Personal Import Scheme: how it works and where it is recognized

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

What Personal Import is

Origin and authorising body. Multi-jurisdictional pattern, present in India (Rule 36), Japan (Yakkan Shomei), Australia (TGA Personal Importation Scheme), New Zealand, several Gulf jurisdictions, and the US (FDA Personal Importation Policy). The authorising body for each individual case is the destination-country pharmacy or medicines regulator (CDSCO in India, MHLW in Japan, TGA in Australia, FDA in the US, and equivalents elsewhere), acting under that jurisdiction's pharmacy or medicines legislation.

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Legal basis. Personal Import Schemes appear under various statutory citations across jurisdictions. The shared design pattern is that an individual patient may import a defined quantity of a medicine for their personal use, subject to a prescription requirement (in most jurisdictions) and quantity limits (typically a three-month supply). The schemes are distinct from commercial import frameworks and do not authorise resale or redistribution.

Personal Import Scheme is the cross-jurisdictional design pattern for patient-led import of unregistered medicines. The framework is patient-friendly in design: it permits direct patient importation, it does not require regulator pre-authorisation in most jurisdictions, and it allows reasonable quantities for personal use. Customs and pharmacy regulators audit imports at the port of entry rather than pre-clearing each case.

Each jurisdiction sets its own rules. India's Rule 36 allows up to three months for chronic conditions. Japan's Yakkan Shomei requires advance certification for quantities above defined thresholds. Australia's TGA scheme allows three months and limits to specified categories. The US FDA Personal Importation Policy is more restrictive and applies primarily to medicines that are not commercially available in the US. The framework operates outside the Named-Patient and Compassionate-Use frameworks: it is for medicines that the patient already knows about and has been prescribed, rather than for medicines that require institutional review and authorisation.

This page consolidates Reserve Meds's operational view of the Personal Import Scheme 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 Personal Import Scheme-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 Personal Import

Personal Import Scheme is used by individual patients (or treating physicians on their behalf) to import medicines for the patient's own use. The medicine must be for personal use and cannot be redistributed or sold.

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 Personal Import

Specialty oncology agents, rare-disease biologics, dermatology specialty agents, paediatric formulations, ophthalmology specialty agents, and post-approval indications. Specific category restrictions vary by jurisdiction; controlled substances and certain biologics may require additional authorisation in most jurisdictions.

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 Personal Import Scheme 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 Personal Import Scheme framework is recognised across the ten destination countries where Reserve Meds currently coordinates cross-border supply. The "Accepts Personal Import Scheme dossiers" column reflects whether the destination regulator typically reviews and grants permits on the strength of a Personal Import Scheme 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 Personal Import Scheme authorisation as the legal basis for import but does recognise a Personal Import Scheme 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 Personal Import 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).

• Prescription from a registered medical practitioner in the destination country.
• Patient identification and clinical justification.
• Quantity calculation per the destination-country rules (typically three months).
• Customs declaration and any required pre-arrival certification.
• For Japan: Yakkan Shomei certificate where the quantity exceeds the routine threshold.

Typical timeline

Customs clearance: typically 3 to 14 business days depending on the destination country and the drug class. End-to-end: 2 to 4 weeks for routine cases.

Costs and reimbursement

Drug cost is the source-country acquisition cost plus international logistics, customs duties, and any coordinator fees. Insurer reimbursement is uncommon for personal imports.

Where Reserve Meds fits in

Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine access. For Personal Import Scheme 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 Personal Import Scheme 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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