Importing medicines into Mexico

The regulator

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) regulates medicines in Mexico under the General Health Law and the Health Supplies Regulation (Reglamento de Insumos para la Salud). Article 131 of that regulation requires a sanitary registration before a medicine is imported for sale, as shown in the 2008 amending decree. Import permits are filed online through the foreign trade single window (VUCEM) with an advanced electronic signature, and COFEPRIS lists the permit modalities for medicines without registration on its import page. Narcotic and psychotropic medicines follow separate permits.

Legal routes for unregistered medicines

COFEPRIS's permit manual explains that article 196 of the Health Supplies Regulation allows a permit to import medicines without Mexican registration for research, laboratory tests, contract manufacturing, special treatments of low incidence diseases with social impact, personal use or donation. Each purpose has its own procedure code, from COFEPRIS-01-010-A to F.

Special treatments, the hospital route

Modality C is for public or private institutions that hold a sanitary licence or operating notice. The application includes the treating physician's professional licence (cédula), a letter from the importer explaining the destination and justifying the import, and a technical letter on the product. The medicine may not be sold or distributed in Mexico, since that requires recognition as an orphan medicine. The General Health Law defines orphan medicines as those for rare diseases affecting no more than 5 people in 10,000.

Personal use and donations

Modality D covers personal use. It needs a valid prescription that shows the prescriber's professional licence number and covers the product and quantity, according to a state procedure listing that gives a maximum of 10 working days and no fee. Modality E covers donations and needs a donation letter and an acceptance letter from the receiving health establishment with a commitment not to sell the goods.

Public sector supply and research

An agreement published on 4 December 2024 created an import permit for public sector supply (COFEPRIS-01-009-C) for medicines authorised by reference regulators in 22 countries or by the European Medicines Agency, for consolidated purchases by bodies such as IMSS, ISSSTE and IMSS-Bienestar. Registration must begin within 10 working days of the first import, and a product approved only in India does not appear to qualify. Research imports use modality A with the approved protocol, and COFEPRIS's modality A guide says the importer must be domiciled in Mexico and use a licensed customs broker.

Validity and timing

The manual states that article 196 sets 10 working days to answer special treatment and donation requests. Under article 160, permits are valid for 180 calendar days and can be extended once for the same period if conditions do not change. COFEPRIS can issue one request for missing information, and the file is rejected if the reply is late or incomplete.

Documents a buyer usually needs

• COFEPRIS sanitary import permit for the correct modality, issued to the Mexican importer or patient
• Prescription with the prescriber's professional licence number, or the treating physician's licence for special treatments
• Importer letter on destination and justification, and a technical letter on the product
• Sanitary licence or operating notice of the importing institution
• Donation and acceptance letters for donated goods
• Certificate of analysis for each batch, commercial invoice and packing list
• Air waybill and the customs entry (pedimento) filed by a licensed customs broker

Timeline: a worked example

A private hospital in Mexico City needs a medicine for a rare disease that has no Mexican registration. The medicine is made in India.

Total: roughly 4 to 7 weeks from request to delivery. These are planning estimates, not published service times.

Shipping lanes from India

There are no direct passenger flights from India to Mexico, so freight to Mexico City connects through a European hub, the Gulf or the United States. Express courier service is typically 5 to 8 days door to door, and air cargo with clearance is typically 7 to 14 days. These are typical estimates. The importer of record clears the goods through a licensed customs broker, who files the customs entry and presents the COFEPRIS permit.

CIP and DAP to the hospital or its broker are the usual terms, and FCA suits importers with their own forwarder. DDP is rarely practical because the Mexican permit holder must be the importer.

Practical tips for buyers

• Choose the permit modality before freight is booked. A special treatment permit cannot be used to resell the medicine.
• Keep the product name, strength, pack size and quantity identical across the permit, invoice, packing list and air waybill, and ship within the 180 day validity.
• Duty on HS 300490 ranges from 0 to 15 percent by tariff line, averaging about 1.5 percent, in World Bank WITS data. From 1 January 2026 Mexico raised duties on 1,463 tariff lines for goods from countries without a trade agreement with Mexico, a group that includes India. Whether any medicine lines are affected was not confirmed, so ask a customs broker.
• Patent medicines carry 0 percent VAT under article 2-A of the VAT law, and imports of goods taxed at 0 percent are not charged VAT. Confirm with a broker that an unregistered product is treated the same way.