In depth
The Resolution establishes the "Provisional Permit for the Development of Activities with Cannabis Sativa L." within the framework of sections 1 and 25 of Decree No. 405/2023, which regulates Law No. 27,669, to meet the requirements related to the development of research projects within the framework of Law No. 27,350 and complementary regulations, or to activities with Cannabis Sativa L. authorized by provincial legislations and/or for subjects in possession of permits and/or authorizations issued by national entities.
"Provisional Permit" is defined as the state authorization issued by ARICCAME for the performance of activities with Cannabis Sativa L. expressly authorized by ARICCAME in the particular resolution enacted for each case.
The Provisional Permit has a transitional nature, being granted for the term of 12 months counted from its notice to the applicant or until the licenses and/or authorizations related to the performance of the activities authorized by the Provisional Permit are granted.
The Provisional Permit may be requested by individuals or legal entities with an authorization issued before Decree No. 405/2023 entered into force for the development of activities with Cannabis Sativa L. within the framework of the following:
- Research projects covered by Law No. 27,350 that have been approved by resolution of the National Ministry of Health and that, as of the date of the Resolution, have complied with the required administrative instances.
- Authorizations issued by the National Seeds Institute ("Instituto Nacional de Semillas" or INASE), the National Agroalimentary Health and Quality Service ("Servicio Nacional de Sanidad y Calidad Agroalimentaria" or SENASA), or other national entities with specific competence.
- Provincial regulations that have adhered to Law No. 27,350 and/or have implemented their own regulatory regimes for scientific research and medicinal and therapeutic use of cannabis and its derivatives.
The adoption of the regime stated by the Resolution is voluntary and requires the submission of a particular application to ARICCAME.
The Provisional Permit may be totally or partially transferable, transmissible or assignable under any title and will only entitle its holder to carry out the activities expressly indicated by ARICCAME, the scope of which may not exceed that of the authorizations previously granted by the entities that have intervened within the framework of the regulations in force.
Holders of Provisional Permits must comply with certain periodic obligations while they are in force, including the submission of reports and attendance to inspections in relation to the activity carried out by the holder.
The Resolution states a preferential treatment for obtaining the licenses and/or authorizations provided by Decree No. 405/2023 for those who have obtained the Provisional Permit, which consists of the following:
- The possibility of adapting, during the term of the Provisional Permit, to the requirements stipulated by ARICCAME for the application for licenses and/or authorizations.
- Priority in the processing of licenses and/or authorizations.
- The monitoring of the execution of the project by ARICCAME during the term of the Provisional Permit, with the eventual directives that may be issued to facilitate the adaptation of the productive regime of Law No. 27,669.
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