Anvisa says that Prati's Cannabidiol has a 5-year sanitary authorization

The commercialization permission granted by Anvisa (National Health Surveillance Agency) for Prati-Donaduzzi's cannabidiol is not exactly a registration, but a sanitary authorization. It is valid for 5 years and cannot be extended.

“This happens because the resolution of the collegiate board 327 published by Anvisa in December is transitional,” explains João Paulo Perfeito, manager of Specific, Notified, Herbal, Dynamized Medicines and Gases at Anvisa. The agency currently authorizes a Cannabis-based product. Later, the company must submit clinical tests, which are being conducted in partnership with the Faculty of Medicine of Ribeirão Preto at the University of São Paulo. Only after this happens, at the end of five years, will the company likely have the definitive registration of cannabidiol.

“There is strong evidence that medicinal Cannabis has therapeutic activities for many pathologies, some of them serious. Anvisa grants the authorization to ensure that patients can use the product without having to resort to individualized importation,” says Perfeito.

According to him, companies that are not in the pharmaceutical sector may have more difficulties obtaining sanitary authorization. The regulation is quite demanding, laborious, and costly as it is based on the rules established for medications.”