Regulatory Framework for the Development of the Medicinal Cannabis and Industrial Hemp Industry

On May 26, 2022, Law 27,669 was published in the official gazette, modifying Law 27,350 published in 2017. This law aims to establish a regulatory framework for the national production and marketing of the cannabis plant.

That is why the Regulatory Agency for the Hemp and Medical Cannabis Industry (ARICCAME) was created as a decentralized body that will function within the scope of the Ministry of Productive Development. It will oversee the regulation and supervision of the productive activity of the cannabis industry, its commercialization and distribution, for medicinal and industrial use in the national territory, in everything related to the registration, control and traceability of seeds, critical supplies and products. derivatives of cannabis, within the framework of an industrial process duly authorized and enabled under the terms of this law and the regulations.

Also, the Federal Council for the Development of the Hemp and Medicinal Cannabis Industry has been created. The functions of the Council are to suggest criteria for the distribution and granting of authorizations at the federal level and to pronounce on their granting in a technical report, the issuance of which will be an essential requirement for the validity of the administrative act for the issuance of authorizations and/or licenses, under the conditions of the regulation; Recommend to the Regulatory Agency for the Hemp and Medicinal Cannabis Industry (ARICCAME) policies aimed at a harmonious development of the industry in each region; Submit to the Regulatory Agency for the Hemp and Medicinal Cannabis Industry (ARICCAME) proposals and studies aimed at improving its work plan based on the national diagnosis reached at the plenary meetings of the Council; Prepare studies and diagnoses in relation to the problems that arise from the application of the law and submit to the Regulatory Agency for the Hemp and Medicinal Cannabis Industry (ARICCAME) proposals designed to improve its work plan, among others.

The Regulatory Agency for the Hemp and Medicinal Cannabis Industry (ARICCAME) will oversee issuing the administrative authorizations that allow the import, export, cultivation, industrial production, manufacture, marketing, and acquisition, by any title, of seeds from the cannabis plant. cannabis, cannabis, and its derivative products for medicinal or industrial purposes. The regulation must contemplate different categories of administrative authorizations based on objective criteria that must be fulfilled by the petitioner, linked to the various productive modalities and the activities to be developed. These components are divided into two:

1) Administrative component: objective evaluation, control and technical and legal monitoring of the parameters required for the granting of authorizations or of those parameters on which the granting was carried out, under the conditions provided for in the regulations.
2) Operational component: monitoring and evaluation activities that are required for the verification of the technical and legal parameters mentioned in the administrative component and whose compliance must be carried out at the operational level as a condition related to the maintenance of the authorization, under the conditions provided in the regulation.
Article 15 of this law establishes that in the event of an infraction, the corresponding administrative sanctions will be given without prejudice to the corresponding criminal sanctions in the event of public action crimes, in accordance with the provisions of articles 204, 204 bis, 204 ter , 204 quater, 204 quinquies and concordant of the Penal Code of the Argentine Nation.
These sanctions will be applied by the Regulatory Agency of the Hemp and Medicinal Cannabis Industry (ARICCAME) after instruction of a summary, which will be substantiated in accordance with the administrative procedure that is timely established by regulation, in which the right will be guaranteed. of defense of the presumed infringers or the presumed infringers.

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