At Affirma Law, our INVIMA lawyers in Colombia advise local and foreign companies on obtaining sanitary registrations and represent them in sanction proceedings before INVIMA, the departmental and municipal health authorities (Secretarías de Salud) and the ICA (Colombian Agricultural Institute). The stakes are high: a sanitary proceeding can end in a warning, successive fines of up to the equivalent of 10,000 legal monthly minimum wages, the seizure of products, the suspension or cancellation of the sanitary registration or license, and the temporary or permanent closure of the establishment or factory (Article 577 of Law 9 of 1979, as amended by Article 98 of Decree-Law 2106 of 2019). Since 2024 that fine ceiling is calculated in Basic Value Units (UVB) under Article 313 of Law 2294 of 2023, which in 2026 puts the maximum above COP 14 billion. Once a fine is final, INVIMA can enforce it through coactive collection (cobro coactivo), an administrative procedure that allows the authority to seize bank accounts and assets without filing a lawsuit.
We are a law firm specialized in INVIMA matters and in sanitary and regulatory law. We manage sanitary registrations in Colombia for food, medicines, phytotherapeutic products, dietary supplements, cosmetics, alcoholic beverages and medical devices, among others. Depending on the product and its risk level, the authorization may be a sanitary registration, a sanitary permit or a sanitary notification, and each one has its own requirements. If you are a foreign manufacturer or exporter, we act as your legal team in Colombia: we confirm how your product is classified, prepare and file the application under a power of attorney, answer INVIMA's requests and coordinate with your Colombian importer so the product can clear customs and reach the market. If you are also structuring your entry into the country, see our guide on investing in Colombia as a foreign company.
We also defend companies in INVIMA sanction proceedings at both stages. In the administrative stage, we act before INVIMA's Directorate of Sanitary Responsibility (Dirección de Responsabilidad Sanitaria), the office that investigates and decides whether sanitary rules were breached: we answer the statement of charges, request and contest evidence and file the appeals available against the decision. If the sanction stands, we take the case to the contentious-administrative courts, where an administrative judge decides whether the authority acted lawfully within the sanction proceeding.
As specialists, we study each case before acting. We review the product, the file and the applicable regulation, and based on that analysis we define the steps so your registration or your defense moves forward without avoidable setbacks. The terms to respond in a sanction proceeding are short, so the earlier we review your case, the more options you have. Our team assists clients in English: book a consultation with our INVIMA lawyers or write to us on WhatsApp at .
INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) is Colombia's national food and drug surveillance authority. It issues the sanitary registrations required to manufacture, import or sell food, medicines, cosmetics, medical devices and other products for human use, inspects the companies that make and sell them, and sanctions those that breach sanitary rules.
Most mass-consumption products for human or veterinary use are monitored by a state authority in each country. In Colombia, INVIMA is responsible for enforcing sanitary rules on products for human consumption or use, while the ICA (Instituto Colombiano Agropecuario) is responsible for veterinary products.
INVIMA was created by Article 245 of Law 100 of 1993 as a national public establishment attached to the Ministry of Health and Social Protection, and its current structure is set out in Decree 2078 of 2012. It inspects, monitors and controls the establishments that produce and sell the products referred to in that article, and it is the authority that grants sanitary registrations for food, dietary supplements, phytotherapeutic products, medicines, cosmetics, alcoholic beverages, medical instruments and devices, among others.
INVIMA also has sanctioning powers, which it exercises through its Directorate of Sanitary Responsibility, the office that determines whether a company breached sanitary regulations. For that reason, owners of companies that produce or sell products for human use should follow any proceeding closely from the first notice and get advice from lawyers with experience in INVIMA matters and sanitary law.
Under Law 9 of 1979 (the National Sanitary Code) and Decree 677 of 1995, INVIMA can also take sanitary security measures, from the seizure, destruction or sealing of goods to the closure of the establishments or factories where the products are made or sold. These measures are preventive and can be applied before any sanction is imposed, so the first days after an inspection are often decisive for your defense.
At Affirma Law, we provide legal counsel and representation in sanitary and regulatory law across the region. If your company operates in the United States, Panama or Peru, we work with allied law firms in those countries, which allows us to coordinate your regulatory strategy beyond Colombia.
Facing an INVIMA inspection, a seized product or a registration that will not move forward? Contact our regulatory team and get a legal strategy from lawyers who know INVIMA. Schedule your consultation in English through our WhatsApp, , or explore our practice areas.
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