Text will be available for suggestions for 60 days, after publication in the Federal Official Gazette; During this period, any interested party may make contributions to the proposal to update the regulation
A He took a significant step in approving the opening of a public consultation last Wednesday (26) intended to review the regulation of the medicinal cannabis in Brazil. This consultation will be available for a period of 60 days, from the date of publication in the Federal Official Gazette. The main objective of this initiative is to update the rules that govern the manufacture, import and marketing of cannabis products for medicinal use. According to the proposal, these products will continue to be classified in a specific category within the current health regulation.
One of the central points of the proposal is that the sanitary authorizations for will be granted temporarily, with initial validity of five years. These permits may be renewed for another five years, but only once. In addition, the document approved by ANVISA provides for the expansion of the administration roads permitted for these products, the requirement to certify good manufacturing practices and the restriction of the advertising of cannabis products. Another important aspect of the proposal is the inclusion of the possibility of manipulating magistral preparations containing exclusively Cannabidiol, provided they have a minimum purity of 98%.
The updating of the rules will also pave the way for medicinal cannabis products to be sold in handling stores, provided they are accompanied by a prescription, according to ANVISA’s analysis. During the period of public consultation, society will have the opportunity to comment on the new proposed rules. Anvisa is committed to evaluating all contributions received, which will be critical to the final decision on the implementation of the suggested changes.
*With information from Marília Ribeiro
*Report produced with the aid of AI
