Anvisa‘s Board of Directors approved, on this Tuesday (December 3rd), the new regulation for cannabis-based medicines. The approved text establishes the necessary requirements for the product to meet quality parameters and to be marketed in Brazil. The measure is effective 90 days after publication in the Federal Official Gazette and should be reviewed within three years.
The National Health Surveillance Agency ‘s challenge to regulate the issue was to find a way to ensure access through pharmaceutical assistance, ensuring a minimum guarantee for product users.
The approved regulation provides about the procedures for granting a Health Authorization for the manufacture and importation of these products, as well as laying down requirements for the marketing, prescribing, dispensing, monitoring and supervision of cannabis products for medicinal purposes. Among them, it established that the drugs can only be purchased with express medical recommendation, and with the THC -substance that causes the psychoactive effect- percentage below 0.2%. Above this parameter will only be allowed for terminally ill patients or those who have exhausted the therapeutic alternatives.
Companies applying to become drug producers must submit a dataset and technical information, prove quality through clinical studies, and submit periodic use evaluation reports. They may choose to import the cannabis substrate and in this case they will not be able to bring the plant or part of it into the country, only the semi-finished raw material.
After this decision, it is likely that the Brazilian Patent and Trademark Office (BPTO) – where the trademarks are registered – will also update its understanding and analyze trademarks that identify these types of drugs with more flexibility.