Indian unlicensed-medicine supplier into UK MHRA Specials, EU Article 5 national schemes, Australia TGA, Singapore HSA and GCC compassionate-use channels.

An unlicensed medicine is a pharmaceutical product that does not hold a marketing authorisation in the destination country. The clinical reason is almost always a special need: a molecule discontinued by the originator, a paediatric strength not commercially produced, a brand variant the patient has tolerated abroad, a tropical-disease medicine not registered locally, an orphan medicine the local importer cannot procure, or a regulatory gap during a shortage. Indian WHO-GMP manufacturers produce the largest generic-medicine catalogue globally and are the natural source of unlicensed supply into the UK, EU, Australia, Singapore and GCC markets where the molecule itself is unregistered or unavailable. M Care is the Indian manufacturer-side exporter; the importer in your country holds the local unlicensed-medicine authorisation under the regime applicable to your jurisdiction.

Two parallel UK regimes. Regulation 167 of the Human Medicines Regulations 2012 governs the import of a finished unlicensed medicine for a named patient on the request of a doctor, dentist or supplementary prescriber. The UK importer must hold a WDA(H) wholesale dealer's licence with the unlicensed-medicines authorisation; the import is notified to MHRA at least 28 working days before, with the standard MHRA notification template. Specials (Manufacturer's Specials, MS) licence under the Medicines Act 1968 covers in-UK manufacture or assembly of an unlicensed medicine. We supply finished-dose unlicensed product into Reg 167 importers and APIs with open DMF into MS licence holders. Detail at named-patient import UK and MHRA Specials.

Yes. Article 5 of Directive 2001/83/EC permits Member States to authorise the supply of unlicensed medicines for special clinical needs, but the implementation is national, not EU-central. Germany operates the Einzelimport (single-import) route under §73 paragraph 3 of the Arzneimittelgesetz, with the pharmacy filing the import for a named patient against a prescription. France runs the Autorisation d'Accès Compassionnel (AAC, the post-2021 successor to ATU) under ANSM, plus Authorisation for Accelerated Access (AAP) for compassionate use of unauthorised products. Italy uses Legge 648/96 to authorise specific molecules for special-need supply. Netherlands, Spain, Sweden and Belgium operate equivalent national schemes. We supply manufacturer-side from Indian WHO-GMP sites; the national-scheme importer in each EU country files the special-access authorisation and the regulatory paperwork carries through the consignment.

Yes, three pathways under the Australian TGA. Special Access Scheme Category A is a notification route for patients defined as 'seriously ill where death is reasonably likely to occur' — the prescriber notifies TGA within 28 days of supply. Category B requires TGA approval before supply, used for non-Category A patients and most chronic indications. Category C covers products notified by TGA as eligible for streamlined supply. The Authorised Prescriber scheme pre-authorises a specific doctor to supply specified unapproved products to specified patients without per-patient TGA approval — useful for ongoing programme supply. We supply manufacturer-side; the Australian prescriber or sponsor handles the SAS or Authorised Prescriber paperwork. CDSCO export documentation and a current GMP certificate accompany every consignment for TGA scrutiny.

Singapore's Health Sciences Authority (HSA) operates the Authorised Prescriber scheme analogous to Australia's TGA: a registered medical practitioner is pre-authorised to import and supply specified unapproved therapeutic products to named patients. The prescriber lodges the application via the HSA's electronic system with patient-specific clinical justification. Imports also need an Importer's Licence held by an HSA-licensed distributor. We supply manufacturer-side from Indian WHO-GMP into the Singapore distributor's bonded warehouse against the prescriber's authorisation. CDSCO export documentation, a current GMP certificate and a Certificate of Pharmaceutical Product (CoPP) accompany every consignment.

The GCC operates case-by-case unregistered-import authorisations rather than a single regime. Saudi Arabia (SFDA) runs the Compassionate Use Programme via the hospital pharmacy and SFDA's drug-evaluation department, with patient-specific approval against an Indian or other-origin CoPP and GMP package. UAE (MoHAP, DHA, DoH) authorises case-by-case unregistered import through the licensed local agent. Kuwait, Qatar, Oman and Bahrain each operate ministry-approved channels through hospital pharmacy applications. M Care supplies manufacturer-side from Indian WHO-GMP into the GCC importer or hospital, with the documentation pack matching the local authority's compassionate-use template. Documentation includes CoA, GMP certificate, manufacturer licence, CoPP authenticated through MEA India and the destination embassy, and Arabic bilingual artwork on request.

No. M Care is an Indian merchant exporter and we say so plainly. We do not hold a UK WDA(H), an EU national-scheme importer status, a TGA sponsorship, an HSA importer's licence or a GCC unregistered-import authorisation in our own name; those local authorisations are held by the importer, MS licence holder, authorised prescriber, distributor or hospital pharmacy in your jurisdiction. Our role is manufacturer-facing: we sit between the Indian WHO-GMP plant and your local authorised channel, prepare the manufacturer-side documentation (CoA, GMP certificate, CoPP, CDSCO export NOC, stability data, DMF for API where applicable) and freight the consignment to your bonded warehouse or hospital goods-in. The local regulatory paperwork is always yours; the supply discipline and documentation is ours.

Every consignment ships with: a batch-specific Certificate of Analysis against the agreed monograph (HPLC assay, related substances per Ph.Eur./USP/JP, water content, dissolution, content uniformity, sterility and pyrogen tests for injectables); the Method of Analysis; Certificate of GMP Compliance for the manufacturing site (WHO-GMP or EU-GMP as applicable); manufacturing licence; Certificate of Pharmaceutical Product (CoPP) issued by CDSCO India, authenticated through the Indian Ministry of External Affairs and the destination-country embassy where required; CDSCO export NOC; Certificate of Origin (chamber-attested); destination-language pack insert; temperature and humidity logs from pre-dispatch through on-arrival; and the Drug Master File open-part (CTD Module 3) where API or finished-dose technical detail is needed for the importer's QP or PV file. Tightened cold-chain documentation (passive-validated container validation report plus continuous temperature-logger trace) accompanies oncology biologicals, peptides, vaccines and other cold-chain Specials.