News on the Regulatory Framework for the Medicinal Cannabis and Industrial Hemp Industry

Regulatory Decree No. 405/2023, which regulates Law No. 27669 on the Regulatory Framework for the Medicinal Cannabis and Industrial Hemp Industry, was published in the Official Gazette on August 7, 2023. Within this regulatory framework, the Regulatory Agency of the Hemp and Medicinal Cannabis Industry (ARICCAME) issued Regulation No. 2/2023, to adapt permits to carry out the activities with Cannabis sativa L granted by competent authorities before the Regulatory Decree No. 405/2023 became effective.

 

1. What can Cannabis be used for?

 

Decree No. 405/2023 states that the uses of cannabis, its seeds, and derivatives are those involving human and animal medicine; those related to nutrition, cosmetics, industry, plant health and fertility; and those stemming from scientific research and technological and industrial development.

 

2. Functions of ARICCAME

 

Created through section 4 of Law No. 27669, ARICCAME is in charge of regulating, controlling, and issuing administrative authorizations to store, fragment, transport, distribute, trace, and use cannabis plant seeds, cannabis, and its derivatives for medicinal, nutritional, and/or cosmetic uses for human or industrial purposes.

 

3. Provisional Permit for carrying out activities with Cannabis sativa L

 

On September 27, ARICCAME issued Regulation No. 2/2023, creating a permit to adapt those authorizations to carry out activities with Cannabis sativa L granted by national and/or provincial authorities before the Regulatory Decree No. 405/2023 (the “Provisional Permit”) became effective.

 

The Provisional Permit can be requested by individuals or legal entities who had an authorization to carry out activities with Cannabis sativa L issued before the Regulatory Decree No. 405/2023 became effective. These activities are framed within:

 

• Research projects covered by Law No. 27350 (Medicinal Cannabis Law) [link Marval News], as amended by Law No. 27669, and approved by the Argentine Ministry of Health.
• Authorizations issued by the Argentine Seed Institute (INASE), the Argentine Agri-food Health and Quality Service (SENASA), or other federal agencies.
• Provincial regulations adhering to Law No. 27350 and/or adopting their own regulations for scientific research and medicinal and therapeutic use of cannabis and its derivatives.

 

The Provisional Permit will be valid for 12 months as of its notification to the applicant, or until the licenses and/or authorizations for the activities included in the Provisional Permit are granted.

 

Those who obtain the Provisional Permit and file before ARICCAME the new authorizations and/or licenses will have preferential treatment.

 

Finally, the Provisional Permit may be requested within six  months as of the date the ARICCAME Regulation No. 2/2023 becomes effective (i.e., September 27, 2023). Afterwards, those who have not obtained the Provisional Permit must request the new authorizations and/or licenses in Decree No. 405/2023—which have not been regulated yet—through the regular procedure.