approve guide for the sanitary authorization of products – Trade and Justice

The National Institute of Medicines (Iname) will be competent for the application of the document for manufacturers, importers and exporters of “Vegetable products based on cannabis and its derivatives intended for use and application in human medicine”, among other aspects.. (See attached annex)

Provision 6431/22-Anmat

City of Buenos Aires, 08/11/2022

SEEN file EX-2022-82617531-APN-ANMAT#MS, Laws Nos. 16,463 and 27,350, its regulatory, amending and complementary norms, Decrees Nos. 1490 of August 20, 1992, 883 of November 11, 2020 and the Resolution of the MINISTRY OF HEALTH No. 781 of April 7, 2022; Y

CONSIDERING:

That Law No. 27,350 regulates medical and scientific research on the therapeutic and/or palliative medicinal use of the Cannabis plant and its derivatives.

That Decree No. 883/20, which regulates Law 27,350, has as its central objective the creation of the necessary conditions to guarantee the population’s access to products that contain derivatives of the cannabis plant in their composition, through the issuance of the operating and procedural standards that must take into account the quality of cannabis and its derivatives, intended for use and application in human medicine.

That pursuant to Article 4 of the aforementioned decree, the MINISTRY OF HEALTH, in its capacity as Enforcement Authority, is empowered to issue complementary and explanatory regulations and other provisions that may be necessary for better compliance.

That in this framework, the Resolution of the MINISTRY OF HEALTH No. 781/22 was issued, whose article 1 created the new category of “Vegetable products based on cannabis and its derivatives intended for use and application in human medicine” which make up a category different from the products already regulated as medicine, medicinal specialty, according to Decree No. 150/1992 (TO 1993) and herbal medicine according to the Resolution of the Ministry of Health No. 1817/2013 and ANMAT Provisions No. 5418/2015 and No. 5482/2015”.

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