Colombia and dried flower: why Decreto 1138/2025 reshapes the regional export map

Regulatory summary

Decreto 1138 de 2025 (Decree 1138 of 2025) introduces a structural change in Colombia's medical cannabis framework: for the first time it recognizes dried flower as a finished product, and not solely as raw material destined for industrial transformation. With that recognition, Colombia joins the group of jurisdictions that already admit dried flower within their regulated medical cannabis scheme, alongside Canada, Germany and Australia.

The practical scope of the rule is not exhausted by the decree itself. Its application depends on subsequent technical regulation by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA, Colombia's national medicines and food surveillance authority), with a drafting deadline extending to March 2026. Until that regulation is available, several of the decree's operational effects remain subject to administrative definition.

For regional actors evaluating export chains, the relevant point is not only the opening of a new product category, but the set of access conditions, the implementation timelines and the role the decree assigns to the health authority.

What Decreto 1138/2025 recognizes

The core of the decree is the classification of dried flower as a finished product within the medical cannabis regime. This distinction has concrete regulatory consequences: a finished product is governed by commercialization, traceability and quality control requirements different from those applicable to a transformation input.

Until this reform, the Colombian scheme had favored derivatives —extracts and preparations— as the main route for commercialization and export. The recognition of dried flower broadens the catalog of exportable products without necessarily requiring a prior industrial transformation stage, which removes a link in the chain for certain producer profiles.

The measure places Colombia in a position comparable to that of already consolidated markets. According to specialized coverage, the recognition of dried flower as a finished product aligns the Colombian framework with that of Canada, Germany and Australia, jurisdictions that admit this pharmaceutical form within their regulated medical cannabis systems.

INVIMA's deadline and the pending technical regulation

The decree is not self-executing in all of its effects. Its implementation is conditioned on the issuance of technical regulation by INVIMA, the health authority responsible for defining the specific conditions for the manufacture, control and surveillance of dried flower as a finished product.

The deadline for that regulation extends to March 2026. That time horizon is decisive for any planning: it defines the moment from which the category can operate fully under explicit technical rules, and it marks a transition period during which the detailed requirements are not yet settled.

A central component of that regulatory development is the Buenas Prácticas de Elaboración (BPE, Good Manufacturing Practices), whose compliance INVIMA is responsible for verifying. The BPE constitute the quality standard that an establishment must demonstrate in order to manufacture and release dried flower as a finished product destined for the regulated market, including export. The precise definition of these requirements for the new category is part of what is expected from the technical regulation in progress.

Exclusivity window for small and medium producers

One of the most discussed design elements of the decree is a two-year exclusivity window aimed at small and medium producers. The mechanism seeks to reserve, during that initial period, preferential access space for that productive segment before the general opening of the category.

From a regulatory perspective, a clause of this type fulfills two functions: it orders the entry of supply into the new dried flower market and establishes a prioritization criterion by producer size. Its concrete effect on export chains will depend on how INVIMA's technical regulation translates the principle into verifiable requirements —quotas, eligibility conditions and traceability of the benefited segment.

For regional operators, the two-year window introduces an additional calendar variable: the timing of entry into the Colombian dried flower market may be conditioned not only by the March 2026 regulation, but also by the validity and scope of this exclusivity period.

Integration with the SEED system and traceability

The decree is part of a framework that contemplates integration with the SEED system, a platform associated with the tracking and control of cannabis in Colombia. End-to-end traceability —from cultivation to the finished product— is a common condition in medical cannabis regimes with an export vocation, and the articulation of the new dried flower category with SEED points in that direction.

For an export chain, systematized traceability is not an accessory requirement: it is one of the elements that destination authorities tend to require in order to accept imported product under regulated schemes. The integration of dried flower with the national control system is, therefore, a relevant factor when evaluating the operational feasibility of exporting under the new framework.

The operational details of that integration for the finished-product category are part of the pending regulatory package. The exact registration conditions, the control points and the required documentation will be determined by INVIMA's technical regulation. Any figure or specific requirement not attributable to the available sources must be verified against the official text once published [VERIFICAR FUENTE].

Implications for the regional export map

The recognition of dried flower reorders Colombia's relative position against other producers in the region. By admitting a form of finished product that destination markets such as Canada, Germany and Australia already receive, the Colombian framework reduces regulatory friction for certain export flows and broadens the range of products that can be structured from origin.

This has implications for other producing countries in Latin America. Colombia's incorporation into the dried flower category raises the regional competitive standard and makes more visible the difference between frameworks that admit this pharmaceutical form and those that keep it restricted to transformation. Each jurisdiction's decision on this point becomes a factor of export positioning, not just an internal technical definition.

It is advisable to maintain a prudent reading of the timelines. The regulatory change has been adopted, but its full operation depends on the technical regulation due by March 2026 and on the validity of the two-year exclusivity window. Planning decisions should incorporate both milestones rather than assuming immediate availability of the category.

CannaTech supports companies and operators in reading comparative regulatory frameworks for medical cannabis and in translating regulatory changes like this one into verifiable operational requirements. Regulatory advisory makes it possible to anticipate implementation timelines, access conditions and traceability requirements before committing an export chain.

Sources

• Función Pública Colombia
• El Colombiano
• Revista Mate
• Publimetro