The Resolution RDC No.327/2019 establishes requirements for the marketing of cannabis products for medicinal purposes. So far, there are seven cannabis products approved by ANVISA.
Brazil’s National Health Surveillance Agency (Anvisa) approved the sanitary authorization of two more cannabis-based products. The novelty of these products, compared to the other five already approved, is that they are composed of plant extracts, i.e., they have in their composition a set of substances extracted from the plant, unlike the others, which are composed of isolated cannabidiol.
Regulation of Cannabis Products
This Resolution defines the conditions and procedures for granting the Health Authorization for manufacturing and importation, as well as establishes requirements for the commercialization, prescription, dispensing, monitoring, and surveillance of cannabis products for medicinal purposes for human use.
Cannabis products containing exclusively plant derivatives or phytochemicals of Cannabis sativa as active ingredients must contain predominantly cannabidiol (CBD) and no more than 0.2% tetrahydrocannabinol (THC).
The company that intends to manufacture, import and commercialize cannabis products in Brazil must apply for regularization through the medicine registration process.
The Health Authorization for Cannabis products will have an unextendible term of 5 (five) years.
About the New Products
There are currently a total of seven cannabis products approved based on RDC No. 327/2019 – which allows the commercialization of these products to the Brazilian population.
Examples of two products already registered are :
– CANNABIS SATIVA PROMEDIOL EXTRACT
– CANNABIS SATIVA EXTRACT ZION MEDPHARMA 200 MG/ML
Both are obtained from ethanolic extract of the aerial parts of Cannabis sativa and are manufactured in Switzerland. In Brazil, they will be imported and distributed as finished products ready for use.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.