pharmacist might ask for, prepared at the Indian end and cross-checked before dispatch. Not at arrival. Before dispatch.
Why a UK pharmacy phones us.
National oncology shortage
Docetaxel, paclitaxel, oxaliplatin, gemcitabine and cisplatin have all had multi-month UK shortages in recent years. When the licensed UK pack is out, an unlicensed equivalent from an Indian WHO-GMP facility — with an MHRA specials importer pulling it in — keeps chemotherapy lists running.
Paediatric strength gap
A commercial UK pack might only come in 500mg; the patient needs a 50mg paediatric presentation. Where an Indian manufacturer routinely produces that strength for other regulated markets, it is sourceable, documentable, and importable on named-patient.
Discontinued UK product
When a marketing authorisation is withdrawn commercially but patients remain on therapy, the named-patient route bridges them. We hold lines on over 600 active ingredients, many of them the quieter molecules that come off UK shelves first.
Homecare and specialist
Haemophilia concentrates, HIV antiretrovirals on unusual regimens, rare-disease enzymes where the licensed UK brand is the only option and stock-outs bite hard. Supplied into homecare pharmacy partners that already hold the right wholesaler and specials authorisations.
Every form an MHRA importer's Responsible Person asks for.
Prepared at the Indian end and cross-checked before the consignment ships. Shared electronically ahead of arrival and physically in the carton.
Batch-specific CoA
HPLC assay, impurity profile, water content, residual solvents, sterility and endotoxin as applicable. Signed by the manufacturer's authorised QC head. Reference standard and method cited.
CoPP, WHO format
Certificate of Pharmaceutical Product issued by CDSCO. Apostilled at Indian MEA where the UK importer has requested it for insurance or MHRA notification attachment.
WHO-GMP certificate
Current WHO-GMP certificate for the specific manufacturing site and the specific dosage form. Expiry verified before dispatch; a six-month minimum residual validity at the point of shipment.
Manufacturing licence
Form 25/28 copy (as applicable), notarised. Establishes the Indian site's authority to manufacture and export the specific dosage form of the molecule.
MHRA notification attachment
The manufacturer-side fields of the MHRA unlicensed-medicine import notification, prepared so your Responsible Person only has to complete the importer-side fields.
Cold-chain logs on arrival
Pre-shipment thermal validation of the shipper configuration. Continuous temperature logging in transit. On-arrival logger read-out issued before the consignment is opened.
Molecule · strength · patient count · target dispatch. One working day.
- Send the specifics. Molecule (INN), strength, dosage form, patient count or course length, prescriber-requested brand or flexible, and the target arrival window.
- Availability and price at source. We confirm the Indian manufacturer, batch availability, expiry, CoPP status and a landed price to your UK importer's nominated warehouse.
- Pre-dispatch document pack. CoA, CoPP, GMP, licence, manufacturer declaration, MHRA notification attachment. Shared electronically for the Responsible Person to review before the carton ships.
- Cold-chain dispatch and arrival. Temperature-validated shipper, continuous logging, on-arrival logger read-out, QP / Responsible Person sign-off. Pharmacy-ready.
- Pharmacovigilance contact. A named PV contact opened in the UK supply chain for the consignment's shelf life. ADR reports routed back to the manufacturer's QA.
Named-patient UK supply — the specifics.
Are you an MHRA-licensed importer?
No. We are the Indian manufacturer-side partner. The UK importer must hold a Wholesale Dealer's Licence (WDA(H)) with the unlicensed-medicine import authorisation. We supply product and documentation into that import chain; we do not hold a UK licence ourselves.
What is the minimum order?
There is no hard minimum. Single-vial and single-pack supply is supported where the molecule is in manufacturer stock. Most named-patient consignments are one to twenty vials or packs.
What's the usual lead time?
Stock-on-hand molecules: 7-12 calendar days door-to-door. Made-to-order batches or unusual strengths: 4-8 weeks. Urgent life-threatening single-patient supply has been moved in under 96 hours with the right prioritisation.
Can you supply during a national shortage?
Yes. We hold lines on over 600 active ingredients across 12 therapeutic categories. When a UK shortage is announced we can typically quote a replacement strength, brand or presentation within one working day.
Which therapeutic areas do you cover most?
Oncology cytotoxics, specialist injectables, anaesthesia and ICU, paediatric strengths, and anti-infectives where a UK brand has been discontinued. Full list under products.
Do you handle cold-chain product?
Yes. Pre-shipment thermal validation per shipper, continuous temperature logging in transit, on-arrival logger read-out. Excursion protocol defined before dispatch, not after the carton lands.
Can you ship into an NHS trust directly?
Only through a trust's nominated MHRA-licensed importer or specials manufacturer. Direct import without a UK import licence would be a regulatory breach we will not participate in.
How do you handle pharmacovigilance?
A named PV contact is opened for the consignment's shelf life. ADR reports are routed back to the manufacturer's QA team and to CDSCO where applicable. Periodic Safety Update Reports compiled to ICH E2C on request.
A UK pharmacy, a patient, a molecule that isn't on the shelf. That's the conversation.
Molecule, strength, patient count, target dispatch. We'll have a manufacturer-side answer inside one working day.