Argentina obliges sponsors to keep supplying a beneficial investigational product after a trial closes, and it gives that obligation a dedicated import procedure: ANMAT Disposición 12792/2016, the “Procedimiento para la solicitud de importación de la medicación/tratamiento y materiales para el acceso post-estudio.” The filing must be made before the study ends, and it is authorized per investigator and center for twelve months at a time.
Most sponsors discover this instrument late — usually when a site asks who will pay for continued supply after last-patient-last-visit, by which point the filing window has closed. This page sets out what Disposición 12792/2016 requires, what it does not cover, and what changed when Argentina reset its GCP framework on 1 December 2025.
The obligation and the import route live in two different instruments
Argentina splits post-trial access (PTA) across a substantive duty and a procedural route.
The substantive duty is ethical-regulatory. The recitals of Disposición 12792/2016 quote Ministry of Health Resolución 1480/2011, section A9, which states that in industry-sponsored trials where an investigational product has been shown to be beneficial, “el patrocinador deberá continuar su provisión a los participantes hasta que su acceso se garantice por otro medio.” The same recitals cite Código Civil y Comercial Article 58(j), which permits human research only where participants are assured “la disponibilidad y accesibilidad a los tratamientos que la investigación haya demostrado beneficiosos.” That is statutory, not guidance.
The procedural route is Disposición 12792/2016 itself. Article 1 establishes it as the import procedure for post-study medication, treatment and materials for participants in an ANMAT-authorized clinical pharmacology study. Article 8 put it in force the day after its 17 November 2016 publication. It has not been repealed.
What Disposición 12792/2016 covers — and what it excludes
Article 2 is the first thing to read. Authorized extension studies are expressly excluded; they are governed by the trial framework and the terms of their own authorization. If your continuation plan is an open-label extension protocol, you are not filing under 12792/2016.
Scope of goods is broader than “drug.” Article 3(f) covers the products and “los materiales,” and requires that neither differ from what was used in the approved study. The phrase “dispositivo médico” does not appear anywhere in the text, so device sponsors should treat coverage as inferential and confirm it with ANMAT.
The Article 3 dossier: eight documents, filed before study close
Article 3 requires the sponsor to submit, previo a la finalización del estudio:
- (a) A note identifying the participating health centers and a list of candidate patients for continued investigational therapy, with identity kept confidential; the final list of patients actually included is filed later under the same safeguards.
- (b) The general patient informed consent form for post-study access, approved by the CEI of the treating institution.
- (c) A copy of the disposición authorizing the clinical study, plus the approval records for the relevant centers.
- (d) The opinion (dictamen) of the CEI for that center approving the access plan — and that same CEI then follows the plan.
- (e) Authorization from the center’s responsible medical director and a letter of acceptance from the investigator.
- (f) Product detail: lot number, expiry date, and quantities to be authorized to the sponsor for import, plus the materials. Products and materials must not differ from those used in the approved study.
- (g) A sponsor declaration guaranteeing that supply of the medication/treatment and materials will be at no cost to the participant, the treating institution, or the participant’s health coverage.
- (h) Habilitación of the location designated for storage of the product to be imported.
Two of these drive most of the schedule risk. Article 3(d)/(e) are per-center documents — a CEI dictamen, a medical director authorization, and an investigator acceptance letter for every site you intend to keep supplying. Article 3(g) is the cost allocation: the sponsor’s declaration extends free-of-charge supply to three distinct parties, including the obra social or prepaga carrying the participant’s coverage. There is no cost-sharing construction available.
Article 3(h) and the habilitación question
Article 3(h) requires habilitación evidence for “el lugar designado para el almacenamiento del producto a importar.” The text names one designated storage location, singular, and does not itself resolve which location that is. In practice two architectures are used, and the choice should be made before the dossier is assembled rather than after:
- Central depósito. Cohort product is imported into a single ANMAT-habilitada depósito and released to sites against per-patient prescriptions. One habilitación certificate satisfies Article 3(h) for the whole cohort; site-level storage becomes a distribution-and-temperature-control question rather than a filing question.
- Per-site storage. Product is imported to each investigator pharmacy. Each of those locations then needs its own habilitación evidence, and every one of them is a document that can hold up the submission.
For a cohort of 40 to 60 participants across three to five centers, the central-depósito architecture is usually the shorter path, because it decouples the Article 3(h) evidence from site-by-site pharmacy documentation that sponsors do not control.
Article 4: twelve months, per investigator and center
Article 4 assigns the review to ANMAT’s Dirección de Evaluación y Registro de Medicamentos (DERM), which verifies the submitted documentation and either authorizes or rejects the import request “en el/los centros a cargo del investigador respectivo,” stating that the authorization “tendrá vigencia por doce meses a partir de la fecha de aprobación del trámite.”
Three consequences follow. The authorization is scoped to the investigator and center, so adding a site later is a new filing rather than an amendment note. It expires twelve months from approval, so any PTA program expected to run longer than a year needs a continuation submission calendar built from day one, with each center’s clock tracked separately. And because Article 3(a) requires the final list of included patients to be filed “oportunamente,” the cohort list itself is a living document.
Article 6 sits alongside this: the sponsor must report every serious and unexpected adverse drug reaction (RAM-SI) related to product imported under this procedure, by separate expediente, cross-referencing both the study authorization and the post-study supply authorization.
Article 5: how the product physically enters
Article 5 routes physical importation of the Article 3(f) products through the Departamento de Comercio Exterior del INAME. Article 7 makes Resolución Conjunta 942/2001 and 426/2001 applicable.
The importer of record matters. ANMAT’s expanded-access instrument, Disposición 828/2017, establishes that laboratories habilitadas by ANMAT as importers and/or manufacturers of especialidades medicinales are the entities that may request expanded-access program authorization, and Article 4(a) requires a copy of that habilitación in the dossier. The same logic governs PTA operations: a foreign sponsor without an Argentine habilitación cannot be the importer. That role is filled by an ANMAT-habilitada operating partner engaged directly by bioaccess® acting as importadora and depósito, with the sponsor retaining the regulatory filing.
What this route is not: RAEM and expanded access
Sponsors are routinely pointed at Disposición 4616/2019, the Régimen de Accesibilidad de Excepción a Medicamentos (RAEM). It is not a post-trial access instrument and contains no reference to clinical trials. It is an individual-patient exceptional import regime, and three of its features make it unusable for a cohort:
- Article 2(a) applies to medicines not registered with ANMAT but registered in a country listed in Anexo I of Decreto 150/92, “destinados a tratar un paciente en particular.” An unapproved investigational product has no such registration.
- Article 4(a) makes the patient (or a family member or legal representative) the responsible filer, on a treating physician’s prescription, and expressly prohibits “la participación de cualquier tipo de gestor o intermediario.” A sponsor cannot file.
- Article 12 gives the authorization 90 days of validity before Customs (AFIP-DGA); Article 5 caps quantities at 90 days of treatment for short courses and all oncology, 180 days otherwise.
RAEM is fast — Article 10 promises a decision within 10 business days for first-time filings and 3 for continuity — but it is a per-patient instrument for registered-elsewhere products. Disposición 12792/2016 is the sponsor-filed cohort route.
What changed on 1 December 2025
Disposición 7516/2025 rebuilt Argentina’s GCP base. Article 3 adopts ICH E6(R3) for registration-purpose clinical trials, to be complemented by local requirements in Anexo II. Article 7 is a completed repeal: “Deróganse las Disposiciones ANMAT Nros. 6677/10, 4008/17, 9929/19 y 2172/25 y las Circulares Nros. 0001/11 y 004/18 y la Circular del 10 de junio de 2024.” Article 8 set entry into force at 1 December 2025 and provided that filings pending on that date are resolved under the repealed norms.
Two points sponsors keep getting wrong. First, Disposición 12792/2016 is not in the Article 7 repeal list and remains the operative cohort import route; the substantive PTA duty formerly at Disp. 6677/10 numeral 6.8 was carried into the Anexo II local-requirements annex, which is the part of 7516/2025 published only in the BORA web edition and which we have so far read in secondary reproduction rather than from the official annex file. Second, Article 5 of 7516/2025 assigns clinical-study authorization and oversight competences to the Dirección de Investigación Clínica y Gestión del Registro de Medicamentos, including, at 5(e), intervening “a través de Comercio Exterior” to authorize entry or exit of study materials. Disposición 12792/2016 Article 4 still names DERM. Sponsors filing today should expect to confirm the receiving unit with ANMAT rather than rely on the 2016 article text.
Data protection for the follow-up data
PTA generates follow-up safety and dispensing records that usually flow to a sponsor or vendor outside Argentina. That is governed by Ley 25.326 Article 12 and its Decreto 1558/01. Disposición 60-E/2016 Article 1 approves model international transfer clauses — Anexo I for data assignment, Anexo II for service provision — for transfers destined to countries without adequate legislation. Article 3 lists the adequate jurisdictions: EU and EEA members, Switzerland, Guernsey, Jersey, Isle of Man, Faroe Islands, Canada (private sector only), Andorra, New Zealand, Uruguay, and Israel (automated processing only). The United States is not on that list. Article 2 requires that contracts departing from the approved models be submitted for approval within 30 calendar days of signature. An Argentina-to-US PTA data flow therefore needs the model clauses executed, not asserted.
Timeline reality
The Article 3 dossier is not hard to write; it is hard to assemble, because most of the eight items originate outside the sponsor’s organization — CEI dictámenes, medical director authorizations, investigator acceptance letters, and the habilitación certificate. Our planning assumption is four to six weeks from a complete evidence pack to a first ANMAT submission, which is an operator estimate, not a regulatory deadline. The binding constraint is Article 3’s requirement to file before the study ends, so site-document collection has to start while the trial is still running.
Frequently asked questions
Does Argentina require post-trial access?
Yes. The duty is grounded in Código Civil y Comercial Article 58(j), which allows human research only where participants are assured availability of and access to treatments the research has shown beneficial, and it is elaborated in Ministry of Health Resolución 1480/2011 section A9, both quoted in the recitals of ANMAT Disposición 12792/2016. Argentina also gives the duty an operating procedure — a dedicated post-study import authorization — which distinguishes it from jurisdictions that state an obligation without providing a route to fulfil it.
What is ANMAT Disposición 12792/2016?
It is the procedure for requesting import of post-study medication, treatment and materials for participants in an ANMAT-authorized clinical pharmacology study, published 17 November 2016 and in force since the following day. Article 1 establishes the procedure, Article 3 lists the eight documents the sponsor must file before the study ends, Article 4 gives DERM the authorization decision with twelve-month validity per investigator and center, and Article 5 routes physical importation through the Departamento de Comercio Exterior del INAME.
What is the difference between Disp. 12792/2016 and Disp. 4616/2019 (RAEM)?
Disposición 12792/2016 is a sponsor-filed cohort route for post-study continuation of an investigational product. Disposición 4616/2019 approves the Régimen de Accesibilidad de Excepción a Medicamentos, an individual-patient exceptional import regime that makes no reference to clinical trials. RAEM Article 2(a) requires the product to be registered in an Anexo I country under Decreto 150/92, Article 4(a) makes the patient the filer and prohibits any gestor or intermediary, and Article 12 limits authorization validity to 90 days before Customs. RAEM cannot carry a sponsor cohort.
Who must file the Article 3 dossier?
Article 3 places the obligation on “el patrocinador” — the sponsor. The filing is the sponsor’s, not the site’s and not the CEI’s, although Article 3(d) and (e) mean the dossier cannot be completed without the center’s ethics committee dictamen, the medical director’s authorization, and the investigator’s letter of acceptance. Article 6 likewise puts the RAM-SI reporting duty for imported post-study product on the sponsor, by separate expediente.
What are the eight documents required under Article 3?
(a) a note naming participating centers plus a confidentiality-preserving candidate patient list, with the final included-patient list filed later; (b) the CEI-approved general informed consent form; (c) a copy of the study authorization disposición and center approval records; (d) the center CEI’s dictamen approving the access plan; (e) the medical director’s authorization and the investigator’s acceptance letter; (f) product and materials detail with lot, expiry and quantities, not differing from the approved study; (g) the sponsor’s free-of-charge declaration; (h) habilitación of the designated storage location.
How long does ANMAT authorization last per center?
Twelve months. Article 4 states the authorization “tendrá vigencia por doce meses a partir de la fecha de aprobación del trámite,” and it is granted for the centers under the respective investigator’s charge. A program running longer than a year needs a continuation submission per center, tracked on that center’s own approval date rather than on a single program-wide clock. Adding a center mid-program is a fresh authorization, not an administrative note.
Does the sponsor pay for post-trial supply in Argentina?
Yes, and the declaration is part of the dossier. Article 3(g) requires the sponsor to guarantee that provision of the medication, treatment and materials will be “sin costo alguno para el participante, el establecimiento asistencial o su cobertura de salud.” That covers three parties: the participant, the treating institution, and the participant’s health coverage entity. There is no mechanism in the disposición for splitting cost with a site, an obra social, or a prepaga.
How did Disp. 7516/2025 affect the PTA framework?
Disposición 7516/2025 took effect 1 December 2025, adopted ICH E6(R3) at Article 3, and at Article 7 repealed Disposiciones 6677/10, 4008/17, 9929/19 and 2172/25 together with Circulares 0001/11 and 004/18 and the 10 June 2024 Circular. Disposición 12792/2016 is not in that repeal list and remains the cohort import route. The substantive post-trial duty previously at Disp. 6677/10 numeral 6.8 moved into the Anexo II local-requirements annex. Article 8 provides that filings pending on 1 December 2025 are resolved under the repealed norms.
Can a foreign sponsor file directly, or must a local regulatory agent file?
The Article 3 filing is the sponsor’s, and Disposición 12792/2016 does not require a local filer. Physical importation is the constraint. Article 5 routes it through the Departamento de Comercio Exterior del INAME, and ANMAT’s expanded-access instrument Disposición 828/2017 Article 1 confirms that the entities able to act as importers of especialidades medicinales are laboratories habilitadas by ANMAT, with Article 4(a) requiring the habilitación certificate in the dossier. A foreign sponsor therefore needs an ANMAT-habilitada importer and depósito even where it holds the filing itself.
Working on a LATAM post-trial access program? bioaccess® is a US-headquartered, LATAM-native operator running regulatory, importadora, and 2–8 °C GDP cold-chain functions directly across the region. If you’re evaluating PTA feasibility in Argentina, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.
Sources
- ANMAT Disposición 12792/2016, Boletín Oficial, published 17 November 2016 — https://www.boletinoficial.gob.ar/detalleAviso/primera/154162/20161117
- ANMAT Disposición 7516/2025, Boletín Oficial, published 9 October 2025, in force 1 December 2025 — https://www.boletinoficial.gob.ar/detalleAviso/primera/332695/20251009
- ANMAT Disposición 4616/2019 (RAEM), Boletín Oficial, published 4 June 2019 — https://www.boletinoficial.gob.ar/detalleAviso/primera/208794/20190604
- ANMAT Disposición 828/2017 (Programas de Acceso Expandido), Boletín Oficial, published 26 January 2017 — https://www.boletinoficial.gob.ar/detalleAviso/primera/158296/20170126
- DNPDP Disposición 60-E/2016 (model international data-transfer clauses under Ley 25.326 Art. 12), InfoLEG — https://servicios.infoleg.gob.ar/infolegInternet/anexos/265000-269999/267922/norma.htm
- ANMAT, “Acceso al producto de investigación postensayo clínico” (institutional communication) — https://www.anmat.gob.ar/comunicados/Acceso_al_Producto_Post_Ensayo_Clinico.pdf
- ANMAT, “Preguntas y Respuestas — Disposición 7516/25,” version 1 December 2025 — https://www.argentina.gob.ar/sites/default/files/preguntas_y_respuestas_-disposicion_7516_25_version_1-1-12-25.pdf
- Ministerio de Justicia, normativa record for Disposición 12792/2016 (modifying and complementary norms) — https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-12792-2016-267853/normas-modifican