On March 10, 2020, the resolution RDC No. 327/2019, published by the Brazilian National Health Surveillance Agency (ANVISA) to regulate cannabis based products in Brazil, came into force.
The resolution defined cannabis based substances as products, not medicine, because the rule for registering new drugs requires clinical research capable of proving the effectiveness of such drug. The cannabis based substances’ current technical-scientific stage would not be enough for their approval as medicines. Thus, ANVISA decided to include it in this category in order to allow patients in Brazil to have access to these products.
The resolution’s Article 12 clearly states: “any advertising of cannabis based products is prohibited”. Moreover, Article 9 provides that cannabis based products cannot bear commercial names and must be designated by the name of the plant derivative or phytopharmaceutical followed by the name of the responsible company. The distribution of free samples is also prohibited by the resolution in its Article 14. The Advertising of this type of product has been banned since 2015, when direct cannabis based products import was authorized for Brazilian patients.
Furthermore, Cannabis based products’ labeling and packaging must not contain:
· Titles, geographical names, symbols, figures, drawings or any indications that may lead to misinterpretation, error or confusion as to origin, nature, composition or quality, which give the products purposes or characteristics different from those they actually have;
· The expressions: Medicine, Herbal Medicine, Supplement, Natural, or any other that bears similarity to them; and
· Any indication as to the intended use, especially including direct or indirect therapeutic or medicinal claims.
Cannabis product packaging labels must display a horizontal black band covering all sides, at the height of the middle third and with a width not less than one third of the width of the longest side. On the black band of Cannabis products containing up to 0.2% THC, the phrases in capital letters, “SALE UNDER MEDICAL PRESCRIPTION” and “CAN ONLY BE SOLD WITH PRESCRIPTION RETENTION” must be included. On those containing more than 0.2% THC, the phrases in capital letters “SALE UNDER MEDICAL PRESCRIPTION” and “USE OF THIS PRODUCT MAY CAUSE PHYSICAL OR PSYCHOLOGICAL DEPENDENCE” must be included.
Finally, cannabis based products’ information sheets must contain warning phrases, such as “THE USE OF THIS PRODUCT MAY CAUSE PHYSICAL OR PSYCHOLOGICAL DEPENDENCE” or “THIS PRODUCT IS FOR INDIVIDUAL USE, IT IS PROHIBITED TO PASS IT ON TO SOMEONE ELSE”.
Despite the resolution’s restrictions, producers of cannabis based products affirm that they will still be able to promote their brands, since the brands may be used on events and medical meetings or on the internet through informational content concerning the theme.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.