Following several discussions over the matter, earlier today the Brazilian Health Surveillance Agency’s (“ANVISA”) Directors finally approved the rules to regularize medicinal products that contain Cannabis (“Products”) for medical purposes. The rule will enter in force within 90 days of its publication in the Federal Official Gazette.
The regulation lists the legal requirements that companies must meet in order to receive the Marketing Authorization, such as, but not limited to:
• Authorization to Operate and Special Authorization to Operate (for manufacturing and/or importing activities) issued by ANVISA;
• Certificate of Good Manufacturing Practices (CGMP) issued by ANVISA;
• Good Distribution and Storage Practices issued by ANVISA;
• Studies that prove the safety and quality of the Products, as well as stability studies;
• Technical justification for the Products’ formulation with Cannabis and its method of administration;
• Proof of the company’s capacity to receive and handle the adverse events and complaints related to the use of the Products (pharmacovigilance / drug safety);
• Technical knowledge related to the main cannabinoids present in the formulation, among them CBD and THC.
The regulation also imposes some restrictions on the Products’ labeling and packaging and establishes that informative package inserts concerning the Products must contain a warning wording or disclaimers, such as “Use of this product may cause physical or psychological dependency” or “This product is for individual use and its administration to another person is forbidden”.
The prescription and administration of the Products are the responsibility of the attending physician, who must provide clear information and explanation to the patient about the Product and its correct use and administration. For such purpose, the patient or his/her legal representative must sign an Informed Consent Form. The requirements to prescribe the Products may vary according to the concentration of THC. Products in which the concentration of THC is under 0.2% may be prescribed through a specific prescription form (type B). Products whose concentration is greater than 0.2% may only be prescribed to terminally ill patients or to those who have exhausted the alternative treatments. In this case, the prescription form will be type A.
It is important to highlight that local manufacturers that intend to import Cannabis substrate to produce the Products must import the ingredient as “semi-finished raw material” and not the plant or parts of it. The approved regulation also prohibits the manipulation of the Product, meaning that the sale and dispensation of the Products in Brazil must occur exclusively through the drugstores and pharmacies and without manipulation of the Product.
Each marketed unit of the Products must be registered with the National System of Controlled Products (“SNGPC”). Products manufactured in the country must be analysed by the Brazilian Network of Health Analytical Laboratories accredited by ANVISA (“REBLAS”) and the analytical data obtained from such analysis must be sent to the Agency.
Urgent situations related to the use of the products that may affect the patient’s safety must be communicated to ANVISA within 72 hours of the adverse event.
The text proposed to regulate the cultivation of Cannabis was appreciated by ANVISA’s Directors and rejected. This means that such proposal will not become a rule and the cultivation of Cannabis remains forbidden in Brazil. Exception is made to those patients and associations that have a court decision allowing them the cultivation for medicinal purposes.
This newsletter is a summary of the main legal requirements listed in new approved regulation.
Our Life Sciences Team and other areas of the firm are ready to assist companies that are wishing to set up their cannabusiness in Brazil, or that require any further assistance regarding this matter.