Importing unregistered medicines into Latin America: Brazil, Mexico, Colombia and Peru

This guide covers four Latin American countries: Brazil, Mexico, Colombia and Peru. Each has a national regulator, ANVISA, COFEPRIS, INVIMA and DIGEMID, and each allows unregistered medicines only through an exceptional route that a local party must use before the goods leave India. The routes look similar on paper but differ in who applies, how fast the regulator answers and how much a patient can do alone.

This guide compares the four countries side by side. Each country guide, for Brazil, Mexico, Colombia and Peru, has the full detail, documents and sources.

The four routes at a glance

Brazil: hospital imports and personal imports

ANVISA's exceptional authorisation service page names RDC 488/2021 as the rule for a health unit importing an unregularised product for its own exclusive use. The hospital shows that no equivalent is available in Brazil, files the import licence and takes responsibility for monitoring use and adverse events. ANVISA's 2026 personal import manual adds an important line: if a hospital or health plan pays for a medicine imported in the patient's name, the hospital route applies.

Brazil is also the most open of the four for individuals. Under RDC 81/2008 a patient can import a non-controlled medicine for personal use with a prescription, acting as importer, buyer and payer, usually without prior ANVISA authorisation although the parcel is inspected. Controlled substances need prior authorisation, and some, such as thalidomide, cannot come in this way.

Other routes cover Ministry of Health programmes under RDC 203/2017, which requires WHO prequalification or registration in an ICH member country, court-ordered supply and clinical trials under RDC 945/2024.

Mexico: one permit, several modalities

COFEPRIS uses one instrument, the sanitary import permit under article 196, with a separate procedure code for each purpose. Its imports page lists the modalities, and its permit manual explains them:

• Special treatments (C). A hospital or clinic with a sanitary licence or operating notice applies, with the treating physician's professional licence, a justification letter and a technical letter on the product. The medicine may not be sold on in Mexico.
• Personal use (D). The patient applies with a prescription showing the prescriber's professional licence number.
• Donations (E). The receiving establishment applies with donation and acceptance letters.
• Research (A). The sponsor or site applies with the approved protocol.

Applications go through the foreign trade single window (VUCEM). The regulation gives COFEPRIS 10 working days for special treatment and donation permits, and permits are valid for 180 calendar days, extendable once. A permit for public sector supply created in December 2024 covers products authorised by reference regulators in 22 countries or by EMA, which does not appear to include India-only approvals.

Colombia: vital medicines not available

INVIMA keeps a list and procedure for vital medicines not available. Under Decree 481 of 2004, these are medicines that are indispensable and irreplaceable, not available in Colombia or not in sufficient quantity, not under clinical research and without a substitute on the market. While they keep that status they are exempt from sanitary registration.

There are three modalities. For a specific patient, the patient or any entity applies and names the authorised pharmaceutical establishment that will import, with a prescription and clinical summary signed by the treating physician. For a clinical emergency, INVIMA can authorise non-commercial quantities on a medical justification alone. For more than one patient, an authorised distributor applies with a free sale certificate or WHO-format product certificate and a certificate of analysis. The Ministry of Health's guidance says foreign certificates must be apostilled or legalised and officially translated, and commercial quantities carry a visible vital medicine sticker. Each specific patient authorisation covers one import, so long treatments need repeat requests.

Peru: exceptional authorisations from DIGEMID

Article 20 of Peru's registration regulation lets DIGEMID authorise products without registration for a declared emergency, research, individual prevention and treatment, and proven public health needs. The individual route, known as TUPA 118, is the clearest. DIGEMID's 2026 instructions say the patient, or a relative with a simple power of attorney, applies with a prescription from a prescriber entitled to practise in Peru that includes the diagnosis.

DIGEMID's 2026 considerations add that the process takes one working day, that DIGEMID stamps the prescription with a registration number instead of issuing a separate permit, that the quantity must match the prescribed treatment and that only the named person may collect the goods. Institutional, emergency and public health routes have no published step-by-step guidance, so hospitals should confirm the procedure with DIGEMID.

Documents that recur across the four

Each route has its own list, but the same core set appears again and again:

• the regulator's permit, licence, authorisation or stamped prescription, issued to the local party
• a prescription and medical justification from a locally registered physician
• the importing institution's licence or operating notice, where an institution applies
• a certificate of analysis for each batch, and evidence of registration and GMP in the country of origin
• a proforma invoice, commercial invoice and packing list with names and quantities matching the permit
• the air waybill and the customs entry filed by a local broker

The document checklist tool builds the list per country, and pharma export documents explained covers what each document proves.

Shipping from India and landed cost

There are no direct passenger flights from India to Brazil, Mexico, Colombia or Peru, so freight connects through the Gulf, Addis Ababa, Europe or the United States, and Lima often needs two connections. Typical door-to-door courier times are 5 to 9 days for Brazil, Colombia and Peru and 5 to 8 days for Mexico, with air cargo taking longer once clearance is included. Cold-chain products need passive packaging qualified for at least 96 to 120 hours depending on the lane, or active containers for larger lots. The cold-chain transit checker compares packaging time with each lane.

Taxes differ sharply. Receita Federal applies 0 percent import tax to medicines an individual imports for personal use by post or courier up to US$10,000. Mexico applies 0 percent VAT to patent medicines, and Colombia's tax authority treats medicines of heading 30.04 as VAT exempt. Peru's customs authority, SUNAT, lists duty of 0, 6 or 11 percent by tariff line plus 16 percent IGV and a 2 percent municipal tax, with exemptions for listed cancer, HIV and diabetes medicines. The landed cost calculator uses the rates in each country guide.

Step by step: a hospital import from India

1. Confirm the route with the hospital or importer, since a hospital, programme, patient and trial import each need a different filing.
2. Ask the supplier in India for product details, a proforma invoice, the certificate of analysis and registration and GMP evidence.
3. Prepare the prescription, justification and any translations or apostilles.
4. File with ANVISA, COFEPRIS, INVIMA or DIGEMID, or have the patient file where the route allows it.
5. Ship only after the permit, licence or stamp is issued, under CIP or DAP to the hospital or its broker. The Incoterms guide explains why DDP rarely works here.
6. Clear customs through a licensed broker and record the brand and batch at the hospital.

For timelines, the lead-time estimator combines the regulator time, export documents and transit for each country.