Hospital Exemption: how it works and where it is recognized

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

What Hospital Exemption is

Origin and authorising body. European Union, Article 28 of Regulation (EC) No 1394/2007 (Advanced Therapy Medicinal Products Regulation), implemented in Member State law. The authorising body for each individual case is the Member State competent authority (BfArM and PEI in Germany, MHRA in the UK, ANSM in France, AIFA in Italy, AEMPS in Spain), acting under that jurisdiction's pharmacy or medicines legislation.

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Legal basis. Article 28 of Regulation (EC) No 1394/2007 permits the preparation of an advanced therapy medicinal product (ATMP) on a non-routine basis according to specific quality standards, used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner in order to comply with an individual medical prescription for a custom-made product for an individual patient. Each Member State implements the provision through its competent authority.

Hospital Exemption is the EU framework that permits hospitals to prepare advanced therapy medicinal products (gene therapies, cell therapies, tissue-engineered products) on a non-routine basis for individual patients. The framework predates the EU's full commercial ATMP framework and remains a parallel route for ATMPs that are not commercially licensed or that are prepared in-house by academic hospitals. Hospital Exemption operates at the Member State level, which means each country interprets the 'non-routine' and 'within the same Member State' requirements according to national policy.

Hospital Exemption is most actively used in Germany (under Section 21 paragraph 2 AMG) and the UK (MHRA Hospital Exemption guidance). The framework has been used for CAR-T cell therapies prepared in academic medical centres (notably at Charite Berlin, Karolinska Stockholm, and University College London), gene therapies prepared at university hospitals, and tissue-engineered products prepared at orthopaedic centres. Cross-border supply under Hospital Exemption is highly restricted: the framework was designed for same-country use, with the explicit Article 28 language that the ATMP must be used within the same Member State as prepared.

This page consolidates Reserve Meds's operational view of the Hospital Exemption 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 Hospital Exemption-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 Hospital Exemption

Hospital Exemption is used by academic medical centres and specialty hospitals with ATMP preparation capability. The treating physician at the dispensing hospital must hold clinical responsibility, and the dispensing must occur in the same Member State as the preparation.

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 Hospital Exemption

Advanced therapy medicinal products: gene therapies, cell therapies (including CAR-T), tissue-engineered products, and combinations of these with medical devices.

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

• Hospital ATMP preparation authorisation from the Member State competent authority.
• Clinical justification per the patient.
• Informed consent specific to ATMP use.
• Manufacturing quality documentation (typically meeting GMP standards adapted for non-routine preparation).
• Hospital ethics committee approval.
• Periodic safety and outcomes reporting to the competent authority.

Typical timeline

Hospital Exemption authorisation is established at the hospital level (not per-patient). Per-patient preparation timelines depend on the specific ATMP and typically run 4 to 12 weeks from initial referral to first dose.

Costs and reimbursement

ATMP preparation costs are typically substantial (often six-figure per-course). Reimbursement varies by Member State and indication.

Where Reserve Meds fits in

Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine access. For Hospital Exemption 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 Hospital Exemption 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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