Getting a US-approved medicine in Peru: the legal route, documents and timing
A sourced guide for patients, families and doctors in Peru, checked against DIGEMID 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 Peru, DIGEMID issues an exceptional authorization to import and use pharmaceutical products for individual prevention and treatment (procedure TUPA 118). The patient, or someone with a simple power of attorney, files online with a sworn application and a medical justification or prescription from a licensed prescriber. Corrections must be made within 48 hours.
- Regulator: Direccion General de Medicamentos, Insumos y Drogas (DIGEMID).
- Main route: Autorizacion Excepcional para la Importacion y Uso, tratamiento individual (TUPA 118).
- Who applies: The patient, a holder of a simple power of attorney, or parents for a minor.
- Price: Quote on request.
Who regulates medicines in Peru
DIGEMID, part of Peru's Ministry of Health, regulates pharmaceutical products. Its exceptional import authorization applies only to individual prevention and treatment cases, based on Article 20 of Supreme Decree 016-2011-SA.[1]
The legal route for a medicine that is not registered in Peru
The authorization is tied to one patient. If the person filing is not the patient, the patient gives a simple power of attorney (carta poder simple). For a minor, the parents or guardian file and attach proof of that status.[1]
Filing is online only, through DIGEMID's Ventanilla Virtual web application, Monday to Friday from 8:00 to 16:30. Holders of a natural person's tax number (RUC) file through VUCE instead. We give you a written timeline estimate for your case before you commit.[1]
Documents you will usually need
DIGEMID's 2026 instructions list:[1]
- A sworn application (Solicitud Declaracion Jurada) with the patient's data
- A medical justification and a report on the product's characteristics from a licensed prescriber (a physician, dental surgeon or obstetrician), and/or a prescription that includes the diagnosis and is clear and legible
- A simple power of attorney if someone other than the patient files
- For minors, proof of parental or guardian status
Timing, quantities and fees
DIGEMID's instructions do not give an overall decision time. They do say that any observations must be corrected within 48 hours, by email to the declared address, so the family should be ready to answer quickly.[1]
How a US-approved medicine reaches a patient in Peru
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 Peru the patient or their authorised representative files online with DIGEMID. We help the treating doctor prepare a clear medical justification and product report, and ship from the US through our wholesale partner once the authorization is issued.
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 Peru. 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 Peru
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 Peru import a medicine for their own treatment?
Yes, with DIGEMID's exceptional authorization for individual prevention and treatment (TUPA 118), filed online with a sworn application and a medical justification or prescription.
How fast must we answer DIGEMID's questions?
Within 48 hours. DIGEMID sends observations to the email declared in the application.
Can someone else file for the patient?
Yes, with a simple power of attorney from the patient. For minors, the parents or guardian file.
Does Reserve Meds apply to the regulator for us?
No. In Peru the patient, or a person with the patient's simple power of attorney, files online with DIGEMID. We help prepare the documents and arrange US supply once DIGEMID authorizes the import.
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.
- DIGEMID Peru: Instructivo 2026, Autorizacion Excepcional para la Importacion y Uso de Productos Farmaceuticos para tratamiento individual (TUPA 118) (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.