The Anvisa Collegiate Board of Directors has approved the new regulation for cannabis products in Brazil. The text includes the necessary requirements for their regularization in the country and establishes quality parameters.
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New class of products
Under the new agreement companies wanting to operate in Brazil will need to focus on proving their safety record. The proposals will bring cannabis under a similar regime as other medicinal products.
The Agency’s challenge to regulate cannabis was to find a way to guarantee access, through pharmaceutical assistance, ensuring a minimum guarantee for cannabis users, both in the sense of effectiveness and safety.
The new regulatory framework creates a new class of products subject to firm standards and quality control: cannabis products, a term that is being used internationally with authorizations from different health authorities around the world.
In addition to specific operating authorizations, the approved regulation demands a Certificate of Good Manufacturing Practices issued by Anvisa. The requesting company is obliged to have a set of data and technical information that demonstrates the quality of the product, specification limits and quality control methods utilized, as well as stability studies and periodic reports of use evaluation.
Any company responsible the Sanitary Authorization of their cannabis product to Anvisa must have:
- Company Operation Authorization (AFE) issued by Anvisa with the activity of manufacturing or importing drugs;
- Special Authorisation (SA);
- Certificate of Good Manufacturing Practices (CBPF) of medicines for the manufacturer of the product;
- Good Practices of Distribution and Storage of medicine;
- Technical and scientific rationale for the cannabis product formulation and the route of administration;
- Technical documentation of product quality;
- Operational conditions to carry out quality control analysis in the Brazilian territory;
- Ability to receive and handle adverse effect notifications and technical complaints about the product;
- Knowledge of the concentration of the main cannabinoids present in the formulation, among them CBD and THC.
Labeling and Packaging
The labeling and packaging of the product may not contain:
- Designations, geographical names, symbols, figures, drawings or any indications that allow false interpretation, error or confusion as to the origin, nature, composition or quality, that attribute to the purposes or characteristics of the product.
- The terms drug, medicine, herbal medicine, supplement, natural, or any other similar terms.
- Any indication as to the destination of use, especially including therapeutic or medicinal claims directly or indirectly.
- Labels on packages of cannabis products must have a horizontal black band covering all sides of the package.
- On the black belt of cannabis products, containing up to 0.2% THC must be included the sentences, in upper case, “SALE ON MEDICAL PRESCRIPTION” and “ONLY SALE WITH REVENUE RETENTION”.
- On the black belt of cannabis products, containing more than 0.2% THC must be included the sentences, in upper case, “SALE ON MEDICAL PRESCRIPTION” and the “USE OF THIS PRODUCT MAY CAUSE PHYSICAL OR PSYCHICAL DEPENDENCE”.
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First published in SECHAT, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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