MHRA Specials supply, from Indian WHO-GMP origin into UK MS licence holders.
When your MS licence compounds or relabels an unlicensed product to meet an individual patient's clinical need, M Care is the Indian manufacturer-side partner feeding finished-dose product and API with open DMF into that chain. Documentation prepared at source. Cold-chain validated. Single-batch supply supported.
Section 10 exemption. MS licence. Individual patient clinical need.
The UK Specials route sits under the Section 10 exemption to the Medicines Act 1968, re-enacted in Part 3 of the Human Medicines Regulations 2012. It permits the manufacture or assembly of an unlicensed medicinal product by an MHRA Manufacturer's Specials (MS) licence holder to meet the special clinical needs of an individual patient, on the request of a prescriber.
Who holds the UK licence
The MS licence is the Manufacturer's Specials Licence, issued by MHRA. Wholesale distribution of Specials sits under a WDA(H) with the unlicensed-medicine authorisation. A Responsible Person and, for imported finished goods, an RP(i) sign product in. None of these authorisations are held by M Care — all are partner-side.
Where the Indian side sits
Manufacturer-side. M Care is the Mumbai-based commercial and regulatory arm of 80+ WHO-GMP partner sites. We supply the finished-dose unlicensed product your MS licence relabels, or the active pharmaceutical ingredient with its open Drug Master File that your MS licence compounds. Not the UK licence holder. The feeder.
How this differs from Reg 167
Reg 167 is direct import of a finished manufactured product for a named patient. Specials is UK manufacture or assembly under an MS licence. The overlap is real — many UK partners run both routes. See the named-patient import route for the Reg 167 variant.
Why a UK Specials manufacturer phones Mumbai.
Paediatric liquid gap
Commercial UK stock is a 250mg tablet; the paediatric patient needs a 10mg/ml oral suspension that no UK MA covers. An Indian manufacturer already produces that presentation for export to other regulated markets. Your MS licence picks up the finished suspension or the API to compound in-house.
Oncology cream and compounding
Unlicensed topical cytotoxic preparations, hormone creams at non-standard strengths, and compounded oncology add-ons where the UK route is MS-licence compounding. Active ingredient supplied with open DMF and CoA, so your QP on the import side can batch-certify without redoing impurity work.
Parenteral nutrition add-on
Individual mineral and trace-element additions to PN regimens where the UK licensed product is out or not available at the concentration the regimen needs. Supplied as sterile finished vials from EU-GMP capable Indian partners, or as USP/EP-grade API into an aseptic MS licence.
Unlicensed biopharma
Biopharmaceuticals and specialty injectables that hold a marketing authorisation in other regulated markets but no UK MA. Your MS licence supplies these on Specials where a clinical need is documented. We ship from cold-chain validated 2-8°C and -25°C lanes with continuous logging.
Every document your MS licence's Responsible Person expects at goods-in.
Prepared at the Indian end and cross-checked before dispatch. Shared electronically ahead of arrival and physically in the carton. Six-month minimum residual validity on every certificate at the point of shipment.
Batch-specific CoA
HPLC assay, related-substances profile, water content, residual solvents, sterility and endotoxin where applicable. Signed by the manufacturer's authorised QC head, with reference standard and pharmacopoeial method cited (USP, BP or Ph. Eur.).
Open DMF (for API supply)
Open-part Drug Master File for the active ingredient, CTD Module 3 format. Restricted part filed separately on your QP's request. Polymorph, particle-size and impurity qualification data to support your MS licence's in-house compounding validation.
WHO-GMP certificate
Current WHO-GMP certificate issued by CDSCO (Central Drugs Standard Control Organization, India) for the specific manufacturing site and the specific dosage form. Expiry verified before dispatch and notarised where your RP has requested.
CoPP, WHO format
Certificate of Pharmaceutical Product issued by CDSCO. Apostilled at the Indian Ministry of External Affairs where the MS holder attaches it to their MHRA notification or internal product file.
Manufacturing licence
Form 25 / 28 (as applicable) copy, notarised. Establishes the Indian site's CDSCO authority to manufacture and export the specific dosage form. For API, the bulk-drug manufacturing licence is supplied in parallel.
Cold-chain validation pack
Pre-shipment thermal validation of the shipper configuration, continuous temperature logging in transit, and the on-arrival logger read-out issued before the consignment is opened. Excursion protocol agreed before dispatch, not after the carton lands.
Molecule, grade, volume, MS-licence use-case. Twenty-four working hours.
- Send the specifics. Molecule (INN), grade (finished dose or API), strength or assay, pack or kg, intended MS-licence use-case, patient-count horizon if known, and your target UK arrival window.
- Source and quote. We confirm the Indian manufacturer, batch availability, expiry, DMF status for API, CoPP status for finished dose, and a landed price to your MS site's nominated goods-in bay.
- Pre-dispatch document pack. CoA, CoPP, WHO-GMP, manufacturing licence, open DMF where applicable, manufacturer declaration, and a cold-chain validation file. Shared electronically for your RP or QP to review before the consignment ships from Mumbai.
- Cold-chain dispatch and arrival. Temperature-validated shipper, continuous logging, on-arrival logger read-out, RP(i) and QP sign-off at the UK end. Product staged in your MS licence's goods-in quarantine ready for batch release.
- Pharmacovigilance and repeat supply. A named PV contact opened for the consignment's shelf life, ADR routing to the manufacturer's QA, and a forward plan for the next batch so your MS licence can plan its dispensing window with confidence.
MHRA Specials supply — the specifics.
Do you hold a UK MS licence or WDA(H)?
No. M Care is the Indian manufacturer-side partner. The MS (Manufacturer's Specials) licence and the WDA(H) wholesale dealer's licence are MHRA authorisations held by UK entities only. We supply finished-dose unlicensed product and active pharmaceutical ingredients into UK MS licence holders and WDA(H) wholesalers; we do not hold any UK regulatory authorisation in our own name and we will not misrepresent that position.
Can you supply the API as well as the finished dose?
Yes. Where your MS licence compounds or assembles the Special in-house, we supply the active pharmaceutical ingredient with its open-part Drug Master File in CTD Module 3 format. The restricted part is filed separately on your QP's request. Pharmacopoeial grade (USP, BP or Ph. Eur.) is the default; tighter in-house specifications are accommodated at quote stage.
What's the minimum order?
There is no hard minimum. Single-batch and single-pack supply is supported where the molecule is in manufacturer stock. For API we ship in quantities from 100g upwards. For finished dose the typical Specials consignment is ten to a few hundred units. Made-to-order batches are quoted on a per-enquiry basis.
What's the usual lead time?
Stock-on-hand molecules: 10-14 calendar days door-to-door into a UK goods-in bay. Made-to-order finished-dose batches or unusual API assay windows: 6-10 weeks. Urgent single-patient Specials supply has been expedited in under two weeks where CDSCO and airfreight align; we do not promise faster than the manufacturer can release.
Are your partner sites EU-GMP certified?
Some of them. A portion of our 80+ WHO-GMP partner roster holds EU-GMP certification issued by a named EU competent authority, which is useful where your MS licence's internal validation prefers EU-GMP inputs. We match the site to the use-case at quote stage and share the specific GMP certificate — we do not imply EU-GMP across the whole roster.
How do you support the MHRA notification process?
For finished-dose Specials, we prepare the manufacturer-side fields of the MHRA unlicensed-medicine import notification so your Responsible Person only completes the importer-side fields. For in-house MS-licence compounding from API, we supply the DMF and CoA package your QP uses to release the compounded product. We do not submit notifications ourselves — that is always the UK licence holder's responsibility.
How does this differ from the named-patient Reg 167 route?
Reg 167 of the Human Medicines Regulations 2012 covers direct import of a manufactured unlicensed product for an individual patient. The Specials route covers UK manufacture or assembly of an unlicensed product under an MS licence. The two overlap — many UK partners run both — but the regulatory mechanics differ. Our named-patient import page covers the Reg 167 side.
Can you ship direct to an NHS trust Specials unit?
Only through the trust's nominated MS licence holder or WDA(H) wholesaler. Direct import of an unlicensed product into an NHS site without a UK import authorisation would breach the Human Medicines Regulations 2012 and we will not participate in it. The MS holder or wholesaler is always the importer of record on the UK side.
Your MS licence. Our manufacturer. One patient at a time.
Molecule, grade, volume, target arrival. We'll quote and share the document pack inside one working day from the Mumbai desk.