On 7 August 2023, Decree 405/2023 (“Decree“) was published to regulate Law No. 27,669 that states the regulatory framework for the development of the medicinal cannabis and industrial hemp industry. Further, the Decree: (i) regulates the chain of domestic production and commercialization and/or for export purposes of the cannabis plant, its seeds, and its derivative products for medicinal use, including scientific research and industrial use; and (ii) complements Law No. 27,350, which initially regulated the medical and scientific research of the medicinal use of the cannabis plant and its derivatives.
The Decree regulates the legal framework for the production and commercialization chain of the cannabis plant, its seeds, and its derivative products for human medicinal, veterinarian, nutritional, cosmetic, industrial, plant health, and fertility uses, including those uses arising from scientific research and technical and industrial development.
The Decree defines “Psychoactive Cannabis,” “Hemp,” “Industrial and/or Horticultural Hemp,” and “Cannabis Plant” while leaving the definition and regulation of “Derivative Products” to the Regulatory Agency of the Hemp and Medicinal Cannabis Industry (ARICCAME).
The regulation refers to the minimum criteria for the analysis of applications as well as the grounds for rejection and the sanctioning regime for infringements to the regulatory framework set forth in Law No. 27,669.
Meanwhile, ARICCAME is also appointed as the agency in charge of setting the general and particular conditions for the analysis of the different authorizations and licenses submitted, giving priority to legal entities that comply with the following requirements: (i) its capital stock must be totally or mostly of national origin; (ii) its registered office must match the jurisdiction in which the economic activity under application is carried out; (iii) 50% or more of the decision-making positions must be held by women or trans persons; and (iv) 50% or more of the jobs in the general staff must be held by women or trans persons.
Moreover, the “Single Window for the Hemp and Medicinal Cannabis Industry” system is established under the scope of ARICCAME for the management of the procedures related to the issuance of authorizations, licenses, and other certifications, as well as the procedures necessary to carry out the activities related to the growing, harvesting, storing, fractioning, processing, industrial production, transport and distribution, commercialization and any other economic activity within the productive chain of cannabis, the cannabis plant, the seeds of the cannabis plant and products derived for medicinal, nutritional, human cosmetic, veterinary or industrial purposes. The ARICCAME will regulate and control these activities in coordination with the ANMAT, SENASA, INASE, INTA, INTI, AFIP, ANLAP, and other public agencies with specific authority in this matter.
Finally, the Decree states that licenses and authorizations issued in accordance with this regulation may not be totally or partially transferable, transmissible, or assignable under any title, and their term in all cases shall not be less than five years.
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