Disposición 12792/2016 is the sponsor-filed cohort route for post-study continuation of an investigational product. Disposición 4616/2019 (RAEM) is an individual-patient exceptional import regime that never mentions clinical trials. RAEM cannot carry a sponsor cohort.
I am Julio Martinez-Clark, CEO of bioaccess®. This page is the short decision cut — not a rewrite of the Argentina pillar. For the full Article 3 dossier, twelve-month clocks, and the Disp. 7516/2025 GCP reset, use Post-trial access in Argentina under ANMAT Disposición 12792/2016.
Short answer
| Disp. 12792/2016 | Disp. 4616/2019 (RAEM) | |
|---|---|---|
| What it is | Post-study import procedure for a trial cohort | Régimen de Accesibilidad de Excepción a Medicamentos |
| Filer | The sponsor (el patrocinador) | The patient (Art. 4(a)); gestor / intermediary prohibited |
| Trial nexus | Explicit — ANMAT-authorized clinical pharmacology study | None |
| Product eligibility | Investigational product used in the approved study | Medicine not registered with ANMAT but registered in an Anexo I country under Decreto 150/92, “destinados a tratar un paciente en particular” (Art. 2(a)) |
| Authorization clock | 12 months per investigator and center (Art. 4), renewable | 90 days before Customs (Art. 12); quantity caps 90/180 days (Art. 5) |
| Decision speed | Operator calendar driven by the eight-document Art. 3 dossier | Art. 10: 10 business days first filing, 3 for continuity |
What Disposición 12792/2016 authorizes
Article 1 of Disposición 12792/2016 establishes the “Procedimiento para la solicitud de importación de la medicación/tratamiento y materiales para el acceso post-estudio.” Article 3 requires the sponsor to file eight documents previo a la finalización del estudio, including the patient list (identity protected), CEI-approved post-study informed consent, the trial autorización, the CEI dictamen for the access plan, medical-director and investigator letters, product/lot detail, and storage habilitación. Article 4 authorizes per investigator and center for twelve months. Article 8 put the instrumento in force the day after its 17 November 2016 publication. It was not repealed by Disp. 7516/2025.
The substantive supply duty sits beside the procedure. The recitals of 12792/2016 quote Ministry of Health Resolución 1480/2011 §A9 and Código Civil y Comercial Art. 58(j): where an investigational product has been shown beneficial, the sponsor must continue provision until access is guaranteed by another means.
What RAEM actually is
Disposición 4616/2019 approves the Régimen de Accesibilidad de Excepción a Medicamentos. It is fast for what it is — Article 10 promises a decision within 10 business days for first-time filings and 3 for continuity — and three of its features make it unusable for a trial cohort:
- Product class. Article 2(a) applies to medicines not registered with ANMAT but registered in an Anexo I country under Decreto 150/92, destined to treat un paciente en particular. An unapproved investigational product has no Anexo I registration to lean on.
- Filer. Article 4(a) makes the patient the filer and prohibits any gestor or intermediary. A sponsor CRO cannot legally stand in that queue for a cohort.
- Clock and quantity. 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.
Can a sponsor use RAEM for a trial cohort?
No. Route the cohort through Disposición 12792/2016 before study close. Keep RAEM for the rare single-patient, registered-elsewhere exceptional case that is not a post-study continuation of an ANMAT-authorized trial. Do not wait until last-patient-last-visit to discover that the 12792 filing window has closed.
For the four-contract stack that sits around any Argentine PTA filing (SDEA, DPA, product liability, sponsor accession), see The legal architecture of Latin American post-trial access.
bioaccess® operates regulatory, importadora and depósito functions for LATAM post-trial access. For Argentina PTA feasibility against the current instrument, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.
Related pillar
Post-trial access in Argentina under ANMAT Disposición 12792/2016
Sources
- ANMAT Disposición 12792/2016 — procedure for post-study import of medication/treatment and materials (Boletín Oficial, 17 Nov 2016)
- ANMAT Disposición 4616/2019 (RAEM), Boletín Oficial, published 4 June 2019 — https://www.boletinoficial.gob.ar/detalleAviso/primera/208794/20190604
- ANMAT Disposición 7516/2025, Boletín Oficial, published 9 October 2025, in force 1 December 2025 — https://www.boletinoficial.gob.ar/detalleAviso/primera/332695/20251009
- Argentina PTA pillar: https://bioaccessla.com/blog/argentina-post-trial-access-anmat-disposicion-12792
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