Getting a US-approved medicine in Brazil: the legal route, documents and timing

Creator: Reserve Meds
Published: 2026-10-17

A sourced guide for patients, families and doctors in Brazil, checked against ANVISA 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 Brazil, an individual can import a medicine for their own treatment under ANVISA's RDC 81/2008, even if it is not regularized with ANVISA, as long as it is not prohibited in Brazil and is not for resale. The quantity must match the treatment, which a prescription demonstrates. Controlled substances follow stricter rules.

Regulator: Brazilian Health Regulatory Agency (ANVISA).
Main route: Import by an individual for personal use under RDC 81/2008.
Who imports: The patient (pessoa fisica), or a representative with a power of attorney.
Price: Quote on request.

Who regulates medicines in Brazil

ANVISA regulates medicines in Brazil and inspects imports. According to ANVISA's manual for imports by individuals, personal-use imports of products under health surveillance that are not prohibited are legal under RDC 81/2008 and do not need ANVISA authorization, provided the rules are followed. That is not an exemption from inspection.^[1]

The legal route for a medicine that is not registered in Brazil

Individuals may import medicines that are not regularized with ANVISA, as long as they are not prohibited in Brazil, the import is not commerce or a service to third parties, and RDC 81/2008 is followed.^[1]

Personal use means a quantity and frequency compatible with the length and purpose of the treatment, which can be shown with a prescription from a competent health professional. The import can come as accompanied or unaccompanied baggage, by express courier, by post, or through Siscomex.^[1]

Since 2 January 2024, Siscomex imports by individuals are filed on the Portal Unico de Comercio Exterior using the licence model I00052, LI/LPCO for imports by individuals, instead of in person at the ANVISA post. A representative can file with a power of attorney. ANVISA's information requests must be answered within 30 days.^[1]

Medicines containing substances on the controlled lists of Portaria 344/1998 follow additional rules, so check the active ingredient before shipping.^[1]

Documents you will usually need

ANVISA's manual centres on the prescription. Our checklist for a personal import (the Portal Unico sets the exact fields):^[1]

A prescription from a competent health professional showing the treatment and quantity
The patient's identification (CPF and identity document) as required on the Portal Unico
The commercial invoice and transport documents
A power of attorney if a representative files the LI/LPCO

Timing, quantities and fees

ANVISA does not publish a single processing time for these imports in the manual we checked. If ANVISA raises a requirement during review, the importer has 30 days to respond. Courier and postal imports are cleared at the point of entry.^[1]

How a US-approved medicine reaches a patient in Brazil

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 Brazil the patient imports in their own name. We help confirm the US approval and the prescription details, and ship from the US through our wholesale partner to the patient or their representative, with the invoice and documents the chosen import mode needs.

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 Brazil. 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 Brazil

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

Can I import a medicine into Brazil that ANVISA has not registered?

Yes, for personal use, if it is not prohibited in Brazil and is not for resale, following RDC 81/2008. The quantity must fit the treatment, shown by a prescription.

Do I need ANVISA authorization before a personal import?

ANVISA states that personal-use imports following RDC 81/2008 do not depend on its authorization, but they are still subject to health inspection. Controlled substances have extra rules.

What changed in January 2024?

Siscomex imports by individuals are now filed online on the Portal Unico using the LI/LPCO model I00052, instead of at the ANVISA post at the point of entry.

Does Reserve Meds apply to the regulator for us?

No. In Brazil the patient, or a representative with a power of attorney, is the importer. We help with the documents and arrange US supply.

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.

ANVISA Brazil: Manual, Importacao por pessoa fisica (LI/LPCO), under RDC 81/2008 (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)

This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.