Allende & Brea – Estudio Jurídico

This report cannot be considered as legal or any other kind of advice by Allende & Brea. For any questions, do not hesitate to contact us.

Approval of the “Provisional Permit to carry out activities with Cannabis Sativa L”

Aprobación del “Permiso Provisorio para la realización de actividades con Cannabis Sativa L.”

Through Resolution No. 2/2023 published in the Official Gazette of the Nation (the “Resolution”), the Regulatory Agency of the Industrial Hemp and Medical Cannabis Industry (the “Agency”) approved the “Provisional Permit for the performance of activities with Cannabis Sativa L”, in order to adapt the authorizations issued for medical and scientific research projects framed in Law No. 27,350, the activities enabled by provincial legislations and/or for subjects that have permits and/or authorizations issued by national agencies.

The Agency was created as an enforcement authority by Law No. 27669, which established the Regulatory Framework for the development of the medical cannabis and hemp industry. It is the competent body to regulate, control and issue administrative authorizations with respect to the use of cannabis plant seeds, cannabis, and its derivative products.

Article 1 of Decree No. 405/2023, which regulates Law No. 27669, sets forth that the crops and projects that had 1. the approval granted within the medical and scientific framework of Law No. 27350, 2. provincial regulations and/or 3. authorizations issued by national agencies, which intend to modify their object to the production and national commercialization and/or for export purposes of the cannabis plant, its seeds, and derived products for medicinal and industrial use and which exceed the framework of Law No. 27350, had to adjust their authorizations and licenses by means of a simplified procedure.

In this respect, all individuals or entities that had authorizations issued by the National Ministry of Health in accordance with the provisions of Law No. 27350 and its regulatory decree, by the National Seed Institute (“INASE”), or by the National Agri-Food Health and Quality Service (“SENASA”) for the production, cultivation, possession, storage, transport, and/or commercialization of seeds of the cannabis plant, cannabis, and its derivative products for medicinal purposes may submit an application to the Agency requesting to be incorporated within the regulatory framework of Law No. 27669 and its regulations.

In this sense, through the Resolution and its Annex I, the Agency established the scope, form, and conditions of the special regime for the adaptation of projects provided for in the Regulatory Decree of Law No. 27669.

The adaptation regime shall be implemented through the granting of Provisional Permits, which shall be valid for 12 (twelve) months as from the notification to the applicant or until the licenses and/or authorizations under Law No. 27669 are granted. The application for licenses and/or authorizations under Law No. 27669 shall be made through a separate procedure, in which holders of Provisional Permits shall have preferential treatment.

The Resolution covers all individuals or entities who hold the following authorizations issued prior to the entry into force of Decree No. 405/23 (i.e., prior to August 7, 2023), for the performance of activities with Cannabis sativa L.:

  1. Research projects under Law No. 27350, its regulatory decree, and complementary regulations, which have been approved by the National Ministry of Health and which, as of the date of the Resolution, have completed the required administrative stages.
  2. Authorizations issued by INASE, SENASA or other national agencies with specific competence.
  3. Provincial regulations that have adhered to Law No. 27350 and/or that have instituted their own regulatory regimes for scientific research and medicinal and therapeutic use of cannabis and its derivatives.

Finally, the Resolution sets forth the documents and information that applicants must submit to complete the procedure and the obligations to which they are subject.

The procedure must be initiated at the front desk of the National Ministry of Economy or through the “Trámites a Distancia” (TAD) platform, paying a fee of 180,000 ARS (one hundred and eighty thousand Argentine pesos) pertaining to the expenses related to the management, the procedures for validation of the documentation, and any other administrative costs.

Applicants may benefit from the simplified procedure for a period of 6 (six) months as from its entry into force. After the 6 months period, applicants interested in adapting their authorizations to carry out activities with Cannabis Sativa L. according to Law No. 27,669, will have to follow the ordinary procedure.

This report cannot be considered as legal or any other kind of advice by Allende & Brea. For any questions, do not hesitate to contact us.

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