The Executive Board of the Brazilian National Health Surveillance Agency ("ANVISA") issued, on December 09, 2019, a resolution designated "Resolution of the Collegiate Board" N. 327, regulating the registry of cannabis products and derivatives in Brazil ("Resolution"). The Resolution provides for the procedures for granting the Sanitary Authorization for manufacturing and importation, as well as establishes requirements for the marketing, prescribing, dispensing, monitoring and surveillance of cannabis products for medicinal purposes.
The Resolution allows manufacturing companies to sell finished cannabis-based products in pharmacies and drugstores in Brazil, and establishes requirements for the manufacturing, importing and selling of cannabis medical products in Brazil. Cultivating cannabis in Brazil remains prohibited.
Until the issuance of the Resolution, Law 11.243/2006 prohibited the cultivation, culture and harvest and exploration of cannabis, except upon legal authorization for medical and scientific uses, in pre-determined places and for pre-determined periods, and upon inspection. Since January 2015, medical oil and extract products with cannabis active principles ("CBD") can be imported by patients in Brazil, upon authorization by ANVISA.
Even though the cannabis-based products were not on the list of banned substances anymore, a patient with a medical prescription for the use of cannabis-based drugs needed an import authorization to import the products into Brazil. Other than that, commercialization of cannabis-based products was not allowed.
Thus, the Resolution has brought important changes to the cannabis regulatory framework in Brazil. As of the publication of the Resolution, patients holding a medical prescription recommending the use of cannabis-based products will be able to buy the products directly from pharmacies / drugstores in Brazil. Manipulation of cannabis products is not allowed.
Rules for prescription will depend on the concentration of THC on the drug. Manufacturing and importing companies will need a special license from ANVISA. The requirements to apply and obtain such license are also set forth in the Resolution.
The Resolution establishes special parameters for the labelling and packaging of Cannabis products. The Resolution shall be reviewed within three (3) years after its publication, therefore, it is a transitional measure, subject to change and edition.
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