Colombia's Ministry of Health and Social Protection (MinSalud) published, on July 21, 2026, a draft Resolution establishing national measures to monitor and manage the supply of medicines and medical devices. The official consultation PDF would create a Sistema de Monitoreo de Abastecimiento de Tecnologias en Salud and bind marketing-authorisation holders (MAHs), importers, wholesalers, logistics operators, insurers and providers to structured stock and disruption reporting.
The text remains a Proyecto de Resolucion under public consultation (calendar fields are still placeholders), so no entry-into-force date is fixed. The perimeter is already clear: the full physical distribution chain for chemical-synthesis medicines, medicinal gases, biologics, radiopharmaceuticals and medical devices (including IVD reagents under Resolucion 184 of 2024) would sit inside one monitoring architecture, with INVIMA, SuperSalud, DIAN and departmental health secretariats as government nodes.
What does the draft Resolution change for supply-chain actors?
It would replace ad-hoc shortage communications with a formal national monitoring system under Article 4, powered by interoperable, timely and verifiable data that MinSalud must host (Article 4, paragraph 1, timed to Article 19 numeral 1). Early-warning alerts and prevention or mitigation actions against scarcity and desabastecimiento become explicit ministerial tools.
Availability is classified into five states under Article 3: not in shortage; at risk of shortage (supply may become insufficient within 3 to 6 months); in shortage; discontinued (no demand, or INVIMA sanitary alert removal); and not available at department or municipality level despite national supply. The draft sits on Ley 1438 of 2011 (articles 4, 86, 90, 114, 130 and 131), Ley 1751 of 2015 (articles 2 and 5), Decreto 120 of 2026 and Constitutional Court Auto 1282 of 2025, which ordered a unified public supply-monitoring platform.
Who must report, and what data is required?
Article 2 applies the Resolution to MAHs and importers of medicines and devices (including vital-no-disponible imports), wholesale distributors, Entidades Administradoras de Planes de Beneficios de Salud (EAPB), special- and exception-regime entities and their networks (including USPEC), Instituciones Prestadoras de Servicios de Salud (IPS) with authorised pharmaceutical services, pharmaceutical managers and logistics operators, health secretariats, INVIMA, DIAN, SuperSalud, Superindustria, and other distribution-chain actors.
Under Article 7.1.1, MAHs, commercialisation-authorisation holders and importers must report units available for sale in Colombia and units distributed; force-majeure events that interrupt production or distribution; temporary non-commercialisation filings; and any exceptional data MinSalud requests. They must correct inconsistencies flagged by MinSalud, use the ministerial tools once deployed, attend collaboration convocations, inform distributors of portfolio interruptions, guarantee product traceability, and adjust production or import volumes to demand.
Wholesalers and logistics operators face a parallel reporting duty under Article 7.1.2. EAPB, special-regime entities, USPEC, IPS with pharmaceutical services and gestores farmaceuticos must report incidents that impair access, implement procedures for immediate and complete delivery (or the exceptional 48-hour home or workplace delivery mechanism under Decreto Ley 019 of 2012 article 131), and articulate prescription and dispensing with MinSalud tools (Article 7.1.3). Economic agents that supply health technologies financed with public resources must meet the information, transparency and continuity duties of Article 6 for those contracts, even if they are not formal SGSSS members.
| Actor group | Core duty under the draft | Primary government counterpart |
|---|---|---|
| MAHs and importers | Report stock, distributions, interruptions and non-commercialisation; ensure traceability | MinSalud; INVIMA |
| Wholesalers and logistics operators | Report portfolio availability and distribution disruptions | MinSalud |
| EAPB, IPS, gestores farmaceuticos | Report access incidents; ensure immediate or exceptional complete delivery | MinSalud; SuperSalud |
| Public-financed supply contractors | Information, transparency and continuity duties for public-funded supply | MinSalud; SuperSalud |
How would SuperSalud and INVIMA use the system?
SuperSalud must collect user-access and incomplete-delivery problems, track overdue receivables financed with public funds that could interrupt supply, and feed both streams into the ministerial tool (Article 7.2.1). Where contractual arrears threaten continuity, SuperSalud may convene mandatory preventive dialogue with supervised health-sector actors and linked economic agents, require contractual and supply-impact information, and report commitments to MinSalud. Unjustified non-attendance or refusal to provide public-resource information may be referred onwards.
INVIMA must track compliance with sanitary reporting by its supervised entities and apply applicable sanitary sanctions or measures, then supply information MinSalud needs for sector policy (Article 7.2.2). Failure to report information requested by MinSalud or SuperSalud remains a conduct that violates the health system under Ley 1438 of 2011 articles 130 and 131, which already attach fines.
What should compliance teams do while the consultation is open?
Map every Colombian SKU (medicines, medicinal gases, biologics, radiopharmaceuticals and devices, including IVD reagents) to the actor roles in Article 2 and identify who owns unit-available and unit-distributed data. Stress-test whether ERP and distributor feeds can produce timely national stock and disruption reports once MinSalud publishes the tool timeline under Article 19. Review public-financed buyer contracts for overdue-receivable exposure that could trigger SuperSalud dialogue, align temporary non-commercialisation and vital-no-disponible processes with the new reports, and file consultation comments on the draft PDF before the ministry closes the window.
Continuous, per-jurisdiction real-time monitoring surfaces this class of Colombian health-technology act as soon as MinSalud publishes the next consultation or final text.
Take advantage of this real-time watch
Next steps: confirm which legal entities in your group are MAHs, importers, wholesalers, logistics operators, EAPB or IPS in Colombia; assign ownership of stock and disruption reporting; and brief regulatory affairs, supply chain and public-payer teams before the Resolution is signed. Obsidian keeps the consultation track and any final Diario Oficial publication in one place.
