12/2/2020
Close to completing its first year, the rule that establishes the procedures for granting health authorization for the manufacture and import of Cannabis-based products for exclusively medical use, has been highlighted again. This is because, in recent months, there has been a growing movement of companies interested in obtaining authorization by Anvisa.
Resolution of the Collegiate Board (RDC) No. 327, of December 9, 2019, made it possible to expand the Brazilian market of Cannabis-based products for medicinal purposes by regulating procedures for the manufacture, import, commercialization, monitoring, inspection, prescription and dispensing industrialized products containing active plant derivatives or phytopharmaceuticals from Cannabis sativa, for human use only.
At the time, there was only a single cannabis-based drug registered in Brazil and available in pharmacies, with very limited application and high cost.
Based on the health authorization that can be granted by Anvisa to products imported or manufactured locally, in Brazil, upon importation of the raw material, it is important to highlight the existence of a product based on Cannabis that has already received said authorization, being the only one present moment. This is the phytopharmaceutical called Cannabidiol Prati-Donaduzzi, produced by the pharmaceutical company from Paraná, Prati-Donaduzzi, whose authorization was granted on April 20th.
In addition, the demands for health authorization continue to grow with Anvisa, with requirements from other companies, and currently four applications are under requirement, one application is in line for analysis and two applications were closed due to the loss of object or by the requesting company.
As planting in Brazilian soil was vetoed by Anvisa regulations, companies that obtain health authorization and want to manufacture locally, will have to import the input for local production of the product based on Cannabis.
In addition to the fact that the rule brought by Anvisa can be revised in up to 3 years, in which case possible changes and adjustments to the rule are possible at any time, other bills related to the use of Cannabis for medicinal purposes are under analysis in the National Congress.
Coauthors: Sueli de Freitas Verissimo Vieira and Raissa Pinati do Nascimento
