Importing medicines into Peru

The regulator

DIGEMID, the General Directorate of Medicines, Supplies and Drugs of the Ministry of Health, is Peru's national authority for pharmaceutical products. It registers medicines under Law 29459 and the regulation approved by Supreme Decree 016-2011-SA, and it grants the exceptional authorisations that let a product without sanitary registration into the country. Customs clearance is handled by SUNAT, which collects duty and sales tax at import.

Legal routes for unregistered medicines

Article 20 of the registration regulation, as amended by Supreme Decree 016-2013-SA, lets DIGEMID provisionally authorise the import and use of products without sanitary registration in defined cases: a declared urgency or emergency, research, training (medical devices only), individual prevention and treatment, and public health situations where need and non-availability are shown. DIGEMID can still check documents, test quality and suspend or cancel an authorisation.

Individual treatment, TUPA 118

This is the route for a named patient. DIGEMID's 2026 instructions say the patient files a sworn statement application, or a relative files it with a simple power of attorney, together with a medical justification and product report or a prescription that includes the diagnosis. The prescriber must be a physician, dentist or obstetrician entitled to prescribe in Peru. The request is filed through DIGEMID's virtual window, through the foreign trade single window (VUCE) for individuals with a tax number, or at DIGEMID's front desk.

DIGEMID's 2026 considerations add that the process takes one working day, that DIGEMID stamps and signs the prescription with a registration number instead of issuing a separate permit, that the quantity must match the prescribed treatment, and that only the person to whom the product is addressed may collect it. Medicines on lists IA and IB of Supreme Decree 023-2001-SA are prohibited, and psychotropics and narcotics are controlled separately.

Institutions, emergencies and research

Hospitals and public bodies rely on the emergency and public health cases in article 20. An emergency request includes the emergency declaration and a product list, and a public health request needs information backed by the National Health Authority. Investigational products are authorised once the trial approval is presented. DIGEMID's published step by step guidance found for this page covers only the individual route, so institutions should confirm the procedure with DIGEMID.

Registration changes in 2025

According to Salud y Fármacos, Peru's Congress passed a law in April 2025 that sets a 45-day maximum for DIGEMID registration decisions on certain products, including those for rare diseases and cancer. This may make registration a faster alternative to repeated exceptional imports, but confirm how it is applied.

Documents a buyer usually needs

• DIGEMID exceptional authorisation, given for individuals as a stamped prescription with a registration number
• Sworn statement application and, if someone else applies, a simple power of attorney from the patient
• Prescription or medical justification from a prescriber in Peru, including the diagnosis
• Report on the product: name, dosage form, active ingredient quantity, manufacturer and country
• Emergency declaration, public health support documents or trial approval for institutional requests
• Certificate of analysis, commercial invoice and packing list with matching names and quantities
• Air waybill and the customs declaration filed with SUNAT

Timeline: a worked example

A clinic in Lima is treating a patient who needs an orphan medicine made in India. The medicine has no Peruvian registration, and the patient files the DIGEMID request with the clinic's help.

Total: roughly 2 to 4 weeks from request to delivery. Institutional routes take longer and have no published service time. These are planning estimates.

Shipping lanes from India

There are no direct passenger flights from India to Peru, so freight to Lima (LIM) connects through a European hub, the United States or another Latin American hub, often with two connections. Express courier service is typically 5 to 9 days door to door, and air cargo with clearance is typically 8 to 15 days. These are typical estimates. The DIGEMID authorisation must travel with the shipment, and the name on the parcel must match the authorised patient or institution.

CIP and DAP to Lima are the usual terms for institutions, and FCA suits importers with their own forwarder. DDP is rarely practical because the authorisation holder must clear the goods.

Practical tips for buyers

• Obtain the DIGEMID stamp before freight is booked, and address the parcel exactly as named on the authorisation.
• Keep the quantity within the prescribed treatment period, since DIGEMID ties the authorisation to the prescription.
• SUNAT lists import duty at 0, 6 or 11 percent depending on the tariff line, plus 16 percent IGV and 2 percent municipal promotion tax. World Bank WITS data shows 6 percent on HS 300490 lines.
• Listed medicines for cancer, HIV and diabetes are exempt from IGV and duty under Law 27450 and Law 28553, using lists approved by supreme decree such as Supreme Decree 023-2016-SA. Check the current list with a customs agent.