Overview:
On October of 2019, Bill No. 5295 was presented to the Brazilian Senate to address the issues of medical cannabis and industrial hemp inside the country. Its approval signified a dramatic shift pushed by the right -winged government of Brazil.
The Brazilian sanitary surveillance regulatory body, Anvisa, approved the guidelines that allow the sale of medicinal products derived from cannabis. The regulation describes the procedures for manufacturing and importing of medicinal cannabis and the requirements for prescription, sale, and supervision of the products.
The new regulatory framework creates a new class of products subject to health surveillance: Cannabis- based products , a term that has been used internationally with authorizations issued by different health authorities in the world.
Background on Cannabis measures:
The company responsible for submitting the Sanitary Authorization of the Cannabis product to Anvisa must have:
- Company Operation Authorization (AFE) issued by Anvisa with the activity of manufacturing or importing medicine.
- Special Authorization (AE).
- Certificate of Good Manufacturing Practices (CBPF) of medicines for the company that manufactures the product.
- Good Medicine Distribution and Storage Practices.
- Technical and scientific rationale that justifies the formulation of the Cannabis product and the route of administration.
- Technical documentation of product quality.
- Operational conditions to carry out quality control analyzes in Brazilian territory.
- Ability to receive and handle notifications of adverse effects and technical complaints about the product.
- Knowledge of the concentration of the main cannabinoids present in the formulation, including CBD and THC, in addition to being able to justify the development of the Cannabis product .
Labeling and packaging:
Product labeling and packaging must not contain:
- Designations, geographical names, symbols, figures, drawings or any indications that allow for false interpretation, error or confusion as to origin, origin, nature, composition or quality, which give the products different purposes or characteristics from those that they actually possess.
- The terms medicine, medicine, herbal medicine, supplement, natural or any other similar to these.
- Any indication as to the intended use, especially including direct or indirect therapeutic or medicinal claims.
- Cannabis-product packaging labels must have a horizontal black band covering all sides, at the height of the middle third and at least one third of the width of the longest side of the longest side.
- On the black band of Cannabis-products containing up to 0.2% THC, the following phrases must be included in upper case: “SALE UNDER MEDICAL PRESCRIPTION” and “CAN ONLY BE SOLD WITH RETENTION OF REVENUE”.
- On the black band of Cannabisproducts containing more than 0.2% THC, the following phrases must be included in capital letters: “SALE UNDER MEDICAL PRESCRIPTION” and “USE OF THIS PRODUCT MAY CAUSE PHYSICAL OR PSYCHIC DEPENDENCE”.
Importation of Medical Cannabis in Brazil:
Manufacturers that choose to import Cannabis substrate must import the semi-prepared raw material, and not the plant or part of it. In order to make it possible to fully monitor the batches of imported Cannabis- based products and medicines , the points of entry of products into the national territory are limited.
Conclusions:
In Latin America, Brazil has now joined both Uruguay and Columbia in the legalization of medical marijuana.
MORE RESOURCES:
https://globalregulatorypartners.com/countries/latin-america/brazils-anvisa/
Anvisa. Registration of First Sativa based Cannabis. ‘Registrado primeiro medicamento à base de Cannabis sativa’
Anvisa. Medical cannabis: know the history of the proposal. ‘Cannabis medicinal: conheça o histórico da proposta.’