Early Access to Medicines Scheme (EAMS, UK): how it works and where it is recognized

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

What EAMS is

Origin and authorising body. United Kingdom, an MHRA-administered voluntary scheme launched April 2014. The authorising body for each individual case is the Medicines and Healthcare products Regulatory Agency (MHRA), acting under that jurisdiction's pharmacy or medicines legislation.

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Legal basis. The Early Access to Medicines Scheme is an MHRA-administered voluntary scheme that allows patients with life-threatening or seriously debilitating conditions to access promising new medicines that do not yet have a marketing authorisation. The scheme operates through a two-step process: a Promising Innovative Medicine (PIM) designation (the first step, granted on the basis of early-phase data), followed by a Positive Scientific Opinion (the second step, granted on the basis of late-phase data with risk-benefit assessment).

EAMS is the UK's structured pre-licensing access programme. A Positive Scientific Opinion (PSO) under EAMS provides a regulatory pathway under which prescribers can access an unlicensed medicine for eligible patients with confidence in the MHRA's assessment of the available data. The scheme is voluntary; the manufacturer applies, the MHRA reviews, and the resulting PSO is published with eligibility criteria. EAMS bridges the gap between Phase 3 completion and full UK marketing authorisation.

EAMS PIM designation requires Phase 1 data and a credible development plan. EAMS PSO requires substantial late-phase data and a benefit-risk assessment in defined patient populations. The scheme has been used for medicines later approved (and some not approved), and the published PSOs serve as a regulatory transparency mechanism. EAMS does not provide reimbursement; the manufacturer typically supplies the medicine free of charge during the EAMS window, and NICE then assesses cost-effectiveness for post-licensing NHS reimbursement. The scheme has been a significant precedent for similar early-access programmes in other jurisdictions, notably the French AAP framework and the Italian AIFA Fondo 5 percent programme.

This page consolidates Reserve Meds's operational view of the EAMS (UK) 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 EAMS (UK)-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 EAMS

EAMS is used by UK prescribers (NHS or private) on behalf of UK patients meeting the published eligibility criteria of a specific PSO. Cross-border patients from outside the UK cannot use the framework directly; the existence of an EAMS PSO for a particular medicine is a useful regulatory precedent for destination-country regulators considering parallel programmes.

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 EAMS

Oncology agents in late-Phase 3 development awaiting MHRA or EMA decision, rare-disease therapies (including gene therapies and cell therapies in late development), advanced therapy medicinal products, and post-approval indications not yet through full UK 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 EAMS (UK) 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 EAMS (UK) framework is recognised across the ten destination countries where Reserve Meds currently coordinates cross-border supply. The "Accepts EAMS (UK) dossiers" column reflects whether the destination regulator typically reviews and grants permits on the strength of a EAMS (UK) 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 EAMS (UK) authorisation as the legal basis for import but does recognise a EAMS (UK) 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 EAMS 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).

• Prescriber confirmation that patient meets the published PSO eligibility criteria.
• Patient informed consent referencing the EAMS PSO.
• Manufacturer supply confirmation under the active PSO.
• Treating hospital pharmacy infrastructure.
• Reporting per the PSO's data collection requirements.
• Patient identifier per the PSO.

Typical timeline

Once an EAMS PSO is open, eligible UK patients can typically receive supply within 2 to 4 weeks. PIM designation: 14 days from a complete application. PSO: 90 days from a complete application. Cross-border patients use parallel home-country frameworks, which typically run 4 to 8 weeks end-to-end.

Costs and reimbursement

During the EAMS window, the medicine is typically supplied free of charge by the manufacturer. Post-licensing, NICE assesses cost-effectiveness for NHS reimbursement. Cross-border patients pay the relevant per-country acquisition cost plus logistics, customs, dispensing, and coordinator fees.

Where Reserve Meds fits in

Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine access. For EAMS (UK) 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 EAMS (UK) 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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