Getting a US-approved medicine in Mexico: the legal route, documents and timing
A sourced guide for patients, families and doctors in Mexico, checked against COFEPRIS 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 Mexico, a patient can apply to COFEPRIS for a sanitary import permit for medicines intended for personal use, including medicines without a Mexican sanitary registration. The patient named on the prescription applies, or a relative with a signed power of attorney. COFEPRIS describes the procedure as free, with a legal response time of 10 business days.
- Regulator: Federal Commission for the Protection against Sanitary Risk (COFEPRIS).
- Main route: Permiso Sanitario de Importacion de Medicamentos destinados a Uso Personal.
- Who applies: The patient, or a family member with a carta-poder.
- Price: Quote on request. COFEPRIS says the permit itself has no government fee.
Who regulates medicines in Mexico
COFEPRIS regulates medicines in Mexico. A medicine sold in Mexico normally needs a sanitary registration (registro sanitario), but COFEPRIS issues an import permit for medicines intended for a specific patient's own treatment, including medicines that are hard to find or not available in the country.[1]
The legal route for a medicine that is not registered in Mexico
COFEPRIS explains the personal-use import permit through a published case study about a family importing a medicine for a father with pulmonary fibrosis. The permit is for a medicine intended for a patient, with a diagnosis, a treating specialist and a treatment purpose. The rules allow permits for medicines that do not have Mexican sanitary registration.[1]
The importer must be the patient named on the prescription. If the patient cannot do it, any family member can act as importer with a carta-poder (letter of authority) stating their relationship to the patient.[1]
The case study is a narrative written by COFEPRIS, so the current form and the exact requirements should be confirmed with COFEPRIS at the time of application.[1]
Documents you will usually need
The COFEPRIS case study lists these documents for the personal-use permit:[1]
- The completed application form
- A current prescription that includes the prescriber's professional licence number (cedula profesional) and states the dose, presentation, route, frequency and duration
- Official identification for Mexican citizens, or a valid immigration document for foreign nationals
- If a relative applies, a carta-poder signed by the patient
Timing, quantities and fees
COFEPRIS states that the legal response time for this permit is 10 business days; in the case study it took five. The permit does not require a government fee payment. Shipping, customs and cold-chain logistics add their own time after the permit is issued.[1]
How a US-approved medicine reaches a patient in Mexico
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 Mexico the patient or the authorised relative holds the import permit. We help prepare the prescription details the permit needs, confirm the US approval, and ship from the US through our wholesale partner to the importer named on the permit, with the permit and invoice for customs.
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 Mexico. 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 Mexico
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 Mexico that is not registered there?
Yes, with a COFEPRIS sanitary import permit for personal use. COFEPRIS allows these permits for medicines without Mexican sanitary registration when they are for a specific patient's treatment.
How long does the COFEPRIS personal-use permit take?
COFEPRIS gives a legal response time of 10 business days. Shipping and customs time come on top of that.
Is there a government fee for the permit?
According to COFEPRIS, the personal-use import permit does not require a fee payment.
Does Reserve Meds apply to the regulator for us?
No. In Mexico the patient named on the prescription, or a relative with a carta-poder, applies to COFEPRIS for the permit. We help prepare the paperwork and arrange US supply once the permit is issued.
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.
- COFEPRIS (Gobierno de Mexico): Caso de estudio 2, Permiso Sanitario de Importacion de Medicamentos destinados a Uso Personal (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.