New Law for the Production of Medicinal Cannabis and Industrial Hemp. New Product Category for Cannabis-Based Plant Products Intended for Medical Use

During the latest months of 2022, the administration provided a legal framework to the cannabis industry by issuing regulations related to cannabis and cannabis research. In that sense, National Ministry of Health (MoH) Regulation No. 781/2022, published in the Official Gazette on April 11^th, 2022, created the category of “Cannabis-based plant products and their derivatives intended for use and application in human medicine.”

 

 

On May 26^th, 2022, Law No. 27,669 on the Regulatory Framework for the Medicinal Cannabis and Industrial Hemp Industry was published on the Official Gazette (the “Law”).

 

We describe below the main aspects of each regulation:

 

 

1. Law No. 27,669: Regulatory Framework for the Development of the Medicinal Cannabis and Industrial Hemp Industry.

 

On July 15^th, 2021, the Senate approved the bill with amendments, by 56 positive votes, 5 negative, and 1 abstention and submitted it to the House of Representatives. On May 5^th 2022, the House of Representatives passed the bill with 155 positive votes, 56 negative and 19 abstentions.

 

On May 23^th, 2022, the Law was enacted by Decree No. 266/2022. Finally, on May 26^th, 2022, Decree No.266/2022 and the Law were published on the Official Gazette.

 

The Law creates a regulatory framework for the production, and national commercialization for export of cannabis plants, seeds, and its derived products for medicinal use, including scientific research, and industrial use; thus, promoting the development of the productive chain.

 

1.a. General provisions

 

The Law establishes a series of definitions for compliance purposes. For example, the term “cannabis” is defined, for the purpose of the Law, as “the flowering or fruit-bearing tops of the cannabis plant (except for the seeds and leaves not attached to the tops) of which the resin has not been extracted, whatever the name that designates them”.

 

The Law excludes the hemp, (industrial and/or horticultural hemp and derivatives), from the application of Law No. 23,737 on Drug Possession and Trafficking, (amendment to the Criminal Code).

 

 

1.b. Creation of the Regulatory Agency of the Hemp and Medicinal Cannabis Industry (“ARICCAME”).

 

The Law creates a new sanitary authority, the Regulatory Agency for the Hemp and Medicinal Cannabis Industry (“ARICCAME” as per Spanish acronym), within the Ministry of Productive Development, that must work in coordination with other state agencies and adopt all necessary measures to ensure the purposes and enforcement of the law.

 

Likewise, the ARICCAME will issue the administrative permits that will allow the import, export, cultivation, industrial production, manufacture, commercialization, and acquisition, of cannabis plant seeds, cannabis and its derivative products for medicinal or industrial purposes, in accordance with the respective regulations.

 

Regarding hemp, a differential regime will be established for issuing the authorizations related to industrial and/or horticultural hemp (not intended for medicinal use) and considering the characteristics of the corresponding industrial sector.

 

 

1.c. Other governmental authorities

 

The National Seed Institute (“INASE” per the Spanish acronym) must issue regulations to allow the traceability of plant products, and in conjunction with ARICCAME, must create a special exceptional and extraordinary registration plan so that seed owners can protect their phytogenic creations, through the registration.

 

ARICCAME must control and regulate the storage, fraction, transport, distribution, traceability and use of cannabis seeds, cannabis and derivatives in a coordinated manner with the Ministry of Productive Development, the Ministry of Health, Ministry of Security; Ministry of Environment; National Service of Agri-food Health and Quality Service (“SENASA” per the Spanish acronym), National Agency of Medicines, Food and Medical Technology (“ANMAT” per Spanish acronym); among others.

 

1.d. Sanction regime

 

The Law establishes a sanction regime with respect to infringements and the administrative sanctions applicable by ARICCAME in case of non-compliance.

 

Without prejudice to the corresponding criminal sanctions, non-compliance with the Law will entail administrative sanctions of (i) warning; (ii) fines, which will depend on the seriousness of the infraction, if it is a case of repeated offences, and other circumstances, established in Fixed Units (UF) equivalent to one (1) litre of fuel (minimum fine will be 100 UF and maximum 300,000 UF); (iii) suspension  or forfeiture of license to carry out the activity; (iv) expiration of the license due to lack compliance of the conditions established by the regulations; and (v) forfeiture of the license to operate within the terms and time established by the complementary regulations.

 

1.e. Complementary sections

 

The Law does not intend to replace the legislation currently in force, but to complement Law No. 27,350 on Medical and Scientific Research of the Medicinal Use of the Cannabis Plant and its Derivatives, its Regulatory Decree No. 883/2020 and other regulations. Consequently, the Law amends Section 6 of Law No. 27,350 to adjust the text and to incorporate ARICCAME into it.

 

The National Executive Branch shall issue the regulation to implement the Law within 180 days from the Official Gazette publication (section 26).

 

2. Ministry of Health Regulation No. 781/2022: Cannabis-based plant products

 

MoH Regulation No. 781/2022, published on April 11^th, 2022, in the Official Gazette, created a new category of "Cannabis-based plant products and derivatives intended for medical use and human medicine", that shall be differentiated from products already regulated as (i) medicine and medicinal specialty (Decree No. 150/1992), and (ii) herbal medicine (MoH Regulation No. 1,817/2013, ANMAT Provision No. 5418/2015 and No. 5,482/2015).

 

This new category would include all products for medical use that contain one or more cannabinoids derived from plant origin obtained as an active pharmaceutical ingredient(s) (API). If the product contains an API with higher percentages of certain cannabinoids (with higher psychoactive components), the psychotropic regime will apply to that product (section 2). Likewise, the product new category may include other non-cannabinoid components.

 

The activities destined to the authorization, elaboration, fractioning, prescription, sale, commercialization, deposit, import and export, in national jurisdiction and/or destined for the interjurisdictional transit of this type of product may only be carried out in duly authorized establishments. authorized by the National Administration of Medicines and Medical Technology (“ANMAT”) (section 4, 5, and 6).

 

The Regulation regulates activities and issues related to the condition of sale, advertising, and samples without commercial value of said products, among others.

 

 

3. Closing remarks

 

The Argentine Executive will determine the specific terms and conditions of the Law and the mechanisms for its implementation.

 

It would be reasonable to expect the authorities to regulate, and issue further cannabis complementary regulation any time soon.