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

Creator: Reserve Meds
Published: 2026-10-17

A sourced guide for patients, families and doctors in Chile, checked against ISP 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 Chile, the Instituto de Salud Publica (ISP) can, as an exception, authorize the provisional use of a medicine without sanitary registration. One listed ground is a product for urgent medical use imported for the importer's exclusive use. For that case the ISP authorization is enough to use the product without the separate internment procedure.

Regulator: Instituto de Salud Publica de Chile (ISP).
Main route: Provisional-use authorization under Article 21 of Decreto 3.
Who applies: The importer, usually the patient or the treating institution.
Price: Quote on request.

Who regulates medicines in Chile

The Instituto de Salud Publica registers and controls pharmaceutical products in Chile under the regulation approved by Decreto 3 of the Ministry of Health. A medicine normally needs a sanitary registration before it can be sold or used.^[1]

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

Article 21 of Decreto 3 says the Institute may, exceptionally, authorize the sale or provisional use of certain pharmaceutical products without sanitary registration, based on grounds that include: urgent medical use arising from shortage or inaccessibility affecting people collectively; products for urgent medical use imported for the exclusive consumption of the importer; and products used in scientific research or clinical trials with ethics committee approval.^[1]

For the first two grounds, the authorization itself is enough for the products to be used, without the internment procedure set out in Title IV of the regulation.^[1]

For a single patient, the relevant ground is usually urgent medical use for the importer's own consumption. The ISP sets the forms and documents on its procedures page, which the treating team checks at the time of application.

Documents you will usually need

Article 21 does not list documents, and the ISP sets the forms. Our checklist for preparing a request (the ISP may ask for more or less):

A prescription and a medical report explaining the urgent need and why registered products are not suitable
Identification of the patient who will use the product
Product details: name, active ingredient, strength, form, manufacturer and country of origin
Evidence of the product's approval abroad, such as the US FDA approval and label

Timing, quantities and fees

Decreto 3 does not set a processing time for Article 21 authorizations. We give a written timeline estimate once we see the case, and the ISP's decision time is outside our control.^[1]

How a US-approved medicine reaches a patient in Chile

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 Chile the importer, often the patient or the treating clinic, requests the ISP authorization. Once it is granted, we ship from the US through our wholesale partner to the importer named in the authorization.

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 Chile. 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 Chile

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 a patient in Chile use a medicine that has no Chilean registration?

Yes, as an exception. Article 21 of Decreto 3 lets the ISP authorize provisional use, including for a product for urgent medical use imported for the importer's exclusive consumption.

Is an internment procedure still needed after ISP authorization?

For the shortage and urgent personal-use grounds, Article 21 says the authorization is enough for use, without the internment procedure in Title IV.

Can investigational medicines be used this way?

Article 21 lists research and clinical trials as a separate ground that needs ethics committee approval. Reserve Meds only coordinates FDA-approved medicines.

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.

Chile, Decreto 3 (2010) Ministerio de Salud, Article 21: provisional use of products without sanitary registration (via IURA) (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.