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Tag: trial supply chain

  • Who pays for post-trial access under Brazil Lei 14.874?

    The sponsor pays. Under Lei nº 14.874/2024 Article 31 §4, free post-trial supply of the experimental medicine is the sponsor’s responsibility; Decreto nº 12.651/2025 Article 31 restates that duty as fornecimento gratuito.

    Brazil is the only Latin American country where free post-trial supply is an explicit, sponsor-funded statutory duty that reaches drugs, medical devices, and advanced therapies. Brazil’s Ministry of Health puts it plainly: continued treatment after the study “não é uma expectativa, mas um dever legal” — not an expectation, but a legal duty (INAEP FAQ). Sponsors budgeting a Brazilian trial in 2026 budget the product, the cold chain, pharmacovigilance, and the ANVISA import trail against that duty — not against an ethics-committee expectation.

    Who pays for post-trial access under Brazil Lei 14.874?

    The sponsor, exclusively, and free of charge to the participant.

    Three instruments say the same thing in slightly different words:

    • Lei 14.874/2024 Article 31 §4 — where continued treatment with the experimental medicine is necessary after trial end, “o fornecimento do medicamento será de responsabilidade do patrocinador.”
    • Lei 14.874/2024 Article 34 §1 — the sponsor guarantees free post-trial supply whenever the investigator considers the product the best therapy for that participant’s condition and the risk-benefit ratio is more favorable than available alternatives.
    • Decreto 12.651/2025 Article 31 — the sponsor “deverá garantir aos participantes da pesquisa o fornecimento gratuito do produto sob investigação” whenever the responsible investigator reaches that same clinical judgment.

    ANVISA’s RDC nº 38/2013 Article 18 adds operational content to the same rule for medicines assistance programs: the sponsor funds complete free treatment (inciso I), keeps custody and storage of the product (II), may not commercialize it under the program (III), and funds integral assistance for complications arising from its use (VI). Separately, Lei 14.874/2024 Article 35 §2 makes the sponsor responsible for care needed because of study-caused reactions.

    Neither the participant, the treating institution, nor the public health network is the primary payer for investigational-product supply under Chapter VI. Availability of the product in the public network is an interruption ground under Article 33 VII, not a cost-shift rule during the program.

    How does the statute allocate cost before the trial even starts?

    Cost allocation is planned before first patient in. Lei 14.874/2024 Article 30 requires the sponsor and the investigator to submit a plano de acesso pós-estudo to the research ethics committee (CEP) before the trial starts, justifying whether free post-trial supply will be needed. If it will, Article 30 §1 requires a programa de fornecimento pós-estudo, and §2 requires that program to guarantee continued safety follow-up and receipt of the experimental treatment “por prazo determinado.” Article 30 §3 adds a scheduling constraint sponsors routinely miss: the program may only begin after regulatory approval, and the request must be filed early enough for participants to transition without a treatment gap.

    At trial end, Article 31 requires an individual assessment for each participant, performed by the investigator with the sponsor and the participant heard. Under Article 31 §2, free supply is triggered whenever the investigational product is the best therapy for that participant’s condition and shows a more favorable risk-benefit ratio than available alternatives. Article 32 sets the four evaluation criteria: disease severity, availability of satisfactory alternatives in the participant’s locality, whether the product addresses an unmet clinical need, and whether evidence of benefit exceeds evidence of risk. Article 31 §3 and Article 34 §2 both provide that the participant “deverá migrar automaticamente” into the post-study program — migration is automatic, not opt-in.

    Article 37 is why MedTech and cell-and-gene sponsors cannot treat cost allocation as a pharma-only issue: “Aplicar-se-ão aos produtos e dispositivos médicos e aos produtos de terapias avançadas experimentais, objeto de ensaio clínico, as disposições deste Capítulo, no que couber.” The whole post-trial chapter — including who pays — applies to medical devices and experimental advanced therapy products, insofar as applicable. Decreto 12.651/2025 Article 31 reinforces the point by using produto sob investigação rather than medicamento.

    How long must the sponsor fund free supply?

    There is no fixed end date measured from trial close. Lei 14.874/2024 Article 33 permits interruption only on seven grounds, each requiring a justification submitted to the CEP:

    1. participant decision;
    2. cure or introduction of a satisfactory alternative;
    3. absence of continued benefit;
    4. a disqualifying adverse reaction;
    5. technical or safety impossibility of manufacture (provided the sponsor supplies an equivalent or better marketed alternative);
    6. inciso VI — “transcurso do prazo de 5 (cinco) anos, contado da disponibilidade comercial do medicamento experimental no País”;
    7. availability in the public health network.

    Inciso VI carries visible veto history on the Planalto text: the original statute showed “VI – (VETADO),” then the five-year text was marked “(Promulgação partes vetadas)” and promulgated on 1 July 2025 (DOU 2 July 2025). The five-year cap is in force after that promulgation.

    The practical effect is that the five-year clock only starts when the product becomes commercially available in Brazil. A sponsor that never commercializes there, or commercializes late, has no five-year backstop running in its favor. The exposure terminates on clinical or supply events under the other six grounds, or on the commercial-availability clock once it has started — not on a date fixed at trial close. That is why Brazil’s Ministry of Health describes the duty as running “desde o planejamento da pesquisa até o período pós-estudo.”

    What roles do the CEP and ANVISA play in who pays?

    The CEP and ANVISA do not pay. They gate the program that the sponsor funds.

    • CEP — approves the pre-trial plan (Art. 30), the post-study program (Decreto Art. 31 §1), and any interruption justification (Art. 33). The INAEP FAQ states that the program must be submitted for CEP evaluation — “Não basta notificar” — and that the competent CEP is, as a rule, the coordinating centre’s CEP. Decreto Article 31 §2 reserves detailed guidelines to a future INAEP norm.
    • ANVISA — Article 34 §3 requires that importation and dispensing during the post-study program be previously authorized by the competent sanitary authority. For medicines, RDC 38/2013 remains the operative assistance-program instrument: the sponsor or a contracted organização representativa do patrocinador files the anuência; for post-study supply ANVISA issues “um ofício autorizando o fornecimento” (Art. 3 §2), not a comunicado especial.
    • INAEP — the Instância Nacional de Ética em Pesquisa issues ethics norms and acts as appellate instance over CEP decisions (Lei Art. 8). It does not fund supply.

    The cost driver for a sponsor is therefore not a regulator invoice. It is the tail: free product, GDP distribution, pharmacovigilance, ANVISA reporting, and CEP maintenance running until one of the seven Article 33 events occurs, with the five-year clock not starting until Brazilian commercial availability. Price that tail in the Article 30 pre-trial plan. For devices and advanced therapies, also decide in the protocol how the product will physically be imported and dispensed after close — RDC 38/2013 speaks of medicamento, while Article 37 of the statute already attaches the duty.

    Related pillar

    For the full Brazil framework — Chapter VI Arts. 30–37, Decreto 12.651/2025 Art. 31, the RDC 38/2013 import sequence, INAEP’s role, and device/ATMP scope — read Post-trial access in Brazil under Lei 14.874/2024 and Decreto 12.651/2025.

    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 Brazil or elsewhere in Latin America, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Sources

    • Lei nº 14.874, de 28 de maio de 2024 (Marco Legal de Pesquisa Clínica), Arts. 30–37, 65; promulgação das partes vetadas (Art. 33 VI), DOU 2.7.2025 — https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm
    • Decreto nº 12.651, de 7 de outubro de 2025, Art. 31 — https://www2.camara.leg.br/legin/fed/decret/2025/decreto-12651-7-outubro-2025-798105-publicacaooriginal-176652-pe.html
    • ANVISA RDC nº 38, de 12 de agosto de 2013, Arts. 3, 18 — https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000038&seqAto=000&valorAno=2013&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=1696&cod_modulo=134&pesquisa=true
    • Ministério da Saúde / INAEP FAQ, “O acesso (fornecimento) pós-estudo é opcional? Como a regra funciona?” (20 Feb 2026) — https://www.gov.br/saude/pt-br/composicao/orgaos-colegiados/inaep/faq/faq/acesso-pos-estudo/o-acesso-fornecimento-pos-estudo-e
    • bioaccess® Brazil PTA pillar — https://bioaccessla.com/blog/brazil-post-trial-access-lei-14874

  • Post-trial access in Peru under DS 021-2017-SA

    Peru obliges sponsors to keep supplying the investigational product, free of charge, to participants who are still benefiting after a trial ends. The duty lives in Título X (Arts. 115–118) of the Reglamento de Ensayos Clínicos approved by Decreto Supremo N.° 021-2017-SA, and it covers medical devices as well as drugs.

    What makes Peru different from the rest of Latin America is not the strength of the obligation but its drafting. Most regional PTA mandates state a duty and stop. Peru states the duty, names two authorization routes, lists the exact documents required for one of them, and assigns the post-access safety reporting. That specificity is why Peru is the most operationally tractable post-trial access market in the region.

    The obligation: Article 115 and Article 40(p)

    Article 115 defines post-study access as the free availability, to the research subject, of the investigational product studied in the trial — expressly including products that already hold a Peruvian sanitary registration — after the study closes or after that subject’s participation ends. It also requires that post-study access be anticipated before the study begins and disclosed during the informed consent process (DS 021-2017-SA, Art. 115).

    The same instrument places the duty on the sponsor directly. Article 40(p) makes the sponsor responsible for “asegurar el acceso de los sujetos de investigación, después de la culminación del ensayo clínico al producto de investigación” under the terms of Título X, and adds that this must be specified in the informed consent form. Article 40(s) separately requires free access to the investigational product, complementary products and trial procedures during participation — so the Peruvian scheme is continuous rather than a distinct post-close programme bolted on later.

    Article 115 sets conditions for when the duty is enforceable: the seriousness of the medical condition, the effect of withdrawing or modifying treatment, the absence of satisfactory therapeutic alternatives in Peru for that subject’s condition, sufficient efficacy and safety information, and a positive benefit-risk balance. The product must have proved beneficial to the subject in the principal investigator’s judgment, and “su uso se mantendrá en cuanto hubiere beneficio” — supply continues as long as benefit continues. There is no fixed end date.

    One clause matters in feasibility modelling. Where the pathology falls under the management of a MINSA General Directorate, the sponsor must maintain access “hasta que le sea accesible a través de dichas direcciones” — until the patient can obtain the product through the public system. For conditions inside a national programme, that converts an open-ended commitment into a handoff with a definable end state. For conditions outside one, it does not.

    Who pays

    The sponsor. Article 89 states that investigational products for use in clinical trials “serán financiados por el patrocinador y proporcionados gratuitamente al sujeto de investigación.” Read with Article 115’s “disponibilidad gratuita” and Article 40(p), there is no cost-sharing construct available in Peru — not co-payment, not reimbursement, not a named-patient sale. Budget the cost of goods, import, storage, dispensing and destruction as sponsor expense for the full benefit period.

    Devices are in scope

    Article 2, numeral 2.1, item 36 defines “producto en investigación” as “un producto farmacéutico o dispositivo médico” investigated or used as a comparator in a clinical trial, referring both terms back to Ley N.° 29459. Título X operates on “producto en investigación,” so the post-trial access duty applies textually to device trials, not only pharmaceutical ones.

    A device PTA commitment can mean continued supply of consumables, continued availability of an implanted system’s disposables, or continued technical support — and the Reglamento gives no device-specific carve-out. We treat device PTA exposure in Peru as live from protocol design onward.

    Two authorization routes under Article 116

    Article 116 provides that post-study access may be authorized through either of two mechanisms:

    Route 1 — an extension clinical trial authorized by OGITT. The Oficina General de Investigación y Transferencia Tecnológica of the Instituto Nacional de Salud grants authorization for a trial that constitutes an extension study, following the ordinary trial-authorization requirements in Article 67. Under Article 7, the INS is the national authority responsible for enforcing the Reglamento and for authorizing and overseeing clinical trials.

    Route 2 — case-by-case authorization by the ANM. The Reglamento’s abbreviation table defines ANM as the Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios. In practice that authority is DIGEMID, which describes itself as “la Autoridad Nacional responsable de garantizar la eficacia, seguridad y calidad de los productos farmacéuticos, dispositivos médicos y productos sanitarios” and lists among its functions to “emitir opinión técnica vinculante y supervisar la autorización de los productos y dispositivos en investigación en el marco de lo dispuesto en el Reglamento de Ensayos Clínicos en el Perú” (DIGEMID, Institución).

    Article 116 also fixes the trigger sequence: the principal investigator who considers post-study access appropriate for a subject communicates that to the sponsor, and the sponsor — not the investigator, not the site — files the application with the ANM.

    The routes are not interchangeable. An extension trial suits a defined cohort continuing on protocol with a data objective, and carries full trial-authorization machinery: ethics committee approval, insurance, reporting. The ANM route suits individual patients continuing after close, with no research objective. Choosing between them is the first decision in a Peru PTA plan.

    Article 117: the seven-document set

    The reason Peru is productizable is Article 117. For the ANM route, authorization is granted “para cada caso concreto,” on application by the sponsor that ran the trial, and the requirements are enumerated:

    # Article 117 requirement
    a Application for authorization addressed to the ANM
    b Written informed consent of the subject or legal representative, signed by the subject and the principal investigator
    c Clinical report in which the principal investigator justifies the need for the treatment
    d Duly completed official medical prescription (receta médica oficial)
    e Agreement of the person responsible for the institution or establishment where the treatment will be applied
    f Updated investigator’s brochure, as applicable
    g Copy of the resolución directoral authorizing the clinical trial from which the case derives

    Two of the seven are not sponsor-controlled — item (d) requires a Peruvian official prescription and item (e) requires institutional sign-off from the treating site. Those are the items that slip. Item (g) is why trial-close document retention matters: sponsors that archive the resolución directoral badly discover it when a case is already pending. Because the list is closed and enumerated, the scope of work is definable in advance: one dossier per patient, seven artifacts, two requiring site coordination. That is a service specification, not an open-ended regulatory exercise.

    Import, dispensing and product handling

    PTA supply still has to physically enter Peru and reach the patient under the Reglamento’s product rules. Article 94 provides that the ANM authorizes importation of the investigational product and complementary products by resolución directoral specifying the authorization’s validity period, and must issue it within three business days of application, against four documents: the import application, a copy of the OGITT trial authorization, a list of products and supplies, and proof of fee payment.

    Downstream, Article 92 requires dispensing through a Unidad de Dispensación para Ensayos Clínicos within the pharmacy service of the research institution, under Good Storage and Good Dispensing Practices. Article 91 requires investigational-product labelling to carry “Solo para uso en investigación” and “Prohibida su venta.” Article 96 requires that unused or returned product be destroyed in the presence of a notary public, with the knowledge of the ANM and OGITT. A PTA programme inherits all of it.

    Timelines that are actually in the regulation

    The Reglamento states review periods for the trial-authorization route but not for the Article 117 case authorization.

    Step Statutory period Source
    ANM technical opinion on safety and quality of the investigational product 30 business days (45 for biologics) Art. 69
    OGITT resolution authorizing a clinical trial, including the ANM opinion 40 business days (60 for biologics or where technical commissions are convened) Art. 70
    ANM import authorization by resolución directoral 3 business days Art. 94
    ANM case-by-case post-study access authorization (Art. 116–117) No period stated in the Reglamento —

    Article 70 also suspends the clock when the authority requests supplementary information, so the 40-business-day figure is a floor on a clean file rather than a service level. Sponsors planning a Peru PTA bridge should build the Route 1 schedule from Article 70 and treat Route 2 duration as an assumption to be confirmed with the ANM for the specific case, not a published commitment.

    Pharmacovigilance after access begins

    Article 118 does not release the sponsor at authorization. The sponsor must report treatment results to the ANM within the established period, along with suspected adverse drug reactions, without prejudice to reporting to the corresponding territorial health authority. Peru PTA is therefore a supervised supply arrangement with a continuing safety-reporting duty — which belongs in the pharmacovigilance agreement and the vendor scope, since trial safety infrastructure is often being wound down at exactly the point PTA begins.

    Stability of the pathway

    Título X has not been amended. Decreto Supremo N.° 028-2023-SA of 17 October 2023 modified numeral 2.1 item 10 of Article 2, Article 34(b), Article 40(b), Article 52(e), the heading of Chapter III of Título V, Anexo 1 and Anexo 4, and incorporated items 2.1.48 and 2.1.49, a third paragraph to Article 6, Article 60(i), and new Articles 85-A and 85-B. Articles 115 through 118 are not among them. The pathway a sponsor plans against today is the pathway approved in DS 021-2017-SA of 28 June 2017.

    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 Peru, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently asked questions

    Does Peru require post-trial access?
    Yes. Título X of the Reglamento de Ensayos Clínicos, approved by Decreto Supremo N.° 021-2017-SA, creates a binding post-study access duty. Article 115 defines it as free availability of the investigational product to the research subject after the study closes or after that subject’s participation ends, and Article 40(p) assigns the duty to the sponsor. The obligation is conditional rather than automatic: Article 115 requires the principal investigator to find the product beneficial for that subject, and weighs the seriousness of the condition, the effect of withdrawal, the absence of satisfactory alternatives in Peru, the available efficacy and safety data, and the benefit-risk balance.

    What is Decreto Supremo 021-2017-SA?
    It is the Peruvian Reglamento de Ensayos Clínicos, dated 28 June 2017, the decree that governs authorization and conduct of clinical trials in Peru. It sets sponsor and investigator responsibilities, ethics committee accreditation, OGITT trial authorization, investigational product controls, import, pharmacovigilance and supervision. Título X (Articles 115–118) is its post-study access chapter. It was amended by Decreto Supremo N.° 028-2023-SA of 17 October 2023, which did not touch Articles 115–118.

    Who pays for post-trial supply in Peru?
    The sponsor, entirely. Article 89 requires that investigational products be financed by the sponsor and provided free of charge to the research subject, and Article 115 describes post-study access itself as “disponibilidad gratuita.” Article 40(p) puts the access obligation on the sponsor and requires that it be disclosed in the informed consent form. There is no cost-sharing, reimbursement or named-patient sale construct available. Sponsors should budget product cost, import, storage, dispensing and destruction for the entire period the principal investigator finds benefit continuing.

    What are the two authorization routes for PTA in Peru?
    Article 116 names them. The first is authorization of a clinical trial constituting an extension study, granted by OGITT at the Instituto Nacional de Salud under the ordinary trial-authorization requirements of Article 67. The second is a case-by-case authorization from the Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM) for an investigational product that the principal investigator judges beneficial to the subject. Under Article 116, the investigator notifies the sponsor and the sponsor files the ANM application.

    What is the 7-document checklist under Article 117?
    For the ANM route, Article 117 requires: (a) an application addressed to the ANM; (b) written informed consent signed by the subject or legal representative and the principal investigator; (c) a clinical report in which the principal investigator justifies the need for treatment; (d) a duly completed official medical prescription; (e) agreement from the person responsible for the institution where treatment will be applied; (f) an updated investigator’s brochure as applicable; and (g) a copy of the resolución directoral authorizing the trial from which the case derives. Authorization is granted case by case.

    Does Peru PTA apply to medical devices?
    Yes, textually. Article 2, numeral 2.1, item 36 defines “producto en investigación” as a pharmaceutical product or medical device investigated or used as a comparator in a clinical trial, referencing Ley N.° 29459 for both terms. Título X operates on that same defined term, so the post-study access duty reaches device trials. The Reglamento contains no device-specific exemption from Articles 115–118, which means MedTech sponsors should model continued availability of the device system and its consumables in the same way drug sponsors model continued dosing.

    How long does OGITT authorization take?
    Article 70 gives OGITT a maximum of 40 business days to issue the resolution authorizing a clinical trial, inclusive of the 30 business days Article 69 allows the ANM for its binding technical opinion on the investigational product’s safety and quality. For biologic investigational products, or where the INS convenes technical commissions for controversial matters, the maximum is 60 business days, inclusive of a 45-business-day ANM opinion. The clock is suspended while the applicant responds to a request for supplementary information, so these are clean-file maxima rather than expected durations.

    How long does DIGEMID/ANM case-by-case authorization take?
    The Reglamento does not state a review period for the Article 116–117 case-by-case authorization. It does set an adjacent deadline that is often confused with it: under Article 94, the ANM must issue the investigational product import authorization by resolución directoral within three business days of application. Sponsors should confirm the expected case-review duration with the ANM for the specific product and patient rather than planning against a published figure, and should not assume the three-day import period applies to the Article 117 dossier.

    What is the difference between OGITT and DIGEMID in Peru PTA?
    OGITT — the Oficina General de Investigación y Transferencia Tecnológica of the Instituto Nacional de Salud — authorizes and supervises clinical trials, including the extension trial that constitutes Route 1 under Article 116. DIGEMID acts as the ANM: it issues binding technical opinions on investigational product safety and quality (Article 69), authorizes importation (Article 94), grants the case-by-case post-study access authorization (Articles 116–117), and receives the post-access safety reports (Article 118). Route 1 is an INS filing; Route 2 is a MINSA medicines-authority filing.

    What are the pharmacovigilance obligations during Peru PTA?
    Article 118 requires the sponsor to communicate the results of the treatment to the ANM within the established period, together with suspected adverse drug reactions attributable to the product, without prejudice to reporting adverse reactions to the corresponding territorial health authority. This duty runs for the life of the post-study access arrangement, which under Article 115 continues as long as the principal investigator finds benefit. Sponsors should ensure safety case processing, medical monitoring and the local reporting channel survive database lock rather than being decommissioned with the trial.

    Sources

  • Post-trial access in Brazil under Lei 14.874/2024 and Decreto 12.651/2025

    Brazil is the only Latin American country where free post-trial supply of an investigational product is an explicit, sponsor-funded statutory duty that reaches drugs, medical devices and advanced therapies alike. Brazil’s Ministry of Health puts it plainly: continued treatment after the study “não é uma expectativa, mas um dever legal” — not an expectation, but a legal duty (INAEP FAQ).

    The duty has two layers. Lei nº 14.874, de 28 de maio de 2024 — the Marco Legal de Pesquisa Clínica — created it in Chapter VI, Articles 30 to 37, entering into force 90 days after its 29 May 2024 publication under Article 65. Decreto nº 12.651, de 7 de outubro de 2025 supplied the mechanics, taking effect on publication in the Diário Oficial da União of 8 October 2025 under Article 41. Sponsors budgeting a Brazilian trial in 2026 budget against both.

    What the statute actually requires

    Chapter VI of Lei 14.874/2024 is titled “Da continuidade do tratamento pós-ensaio clínico,” and it front-loads the work. Article 30 requires the sponsor and the investigator, before the trial starts, to submit a plano de acesso pós-estudo to the research ethics committee, justifying whether free post-trial supply will be needed. If it will, Article 30 §1 requires a programa de fornecimento pós-estudo, and §2 requires that program to guarantee continued safety follow-up and receipt of the experimental treatment “por prazo determinado.” Article 30 §3 adds a scheduling constraint sponsors routinely miss: the program may only begin after regulatory approval, and the request must be filed early enough for participants to transition without a treatment gap.

    At the end of the trial, Article 31 requires an individual assessment for each participant, performed by the investigator with the sponsor and the participant heard. Under Article 31 §2, free supply is triggered whenever the investigational product is the best therapy for that participant’s condition and shows a more favorable risk-benefit ratio than available alternatives. Article 32 sets the four criteria: disease severity, availability of satisfactory alternatives in the participant’s locality, whether the product addresses an unmet clinical need, and whether evidence of benefit exceeds evidence of risk. Article 31 §3 and Article 34 §2 both provide that the participant “deverá migrar automaticamente” into the post-study program — migration is automatic, not opt-in.

    Article 31 of the Decreto: the operative sentence

    Decreto 12.651/2025 Article 31 states the duty in the language sponsors should quote in their own SOPs: the sponsor, after the trial ends, “deverá garantir aos participantes da pesquisa o fornecimento gratuito do produto sob investigação sempre que este for considerado pelo pesquisador responsável como a melhor alternativa terapêutica para a condição clínica do participante, com base em evidências disponíveis e em avaliação favorável da relação risco-benefício.”

    Two details matter. First, the decree says produto sob investigação — investigational product — not medicamento. Second, Article 31 §1 requires the program to be drafted by the sponsor and submitted to the competent CEP, and to contain the supply strategy for the period after individual participation ends. Article 31 §2 reserves the detailed guidelines to a future norm from the Instância Nacional de Ética em Pesquisa.

    Brazil’s Ministry of Health has already closed the obvious loophole. Asked whether the program can simply be notified, the INAEP FAQ answers: “Deve ser submetido para avaliação do CEP competente. Não basta notificar” (INAEP FAQ on submission). Pending the INAEP norm, the same page recommends a minimum submission package: program description, technical and risk-benefit justification, inclusion and maintenance criteria, a participant safety follow-up plan, expected supply duration and termination conditions under Article 33, allocation of sponsor, investigator and institution responsibilities, care-transition strategy, and whether ANVISA authorization is required.

    Who pays, and for how long

    Cost allocation is unambiguous. Lei 14.874/2024 Article 31 §4 states that where continued treatment with the experimental drug is necessary after trial end, “o fornecimento do medicamento será de responsabilidade do patrocinador.” Article 34 §1 repeats that the sponsor guarantees free post-trial supply, and Decreto 12.651/2025 Article 31 says fornecimento gratuito. ANVISA’s own RDC nº 38, de 12 de agosto de 2013 Article 18 assigns the sponsor complete free treatment (inciso I), product custody and storage (II), a bar on commercializing the product (III), and funding of integral assistance for complications arising from its use (VI). Article 35 §2 of the statute separately makes the sponsor responsible for care needed because of study-caused reactions.

    Duration is where Brazil diverges from every other regime in the region. Article 33 permits interruption only on seven grounds, each requiring a justification submitted to the CEP: participant decision, cure or introduction of a satisfactory alternative, absence of continued benefit, a disqualifying adverse reaction, technical or safety impossibility of manufacture (provided the sponsor supplies an equivalent or better marketed alternative), inciso VI “transcurso do prazo de 5 (cinco) anos, contado da disponibilidade comercial do medicamento experimental no País,” and inciso VII availability in the public health network.

    Inciso VI carries visible veto history: the Planalto text shows “VI – (VETADO)” immediately followed by the five-year text marked “(Promulgação partes vetadas)” — the vetoed passage was subsequently promulgated. The practical effect is that the five-year clock only starts when the product becomes commercially available in Brazil. A sponsor that never commercializes there, or commercializes late, has no five-year backstop running in its favor. The exposure terminates on clinical or supply events, not on a date fixed at trial close.

    Devices and advanced therapies are in scope

    Article 37 of Lei 14.874/2024 is one sentence, and it is why MedTech and cell-and-gene sponsors cannot treat this as a pharma-only issue: “Aplicar-se-ão aos produtos e dispositivos médicos e aos produtos de terapias avançadas experimentais, objeto de ensaio clínico, as disposições deste Capítulo, no que couber.” The whole post-trial chapter applies to medical devices and experimental advanced therapy products, insofar as applicable. Decreto 12.651/2025 Article 31 reinforces this by using produto sob investigação.

    The caveat is operational, not legal: RDC 38/2013 was written in 2013 and speaks only of medicamento. ANVISA maintains a separate service channel for advanced-therapy product programs, but there is no equivalent device-specific post-study petition. For an implantable or an active device, the statutory duty exists while the import and dispensing pathway has to be built from the trial’s own authorization documents — a problem to solve in the protocol, not at trial close.

    CEP, ANVISA and INAEP: three approvals, three functions

    Lei 14.874/2024 Article 5 splits Brazil’s Sistema Nacional de Ética em Pesquisa into a national ethics instance and the CEPs. In post-trial access, the division of labor is:

    • CEP — approves the pre-trial plan (Art. 30), the post-study program (Decreto Art. 31 §1), and any interruption justification (Art. 33). The INAEP FAQ states this is, as a rule, the coordinating centre’s CEP.
    • ANVISA — Article 34 §3 requires that importation and dispensing during the post-study program be previously authorized by the competent sanitary authority.
    • INAEP — the Instância Nacional de Ética em Pesquisa issues ethics norms, credentials and accredits CEPs, and acts as appellate instance over CEP decisions (Art. 8). Decreto Article 31 §2 assigns it the post-study guidelines.

    INAEP became operational during 2026. It adopted its internal regulation by Resolução nº 1 of 2 April 2026 and transitional CEP accreditation procedures by Resolução RCI nº 2 of 8 May 2026 (INAEP legislation index), and held its first ordinary meeting with full membership in Brasília on 14 August 2026, seating 15 titular and 15 alternate members from the scientific community alongside representatives of ANVISA, the Conselho Nacional de Saúde and three ministries (Ministério da Saúde). No post-study-specific INAEP norm appears in its legislation index yet. Two transitional rules still shape practice: Decreto Article 39 keeps Conselho Nacional de Saúde norms valid until INAEP replaces them, and Article 40 keeps CONEP as the appellate instance until INAEP’s members are seated.

    The import mechanism

    For medicines, RDC 38/2013 is still the operative instrument — ANVISA’s own programas assistenciais page lists post-study supply as one of three assistance programs under it. The sequence:

    1. The sponsor or a contracted organização representativa do patrocinador (ORP) files the anuência request with ANVISA (Art. 4).
    2. For post-study supply specifically, ANVISA does not issue a comunicado especial. Article 3 §2 provides that it issues “um ofício autorizando o fornecimento.”
    3. The import licence (LI) is filed on the RDC 39/2008 form and, per Article 16 parágrafo único, may be filed together with the anuência process.
    4. The dossier per Anexo I §IV is the Anexo IV petition form, the sponsor’s Anexo VI commitment declaration, the physician’s Anexo VII declaration, the physician’s CV, the Anexo VIII import quantity estimate, and the comunicado especial that authorized the trial.
    5. Post-anuência, imports follow the trial’s own comunicado especial or import document, and under Orientação de Serviço nº 01/2020 no pre-shipment authorization is required.
    6. Reporting continues: annual reports from the date of anuência, a final report within 90 days of program close, discontinuation notice within 60 days, and serious adverse event notification within 15 calendar days, or 7 in case of death (Arts. 17 and 18).

    On timing, ANVISA’s service pages state an average of 20 calendar days for the medicines and biologics post-study petition service and 10 calendar days for advanced therapies. Those are service-level averages, not statutory deadlines — RDC 38/2013 sets no analysis period. Treat the CEP submission and the ANVISA filing as parallel critical-path items.

    One watch item: ANVISA Consulta Pública nº 1.210/2023 proposed a risk-based revision of RDC 38/2013 allowing the post-study program to proceed by notification. Comments closed 2 January 2024 and the revision has not been finalized. The same notice disclosed that between 2019 and 2023 ANVISA received 256 post-study supply requests, alongside 558 compassionate use and 41 expanded access requests.

    Brazil converts post-trial access from an ethics-committee expectation into a balance-sheet item with an indeterminate end date. The cost driver is not the product; it is the tail — free supply, cold-chain distribution, pharmacovigilance, ANVISA reporting and CEP maintenance running until one of seven Article 33 events occurs, with the five-year clock not starting until Brazilian commercial availability. Price that tail in the Article 30 pre-trial plan, decide in the protocol how a device or advanced therapy will physically be imported and dispensed post-close, and treat the eventual INAEP norm under Decreto Article 31 §2 as a change-control trigger.

    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 Brazil or elsewhere in Latin America, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently asked questions

    Does Brazil require post-trial access?
    Yes, as a matter of statute. Lei 14.874/2024 Chapter VI (Arts. 30–37) and Decreto 12.651/2025 Article 31 require the sponsor to guarantee free continued supply of the investigational product to participants whenever the responsible investigator considers it the best therapeutic alternative for that participant’s clinical condition and the risk-benefit assessment is favorable. Brazil’s Ministry of Health describes this as “não é uma expectativa, mas um dever legal.” The obligation begins before the trial does: Article 30 requires a post-study access plan to be filed with the research ethics committee before enrollment starts.

    What is Lei 14.874/2024?
    Lei nº 14.874 of 28 May 2024 is Brazil’s Marco Legal de Pesquisa Clínica, the statute governing research with human subjects. It created the Sistema Nacional de Ética em Pesquisa com Seres Humanos, split into a national ethics instance and the CEPs, and devoted Chapter VI to continuity of treatment after the clinical trial. It entered into force 90 days after its 29 May 2024 official publication under Article 65. Its post-trial provisions replaced a regime that previously rested largely on Conselho Nacional de Saúde resolutions.

    What is Decreto 12.651/2025?
    Decreto nº 12.651 of 7 October 2025 is the implementing decree for Lei 14.874/2024. It took effect on publication in the Diário Oficial da União of 8 October 2025 under Article 41. Article 31 restates the sponsor’s free-supply duty using the broader phrase produto sob investigação, requires the sponsor to draft the post-study access program and submit it to the competent CEP with its supply strategy, and reserves detailed elaboration and review guidelines to a future INAEP norm. Articles 39 and 40 set transitional rules preserving CNS norms and CONEP’s appellate role.

    Who pays for post-trial supply in Brazil?
    The sponsor, exclusively and free of charge to the participant. Lei 14.874/2024 Article 31 §4 provides that supply of the medicine is the sponsor’s responsibility; Article 34 §1 requires the sponsor to guarantee free post-trial supply; and Decreto 12.651/2025 Article 31 uses fornecimento gratuito. RDC 38/2013 Article 18 adds that the sponsor must fund complete free treatment, keep the product properly stored, refrain from commercializing it, and fund integral assistance for complications arising from its use. Article 35 §2 of the statute separately covers care for study-caused reactions.

    How long must sponsors provide post-trial access in Brazil?
    There is no fixed end date. Lei 14.874/2024 Article 33 allows interruption only on seven grounds, each requiring justification submitted to the CEP: participant decision, cure or a satisfactory alternative, absence of continued benefit, a disqualifying adverse reaction, technical or safety impossibility of manufacture with an equivalent alternative supplied, five years counted from commercial availability in Brazil, or availability in the public health network. Because the five-year clock starts at Brazilian commercial availability rather than trial close, the practical tail is the longest in Latin America.

    Does Brazil PTA apply to medical devices?
    Yes. Article 37 of Lei 14.874/2024 extends the entire post-trial chapter to produtos e dispositivos médicos used in clinical trials, insofar as applicable, and Decreto 12.651/2025 Article 31 speaks of the investigational product rather than the medicine. The operational gap is that ANVISA’s RDC 38/2013 assistance-program framework addresses medicamento only, so device sponsors have a clear statutory duty but must build the post-close import and dispensing route from the trial’s own authorization documents. Resolve this in the protocol, not at close-out.

    Does Brazil PTA apply to advanced therapy medicinal products (ATMPs)?
    Yes. Article 37 names produtos de terapias avançadas experimentais alongside devices, so the post-trial chapter applies to cell, gene and tissue-engineered investigational products insofar as applicable. Unlike devices, ATMPs have a dedicated ANVISA service channel for compassionate use, expanded access and post-study supply of advanced therapy products, for which ANVISA states an average service time of 10 calendar days. Lei 14.874/2024 Article 28 §2 separately requires that import and export of experimental advanced therapies be authorized under specific regulation.

    What is INAEP and what role does it play?
    INAEP is the Instância Nacional de Ética em Pesquisa, the national ethics instance created by Lei 14.874/2024 Article 5 and structured by Decreto 12.651/2025. Under Article 8 of the statute it issues research ethics norms, credentials and accredits CEPs, monitors and inspects them, and serves as appellate instance over CEP decisions. For post-trial access specifically, Decreto Article 31 §2 assigns INAEP the complementary guidelines for preparing, presenting and ethically reviewing the post-study plan and program. INAEP adopted its internal regulation on 2 April 2026 and held its first full-membership ordinary meeting on 14 August 2026.

    What is the import mechanism for post-trial supply in Brazil?
    For medicines, ANVISA RDC 38/2013. The sponsor or a contracted ORP files an anuência request; for post-study supply ANVISA issues not a comunicado especial but “um ofício autorizando o fornecimento” (Art. 3 §2). The import licence is filed on the RDC 39/2008 form and may be submitted together with the anuência process (Art. 16). The Anexo I §IV dossier comprises the Anexo IV petition, the sponsor’s Anexo VI and physician’s Anexo VII declarations, the physician’s CV, the Anexo VIII quantity estimate, and the trial’s comunicado especial. Lei 14.874/2024 Article 34 §3 makes this prior authorization mandatory.

    How does Brazil’s 5-year commercial-availability tail work in practice?
    Article 33 inciso VI permits interruption after “transcurso do prazo de 5 (cinco) anos, contado da disponibilidade comercial do medicamento experimental no País.” The trigger is Brazilian commercial availability, not trial completion, marketing authorization elsewhere, or first commercial sale in another market. A sponsor that obtains ANVISA registration but delays Brazilian launch delays the start of its own five-year clock. Sponsors that never commercialize in Brazil cannot rely on inciso VI at all and must exit through one of the other six grounds, each of which requires a CEP-reviewed justification.

    Sources

    • Lei nº 14.874, de 28 de maio de 2024 (Marco Legal de Pesquisa Clínica), Arts. 5, 8, 28, 30–37, 65 — https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm
    • Decreto nº 12.651, de 7 de outubro de 2025, Arts. 3, 30–31, 39–41 — https://www2.camara.leg.br/legin/fed/decret/2025/decreto-12651-7-outubro-2025-798105-publicacaooriginal-176652-pe.html
    • ANVISA RDC nº 38, de 12 de agosto de 2013, Arts. 1–4, 15–18, 26, Anexo I §IV — https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000038&seqAto=000&valorAno=2013&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=1696&cod_modulo=134&pesquisa=true
    • Ministério da Saúde / INAEP FAQ, “O acesso (fornecimento) pós-estudo é opcional? Como a regra funciona?” (20 Feb 2026) — https://www.gov.br/saude/pt-br/composicao/orgaos-colegiados/inaep/faq/faq/acesso-pos-estudo/o-acesso-fornecimento-pos-estudo-e
    • Ministério da Saúde / INAEP FAQ, “O programa de acesso pós-estudo deve ser submetido para aprovação ou basta notificar?” (20 Feb 2026) — https://www.gov.br/saude/pt-br/composicao/orgaos-colegiados/inaep/faq/faq/acesso-pos-estudo/o-programa-de-acesso-pos-estudo
    • Ministério da Saúde / INAEP, Legislação (Resolução nº 1 of 2 Apr 2026; Resolução RCI nº 2 of 8 May 2026) — https://www.gov.br/saude/pt-br/composicao/orgaos-colegiados/inaep/legislacao
    • Ministério da Saúde, “Inaep amplia colegiado com especialistas de diferentes regiões do Brasil” (18 Aug 2026) — https://www.gov.br/saude/pt-br/assuntos/noticias-ms/2026/agosto/inaep-amplia-colegiado-com-especialistas-de-diferentes-regioes-do-brasil
    • ANVISA, Programas assistenciais (RDC 38/2013 programs; Orientação de Serviço nº 01/2020) — https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/pesquisaclinica/programas-assistenciais
    • gov.br service, “Solicitar autorização para uso compassivo, acesso expandido e fornecimento de medicamentos e produtos biológicos pós-estudo” — https://www.gov.br/pt-br/servicos/solicitar-autorizacao-para-uso-compassivo-acesso-expandido-e-fornecimento-de-medicamentos-e-produtos-biologicos-pos-estudo
    • gov.br service, “Solicitar autorização para uso compassivo, acesso expandido e fornecimento de produtos de terapias avançadas” — https://www.gov.br/pt-br/servicos/solicitar-autorizacao-para-uso-compassivo-acesso-expandido-e-fornecimento-de-produtos-de-terapias-avancadas
    • ANVISA, “Anvisa abre consulta pública sobre programas assistenciais” (Consulta Pública nº 1.210/2023) — https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2023/anvisa-abre-consulta-publica-sobre-programas-assistenciais

  • Post-trial access in Argentina under ANMAT Disposición 12792/2016

    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

  • Post-trial access in Latin America: the operator’s map

    Ten Latin American countries legally require a trial sponsor to keep supplying the investigational product after the study closes. Three more address post-trial continuation in binding instruments with weak or unassigned duties. Seven impose nothing. If your Phase 3 has LATAM sites, that distinction is a line item, not an ethics footnote.

    We built this map because the region is now diverging fast. Brazil enacted a statute in 2024 and its regulation in 2025. Honduras went from zero to a mandate in February 2026. Panama replaced its research decree in April 2026. Meanwhile most global vendor and law-firm summaries still cite instruments that have been repealed, and several repeat citation errors that a regulator would catch on the first review cycle.

    Where the mandates actually are

    Across 20 jurisdictions, the classification breaks down as follows.

    Binding statutory mandate (10): Argentina, Brazil, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, Nicaragua, Panama. Each has a law, decree, resolution or ministerial normativa that obliges continued provision of the investigational product after the trial ends.

    Binding instrument, weak or unassigned duty (3): Uruguay, Bolivia, Venezuela. Venezuela’s Buenas Prácticas Clínicas §6.12.1 requires the sponsor only to “procurar… la provisión del tratamiento” after the trial — endeavour, not provide (INHRR). Uruguay’s Decreto 158/019 Anexo numeral 24 says participants “deben tener la certeza de que contarán con los beneficios demostrados” but names no obligor at all (IMPO). Bolivia’s Art. 99 routes continuation entirely into the compassionate-use chapter, requiring per-patient DINAMED authorization (AGEMED).

    No mandate (7): Mexico, Colombia, Paraguay, El Salvador, Dominican Republic, Cuba, Puerto Rico. In each case we read the operative clinical-trial instrument and it contains no post-trial supply obligation.

    The comparative matrix

    Country Mandate status Primary instrument Cost allocation Import mechanism
    Argentina Binding statute Disp. ANMAT 12792/2016; GCP base reset by Disp. 7516/2025 Sponsor, free to participant, site and payer (Art. 3(g)) Dedicated PTA import expediente to ANMAT–DERM, valid 12 months (Art. 4); physical import via INAME (Art. 5)
    Brazil Binding statute Lei 14.874/2024 Arts. 30–37 + Decreto 12.651/2025 Art. 31 Sponsor (Lei Art. 31 §4); free supply (Decreto Art. 31) ANVISA authorization + import licence under RDC 38/2013
    Chile Binding statute Ley 20.850 Art. 17; Cód. Sanitario Art. 111 C “Sin costo para el paciente”; duty on provisional-authorization holder, then registration holder ISP special provisional-use authorization (Art. 111 A); CENABAST exceptional import
    Peru Binding statute DS 021-2017-SA Arts. 115–118 Sponsor-funded, provided free (Arts. 40(p), 89) OGITT extension trial or case-by-case ANM/DIGEMID authorization (Art. 116) with a seven-document set (Art. 117)
    Panama Binding statute Decreto Ejecutivo 21/2026 Art. 68, Gaceta Oficial 30510-C, 23 Apr 2026 Investigators and sponsors co-obligated to ensure access; cost not stated verbatim Extension of the trial import permit for exclusive participant use (Art. 68); RESEGIS registration + DNFD authorization (Art. 99)
    Ecuador Binding statute AM 00069-2024 Arts. 80–81, 95(c) Sponsor or legal representative, “entrega gratuita” (Art. 80) No PTA-specific route; general ARCSA import authorization
    Costa Rica Binding statute Ley 9234 Arts. 28, 53(k) Sponsor, free, “mientras lo requieran” None identified in the statute for post-trial product
    Guatemala Binding statute (instrument version unconfirmed) AM 82-2019 Art. 64; MSPAS index lists AM 206-2021 Supply “podrá ser solicitada al patrocinador” — request-driven, not automatic Compassionate-use authorization by the DRCPFA (Art. 65)
    Honduras Binding statute (new) Acuerdo 0256-ARSA-2025 Art. 63 Sponsor or legal representative, “sin costo” (Art. 63) Extension trial or compassionate use (Art. 63); special ARSA import authorization (Art. 86)
    Nicaragua Binding statute Normativa-166 Cap. VI num. 16 Sponsor obliged; free-of-charge stated for the trial phase only General trial import rules; no PTA route
    Uruguay Binding guidance Decreto 158/019 Anexo num. 24 No obligor named n.a.
    Bolivia Binding guidance Norma para Estudios Clínicos Art. 99 → Arts. 74–76 Not allocated post-trial Per-patient DINAMED compassionate-use authorization
    Venezuela Binding guidance Normas de BPC §§5.4.5, 6.12.1 Free during trial only; post-trial duty is “procurar” None described
    Mexico No mandate for product supply NOM-012-SSA3-2012 §11.2.2 Investigator must arrange continued “tratamiento y cuidados” — not IP supply n.a.
    Colombia No mandate Res. 2378/2008 n.a. n.a.
    Paraguay No mandate Resol. DINAVISA 238/2024 n.a. n.a.
    El Salvador No mandate Lineamientos Técnicos, Ac. Ejec. 1530 (2025) n.a. n.a.
    Dominican Republic No mandate Manual CONABIOS, 2ª ed. n.a. — §7.1 gives an information right only n.a.
    Cuba No mandate BPC en Cuba (CECMED) n.a. — §4.3.2 covers adverse-event medical care only n.a.
    Puerto Rico (US) No mandate 21 CFR 312 Subpart I n.a. — permissive expanded-access framework n.a. (US customs territory)

    Why this is a closing cost, not an ethics footnote

    A sponsor that runs sites in Brazil, Chile, Peru, Panama and Argentina and then closes the study has, in five jurisdictions, a legally enforceable duty to keep shipping product to responders — free of charge, under separate authorizations, for a period the sponsor does not control.

    Brazil’s Ministry of Health states the position without hedging: continued post-study treatment “não é uma expectativa, mas um dever legal, aplicável desde o planejamento da pesquisa até o período pós-estudo” (INAEP FAQ). That duty is priced nowhere in a standard Phase 3 budget. It requires a cohort-scale filing distinct from the trial dossier, an import authorization with its own clock, GDP-compliant cold chain for as long as the cohort persists, and pharmacovigilance reporting after database lock.

    The obligation also survives corporate events. Chile’s Código Sanitario Art. 111 C states the duty “afectará al titular del registro sanitario, aun cuando no haya sido el titular de la autorización provisional o haya adquirido con posterioridad el registro sanitario” (BCN). Buy a Chilean registration and you buy the free-supply obligation attached to it. That belongs in diligence, not in a site-activation checklist.

    The five strongest sponsor obligations

    Brazil. Lei 14.874/2024 Art. 30 requires the sponsor and investigator to file a post-study access plan with the CEP before the trial starts. Art. 31 §4 puts the cost on the sponsor. Art. 33 permits interruption only on listed grounds, including the “transcurso do prazo de 5 (cinco) anos, contado da disponibilidade comercial do medicamento experimental no País.” Decreto 12.651/2025 Art. 31 restates the free-supply duty whenever the investigator judges the product the best therapeutic alternative. Full detail in our Brazil post-trial access pillar.

    Chile. Art. 111 C obliges continuity “sin costo para el paciente… por todo el tiempo que persista su utilidad terapéutica” — no commercialization endpoint, no five-year cap. See the Chile Ley 20.850 analysis.

    Panama. Article 68 of Decreto Ejecutivo 21/2026 (Gaceta Oficial 30510-C, 23 April 2026) reads: “Los investigadores y patrocinadores deben asegurar a todos los participantes el acceso al producto, siempre que se haya comprobado el beneficio clínico o de salud pública de la intervención durante el estudio; hasta su comercialización en el país.” It then requires the sponsor to apply for “una extensión del permiso de importación del producto utilizado durante la investigación para uso exclusivo de los participantes.” The decree entered into force on promulgation under Art. 105. Detail in the Panama Decreto 21/2026 pillar.

    Argentina. Disposición ANMAT 12792/2016 is the only instrument in the region that is purely a post-trial access import procedure. Art. 3(g) requires a sworn sponsor declaration that supply will be “sin costo alguno para el participante, el establecimiento asistencial o su cobertura de salud” — note that the site and the payer are named, not just the patient. Art. 4 gives the DERM authorization a 12-month validity. Art. 2 excludes authorized extension studies, which run on a different track. See the Argentina Disposición 12792 pillar.

    Peru. DS 021-2017-SA is the best-drafted operational regime in the region: Art. 115 defines the obligation and its trigger conditions, Art. 116 names two authorization routes (OGITT extension trial or case-by-case ANM/DIGEMID authorization), Art. 117 lists the documents, Art. 118 assigns post-access pharmacovigilance. Art. 40(p) makes it a sponsor duty. See the Peru DS 021-2017-SA pillar.

    Where the duty reaches devices

    Most LATAM post-trial provisions were drafted for medicines. Four jurisdictions reach hardware textually.

    Costa Rica is the clearest. Ley 9234 Art. 53(k) obliges the sponsor to provide, free of charge and after the study concludes, “el medicamento, dispositivo o procedimiento que ha sido objeto de investigación,” with four exhaustive exits — including a reasoned treating-physician resolution filed in the record and communicated to the CEC within three working days. Art. 28 sets the duration at “mientras lo requieran.”

    Brazil reaches devices through Lei 14.874/2024 Art. 37: “Aplicar-se-ão aos produtos e dispositivos médicos e aos produtos de terapias avançadas experimentais… as disposições deste Capítulo, no que couber.” Chile reaches them through Código Sanitario Art. 111 A, which covers “los productos farmacéuticos y los elementos de uso médico.” Peru reaches them through the definition of producto en investigación in Art. 2.1.36.

    Ecuador does not. AM 00069-2024 is a reglamento for medicines and processed natural medicinal products, so a device sponsor’s Ecuadorian exposure runs through ethics-committee expectations and the informed consent, not through Arts. 80–81.

    What changed between 2024 and 2026

    Honduras added a mandate. Acuerdo 0256-ARSA-2025 Art. 63 defines post-trial access as “la entrega sin costo por parte del patrocinador o su representante legal,” even where the product has no Honduran sanitary registration, subject to three cumulative conditions. Published in La Gaceta on 28 January 2026, in force 30 days later. The predecessor Acuerdo 041-2020 had no post-trial provision at all. Read Art. 63 alongside Art. 18 numeral 5, which softens the duty to facilitating access “cuando el patrocinador lo considere” — a real internal tension, and a reason not to treat Honduras as equivalent to Brazil.

    Panama replaced its research decree. Decreto Ejecutivo 21/2026 reglamenta Titles III and IV of Ley 84 de 14 de mayo de 2019 and entered into force on promulgation, 23 April 2026. Its Art. 104 repeals Decreto Ejecutivo 1843 of 2014, Decreto Ejecutivo 6 of 2015 and Resolución 390 of 2003.

    Ecuador deleted its endpoint. AM 00069-2024 Art. 80 states the free-supply duty with no termination point. The repealed AM 0075-2017 had capped it: Art. 39(w) ran only “hasta que el producto se comercialice en el país” (MSP Ecuador). Art. 81 narrowed the trigger to three cumulative conditions while the duration became open-ended. Almost nobody has flagged that trade.

    Brazil completed a two-step build. Statute in 2024, regulation in 2025, with further INAEP guidance promised by Decreto 12.651/2025 Art. 31 §2.

    Argentina reset its GCP base. Disposición 7516/2025 took effect 1 December 2025 (Art. 8). Its Art. 7 repealed Disposiciones 6677/10, 4008/17, 9929/19 and 2172/25 plus Circulares 0001/11 and 004/18. Disp. 12792/2016 is absent from that repeal list, so the post-trial import procedure stands — but the substantive continuity duty moved into the new GCP annex, and sponsors are filing against instruments that no longer exist. The legal architecture of LATAM PTA piece works through how the obligation layer and the import layer interact.

    Colombia: no binding post-trial access statute

    We read Resolución 2378 de 2008 and Resolución 8430 de 1993 in full, checking expressly for post-trial supply language. Neither contains any. Res. 8430/1993 allocates only harm-related costs — Art. 13 medical care for research-related injury, Art. 15(j) treatment availability and indemnification, Art. 15(k) additional costs against the research budget.

    That makes Colombia a cost-certainty jurisdiction: no statutory tail obligation, no separate post-trial filing, no open-ended supply exposure. It does not make post-trial access impossible. A sponsor that wants to continue supplying responders in Colombia can run a voluntary continuity program on its own initiative, handled through the ethics committee, the informed consent and the general product import rules. The exposure is contractual and reputational rather than statutory, which means it has to be allocated in the CRO and site agreements rather than assumed away.

    Mexico sits in an adjacent position and is routinely misdescribed. NOM-012-SSA3-2012 §11.2.2 obliges “el investigador principal” to arrange continuation of “el tratamiento y cuidados” to prevent withdrawal effects. That is an investigator duty about care, not a sponsor duty to supply the investigational product.

    What sponsors get wrong

    Citing repealed instruments. Argentina’s Disp. 6677/2010, which historically carried the continuity obligation, is repealed. Ecuador’s AM 0075-2017 is repealed. Honduras’s Acuerdo 041-2020 is revoked in its entirety. Panama’s Decreto Ejecutivo 1843/2014 and 6/2015 are repealed. Filings and legal memos still quote all of them.

    The “Ley 419/2023” error. Panama’s medicines statute is Ley 419 of 1 February 2024, not 2023 — and it is a commercial-medicines law, not the post-trial access instrument. The binding post-trial duty sits in Decreto Ejecutivo 21/2026 Art. 68, under Ley 84 of 2019. Getting this wrong signals to a Panamanian reviewer that the filer has not read the current framework.

    Treating Argentina’s RAEM as post-trial access. Disposición 4616/2019 approves the Régimen de Accesibilidad de Excepción a Medicamentos: an individual-patient exceptional import route with 90-day, 180-day and one-year quantity windows (Boletín Oficial). It contains no reference to clinical trials or post-trial access. Filing a trial cohort through RAEM means one expediente per patient, per renewal, on the wrong legal basis. Cohort post-trial access in Argentina runs on Disp. 12792/2016.

    Assuming an obligation implies a pathway. Costa Rica mandates continued free provision of the device or medicine under Art. 53(k), but Art. 55 addresses importation only before an approved study begins. No post-trial import route is identified in the statute. Ecuador and Nicaragua have the same shape. The obligation is real; the mechanism has to be constructed.

    The fastest route to compliance

    For a sponsor closing a multi-country LATAM Phase 3, the sequence that works is: classify each participating country into mandate / soft / none using the operative current instrument; identify which mandate countries require a filing distinct from the trial dossier (Argentina, Brazil, Panama, Peru at minimum); confirm whether your product class is textually in scope, which matters most for devices; establish who the legal importer of record will be in each country, since the trial import authorization frequently expires with the trial; and only then estimate cohort size, duration and cold-chain cost. Countries with no mandate still need a documented position, because the ethics committee and the informed consent will ask.

    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, Brazil, Chile, Peru, Panama, Costa Rica or elsewhere in Latin America, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently Asked Questions

    Which Latin American countries require post-trial access?
    Ten jurisdictions impose a binding statutory duty: Argentina, Brazil, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, Nicaragua and Panama. Three more — Uruguay, Bolivia and Venezuela — address post-trial continuation in binding instruments but with weak verbs, no named obligor, or routing into per-patient compassionate use. Seven impose nothing: Mexico, Colombia, Paraguay, El Salvador, the Dominican Republic, Cuba and Puerto Rico. The classification depends on reading the operative current instrument, not a secondary summary, because five of these countries changed their framework between 2024 and 2026.

    Which LATAM country has the strongest post-trial access mandate?
    Brazil. Lei 14.874/2024 Art. 30 requires a post-study access plan to be filed with the ethics committee before the trial begins, Art. 31 §4 assigns the cost to the sponsor, and Art. 33 permits interruption only on listed grounds — one of which is the passage of five years from the product’s commercial availability in Brazil. Decreto 12.651/2025 Art. 31 restates the free-supply duty. Brazil’s Ministry of Health describes this as a legal duty rather than an expectation. Chile is the closest runner-up because Art. 111 C has no endpoint at all and the obligation follows the sanitary registration to any subsequent holder.

    Does post-trial access in LATAM apply to medical devices or only drugs?
    Both, in four jurisdictions. Costa Rica’s Ley 9234 Art. 53(k) is the most explicit, obliging free post-study provision of “el medicamento, dispositivo o procedimiento.” Brazil extends its post-trial chapter to devices and advanced therapies through Lei 14.874/2024 Art. 37. Chile’s Código Sanitario Art. 111 A covers “elementos de uso médico.” Peru’s definition of producto en investigación in DS 021-2017-SA Art. 2.1.36 includes devices. Ecuador’s AM 00069-2024 does not cover devices. Argentina’s Disp. 12792/2016 covers products and “materiales” without using the word dispositivo médico, so device coverage there is inferential.

    Which LATAM countries do NOT require post-trial access?
    Mexico, Colombia, Paraguay, El Salvador, the Dominican Republic, Cuba and Puerto Rico. Colombia’s Resoluciones 2378/2008 and 8430/1993 contain no post-trial supply obligation; Res. 8430/1993 allocates only harm-related costs. Mexico’s NOM-012-SSA3-2012 §11.2.2 imposes a continuity duty on the principal investigator covering treatment and care, not on the sponsor to supply the investigational product. Notably, both Paraguay (2024) and El Salvador (2025) rewrote their research frameworks in this window and declined to add a post-trial provision, which cuts against the assumption that the whole region is converging on mandatory access.

    What changed in LATAM post-trial access regulation in 2024-2026?
    Five substantive moves. Brazil completed a two-step build with Lei 14.874/2024 and Decreto 12.651/2025. Ecuador’s AM 00069-2024 repealed AM 0075-2017 and deleted the “until commercialized in the country” endpoint, converting a bounded duty into an open-ended one. Argentina’s Disposición 7516/2025 took effect 1 December 2025 and repealed Disp. 6677/10 among others, resetting the GCP base while leaving the 2016 post-trial import procedure standing. Honduras moved from no mandate to a binding mandate via Acuerdo 0256-ARSA-2025 Art. 63, in force from late February 2026. Panama’s Decreto Ejecutivo 21/2026 entered into force 23 April 2026 with a binding post-trial duty in Art. 68.

    What is the difference between cohort PTA (Argentina) and individual expanded access (RAEM)?
    They are separate legal regimes with separate instruments. Post-trial access under Disposición ANMAT 12792/2016 is a cohort-level procedure: one expediente covering the named participants from an ANMAT-authorized trial, approved by the ethics committee, filed with the Dirección de Evaluación y Registro de Medicamentos, with a 12-month import authorization under Art. 4. The Régimen de Accesibilidad de Excepción a Medicamentos under Disposición 4616/2019 is an individual-patient exceptional import route with 90-day, 180-day and one-year quantity limits, and it makes no reference to clinical trials. Using RAEM for a trial cohort produces per-patient filings on the wrong basis.

    Who pays for post-trial access in Latin America?
    The sponsor, in every country where the duty is clearly allocated. Brazil’s Lei 14.874/2024 Art. 31 §4 puts the supply on the sponsor. Peru’s DS 021-2017-SA Art. 89 requires products to be sponsor-financed and provided free. Costa Rica’s Ley 9234 Art. 53(k) and Ecuador’s AM 00069-2024 Art. 80 both name the sponsor. Chile’s Art. 111 C places the duty on the provisional-authorization holder and then the registration holder. Argentina goes furthest: Disp. 12792/2016 Art. 3(g) requires a sworn declaration that supply carries no cost to the participant, the treating institution or the health coverage. Uruguay, Bolivia, Nicaragua and Honduras leave the cost-bearer partly or wholly unstated.

    How does a sponsor find a qualified PTA operator in Latin America?
    Test three capabilities separately. First, regulatory: can the operator file the country-specific post-trial authorization itself, naming the correct current instrument and article, rather than subcontracting it blind. Second, importation: can it act as legal importer of record after the trial import authorization lapses, which it does in several countries. Third, distribution: can it hold and ship the product under 2–8 °C GDP conditions for the life of the cohort, with pharmacovigilance reporting after database lock. Global post-trial supply vendors market the service regionally without naming Latin American countries or local filing capability on their public pages, so ask for the specific article and the specific authorizing office.

    What is the fastest route to compliance for a sponsor closing a multi-country LATAM Phase 3?
    Start from the operative instrument in each participating country, not from a regional summary. Classify each country as binding mandate, weak instrument or no mandate; determine which mandate countries require a filing distinct from the trial dossier — Argentina, Brazil, Panama and Peru at minimum; confirm your product class is textually in scope, which is the decisive question for devices; appoint a legal importer of record in each country because trial import authorizations frequently expire with the trial; then size the cohort, the duration and the cold chain. Countries with no mandate still need a documented, defensible position for the ethics committee.

    Sources

    • Argentina — Disposición ANMAT 12792/2016: https://www.boletinoficial.gob.ar/detalleAviso/primera/154162/20161117
    • Argentina — Disposición ANMAT 7516/2025: https://www.boletinoficial.gob.ar/detalleAviso/primera/332695/20251009
    • Argentina — Disposición ANMAT 4616/2019 (RAEM): https://www.boletinoficial.gob.ar/detalleAviso/primera/208794/20190604
    • Brazil — Lei nº 14.874/2024: https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm
    • Brazil — Decreto nº 12.651/2025: https://www2.camara.leg.br/legin/fed/decret/2025/decreto-12651-7-outubro-2025-798105-publicacaooriginal-176652-pe.html
    • Brazil — ANVISA RDC nº 38/2013: https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000038&seqAto=000&valorAno=2013&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=1696&cod_modulo=134&pesquisa=true
    • Brazil — Ministério da Saúde / INAEP FAQ on acesso pós-estudo: https://www.gov.br/saude/pt-br/composicao/orgaos-colegiados/inaep/faq/faq/acesso-pos-estudo/o-acesso-fornecimento-pos-estudo-e
    • Chile — Ley 20.850 and Código Sanitario Arts. 111 A–111 C: https://www.bcn.cl/leychile/navegar?idNorma=1078148
    • Peru — Reglamento de Ensayos Clínicos, DS 021-2017-SA: https://ensayosclinicos-repec.ins.gob.pe/images/Reglamento_de_EC.pdf
    • Panama — Decreto Ejecutivo No. 21 de 23 de abril de 2026, Gaceta Oficial Digital No. 30510-C (Arts. 68, 99, 104, 105); primary text read from the Gaceta Oficial PDF
    • Panama — Ley 419 de 1 de febrero de 2024 (medicamentos): https://www.minsa.gob.pa/sites/default/files/normatividad/ley-419-de-2024-ley-de-medicamentos.pdf
    • Ecuador — Acuerdo Ministerial 00069-2024: https://www.espoch.edu.ec/wp-content/uploads/2025/10/ac-00069-2024_dic_31_compressed_1-1.pdf
    • Ecuador — Acuerdo Ministerial 0075-2017 (repealed): https://www.salud.gob.ec/wp-content/uploads/2022/09/A.M.-0075-REGLAMENTO-ENSAYOS-CLINICOS-1.pdf
    • Costa Rica — Ley N.º 9234, Ley Reguladora de Investigación Biomédica: https://documentos.una.ac.cr/bitstream/handle/unadocs/5670/Texto%20Completo%20Norma%209234.pdf?sequence=1&isAllowed=y
    • Guatemala — Acuerdo Ministerial 82-2019: https://medicamentos.mspas.gob.gt/phocadownload/Acuerdo%20Ministerial%2082-2019.pdf
    • Guatemala — MSPAS legislación vigente index (AM 206-2021): https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/acuerdos
    • Honduras — Acuerdo No. 0256-ARSA-2025: https://www.tsc.gob.hn/web/leyes/Acuerdo-0256-ARSA-2025.pdf
    • Nicaragua — Normativa-166, Norma para la Regulación de Ensayos Clínicos: https://www.minsa.gob.ni/sites/default/files/2022-10/Norma%20de%20Ensayos%20Clinicos.11833.pdf
    • Uruguay — Decreto N° 158/019, Anexo: https://www.impo.com.uy/bases/decretos-originales/158-2019/8
    • Bolivia — Norma para Estudios Clínicos (AGEMED): https://www.agemed.gob.bo/archivos_agemed/ensayosclinicos/001-2021.pdf
    • Venezuela — Normas de Buena Práctica Clínica (INHRR): https://inhrr.gob.ve/pdf/pdf_jr/JR-1311-2013.pdf
    • Mexico — NOM-012-SSA3-2012: https://sidof.segob.gob.mx/notas/docFuente/5284148
    • Colombia — Resolución 2378 de 2008: https://www.ins.gov.co/Normatividad/Resoluciones/RESOLUCION%202378%20DE%202008.pdf
    • Colombia — Resolución 8430 de 1993: https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/de/dij/resolucion-8430-DE-1993.PDF
    • Paraguay — Resolución DINAVISA 238/2024: https://dinavisa.gov.py/wp-content/uploads/2024/10/2.-Requisitos-de-Ensayos-Clinicos.-Resol.-238_2024.pdf
    • El Salvador — Lineamientos Técnicos para la Investigación en Salud, Acuerdo Ejecutivo 1530 (2025): https://asp.salud.gob.sv/regulacion/pdf/lineamientos/lineamientostecnicosparalainvestigacionensalud-Acuerdo-Ejecutivo-1530-29052025_v1.pdf
    • Dominican Republic — Manual de Normas y Procedimientos Operativos, CONABIOS: https://conabios.gob.do/wp-content/uploads/2025/02/1.Manual-de-Normas-y-Procedimientos-Operativos-V2-13-02.pdf
    • Cuba — Buenas Prácticas Clínicas en Cuba (CECMED): https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/Dir_BPC.pdf
    • United States / Puerto Rico — 21 CFR 312.310 (Expanded Access, Subpart I): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-I/section-312.310
    • FDA — Expanded Access training materials: https://www.fda.gov/media/193381/download

  • Post-trial access in Panama under Decreto Ejecutivo 21/2026 Article 68

    Panama now imposes a binding post-trial access obligation. Article 68 of Decreto Ejecutivo No. 21 de 23 de abril de 2026 requires investigators and sponsors to ensure that every participant who demonstrated clinical or public-health benefit keeps access to the investigational product until that product is commercialized in Panama.

    The instrument is four months old. It was published in Gaceta Oficial Digital No. 30510-C on 23 April 2026 and entered into force on promulgation under Article 105. Most post-trial access (PTA) guidance in circulation still describes Panama as having an import mechanism but no obligation, or cites instruments that no longer govern health research. Sponsors closing studies in Panama in 2026 and 2027 are exposed to a requirement their vendors have not read.

    What Decreto Ejecutivo 21/2026 actually is

    Decreto 21/2026 is the implementing regulation for Titles III and IV of Ley 84 de 14 de mayo de 2019, the statute that regulates and promotes health research in Panama and establishes its governance. Per the Infojurídica record for the decree, Title III of Ley 84/2019 covers the Comité Nacional de Bioética de la Investigación (CNBI) and Title IV covers the management of health research projects. Ley 84/2019 was published in Gaceta Oficial 28775-A on 16 May 2019.

    The decree runs 105 articles across fifteen chapters, is signed by President José Raúl Mulino Quintero and Minister of Health Fernando Boyd Galindo, and rests on the Constitution, Ley 66 de 10 de noviembre de 1947 (Código Sanitario) and Ley 84 de 2019. The CNBI hosts its own copy, a practical signal that the bioethics system treats it as the operative reference.

    Article 68 verbatim

    Article 68 is titled “Acceso a productos por parte de los participantes.” The operative first paragraph reads:

    “Los investigadores y patrocinadores deben asegurar a todos los participantes el acceso al producto, siempre que se haya comprobado el beneficio clínico o de salud pública de la intervención durante el estudio; hasta su comercialización en el país, de conformidad con criterios especificados en la reglamentación y en cumplimiento de la normativa correspondiente a la importación de estos productos. Para tales efectos, solicitará ante la autoridad competente, una extensión del permiso de importación del producto utilizado durante la investigación para uso exclusivo de los participantes de dicho estudio hasta cumplir la fase post investigación.”

    Our English translation: “Investigators and sponsors must ensure access to the product for all participants, provided the clinical or public-health benefit of the intervention was demonstrated during the study; until its commercialization in the country, in accordance with criteria specified in the regulations and in compliance with the rules governing importation of these products. For such purposes, they shall request from the competent authority an extension of the import permit for the product used during the research, for the exclusive use of the participants in that study, until the post-research phase is complete.”

    The second paragraph assigns exceptional cases to the research bioethics committee. The third requires “acuerdos, convenios u otras figuras” reflecting the sponsor’s intent to commercialize the product in Panama, modelled on the CIOMS guidelines, so the sponsor can offer access once study participation ends — expressly “a fin de evitar que la descontinuación de una intervención prive a los participantes de la investigación de capacidades básicas o reduzca considerablemente la calidad de vida que habían logrado durante el estudio.”

    Investigators and sponsors are co-obligated

    The subject of Article 68 is plural: “los investigadores y patrocinadores.” That is unusual in the region, where most PTA provisions name the sponsor alone. Panama makes the local principal investigator jointly responsible.

    The investigator therefore carries a personal regulatory duty to escalate if the sponsor does not fund continued supply, and Article 69 requires the sponsor to secure at least one principal investigator resident in Panama answering scientific, ethical and legal questions — so there is always an identifiable domestic co-obligor the CNBI and the accredited Comité de Bioética de la Investigación (CBI) can hold to account.

    Article 68 does not use the word gratuito, so cost allocation is not stated verbatim. It is reached indirectly: Article 71 num. 2 makes the CIOMS international ethical guidelines for health-related research involving humans a fundamental document governing approval, execution and follow-up of research, and Article 66 requires the CBI to apply CIOMS in vulnerability analysis. CIOMS Guideline 6 states that “the obligation to care for participants’ health needs rests with the researcher and the sponsor” and requires plans for “providing continued access to study interventions that have demonstrated significant benefit.” Read with Article 61, under which participants “no deben incurrir en ningún gasto por participar en un estudio de investigación,” the practical outcome is sponsor-funded supply — inferred from Articles 61, 66 and 71, not quoted from Article 68.

    Duration: until commercialization in Panama

    The end point in Article 68 is “hasta su comercialización en el país” — until the product is commercialized in Panama. There is no fixed month count and no cap. For a device or drug with no Panamanian registration plan that phrasing is open-ended, which is why the third paragraph of Article 68 demands agreements documenting the sponsor’s commercialization intent. A sponsor not planning to commercialize must either negotiate a defined exit with the CBI under the exceptional-cases paragraph or plan for a long tail.

    CIOMS supplies the standard the CBI will most likely apply: provision “may end as soon as the study intervention is made available through the local public health-care system or after a predetermined period of time that the sponsors, researchers and community members have agreed before the start of a trial.” A sponsor that has not defined the PTA exit at protocol stage has weaker footing at study close.

    The extension of the import permit

    Article 68 names a specific filing: an extensión del permiso de importación covering the investigational product for the exclusive use of that study’s participants, through the post-research phase. It is not a compassionate-use application — it is an extension of the existing research import permit, scoped to a closed cohort.

    The surrounding machinery sits in Chapter XIII. Under Article 95, where a high-risk study uses medicines or products for human health, product evaluation before the trial starts belongs to the Dirección Nacional de Farmacia y Drogas (DNFD), filed through the RESEGIS platform of the Dirección General de Salud Pública with GMP certification, certificate of analysis, investigator’s brochure and product manuals; the DNFD answers within fifteen working days. Article 99 states plainly that “la importación de los productos de investigación se hará en base al registro del proyecto de investigación en la plataforma RESEGIS, la aprobación ética y su autorización por la Dirección Nacional de Farmacia y Drogas.” Article 100 makes the investigator or tramitante responsible for evidencing all approval and importation documentation in RESEGIS.

    Three approvals therefore gate every post-trial shipment: an active RESEGIS project record, CBI ethical approval covering the post-trial phase, and DNFD authorization. Article 97 adds labelling minimums — identification or code, lot, expiry, storage conditions, special warnings — with Spanish required except where the DNFD accepts English on prior justification. For a 2–8 °C product that chain must hold through a supply period that may run years past the last patient visit.

    RESEGIS, the DNFD and the CBI

    RESEGIS is the Registro y Seguimiento de la Investigación para la Salud, established under Article 79 in the Dirección General de Salud Pública. The MINSA introductory guide confirms that the principal investigator registers the project and that a third party or tramitante may file on the investigator’s behalf provided the investigator is already enrolled. That tramitante route is how a sponsor without a Panamanian legal entity gets filings made locally.

    The CBI’s role in PTA is decision-making, not advisory. Article 68 paragraph 2 gives the accredited committee authority over exceptional cases and requires it to determine the applicable mechanisms against previously defined criteria; Article 66 requires the CNBI and accredited CBIs to hold a standard operating procedure for these situations. The CBI that approved the protocol is the body that will approve, condition or reject a proposed PTA arrangement, and Article 91 requires the investigator to load approval certifications into RESEGIS.

    What Article 104 repealed — and what it did not

    Article 104 repeals Decreto Ejecutivo No. 1843 de 16 de diciembre de 2014, Decreto Ejecutivo No. 6 de 3 de febrero de 2015 (the prior bioethics regulation) and Resolución No. 390 de 6 de noviembre de 2003. Any PTA position built on the pre-2026 bioethics-committee framework rests on repealed instruments.

    Article 104 does not repeal Decreto Ejecutivo No. 27 de 10 de mayo de 2024, published in Gaceta 30028-C. That decree implements Ley 419 de 1 de febrero de 2024, the commercial medicines and public-procurement statute, and defines “acceso a medicamento post-estudio clínico” in Article 2 num. 3 as a pharmaceutical product used in a clinical study in Panama, supplied on the treating investigator’s justification of continued benefit “hasta que este esté comercialmente disponible en el país o según lo determine el Comité de Bioética en Investigación.” It stays part of the medicines regime. What changed on 23 April 2026 is that the obligation now lives in Article 68 of the health-research decree. Decreto 27/2024 describes an available route; Article 68 imposes a must.

    Misconceptions worth correcting

    “Panama has a mechanism but no mandate.” Accurate before 23 April 2026, wrong now. Article 68 uses deben asegurar.

    “Ley 419/2023 is the Panamanian PTA law.” The number is right, the year is wrong, and the statute is the wrong one. It is Ley 419 of 1 February 2024, and it regulates commercial medicines and public procurement, not health research. The health-research statute is Ley 84 de 14 de mayo de 2019.

    “Decreto Ejecutivo 27/2024 is the operative PTA instrument.” It is the operative instrument for the medicines regime and it still contains the definition, but the binding continued-supply obligation for study participants now sits in Decreto 21/2026 Article 68.

    “PTA in Panama is a compassionate-use filing.” Article 68 instead routes it through an extension of the research import permit for a defined cohort, evidenced in RESEGIS under Articles 99 and 100.

    What sponsors should do before database lock

    Define the PTA exit in the protocol and informed consent, not at close-out. Get the CBI to approve the arrangement and the acuerdos o convenios required by Article 68 paragraph 3 while the study is still open. Keep the RESEGIS record live through the post-research phase. Budget the import-permit extension, DNFD interaction and Spanish labelling as a workstream distinct from the trial, with a named local filer able to act as tramitante. And confirm which accredited CBI holds the file — that committee, not MINSA centrally, decides the exceptional-case mechanism.

    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 Panama or elsewhere in Latin America, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently asked questions

    What does Panama require for post-trial access?
    Panama requires investigators and sponsors to ensure that every trial participant who demonstrated clinical or public-health benefit continues to receive the investigational product until it is commercialized in Panama. The requirement is Article 68 of Decreto Ejecutivo No. 21 de 23 de abril de 2026. Operationally the sponsor must request an extension of the research import permit covering only that study’s participants, keep the project record active in the RESEGIS platform, obtain Dirección Nacional de Farmacia y Drogas authorization for importation under Article 99, and document the arrangement with the accredited research bioethics committee that approved the protocol.

    Is post-trial access mandatory in Panama?
    Yes, since 23 April 2026. Article 68 of Decreto Ejecutivo 21/2026 uses the mandatory verb deben asegurar (“must ensure”) and names both investigators and sponsors as obligors. The decree entered into force on promulgation under Article 105 and was published in Gaceta Oficial Digital No. 30510-C. Before that date, Panama had a definitional and import route for post-study medicine access under Decreto Ejecutivo 27/2024 but no clearly worded affirmative duty on the sponsor. Guidance describing Panama as a mechanism-only jurisdiction is out of date.

    Who pays for post-trial access in Panama?
    In practice the sponsor. Article 68 does not use the word gratuito, so cost allocation is not stated verbatim in that article. It arrives through three linked provisions: Article 61 states that participants must not incur any expense for participating in a research study; Article 71 num. 2 makes the CIOMS international ethical guidelines a fundamental governing document; and CIOMS Guideline 6 places the obligation to meet participants’ health needs on the researcher and the sponsor. Sponsors should budget product, importation, labelling, cold-chain and local filing costs.

    How long must sponsors provide post-trial access in Panama?
    Until the product is commercialized in Panama — “hasta su comercialización en el país” in Article 68. There is no fixed duration and no statutory cap. Where the sponsor does not intend to register and commercialize in Panama, the obligation is open-ended on its face, and the exit must be negotiated with the research bioethics committee under the exceptional-cases paragraph of Article 68. CIOMS Guideline 6 supports ending provision once the intervention is available through the local public health system or after a period agreed before the trial started, which is why the exit should be defined in the protocol.

    What is Decreto Ejecutivo 21/2026?
    Decreto Ejecutivo No. 21 de 23 de abril de 2026 is the Panamanian regulation implementing Titles III and IV of Ley 84 de 14 de mayo de 2019 on health research. It has 105 articles across fifteen chapters covering the CNBI, accredited bioethics committees, participant rights, the RESEGIS registration platform, the administrative review procedure, and Chapter XIII on research using medicines and other products for human health. It was published in Gaceta Oficial Digital No. 30510-C and entered into force on promulgation.

    What happened to Decreto Ejecutivo 27/2024?
    It is still in force as the implementing regulation for Ley 419 de 1 de febrero de 2024, the commercial medicines and public-procurement statute, and it still defines acceso a medicamento post-estudio clínico in Article 2 num. 3. Article 104 of Decreto 21/2026 repeals Decreto Ejecutivo 1843/2014, Decreto Ejecutivo 6/2015 and Resolución 390/2003 — not Decreto 27/2024. What changed is authority: the binding post-trial obligation on investigators and sponsors now comes from Article 68 of Decreto 21/2026, so citing Decreto 27/2024 as the whole picture understates the duty.

    Does Panama post-trial access apply to medical devices?
    Article 68 refers to “el producto” without limiting it to medicines, and Chapter XIII is titled “De la investigación para la salud donde se utilizan medicamentos y otros productos para la salud humana.” Article 95 covers “medicamentos o productos para la salud humana,” and the glossary in Article 2 num. 8 defines high-risk intervention technology as a medical or health technology used to intervene in diagnosis, treatment, prevention or rehabilitation. On that reading device studies are within scope. Sponsors of device trials should confirm the specific import pathway with the Dirección Nacional de Farmacia y Drogas rather than assume the medicine route applies unchanged.

    What is the difference between Ley 84/2019 and Ley 419/2024?
    Ley 84 de 14 de mayo de 2019 regulates and promotes health research and establishes its governance; its Title III creates the Comité Nacional de Bioética de la Investigación and its Title IV governs management of health research projects. Ley 419 de 1 de febrero de 2024 regulates medicines and other products for human health and their public procurement. Post-trial access as an obligation flows from Ley 84/2019 through Decreto 21/2026 Article 68. Note also that the frequently seen citation “Ley 419/2023” is wrong on the year.

    Who reviews and approves post-trial access requests in Panama?
    Three bodies, in sequence. The accredited Comité de Bioética de la Investigación that approved the protocol reviews the post-trial arrangement and, under Article 68 paragraph 2, decides exceptional cases against previously defined criteria. The Dirección Nacional de Farmacia y Drogas evaluates the product and authorizes importation under Articles 95 and 99. The Dirección General de Salud Pública operates the RESEGIS platform under Article 79, where the investigator or tramitante must evidence all approval and importation documentation under Article 100.

    Sources

  • Importer of Record (IOR) for Multi‑Country MedTech Trials in Latin America: A Sponsor‑Ready Playbook

    Importer of Record (IOR) for Multi‑Country MedTech Trials in Latin America: A Sponsor‑Ready Playbook

    In Latin America, getting a first-in-human or early-stage MedTech study approved is only half the battle. The other half is operational: getting investigational devices, accessories, and consumables through customs reliably—on time, every time, across multiple countries.

    That is why the Importer of Record (IOR) decision becomes a critical-path item for sponsors. An IOR strategy is not just “paperwork.” It is the control system that determines who is legally responsible for the import, who holds product registrations (when needed), how the shipment is classified, and who can react when a package is held.

    This playbook explains what an IOR does in the context of MedTech clinical trials in Latin America, how to choose an IOR model for multi-country programs, and which checklists reduce the most common causes of delays.

    What is an Importer of Record (IOR) in a clinical trial context?

    An Importer of Record is the entity that assumes legal responsibility for bringing goods into a country. In MedTech clinical trials, the IOR is typically responsible for:

    • Customs declaration and classification (HS codes, declared value, product description consistency)
    • Regulatory alignment for investigational-use shipments (where applicable)
    • Coordination with brokers and resolution of holds, inspections, and documentation requests
    • Chain-of-custody documentation and receiving confirmation for sites
    • Import compliance (licenses, tax IDs, authorizations, and record retention)

    For a sponsor running a multi-country LATAM program, the IOR is a practical risk owner: when the shipment is delayed, the IOR is the party with standing to respond, correct documents, and release the goods.

    Why the IOR decision becomes a critical path in Latin America

    Multi-country execution introduces parallel risk. Even if each country has a clean regulatory path, supply chain variability can create staggered site activations and missed enrollment windows. Common delay drivers include:

    • Inconsistent product descriptions between invoice, packing list, airway bill, and regulatory letters
    • Misaligned declared value (e.g., “free of charge” shipments that trigger valuation questions)
    • Unclear purpose-of-import (commercial vs investigational vs donation terminology)
    • Missing or outdated IOR registrations (tax IDs, legal entity status, import licenses)
    • Cold chain ambiguity (temperature ranges not specified, packaging validation gaps)

    The impact is rarely isolated. A single held shipment can create a cascade: rescheduled site initiation visits, re-booked monitoring travel, delayed training, and protocol deviations when replacement components arrive late.

    IOR models for multi-country LATAM MedTech trials (and how to choose)

    There is no universal best model. The right answer depends on the investigational product profile, the number of countries, and how much operational control the sponsor needs.

    Model A: Site or hospital as IOR

    When it works: small studies, low-complexity devices, and highly experienced research institutions with established import processes.

    Risks: sites often lack bandwidth for repeated customs interactions; import experience varies widely; accountability becomes fragmented across countries.

    Model B: Local distributor as IOR

    When it works: later-stage programs where a commercial partner already exists and can support consistent import flows.

    Risks: distributor incentives may not match trial urgency; conflict may arise around product classification, pricing, or future commercial rights.

    Model C: Sponsor-appointed specialized IOR/clinical logistics partner

    When it works: multi-country studies, time-sensitive shipments, accessory-heavy devices, and programs requiring consistent compliance documentation.

    Benefits: centralized process control, repeatable templates, proactive broker management, and stronger visibility across the supply chain.

    Sponsor selection criteria should include: country coverage, medical product import track record, temperature-controlled capability (if relevant), speed of document turnaround, and documented escalation procedures.

    The sponsor-ready IOR checklist (what to confirm before first shipment)

    • Legal entity readiness: confirm the IOR’s legal registration, tax identifiers, and ability to act as importer for investigational medical products.
    • Defined shipment purpose language: use consistent terms such as “investigational-use medical device for clinical study” and avoid mixed commercial language.
    • Standard document pack: commercial invoice (even if no charge), packing list, airway bill, letter of authorization, and study documentation as required.
    • HS code governance: lock a primary HS classification per SKU/component and document the rationale for re-use across shipments.
    • Broker alignment: confirm who the broker is, how communications flow, and who can approve changes under time pressure.
    • Receiving plan: define site receiving hours, quarantine process (if any), and confirmation steps to close the logistics loop.

    In multi-country programs, treat this checklist as a controlled document. Once validated, it becomes the baseline for every country pack with only country-specific annexes.

    How to reduce customs holds and avoid “silent delays”

    Many delays occur because the sponsor does not hear about an issue until the shipment has already been held for days. Reduce that risk with:

    • Pre-alerts: send document packs to the IOR/broker before shipment departure for pre-review.
    • Single source of truth: maintain a shipment register shared with the IOR and the clinical team (SKU, lot/serial ranges, destination sites, temperature requirements).
    • Escalation SLAs: require response times for holds (e.g., 2–4 hours during business days) and define who can approve revised declarations.
    • Component rationalization: where possible, reduce “mixed shipments” with many line items that increase classification complexity.

    Sponsors should also build a buffer into the activation plan. Even with a strong IOR, variability exists. The objective is not perfection; it is predictable, recoverable execution.

    FAQ

    Do we need one IOR per country for a multi-country LATAM trial?

    Yes—imports occur at the country level, so each country requires an importer. The strategic decision is whether to use the same specialized partner (with local entities) across countries to standardize documentation and escalation.

    Can we ship devices as “no commercial value” to simplify customs?

    Not necessarily. “No commercial value” language can trigger valuation questions. A clearer approach is to declare an appropriate value and describe the purpose consistently as investigational-use for a clinical study.

    What should sponsors measure to manage IOR performance?

    Track time from shipment tender to customs release, number of holds per shipment, root causes of holds, and time-to-response during escalation. These metrics quickly reveal whether the IOR process is improving or drifting.

    Bottom line: In Latin America, the IOR model is a study design decision as much as an operations decision. Define it early, standardize it across countries, and your activation timeline becomes far more reliable.