Specialty medicine access in Latin America: seven countries compared
Mexico, Brazil, Argentina, Colombia, Chile, Peru and Ecuador: the official route for a medicine that is not registered, side by side.
Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.
The short answer
Most Latin American regulators allow a patient to import a medicine that is not registered, for their own treatment, with a prescription and medical justification. The routes differ: some are personal imports filed by the patient, others need a regulator's authorization for each case, and some limit quantity. Mexico, Brazil, Argentina, Colombia, Chile, Peru and Ecuador each have a defined procedure.
- Patient files: Mexico, Brazil, Peru, and often Colombia and Ecuador.
- Doctor-led file: Argentina's RAEM.
- Quantity limits: Argentina 60 days per authorization.
- Price: Quote on request.
Country by country
- Mexico (COFEPRIS): a free sanitary import permit for medicines intended for personal use, including medicines without Mexican registration. The patient named on the prescription, or a relative with a carta-poder, applies; the legal response time is 10 business days. See our Mexico guide.[1]
- Brazil (ANVISA): individuals may import medicines for personal use, even if not regularized with ANVISA, if not prohibited and not for resale, under RDC 81/2008. Since January 2024, Siscomex imports by individuals use the online LI/LPCO model I00052. See our Brazil guide.[2]
- Argentina (ANMAT): the RAEM (Disposition 10401/2016) for a particular patient with no adequate alternative; the treating physician signs a sworn declaration, and each authorization covers up to 60 days of treatment. See our Argentina guide.[3]
- Colombia (INVIMA): import of a 'vital medicine not available' for a specific patient under Decreto 481 de 2004, with a prescription and clinical summary; the medicine must not be in clinical research. See our Colombia guide.[4]
- Chile (ISP): exceptional provisional-use authorization under Article 21 of Decreto 3, including for products for urgent medical use imported for the importer's own use. See our Chile guide.[5]
- We give you a written timeline estimate for your case before you commit. See our Peru guide.[6]
- Ecuador (ARCSA): import by exception for specialized treatments and catastrophic, rare or orphan diseases, filed by the patient, a representative or the treating facility. See our Ecuador guide.[7]
What the routes have in common
Every route starts with the treating doctor: a prescription, a medical justification or clinical summary, and a clear reason why registered alternatives do not work. Most also ask for evidence that the medicine is approved and marketed in its country of origin.
For a medicine approved in the US, Drugs@FDA lists the approval and links to the label, which regulators use as reference.[8]
What differs
- Who files: in Mexico, Brazil and Peru the patient or a representative files; in Argentina the treating physician prepares the RAEM file.
- How long one approval lasts: Argentina authorizes up to 60 days of treatment at a time, and its customs declaration is valid for 30 days.[3]
- Fees: COFEPRIS states its personal-use permit has no government fee; Colombia's INVIMA asks for a payment receipt.[1, 4]
- Investigational medicines: Colombia's vital-medicine route excludes medicines in clinical research; Argentina's RAEM can include them under strict conditions.[4, 3]
Practical tips for families
- Ask the treating doctor to write the prescription with every detail the regulator lists, including the professional licence number where required.
- Use the regulator's online system where one exists, and answer queries fast; Peru allows 48 hours.
- Plan shipping around permit validity, especially for cold-chain medicines.
- Keep the permit, invoice and prescription together for customs.
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.
We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.
Ask us about a medicine
Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
Which Latin American countries allow personal import of unregistered medicines?
Mexico, Brazil and Peru have defined personal or individual-treatment import procedures; Argentina, Colombia, Chile and Ecuador have exceptional authorization routes for specific patients.
Who applies in Argentina?
The treating physician prepares the RAEM file with a prescription, clinical summary and sworn declaration, and the patient signs informed consent.
How long does COFEPRIS take?
We give you a written timeline estimate for your case before you commit.
Does Reserve Meds file with these regulators?
No. The patient, physician or facility files as each country's rules require. We help prepare the documents and supply the medicine from the US once permission is granted.
Which Latin American regulators take part in FDA's Project Orbis?
Brazil's ANVISA is listed as a Project Orbis partner. The other regulators on this page are not on FDA's partner list as checked on 17 October 2026.
Sources for these answers: [1, 3, 2, 9]
Sources
All sources were opened and checked on 17 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.
- COFEPRIS (Gobierno de Mexico): Caso de estudio 2, Permiso Sanitario de Importacion de Medicamentos destinados a Uso Personal (accessed 17 October 2026)
- ANVISA Brazil: Manual, Importacao por pessoa fisica (LI/LPCO), under RDC 81/2008 (accessed 17 October 2026)
- ANMAT Argentina: Disposicion 10401/2016, Regimen de Acceso de Excepcion a Medicamentos (RAEM) (accessed 17 October 2026)
- Colombia Ministerio de la Proteccion Social: Decreto 481 de 2004, medicamentos vitales no disponibles (accessed 17 October 2026)
- Chile, Decreto 3 (2010) Ministerio de Salud, Article 21: provisional use of products without sanitary registration (via IURA) (accessed 17 October 2026)
- DIGEMID Peru: Instructivo 2026, Autorizacion Excepcional para la Importacion y Uso de Productos Farmaceuticos para tratamiento individual (TUPA 118) (accessed 17 October 2026)
- ARCSA Ecuador (gob.ec): Autorizacion de Importacion de Productos por Excepcion (accessed 17 October 2026)
- US FDA: How do I find out if a drug is approved? (accessed 17 October 2026)
- US FDA Oncology Center of Excellence: Project Orbis (accessed 17 October 2026)
Related
- All country guides
- Answers to common access questions
- Named-patient access, explained
- US expanded access (compassionate use)
This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.