The National Health Surveillance Agency (Anvisa) published, today (4), health authorization for two more cannabis-based products: cannabis sativa promediol extract and cannabis sativa zion Medpharma 200 mg/ml extract.
Used for health treatments, the novelty of these products in relation to the other five already approved is that they are composed of plant extracts, that is, they have in their composition a set of substances extracted from the plant, unlike the others, composed of isolated cannabidiol .
Both are obtained from the ethanol extract of the aerial parts of cannabis sativa and are manufactured in Switzerland. In Brazil, they will be imported and distributed as finished products ready for use.
“Vegetable extracts have a complex composition, and may contain many active substances, which can act through different mechanisms in the human body, which makes the control and monitoring applied to these products by the National Health Surveillance System (SNVS) even more important. There is also all verification of the absence of contaminants that may exist in plant extracts, which is carried out in detail by the manufacturer and verified by Anvisa, so that the safe use of these products can be guaranteed”, explained the agency.
He added that the two new authorized products will be available in the form of a drop solution, containing 50 mg/ml of cannabidiol (CBD) and no more than 0.2% of tetrahydrocannabinol (THC), and, therefore, should be marketed in pharmacies and drugstores from medical prescription through type B prescription (blue).
Quality control
The informed CBD and THC are considered markers in the quality control of these extracts, which are also composed of other substances, such as other cannabinoids and tannins.
Brazil currently has seven cannabis products approved by Anvisa based on resolution 327/201. Considered still recent, for being less than two years old, it has allowed these products to be made available to the population. All of them, the agency emphasizes, are produced by companies certified as to good manufacturing practices, which were evaluated in relation to their quality and suitability for human use.
“The regulation of medicinal cannabis products is a challenge for Anvisa and for the main international regulatory authorities. Resolution 327/2019, based on the benefit x risk ratio, is the agency’s first step in evaluating these products prior to their availability on the market and monitoring their use. We remain vigilant and improve our actions, always seeking to promote the access of the Brazilian population to products suitable for their use”, said João Paulo Perfeito, from the Management of Specific Medicines, Notified, Herbal Medicines, Dynamized and Medicinal Gases at Anvisa.
Reference: CNN Brasil
