On April 20, 2023, Resolution No. 767/2023 was published in the National Official Gazette, amending Resolution No. 781/2022 of the Ministry of Health, which 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 and herbal medicine.
This Resolution is issued within the scope of 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 access of the population to products containing cannabis derivatives in their composition, through the issuance of operational standards and procedures that must take into account the quality of the compsition and its derivatives, intended for use and application in human medicine.
Resolution No. 781/2022 defined “Cannabis-based herbal products and their derivatives intended for use and application in human medicine” as any product with a clearly defined and verifiable qualitative-quantitative composition containing as Active Pharmaceutical Ingredient(s) (hereinafter “API”) one or more cannabinoids derived from herbal origin obtained with the requirements of established good manufacturing practices. It 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 any ATHC that may be present – will not be considered psychotropic substances.
The modification to that Resolution, dealt with article 2 regarding the percentages of cannabinoid APIs in accordance with comparative law on the matter. Currently, according to Resolution No. 767/2023, cannabinoid APIs with THC percentages of less than 1% w/w on a dry basis are not considered psychotropic substances. In turn, other non-cannabinoid components may form part of the previously defined category.
Moreover, finished products with THC percentages less than or equal to 0.3% w/w on a dry basis – considering the ATHC that may be present, shall not be considered as psychotropic substances. On the other hand, above the level of 0.3% w/w on a dry basis – considering the ATHC that may be present, they will be considered as such. Likewise, other non-cannabinoid constituents derived from the cannabis plant may be included in this category.
The aim of the amendment is to generate an impact and produce a better access to the medicinal, therapeutic and/or palliative use of cannabis and its derivatives, understanding that the world’s regulations have already generated such modifications, to follow the advances of science in order to consolidate an efficient and quality public policy in the existing regulatory framework.
This report cannot be considered as legal or any other kind of advice by Allende & Brea.
