Named Patient Program (NPP): how it works and where it is recognized

Last reviewed 2026-05-16 by Reserve Meds clinical and regulatory team.

What NPP is

Origin and authorising body. European Union (Directive 2001/83/EC, Article 5), adopted across most Commonwealth, Gulf, and Mediterranean regulators under parallel national pharmacy and drug-control decrees. The authorising body for each individual case is the destination-country regulator (the EDE in the UAE, SFDA in Saudi Arabia, NHRA in Bahrain, MoPH-DPA in Qatar, KDFC in Kuwait, MoH-DGPADC in Oman, JFDA in Jordan, MoPH in Lebanon, EDA in Egypt, and CDSCO in India), acting under that jurisdiction's pharmacy or medicines legislation.

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Legal basis. Article 5(1) of Directive 2001/83/EC permits Member States to authorise the supply of an unauthorised medicine in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional, for use by an individual patient under that professional's direct personal responsibility. Most non-EU regulators have adopted parallel rules through national pharmacy or drug-control decrees that mirror this architecture.

Named Patient Program (NPP) is the foundational regulatory architecture for supplying a medicine that is not registered, not stocked, or not reimbursed in the destination country to a specific named patient at the written direction of that patient's treating physician. The framework is patient-specific (one prescription, one named patient, one shipment), physician-led (the prescribing clinician carries clinical responsibility), and time-bound (most permits cover a defined treatment duration rather than an open standing order). The framework is not a marketing tool and cannot be used to bypass a manufacturer's commercial registration decision; it is reserved for individual patient need where the locally available route is unsuitable or unavailable.

Across jurisdictions the program goes by different names. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) refers to the practice as supply against a specials licence or under regulation 167 of the Human Medicines Regulations 2012. In France, the Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM) administers Autorisations d'Acces Compassionnel (AAC) and Autorisations d'Acces Precoce (AAP). In Germany, the Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM) recognises Einzelimport under Section 73 paragraph 3 of the Arzneimittelgesetz. In the Gulf, the UAE's Emirates Drug Establishment (EDE, federal, effective 29 December 2025 under Federal Decree-Law No. 38 of 2024), Saudi Arabia's SFDA, Qatar's MoPH-DPA, Kuwait's KDFC, Oman's MoH-DGPADC, Bahrain's NHRA, and Jordan's JFDA each run a Named-Patient or Compassionate-Use track under their pharmacy decrees. Egypt's EDA administers single-patient imports under Ministerial Decree 425. India's CDSCO recognises personal-use import under Rule 36 of the Drugs and Cosmetics Rules 1945.

This page consolidates Reserve Meds's operational view of the Named Patient Program framework across the ten destination countries where we currently coordinate cross-border supply. Earlier in our content build we maintained separate per-country sub-pages for each Named Patient Program-in-country combination; those sub-pages remain available for archival reference but are no longer separately indexed, and the operational intelligence they carried has been folded into the country-compatibility table below.

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Who can use NPP

Named Patient Program is used by treating physicians on behalf of a specific patient when the clinically indicated medicine is not registered in the destination country, when the locally registered version does not match the required indication (paediatric use, stage of disease, weight band), when the local agent does not stock the relevant presentation or strength, or when the patient cannot obtain the medicine through the local reimbursed channel and is paying cash. The treating physician must be licensed in the destination jurisdiction, must hold prescribing rights for the relevant therapeutic class, and must accept clinical responsibility for the prescription. The pathway is reserved for individual patient need: it is not intended to substitute for ordinary commercial supply where a registered alternative is clinically suitable, and it cannot be used to bypass a manufacturer's commercial registration decision.

In practical terms, a Reserve Meds case opens when the treating physician has identified the clinical need, has reached a decision to prescribe a specific medicine, and has determined that the locally available route is unsuitable or unavailable. We then layer the regulatory and supply-chain coordination on top of that clinical decision; we do not originate the prescribing question and we do not advise on the clinical choice. The decision sits with the physician throughout.

Drug categories typically covered under NPP

Specialty oncology agents (CAR-T constructs, antibody-drug conjugates, immune checkpoint inhibitors, late-line oral targeted therapies), rare-disease biologics (enzyme replacement therapies, gene therapies, antisense oligonucleotides, exon-skipping therapies), advanced biologics for inflammatory and autoimmune conditions (IL-4 and IL-13 blockers, IL-17 and IL-23 inhibitors, JAK inhibitors, complement inhibitors), advanced therapy medicinal products in indications not yet locally registered, paediatric formulations of adult-approved medicines, ophthalmology specialty agents, and high-cost small molecules in oncology, neurology, and metabolic disease where the FDA or EMA label has moved ahead of local registration.

The medicine itself must be source-country approved or in active regulatory development under a recognised reference authority (typically the US FDA, the European Medicines Agency, the UK MHRA, the Japan PMDA, or Health Canada). Most destination regulators will not authorise a Named Patient Program import for a medicine that lacks a recognised reference authorisation anywhere in the world, because the regulator's risk assessment leans on the source-country review as a substitute for its own.

Country compatibility

The table below summarises how the Named Patient Program framework is recognised across the ten destination countries where Reserve Meds currently coordinates cross-border supply. The "Accepts Named Patient Program dossiers" column reflects whether the destination regulator typically reviews and grants permits on the strength of a Named Patient Program clinical justification packet, or whether the patient must use a different parallel framework on the receiving side. Timelines reflect routine cases with a complete documentation set; first-import scenarios, paediatric weight-banded presentations, advanced therapy medicinal products, and large multi-cycle quantities can extend the regulator review by several weeks.

Notes. "Indirect" means the destination regulator does not directly accept Named Patient Program authorisation as the legal basis for import but does recognise a Named Patient Program authorisation as supporting precedent within its own named-patient or compassionate-use review. "Not applicable" means the framework is not a patient-access pathway in the cross-border sense and is shown here for completeness. Regulator names: NHRA (Bahrain), EDA (Egypt), CDSCO (India), JFDA (Jordan), KDFC (Kuwait), MoPH (Lebanon), MoH-DGPADC (Oman), MoPH-DPA (Qatar), SFDA (Saudi Arabia), and EDE (United Arab Emirates, federal from 29 December 2025).

Documentation required

A NPP application is typically assembled in coordination with the treating physician, the dispensing facility, and the cross-border supply partner. The documentation set below covers the routine case; specific destination countries may require additional items (most frequently a hospital ethics committee notification for paediatric or complex cases, and an insurer pre-authorisation letter where the patient intends to seek reimbursement).

• Clinical justification letter from the treating physician documenting diagnosis, severity, prior therapies, why this specific drug is appropriate, and why the locally available option is unsuitable.
• Treating physician's destination-country medical licence verification including issuing health authority, licence number, and scope of practice.
• Anonymised or initialled patient identifier where the destination regulator allows, or full identifier where required.
• Full product details: brand name, generic name (INN), manufacturer, strength, dosage form, pack size, quantity requested, and intended treatment duration.
• Destination dispensing facility name, pharmaceutical establishment licence number, and pharmacy-in-charge contact details.
• Chain-of-custody plan describing how the medicine moves from the US manufacturer through the importer to the dispensing pharmacy, including cold-chain handling and temperature-monitoring arrangements where required.
• Patient consent for cross-border import and for the documentation set that travels with the application.
• Where required by the destination regulator: insurer pre-authorisation correspondence or evidence of cash-pay arrangement; institutional ethics committee notification for paediatric or complex cases.

Typical timeline

Routine cases typically clear regulator review in 5 to 25 business days depending on jurisdiction. UAE EDE and Bahrain NHRA tend to be the fastest in the Gulf cluster, often processing complete dossiers within 5 to 15 business days. Egypt EDA, Saudi SFDA, and Lebanon MoPH can extend longer for first-import requests of a given product, where the regulator reviews the source-country manufacturing and registration evidence in addition to the patient-specific clinical justification. Cold-chain shipment adds 2 to 5 days versus an ambient small molecule because validated thermal packaging, continuous temperature monitoring, and customs clearance scheduled to avoid tarmac heat exposure are non-negotiable. End-to-end from first complete documentation set to dispensing-pharmacy release, most cases complete within 3 to 6 weeks. Complex cases involving paediatric weight-banded presentations, advanced therapy medicinal products, or large multi-cycle quantities can run 6 to 10 weeks.

Costs and reimbursement

Drug cost on a named-patient import is the US wholesale acquisition cost (WAC) or its international equivalent, plus international cold-chain logistics, plus destination customs and permit fees, plus the dispensing pharmacy handling fee, plus the coordinator's concierge fee where one is engaged. Most destination insurers assess named-patient imports case by case. Some reimburse fully when the medicine is on formulary even if not locally stocked; some reimburse a percentage subject to copay; many require pre-authorisation; some decline coverage for unregistered-route imports as a matter of policy. Manufacturer copay cards and US patient-assistance programmes typically do not extend across borders, and cross-border patients should plan on a cash-pay basis unless the destination insurer has affirmatively confirmed coverage in writing. Reserve Meds itemises each fee on every firm quote so there are no surprises at the point of decision.

Where Reserve Meds fits in

Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine access. For Named Patient Program cases, we coordinate the US-side sourcing through a DSCSA-compliant specialty channel, prepare the documentation packet your physician submits, coordinate validated cold-chain logistics with continuous temperature logging into the destination country, and assign a single named coordinator through the case. We do not replace your treating physician, we do not replace the destination-country regulator, and we do not replace your dispensing pharmacy. We coordinate the supply side so the physician can focus on patient care.

For each of the ten destination countries above, we publish a country-specific page documenting the operational realities (which dispensing facilities handle named-patient cases, how the cold chain is verified at the local airport, how the dispensing pharmacy releases the medicine, and what the typical insurer interaction looks like). Those country pages, combined with this pathway page and the specific drug pages, give the prescribing physician and the patient a coherent picture of what to expect before any commitment is made.

Our concierge fee is itemised separately on every firm quote alongside the drug acquisition cost, international logistics, customs, and dispensing pharmacy handling. The patient sees the full breakdown before deciding to proceed; we do not bundle costs and we do not charge an intake deposit. If the case cannot proceed for regulatory or supply reasons, we say so before any payment is taken.

Next step

If your treating physician has identified a clinical need that fits the Named Patient Program framework and you are weighing the cross-border route, the next step is a short intake. We confirm eligibility within 24 to 48 hours and send a documentation kit to your physician.

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Related

• All access pathways
• UAE access landscape
• Saudi Arabia: SFDA named-patient pathway
• When conventional access fails
• How Reserve Meds works