The National Institute of Medicines (Iname) will be competent to implement the document for manufacturers, importers and exporters of “plant products based on cannabis and its derivatives intended for use and application in human medicine,” among other aspects.. (See the attachment)
Imdad 6431/22-Anmat
City of Buenos Aires, 08/11/2022
See File EX-2022-82617531-APN-ANMAT#MS, Laws Nos. 16,463 and 27,350, their Regulatory, Amendment and Supplementary Rules, Decree No. 1490 of August 20, 1992, 883 of November 11, 2020 and Resolution of the Ministry of Health No. 781 of April 7, 2022; s
Taking into account the:
This Law No. 27350 regulates medical and scientific research for the curative and/or palliative use of the cannabis plant and its derivatives.
The main objective of this Decree No. 883/20, which regulates Law 27350, is to create the necessary conditions to ensure the access of the population to products containing derivatives of the cannabis plant in their composition, by dictating operational and procedural procedures. Standards that must take into account the quality of cannabis and its derivatives, intended for use and application in human medicine.
That in accordance with Article 4 of the above-mentioned decree, the Ministry of Health, as the enforcement authority, is empowered to issue supplementary and interpretative regulations and other provisions that may be necessary to improve compliance.
That in this context, the Ministry of Health Resolution No. 781/22 was issued, the first article of which established a new category of “plant-based products based on cannabis and its derivatives intended for use and application in human medicine” which constitutes a different category from products that have already been regulated such as medicines and medical specialties, According to Decree No. 150/1992 (TO 1993) and herbal medicine in accordance with Ministry of Health Resolution No. 1817/2013 and ANMAT Provisions No. 5418/2015 and No. 5482/2015”.
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