ATU Nominative (France): how it works and where it is recognized
A cross-border regulatory framework for supplying an unregistered or off-label medicine to a specific patient, on the order of a treating physician, under a defined permit issued by the destination-country medicines regulator.
Last reviewed 2026-05-16 by Reserve Meds clinical and regulatory team.
What ATU Nominative is
Origin and authorising body. France, under the access reform of 1 July 2021 which restructured ATU as Autorisations d'Acces Compassionnel (AAC) and Autorisations d'Acces Precoce (AAP). The authorising body for each individual case is the Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM), acting under that jurisdiction's pharmacy or medicines legislation.
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Legal basis. The pre-2021 framework was the Autorisation Temporaire d'Utilisation Nominative (ATU Nominative) under Article L.5121-12 of the French Code de la Sante Publique. The 2021 reform replaced it with AAC Nominatif (Acces Compassionnel a titre Nominatif) for individual-patient compassionate use of medicines without an active marketing authorisation in the indication, and with AAP equivalents where a marketing authorisation is expected.
ATU Nominative (now AAC Nominatif) is the French framework for individual-patient pre-registration access to medicines that are not authorised in France or not authorised for the patient's indication. The treating physician submits a request to ANSM documenting the patient's serious or life-threatening condition, the absence of satisfactory authorised alternatives, and the rationale for the requested medicine. ANSM reviews on a case-by-case basis. Unlike the cohort framework, the nominative pathway does not require the manufacturer to commit to a marketing authorisation programme; the patient is the unit of authorisation, not the cohort.
AAC Nominatif applications can be filed by hospital-licensed physicians and are reviewed individually by ANSM. The framework is the closest French equivalent to a generic Named-Patient or compassionate-use authorisation seen in other jurisdictions. ANSM's review typically takes 2 to 4 weeks for routine cases. The treating physician retains clinical responsibility, and the dispensing pharmacy must be authorised to receive imported unregistered medicines. Cross-border patients cannot directly use ATU Nominative; the framework supplies French patients in France.
This page consolidates Reserve Meds's operational view of the ATU Nominative (France) 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 ATU Nominative (France)-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 ATU Nominative
AAC Nominatif is used by hospital-affiliated French physicians on behalf of individual patients with serious or life-threatening conditions for whom no satisfactory authorised alternative exists. The medicine must be authorised somewhere (typically the US, EU, or UK) or in late-stage development. Cross-border patients from outside France cannot directly use ATU Nominative; the existence of an ANSM nominative authorisation for a particular medicine in a particular indication 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 ATU Nominative
Specialty oncology agents not registered in France in the relevant indication, rare-disease therapies, advanced therapy medicinal products in pre-registration limbo, post-approval extensions of US-approved medicines not yet registered in France, and paediatric formulations of adult-approved medicines.
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 ATU Nominative (France) 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 ATU Nominative (France) framework is recognised across the ten destination countries where Reserve Meds currently coordinates cross-border supply. The "Accepts ATU Nominative (France) dossiers" column reflects whether the destination regulator typically reviews and grants permits on the strength of a ATU Nominative (France) 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.
| Country | Local pathway equivalent | Accepts ATU Nominative (France) dossiers? | Typical timeline | Local regulator |
|---|---|---|---|---|
| Bahrain | NHRA Compassionate / Special Import Permit | Indirect (reference precedent only) | 5 to 15 business days | NHRA |
| Egypt | EDA Single-Patient Import (Decree 425) | Indirect (reference precedent only) | 10 to 25 business days | EDA |
| India | Rule 36 personal-use import (D&C Rules 1945) | Indirect (reference precedent only) | 7 to 21 business days | CDSCO |
| Jordan | JFDA Compassionate / Special Use Import | Indirect (reference precedent only) | 10 to 20 business days | JFDA |
| Kuwait | MoH Unregistered Medicine Import Permit | Indirect (reference precedent only) | 10 to 20 business days | KDFC (MoH) |
| Lebanon | MoPH Special Import for Named Patient | Indirect (reference precedent only) | 10 to 25 business days | MoPH |
| Oman | MoH Compassionate / Named-Patient Import | Indirect (reference precedent only) | 10 to 20 business days | MoH-DGPADC |
| Qatar | MoPH Single-Patient Unregistered Drug Import | Indirect (reference precedent only) | 10 to 20 business days | MoPH-DPA |
| Saudi Arabia | SFDA Personal Importation Permit | Indirect (reference precedent only) | 10 to 25 business days | SFDA |
| United Arab Emirates | EDE Unregistered Medicine Import Permit | Indirect (reference precedent only) | 5 to 15 business days | EDE |
Notes. "Indirect" means the destination regulator does not directly accept ATU Nominative (France) authorisation as the legal basis for import but does recognise a ATU Nominative (France) 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 ATU Nominative 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).
- Treating physician's clinical justification letter documenting diagnosis, severity, and absence of satisfactory authorised alternatives.
- Patient clinical history.
- Informed consent specific to AAC Nominatif use.
- Hospital ethics committee notification.
- Manufacturer letter confirming supply willingness (where the medicine is not on a public access programme).
- Pharmacy dispensing plan (the dispensing pharmacy must be authorised to receive imported unregistered medicines).
- Physician specialty credentials.
Typical timeline
ANSM review for routine nominative cases typically completes within 2 to 4 weeks of a complete submission. Cross-border patients cannot directly use ATU Nominative; their parallel home-country named-patient or compassionate-use route typically runs 4 to 8 weeks end-to-end including documentation, regulator review, and shipment.
Costs and reimbursement
The medicine is supplied at the manufacturer's stated price; insurer coverage in France is typically available through the Securite Sociale specialty channel, subject to indication-specific reimbursement. Cross-border patients pay the relevant per-country acquisition cost and do not benefit directly from French reimbursement.
Where Reserve Meds fits in
Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine access. For ATU Nominative (France) 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 ATU Nominative (France) 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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