On August 7, 2023, the Executive Branch issued a publication in the Official Gazette outlining the regulations specified in Law 27.669. This law establishes the framework for overseeing scientific research, industrial production, and the commercialization of the cannabis plant and its derivatives for medicinal and industrial purposes.

Establishment of the Regulatory Agency for the Cannabis and Medical Cannabis Industry (ARICCAME)

The Decree prominently outlines the operational guidelines of ARICCAME, the agency responsible for regulating the cannabis industry. ARICCAME's role includes overseeing scientific research, industrial production, and the commercialization of cannabis and its derivatives, as well as issuing licenses required for activities governed by the law.

Licensing System for Cultivation, Processing, and Marketing

The regulations introduce a licensing system for individuals and legal entities engaged in cultivating, processing, and marketing cannabis. These licenses will be granted by ARICCAME to entities that fulfill the prerequisites specified in the regulations. For instance, obtaining a cultivation license necessitates suitable land, equipment, and infrastructure, while a processing license requires a suitable processing plant, among other criteria.

Scientific Research Regulation

The Decree sets forth a regulatory framework for scientific research involving cannabis. Any research involving cannabis requires authorization from ARICCAME. Applicants seeking research authorization must present an approved research plan and maintain a quality control system, in addition to other requirements.

Patient Registry for Medicinal Cannabis

The regulations establish a patient registry for individuals using cannabis for medicinal purposes. Managed by ARICCAME, this registry mandates patients to submit a medical prescription and sworn statement. Those registered will be permitted access to medical cannabis products available in authorized pharmacies.

Public Consumption Restrictions

Public consumption of cannabis is strictly prohibited under the regulations. Consumption is only allowed in private spaces.

Enforcement and Sanctions

Non-compliance with the regulatory framework outlined for cannabis and medical hemp carries sanctions, as stipulated in Article 15 of the Decree. ARICCAME can initiate administrative investigations linked to licenses or authorizations and may temporarily suspend granted authorizations or licenses. Article 17 ensures that sanctions from Article 16 of Law 27.669 will be imposed by the Enforcement Authority before a thorough investigation, with guaranteed rights to defense.