Executive order No. 462/2025 (the “Order”) provides the dissolution of the Regulatory Agency for the Hemp and Medicinal Cannabis Industry (ARICCAME), with the aim of promoting the effective and efficient allocation of the resources of the National Government in pursuit of the public interest.
The executive order introduced a series of amendments and new definitions into Article 2 of Law No. 27,669 – Regulatory Framework for the Development of the Medicinal Cannabis and Industrial Hemp Industry. The regulation introduces new key categories to govern the production and use of cannabis and hemp. It defines “Flower” as the flowering or fruiting tops of Cannabis Sativa L., without resin extraction, excluding seeds and loose leaves; “Industrial Hemp Biomass” refers to the organic material harvested from hemp crops intended for grain and fiber, destined for the production of biocomposites; “Hemp for Flower” is defined as flowers containing less than 1% THC by dry weight, intended for medicinal use, while “Hemp Flower Biomass” refers to the plant material derived from such hemp flowers, also for medicinal purposes; “Cannabis for Flower” is defined as flowers with more than 1% THC by dry weight, likewise intended for medicinal use. Finally, “Cannabis Flower Biomass” refers to the organic plant material obtained from the cultivation of Cannabis Sativa L. flowers with a THC content exceeding 1% by dry weight, also for medicinal purposes. These definitions aim to clearly delineate the industrial and medicinal uses of cannabis and its derivatives.
The dissolution of ARICCAME also entails the transfer of all its powers and responsibilities to the relevant departments within the National Public Administration that hold specific competencies. Following this new amendment, the enforcement authorities of Law No. 27,669 are the National Administration of Drugs, Food and Medical Technology (ANMAT), the Secretariat of Industry and Commerce, and the Secretariat of Agriculture, Livestock and Fisheries.
ANMAT will be responsible for regulating cannabis-derived products intended for medicinal use, including flowers and biomass, from both hemp and cannabis.
The Secretariat of Industry and Trade, under the Ministry of Economy, will have jurisdiction over industrial hemp (excluding the flower) and its biomass, regulating its production, commercialization, import, and export.
Meanwhile, the Secretariat of Agriculture, Livestock and Fisheries, also under the Ministry of Economy, will be the competent authority regarding cannabis seeds. It will be responsible for establishing traceability standards and a special registration regime aimed at protecting the intellectual property of plant breeding innovations.
Individuals and legal entities may not commence their activities without prior authorization from the competent enforcement authorities. Any merger, assignment, or transfer of shares and/or business assets shall likewise require prior and express authorization issued by the competent regulatory authority.
The implementing regulations of the executive order must provide for different categories of administrative authorizations, based on objective criteria to be fulfilled by the applicant, in accordance with the various types of production models and activities to be undertaken.
When evaluating applications for operational authorization, the enforcement authorities must assess the specific characteristics of each project, the general and particular conditions of the market, the applicant’s experience in related activities, and the legal structure under which the applicant operates.
Finally, the executive order created the Federal Council for the Development of the Hemp and Medicinal Cannabis Industry. This Council shall be composed of two (2) representatives from the National Government and one (1) representative from each Province and from the Autonomous City of Buenos Aires (CABA).
