Brazil health regulator authorizes sale of two cannabis-based products
RIO DE JANEIRO, BRAZIL – Used for medical treatments, these products differ from the 5 others already approved in that they are composed of plant extracts, i.e., they have a set of substances extracted from the plant in their composition, unlike others composed of isolated cannabidiol.
Both are prepared from ethanolic extracts of the aerial parts of cannabis sativa and manufactured in Switzerland. They will be imported and distributed in Brazil as ready-to-use finished products.
“Plant extracts have a complex composition and can contain many active substances, which act through different mechanisms in the human body, making the control and monitoring of these products by the national health regulatory agency (ANVISA) even more important. The presence of contaminants in plant extracts is checked in detail by the manufacturing company and confirmed by ANVISA to ensure the safe use of these products,” the agency explained.
It added that the two new authorized products will be available as 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 upon prescription through a type B prescription (blue).
QUALITY CONTROL
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 7 cannabis products approved by ANVISA based on resolution 327/201. Still considered recent, because it is less than 2 years old, it has enabled these products to be available to the population. All of them are produced by companies certified for good manufacturing practices, evaluated for their quality and suitability for human use, the agency points out.
“The regulation of medicinal cannabis products is a challenge for ANVISA and leading international regulatory bodies. Resolution 327/2019, based on the benefit-risk ratio, is a first step in the agency’s assessment of these products prior to their availability on the market and the monitoring of their use. We remain vigilant and improving our actions, seeking to constantly promote the Brazilian population’s access to products suitable for use,” said João Paulo Perfeito of ANVISA’s Management of Specific, Pharmaceutical, Phytotherapeutic, Dynamized, and Medicinal Gases Drugs.
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