ATU Cohort (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 Cohort is
Origin and authorising body. France, under the access reform of 1 July 2021 which restructured ATU (Autorisations Temporaires d'Utilisation) 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), with the Haute Autorite de Sante (HAS) reviewing access designations alongside ANSM for AAP cases, 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 de Cohorte (ATU de Cohorte) under Article L.5121-12 of the French Code de la Sante Publique. The 2021 reform replaced ATU with two new categories: AAC (Acces Compassionnel) for compassionate-use cases without a planned marketing authorisation in the indication, and AAP (Acces Precoce) for medicines where a marketing authorisation is expected in the indication. The historical ATU Cohort lineage maps most closely to today's AAP Cohorte, which is the operative framework for a manufacturer-sponsored cohort programme tied to a forthcoming EMA decision.
ATU Cohort (now AAC or AAP Cohorte depending on the indication and the manufacturer's regulatory programme) is the French framework for cohort-level pre-registration access to investigational or pre-registered medicines. The cohort is defined by the manufacturer's protocol and approved by ANSM as a single authorisation that covers all enrolling patients. This contrasts with the nominative ATU (now AAC Nominatif), which is a single-patient authorisation. The cohort framework is widely used for late-Phase 3 oncology agents awaiting EMA decision and for rare-disease medicines where a structured cohort allows data collection alongside therapeutic access.
Under the 2021 reform, AAP Cohorte requires that the manufacturer commit to filing a full marketing authorisation application within an agreed timeline (typically two years), pay an initial fee, and submit quarterly safety and efficacy data. AAC Cohorte applies when the medicine is not the subject of an ongoing marketing authorisation programme in the indication; the framework still permits cohort enrolment but with a different commercial commitment structure. The cohort designation also enables transparent pricing during the access window, with prices later reconciled against the post-authorisation negotiated price. Cross-border patients cannot directly enrol under a French cohort authorisation: the framework is for French patients in France. However, the existence of an ANSM cohort decision is a useful regulatory precedent for destination-country regulators considering parallel programmes.
This page consolidates Reserve Meds's operational view of the ATU Cohort (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 Cohort (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 Cohort
ATU Cohort access is granted at the cohort level by ANSM; individual French-licensed physicians then enrol qualifying patients under the cohort protocol. Cross-border patients from outside France cannot directly receive supply through the French ATU framework. The cohort's existence in France often signals that the manufacturer is willing to operate parallel cohort or named-patient supply in other jurisdictions, and the cohort protocol is a useful reference document 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 Cohort
Late-Phase 3 oncology agents awaiting EMA centralised procedure decisions, rare-disease therapies in pre-registration limbo, advanced therapy medicinal products (gene and cell therapies) in late development, paediatric extensions of adult-approved medicines, and investigational antivirals in late development for emerging or resistant pathogens.
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 Cohort (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 Cohort (France) framework is recognised across the ten destination countries where Reserve Meds currently coordinates cross-border supply. The "Accepts ATU Cohort (France) dossiers" column reflects whether the destination regulator typically reviews and grants permits on the strength of a ATU Cohort (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 Cohort (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 Cohort (France) authorisation as the legal basis for import but does recognise a ATU Cohort (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 Cohort 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).
- Manufacturer-submitted cohort protocol with eligibility criteria and monitoring plan.
- Patient clinical eligibility confirmation per the protocol.
- Informed consent specific to the cohort framework.
- Hospital ethics committee (Comite de Protection des Personnes, CPP) review.
- Quarterly safety and efficacy data reporting per the cohort framework.
- Treating physician's specialty credentials and prescribing-rights verification.
- For cross-border reference: the French cohort decision is a useful regulatory precedent for destination-country regulators.
Typical timeline
Initial ANSM review of a new cohort application typically runs 2 to 3 months from a complete submission. Once the cohort is open, individual patient enrolment is rapid (days to a few weeks) because the regulatory authorisation already covers all eligible patients. Cross-border patients cannot directly enrol; they must use a parallel framework in their home jurisdiction, which typically runs 4 to 8 weeks end-to-end including documentation assembly, regulator review, and shipment.
Costs and reimbursement
Pricing under AAP Cohorte is set by the manufacturer during the access window and later reconciled against the post-authorisation negotiated price. Under AAC Cohorte, pricing can also be set, though the commercial mechanics differ. Cross-border patients pay the relevant per-country acquisition cost plus logistics; they do not benefit directly from the French pricing arrangement. Reserve Meds itemises each fee on every firm quote.
Where Reserve Meds fits in
Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine access. For ATU Cohort (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 Cohort (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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