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Medical cannabis: guide to the hygiene authorization of approved products

The National Institute of Medicine (INAAM) will enable the application of the document for manufacturers, importers and exporters of “vegetable products based on cannabis and its derivatives for use and application in human medicine”, among other aspects., (see attached annexure)

Provision 6431/22-Approved

City of Buenos Aires, 08/11/2022

Sc File EX-2022-82617531-APN-ANMAT#MS, Law No. 16,463 and 27,350, its regulatory, amendment and supplementary norms, Decree No. 1490 of 20 August 1992, 883 of 11 November 2020 and Ministry of Health Resolution No. 781 of 7 April 2022; You

assuming:

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

The central objective of that Decree No. 883/20, which regulates Law 27,350, is to create, through dictation of operational and procedural, the conditions necessary to guarantee the access of the population to products containing derivatives of the cannabis plant in their composition Is. The quality of cannabis and its derivatives intended for use and use in human medicine must be taken into account.

That in accordance with paragraph 4 of the above decree, the Ministry of Health, in its capacity as enforcement authority, is empowered to issue supplementary and explanatory rules and other provisions as may be necessary for better compliance.

That within this framework, Resolution of the Ministry of Health No. 781/22 was issued, Article 1 of which created a new category of “vegetable products based on cannabis and its derivatives for use and use in human medicine”, a Ministry of Health Separate category for products already regulated as pharmaceutical, medicinal specialty in accordance with the Resolution No. 1817/2013 of Decree No. 150/1992 (TO 1992) and herbal medicine. 5418/2015 and No. 5482/2015″.

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