Medical cannabis: Paraguay eyes opportunity in the US
Diego Barros, CCO of Pharma Industries, analyzes Paraguay's regulations and the impact of the new hemp definition in the US. Read more.
Paraguay is experiencing a moment of regulatory maturation in the medical cannabis sector. Since December 2025, new resolutions have expanded medical prescriptions and allowed the commercialization of cannabis-derived products without requiring individual sanitary registration per product.
Regulatory progress in Paraguay
According to Diego Barros, CCO of Pharma Industries S.A., the country has begun offering a more favorable environment for companies interested in the production and commercialization of cannabis derivatives.
“Paraguay is experiencing a moment of regulatory maturation in the medical cannabis sector. Since December 2025, Resolutions No. 488/2025 (DINAVISA) and No. 902/25 (Ministry of Health) expanded medical prescriptions — today any specialty can prescribe — and allowed the commercialization of cannabis-derived products without requiring individual sanitary registration per product, both for local sale and export.”
The new regulatory scenario encompasses local sales and export operations. The change expands the space for companies intending to develop plant-derived products in Paraguay.
The country also has licensed companies operating in the segment, including Pharma Industries S.A., considered one of the pioneers of the Paraguayan sector.
“The country currently has 12 licensed companies operating in the segment, including Pharma Industries S.A., one of the pioneers of the sector in Paraguay.”
Exports still face obstacles
Despite the evolution of rules, the absence of a specific THC limit for export remains a point of concern for the sector. The existence of a favorable regulatory framework has not been sufficient to clear shipments of higher-concentration products.
“Despite regulatory progress, Paraguayan legislation does not establish a specific THC limit for export purposes — which, in practice, has not been sufficient to unlock shipments of higher-concentration products.”
The issue shows that authorization for production and commercialization in Paraguay alone does not solve requirements related to product exports. Operational and administrative challenges continue to influence the export flow.
Regulatory change in the United States
The Paraguayan scenario gains relevance in light of a regulatory change in the United States. Starting November 12, 2026, a new federal definition of hemp will limit total THC content to 0.4 milligrams per package.
The measure is expected to remove about 95% of currently available psychoactive hemp products from the US market. The change was enacted in November 2025 and is separate from the recent rescheduling of medical marijuana from Schedule I to Schedule III.
The rescheduling of medical marijuana does not alter the new federal THC limit established for hemp products.
Interest in the white-label model
With a portion of domestic US supply becoming ineligible, sector companies are evaluating manufacturing alternatives outside the United States. In this context, Paraguay emerges as a possibility for businesses interested in production under the white-label model.
“With a significant portion of domestic US supply becoming ineligible, interest in manufacturing alternatives outside the United States is growing. In this context, Paraguay — with a legal framework already favorable to the export of derivatives — stands out as an option for companies seeking production under the white-label model, provided that the operational and administrative challenges regarding product output are resolved.”
The white-label model allows a company to build its operation with products manufactured by another company, marketing them under its own brand. In Paraguay's case, the opportunity is linked to the regulatory framework focused on cannabis derivatives and the possibility of serving companies interested in producing outside the United States.
The consolidation of this movement, however, depends on solving export-related hurdles. For the sector, Paraguay has the regulatory conditions to attract new businesses, but still needs to overcome administrative and operational challenges that hinder shipments of products with higher THC concentrations.