Importing medicines into Colombia

The regulator

The National Institute for Food and Drug Surveillance (INVIMA) registers medicines in Colombia and authorises imports of medicines without sanitary registration. Its Specialised Medicines Room of the Review Commission decides which medicines count as vital medicines not available and keeps the official list. The Ministry of Health and Social Protection sets the rules and issues guidance to health insurers (EPS) and providers (IPS) on how these medicines reach patients.

Legal routes for unregistered medicines

Vital medicines not available, Decree 481 of 2004

Decree 481 of 2004 defines a vital medicine not available as one that is indispensable and irreplaceable to save a life or relieve a patient's suffering and that, because of low commercial return, is not available in Colombia or not in sufficient quantities. Article 4 adds three criteria: the medicine is not in clinical research, it is not marketed in Colombia or supply is insufficient, and it has no substitute on the market. Article 5 exempts these medicines from sanitary registration while they keep that status. A Ministry of Health guide to the process describes four steps: request, review, import and delivery to the patient.

Specific patient

Under article 8 the patient, or any public or private person or entity, can ask INVIMA for an import authorisation. The request names the pharmaceutical establishment that will import the medicine and includes the patient's identity, the generic active ingredient, and a prescription and clinical summary signed by the treating physician with the dose, duration, quantity and professional card number. The ministry guide adds the unique medicine identifier, a fuller clinical history with confirmatory tests and previous treatments, the health plan's authorisation letter to the importer, a pharmacovigilance report and scientific evidence. The authorisation is granted once and can be requested again as the prescription requires.

Clinical emergency and more than one patient

Article 9 lets INVIMA authorise non-commercial quantities for use only in clinical emergencies with a medical justification alone. Article 10 covers imports for more than one patient by an entity authorised to distribute medicines, with a free sale certificate or WHO-format product certificate, a certificate of legal existence and a certificate of analysis. The ministry guide says foreign certificates must be apostilled or legalised and officially translated. Labels may be accepted as they come from the country of origin, but commercial quantities need a visible medicamento vital sticker with the distributor's name.

Recent practice

A Ministry of Health circular of 29 July 2025 (Circular Externa 027) told every EPS to manage imports and purchases of vital medicines not available and to deliver prescribed treatments in full, according to a summary by G&D Consulting. In ruling T-298 of 2021, the Constitutional Court held that INVIMA must assess the specific patient's situation and ordered it to authorise a rare disease medicine for a child after a general denial.

Documents a buyer usually needs

• INVIMA import authorisation issued for the specific patient, emergency or multi-patient modality
• Prescription and clinical summary signed by the treating physician, with dose, duration, quantity and professional card number
• Patient identity document and, where a health plan pays, its authorisation letter to the importer
• Free sale certificate or WHO-format product certificate, apostilled or legalised and translated, for multi-patient imports
• Certificate of analysis for the batch and the importer's certificate of legal existence
• Proof of payment of the INVIMA fee
• Commercial invoice, packing list and air waybill naming the authorised importer

Timeline: a worked example

A hospital in Bogotá treats a patient with a rare disease who needs a medicine made in India. The medicine has no Colombian registration and no substitute, and the patient's health insurer pays.

Total: roughly 3 to 8 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 Colombia, so freight to Bogotá El Dorado (BOG) connects through a European hub, the Gulf or the United States. 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 consignee should be the authorised pharmaceutical establishment named in the INVIMA request, not the patient.

CIP and DAP to Bogotá are the usual terms, and FCA suits importers with their own forwarder. DDP is rarely practical because the Colombian importer holds the INVIMA authorisation and clears the goods.

Practical tips for buyers

• Confirm with the health insurer or hospital which importer will be named before the request goes to INVIMA, since the authorisation follows that importer.
• Keep the active ingredient, strength, quantity and patient details identical across the authorisation, prescription and invoice.
• Duty on HS 300490 ranges from 5 to 10 percent by tariff line in World Bank WITS data.
• DIAN states that since Law 2010 of 2019 medicines of heading 30.04 are exempt from VAT, meaning a 0 percent rate. Ask a Colombian customs agent to confirm the import treatment for each product.
• Each specific patient authorisation covers one import, so plan repeat requests early for long treatments.