On August 7, 2023, Decree 405/2023 (the “Decree”) was published in the Official Gazette and entered into force, approving the regulation of Law No. 27,669 (the “Regulation”), which created the regulatory framework for the national production and commercialization for export of the cannabis plant, its seeds and derived products for medicinal use, including scientific research and industrial use, promoting the development of the production chain.
The Regulation stands out for the following aspects:
- The functions, organizational structure and assets granted to the Hemp and Medical Cannabis Industry Regulatory Agency.
- The creation of a Federal Council for the Development of the Industry.
- The creation of the “Single Window for the Hemp and Medical Cannabis Industry” system, through which the procedures related to the issuance of authorizations, licenses and other certifications and/or formalities necessary to carry out the operations related to Law 27,669 will be managed.
- It details the types of licenses and authorizations and establishes the procedure for the evaluation of applications for licenses and authorizations and the obligations of the persons holding the license and/or authorization.
- It establishes a sanctioning regime.
The Regulation establishes that persons who, as of the date of the Regulation, have authorization issued by the Ministry of Health on medicinal use of the cannabis plant under the terms of Law 27,350 may submit a request for adaptation to be incorporated into the regulatory framework of Law 27,669.