On April 11, 2022, through Resolution No. 781/2022, the Ministry of Health created the category of “Cannabis-based plant products and their derivatives intended for use and application in human medicine”, differentiating them from the existing category that includes products already regulated as medicine, medicinal specialty, according to the provisions of Decree No. 150/1992, and herbal medicine, according to Resolution of the Ministry of Health No. 1817/2013 and ANMAT provisions No. 5418/2015 and No. 5482/2015.
This is framed within Law No. 27,350, which regulates the medical and scientific research on the medicinal, therapeutic and/or pain palliative use of the cannabis plant and its derivatives, and its regulatory decree No. 883/2020, which has as one of its main objectives, the creation of the necessary conditions to guarantee the population’s access to products containing cannabis derivatives in their composition, through the issuance of operating rules and procedures that must take into account the quality of the same and its derivatives, intended for use and application in human medicine.
In fulfillment of this objective, the Ministry of Health considered the creation of this category to be of singular importance.
In this regard, Article 2 of the Resolution established that “Cannabis-based plant products and their derivatives intended for use and application in human medicine” shall be understood as any product with a clearly defined and verifiable qualitative-quantitative composition containing as Active Pharmaceutical Ingredient/s (hereinafter “API/s”) one or more cannabinoids derived from plant origin obtained in compliance with the requirements of good manufacturing practices.
It was also established that when cannabinoid APIs have percentages of Tetrahydrocannabinol (THC) higher than 0.3% w/w on a dry basis, considering the tetrahydrocannabinol acid (ATHC) that may be present, the regime corresponding to psychotropic substances will be applied to them. Whereas, cannabinoid APIs with THC percentages less than or equal to 0.3% w/w on a dry basis – considering the ATHC that may be present – will not be considered psychotropic substances.
The products that integrate the created category will be available in pharmacies for dispensing and the condition of sale will be established as “Sale Under Prescription” by virtue of the nature or dangerousness of their abuse. Accordingly, any type of advertising and/or the production, delivery and circulation of free samples, samples for professionals, samples without commercial value, or any other denomination of similar scope of the same is prohibited. In this sense, article 8º establishes that the prescribed dose, as well as the therapeutic indication and the route of administration, must be indicated in each case by the treating physician.
The activities destined to product authorization, elaboration, fractionation, prescription, dispensing, commercialization, deposit, import and export of such products in national jurisdiction and with destination to interjurisdictional transit are included in the terms of the Resolution. Such activities may only be carried out by duly authorized establishments that comply with the regulations in force and international standards.
The NATIONAL ADMINISTRATION OF MEDICINES, FOOD AND MEDICAL TECHNOLOGY (ANMAT) will be the application authority and will be in charge of issuing the complementary, clarifying and/or modifying procedural rules within the framework of its competences and necessary for the best implementation of the product category created. In addition, it may order the corresponding investigation of quality deviations and the withdrawal from the market of the products included in the created regime.
Finally, according to article 10, products based on Cannabidiol (CBD) or other cannabinoids registered in the Register of Medicinal Specialties (REM) of ANMAT are excluded from the scope of the Resolution.
This report should not be considered as legal or any other type of advice by Allende & Brea.
