The Ministry of Health of the Nation created the category of cannabis-based plant products for use and application in human medicine, which “is one more step to facilitate safe access to the population that needs them,” they assured from the portfolio sanitary.
“A regulation of its own is defined for this type of product, differentiating it from medicinal specialties and herbal medicines. It is one more step to facilitate safe access to the population that needs them”they indicated from the health portfolio.
From Ministerial Resolution number 781/2022, published this Monday in the Official Gazettethe Ministry of Health of the Nation created the category of “Vegetable products based on cannabis and its derivatives intended for use and application in human medicine”.
Thus, the health portfolio defines its own regulation for this type of product for therapeutic purposes.
In addition, the resolution promotes that “The treating physicians have guarantees of the quality of the products they prescribe, which will result in guaranteeing the safety of users.”
“This will allow not only to expand its use in different pathologies, but will also ensure the certification of the processes in terms of good cultivation and processing practices required by national and international regulatory agencies,” they maintained from the ministry.
through the resolution Those products whose composition is clearly defined and verifiable with THC percentages less than or equal to 0.3% will be included in this new category; meanwhile, when the concentration of THC exceeds 0.3% in the product, the regime corresponding to psychotropic substances will be applied.
The products must be indicated by a physician or prescriber, who will define the formulation of a known concentration of active ingredients (cannabinoids) and will carry out the corresponding control, with the certainty of the quality of the indicated product.
On the other hand, the dispensation will be made through pharmacies under prescriptionwhile the qualification of the elaboration laboratories will be in charge of the National Administration of Medicines, Food and Medical Technology (ANMAT), which will control the production.
“With this new category, a consistent and balanced response is being given that guarantees health safety with concentrations of known active ingredients, free of contaminants and with medical advice and information on their benefits and risks,” the official sources concluded.