The Board of Directors of the National Health Surveillance Agency (Anvisa) approved, on Wednesday (26), the opening of public consultation to review the current regulation of cannabis products.
After publication in the Federal Official Gazette, the draft resolution should be open for 60 days and, during this period, any interested party can make contributions to the proposal to update the regulation made by the agency.
Cannabis products are currently regulated for the RDC 327/2019which defines the rules so that these products can be authorized in the country and sold in pharmaceutical retail.
The review of the rules involve themes such as:
- Compliance with good manufacturing practices
- ADMINISTRATION ROADS
- Advertising of Products
- Sanitary authorization validity
- Prescription
- Dispensation
- Import of inputs for national production
- Labeling
In Brazil, products containing cannabis derivatives can be regularized into two distinct categories: as a medicine, following the proof of drug effectiveness and safety, or as a cannabis product, which have a simplified process, according to the agency.
Currently, there is only one approved cannabis medicine and 36 regularized cannabis products.
Anvisa directors also approved the opening of a regulatory process to review the resolution RDC 660/2022which deals with the exceptional importation of cannabis products for personal use.
This content was originally published in the use of Cannabis: Anvisa will open public consultation on regulation on CNN Brazil.
Source: CNN Brasil
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