How named-patient supply works

Named-patient supply is the route a hospital or doctor uses when a patient needs a medicine that is not licensed, registered or available in their country. Instead of waiting for a company to register the product, the law lets a licensed local party bring in a stated quantity for a stated patient, under the treating physician's responsibility. The same idea appears under different names: specials in the United Kingdom, Section 21 in South Africa, special access in Saudi Arabia and non-registered medicine approvals across much of the Gulf.

This guide explains the common pattern behind those routes, who does what, the order of the steps and where a supplier in India fits. Country details sit in the individual import guides, for example United Kingdom, South Africa and Saudi Arabia.

What named-patient supply is

Most countries require a marketing authorisation before a medicine is sold. Named-patient supply is a narrow exception to that rule. In the European Union, Article 5(1) of Directive 2001/83/EC lets a Member State exclude from the authorisation rules a medicine supplied in response to a bona fide unsolicited order, made to the specification of an authorised health care professional, for an individual patient under that professional's direct personal responsibility. National laws then set the details.

Three features recur in almost every country:

• One identified patient, or a small defined need. The request is tied to a patient, or in some countries to a hospital's expected use over a short period.
• A clinical reason. The prescriber decides that no licensed medicine meets the patient's need. The MHRA's specials guidance says these needs are clinical in nature and are determined by the prescriber responsible for the patient's care.
• A licensed local party. A hospital, pharmacy or licensed importer receives the medicine and answers to the regulator.

Price is not a clinical reason. In case C-185/10 the Court of Justice of the European Union found that Poland had breached the Directive by allowing unauthorised medicines in when they were cheaper than authorised ones, and held that financial considerations cannot in themselves establish a special need. South Africa's Section 21 guideline similarly says affordability alone is not usually a reason to approve.

What it is not

Named-patient supply is different from a clinical trial, where a product is studied under a protocol, and from a compassionate use or expanded access programme, where a developer makes an investigational medicine available before approval. The comparison guide sets out those differences. In practice, named-patient requests often concern medicines that are already approved somewhere else, for example in India, Europe or the United States, but not in the patient's country.

Who does what

The patient is the reason for the request but is rarely the applicant. SAHPRA's Section 21 FAQs say the treating practitioner, who takes full clinical responsibility, must complete the application. In Canada, the Special Access Program accepts requests from practitioners, and the manufacturer then supplies the drug to the practitioner.

How the process runs, step by step

1. The physician identifies the need. The physician confirms that no registered alternative is suitable and records the diagnosis, earlier treatment, product, strength, dose and expected duration.
2. The hospital or importer sends a sourcing request. A complete request names the active ingredient, any required brand, strength, pack, quantity, destination and the licensed consignee. The guide on how to prepare a medicine sourcing request lists the fields, and requests can be sent through the quote request form.
3. The exporter confirms availability and documents. The exporter checks the product's status in India, the remaining shelf life and any cold-chain needs, then issues a proforma invoice with the certificate of analysis, GMP evidence and, where asked, a certificate of pharmaceutical product.
4. The local party applies to the regulator. The hospital or importer files the application, permit request or notification with the proforma and product documents attached.
5. The regulator decides. It may approve, ask questions, object or simply let a waiting period run out, depending on the country.
6. The exporter clears Indian export controls. Under CDSCO's export guidance, a manufacturer holding a Form 25 or Form 28 licence obtains a no objection certificate from a CDSCO zonal office to export an unapproved, approved new or banned drug, against the foreign buyer's purchase order. Narcotic and psychotropic medicines need a separate export authorisation from India's Narcotics Commissioner, which requires the importing government's original import certificate and allows one consignment only (Central Bureau of Narcotics). The guide to Indian export rules explains both.
7. The goods ship to the licensed consignee. Product name, strength, pack size and quantity should match across the approval, invoice, packing list and air waybill. For temperature-sensitive products, the cold-chain transit checker compares packaging hold times with the lane.
8. The hospital dispenses and reports. The hospital keeps records, and the physician reports suspected adverse reactions. SAHPRA asks for progress reports every six months, and the SFDA Special Access Program guideline requires serious unexpected reactions to be reported within 15 days, or 7 days if fatal or life-threatening. See what a pharmacovigilance report needs.

How the main routes compare

Published times cover the regulator's step only. Sourcing, Indian export clearance and transit come on top, which is why the lead-time estimator adds them separately. Detailed guides cover the United Kingdom, South Africa, the GCC and Nigeria.

Why the patient is not usually the importer

Named-patient routes are built around licensed parties that a regulator can inspect. In the United States, the FDA's personal importation page says that in most circumstances it is illegal for individuals to import drugs for personal use, and that a drug approved in another country but unapproved in the US is illegal to import. In the United Kingdom, unlicensed imports are notified by a licence holder and supplied through the prescriber, hospital or pharmacy. In the European Union, Article 5(1) depends on an order from a health care professional. Direct-to-patient supply is therefore not the route in the US, the UK or the EU.

A few countries run personal-use permits, such as the UAE's EDE permit and Saudi Arabia's clearance of up to three months of use, described in the GCC guide. These have their own limits and exclusions and do not replace hospital routes for complex or hospital-administered medicines. A patient or family member should ask the treating physician or hospital to make the request.

Controlled medicines need extra permits on both sides. The importing country issues an import certificate or permit, and India issues a per-consignment export authorisation. Courier options are narrower too. Saudi Arabia's personal-use clearance conditions, for example, do not allow narcotic and psychotropic medicines to travel by courier.

Documents and practical limits

A named-patient consignment usually carries:

• The regulator's approval, permit or notification acknowledgement, naming the consignee
• The prescription and the physician's justification letter
• Proforma invoice, commercial invoice and packing list with matching details
• Certificate of analysis for each batch and GMP evidence for the manufacturing site
• A certificate of pharmaceutical product or proof of registration in the country of origin, where asked
• Air waybill and temperature logger records for cold-chain lots

The document checklist builds this list per country, and pharma export documents explained describes each item. Regulators also cap quantities and dates. The MHRA usually caps a notification at 25 packs unless justified, a Section 21 named patient authorisation covers up to six months of treatment and lapses six months after approval, and Qatar expects imported medicines to arrive with two thirds of their shelf life left. Shipping before the approval is issued risks detention or return, so the exporter should dispatch only once the consignee confirms the approval in writing. For cost and timing questions, see medicine pricing and lead times explained.