APRIL 13, 2022

Resolution No. 781/2022: New product category – Regulation on the manufacture and commercialization of cannabis-based plant products.


Healthcare & Life Sciences Department Report | Resolution No. 781/2022: New product category – Regulation on the manufacture and commercialization of cannabis-based plant products

Dear Sir or Madam,

The National Ministry of Health issued Resolution No. 781/2022 on April 7th, 2022 (the “Resolution”), published in the Official Gazette on April 11th, creating the new category of “Cannabis-based plant products and their derivatives intended for use and application in human medicine” (the “New Category”), a category different from the products regulated as medicine, medicinal specialty, or herbal medicine.

The Resolution regulates the manufacture and commercialization of cannabis-based plant products, aligned with recent Decree No. 883/2020 regulating Law No. 27,350, whose main purpose was to create the necessary conditions to guarantee the population’s access to products containing cannabis plant derivatives in their composition and that the medicinal, therapeutic and/or palliative use of cannabis and its derivatives, currently in constant development around the world. You will find a summary of the Resolution’s main points as follows.

• The Resolution included in the New Category any product containing as Active Pharmaceutical Ingredient/s (API/s) one or more cannabinoids derived from plant origin obtained with the requirements of established good manufacturing practices (verifiable).
• The Resolution established that the National Administration of Medicines, Food and Medical Technology (ANMAT) will be the enforcement authority of the Resolution, and consequently, together with the Ministry of Health, will issue the complementary regulations.
• It was expressly established that all activities related to products of the New Category may only be carried out in duly authorized establishments.
• The dispensing of the products elaborated according to the Resolution will be carried out in pharmacies and the dispensing condition will be established as Sale Under Prescription.
• All kinds 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 products that respond to the New Category is prohibited.
• Products based on Cannabidiol (CBD) or other cannabinoids registered in the Register of Medicinal Specialty (REM) of ANMAT are not covered by the Resolution.
• ANMAT was reserved the power to order the corresponding quality deviation investigation and the withdrawal from the market of the products subject to the Resolution.
• When the API of cannabinoids previously mentioned has percentages of Tetrahydrocannabinol (THC) higher than 0.3% w/w in dry base considering the tetrahydrocannabinol acid (ATHC) that could be present, the corresponding regime for psychotropic substances will be applied.

Please, do not hesitate to contact us should you require any additional information on this matter.


Ana Andrés
Julieta Gonzalez