Getting a US-approved medicine in Argentina: the legal route, documents and timing
A sourced guide for patients, families and doctors in Argentina, checked against ANMAT rules on 17 October 2026.
Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.
The short answer
In Argentina, ANMAT's Exceptional Access to Medicines Regime (RAEM, Disposition 10401/2016) lets a specific patient receive a medicine from abroad when there is no adequate alternative in the country. The treating doctor prepares a prescription, a clinical summary and a sworn declaration, the patient signs informed consent, and each authorization covers up to 60 days of treatment.
- Regulator: National Administration of Drugs, Foods and Medical Technology (ANMAT).
- Main route: Regimen de Acceso de Excepcion a Medicamentos (RAEM).
- Who prepares it: The treating physician, with the patient's signed consent.
- Price: Quote on request.
Who regulates medicines in Argentina
ANMAT regulates the import and sale of medicines in Argentina. Unregistered medicines may not be sold or supplied, except in cases the health authority allows. One long-standing exception is a medicine imported by an individual for personal use on the basis of a specific prescription.[1]
The legal route for a medicine that is not registered in Argentina
Disposition 10401/2016 created the RAEM, the procedure for bringing in from abroad a medicine for the treatment of a particular patient for whom there is no adequate therapeutic alternative in Argentina. It applies when the patient needs a medicine, form or strength that is not available in the country, when available medicines are contraindicated, or when a patient at serious risk needs a medicine still in research with enough supporting information.[1]
The medicine must be marketed in its country of origin. If it is still in clinical research, the trial must be registered with the health authority of the country where it is running. For complex cases ANMAT can ask its scientific areas or outside experts for an opinion, and it can require that the medicine is used only in a health facility with the approval of that facility's ethics committee.[1]
Documents you will usually need
Article 4 of the disposition lists what is filed with ANMAT's foreign trade department (INAME):[1]
- The medical prescription
- A summary of the clinical history, including the justification for the indication, signed by the treating physician
- A sworn declaration signed by the treating physician, on the model annexed to the disposition, taking responsibility for the prescription
- The informed consent signed by the patient or legal guardian, stating that the medicine is not marketed in Argentina and explaining its risks and benefits
Timing, quantities and fees
Each RAEM authorization covers at most the quantity needed for 60 calendar days of treatment. A new request can be started once 60 days have passed since the previous authorization. The sworn declaration, once signed and stamped by the responsible ANMAT official, is the document presented to customs and is valid for 30 calendar days.[1]
The disposition dates from 2016. Ask the hospital or ANMAT whether any later rule has changed the procedure before filing.
How a US-approved medicine reaches a patient in Argentina
First, confirm the medicine is approved in the US. FDA's Drugs@FDA database lists approved prescription medicines and links to the approved label.[2]
In Argentina the treating physician prepares the RAEM file and ANMAT stamps the sworn declaration that customs accepts. We help the physician gather the US approval documents and arrange supply from the US through our wholesale partner, timed so the shipment arrives while the 30-day declaration is still valid.
Once the local permission is in place, the medicine is bought from the US supply chain, packed for the temperature the label requires, and shipped to the named hospital, clinic or importer with the documents customs will ask for. Cold-chain medicines need a validated shipper and a temperature record for the whole journey.
If the medicine is a cell or gene therapy, the rules are different: these are usually given only at qualified treatment centers chosen by the manufacturer, so the realistic route is often treatment at a center abroad rather than import.[3]
Practical checks before you start
- Ask the treating specialist whether a registered alternative already exists in Argentina. Most special routes only apply when it does not.
- Check whether the medicine is a controlled drug. Controlled medicines need extra permits in almost every country.
- Ask the hospital pharmacy whether it has handled this route before and who signs the application.
- Keep copies of every document and approval. Customs and the hospital will ask for them again at delivery.
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 for a patient in Argentina
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
Is it legal to bring a medicine into Argentina that is not registered there?
Yes, for a specific patient through ANMAT's RAEM when there is no adequate alternative in Argentina, or as personal-use import on the basis of a specific prescription.
How much medicine can be authorized under RAEM?
At most enough for 60 calendar days of treatment per authorization. A new request can start after 60 days.
How long is the ANMAT customs declaration valid?
The sworn declaration stamped by ANMAT is valid for 30 calendar days from the date the ANMAT official records.
Does Reserve Meds apply to the regulator for us?
No. The application is made by the person or institution the rules name, usually the treating doctor or hospital. We help prepare the paperwork, confirm the US approval and arrange supply from the US once permission is granted.
How much does it cost?
Quote on request. The total depends on the medicine, the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.
Sources for these answers: [1]
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.
- ANMAT Argentina: Disposicion 10401/2016, Regimen de Acceso de Excepcion a Medicamentos (RAEM) (accessed 17 October 2026)
- US FDA: How do I find out if a drug is approved? (accessed 17 October 2026)
- US FDA: Approved Cellular and Gene Therapy Products (accessed 17 October 2026)
Related
- All country guides
- Named-patient access, explained
- US expanded access (compassionate use)
- Answers to common access questions
- How cold-chain medicines are shipped
This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.