The National Health Surveillance Agency (Anvisa) approved in late 2019 the release of the sale in pharmacies of cannabis products in Brazil. The regulation was approved unanimously and is valid for three years.
The resolution creates a new class of product subject to health surveillance: the “cannabis product”. That is, during the period, the products will not yet be classified as medicines.
The delimitation of three years was suggested with the justification that there is no evidence of the efficacy of treatments based on the products.
This already indicates an extra step of the agency in relation to this market, even if the endorsement to cultivation is not approved, since the new rules bring their own model for registration of these products in the country.
The text also cites the possibility that companies import Cannabis substrates for the manufacture of products. In this case, however, they must import the semi-finished raw material, not the plant or part of it.
The standard cites requirements necessary for granting sanitary authorization for the manufacture and importation of these products. It also brings rules for sale, prescription, monitoring and enforcement.
The measures were suggested by director Fernando Mendes, who had requested a view of the proposal presented in October by the agency’s CEO, William Dib.
The proposal maintains the veto on the possibility of releasing cosmetics, cigarettes and other herbal products. After being submitted by Mendes, the proposals were approved by the other directors.
Companies interested in obtaining health authorization must present operating authorizations and certificates of good practice. They must also prove conditions for product quality control.
As embalagens desses produtos devem conter uma faixa de cor preta e não The packaging of these products must contain a black band and cannot contain the terms medicine, medicine, herbal medicine, supplement or others.
The sale will be restricted to prescription and prescription retention and may only be made in pharmacies and drugstores. It will be forbidden to sell in handling pharmacies.
Cannabis products containing more than 0.2% THC, one of the cannabis derivatives, should also contain the warning that the use of the products “may cause physical and mental dependence”.
The prescription of products should earn different types of prescription depending on the concentration of THC. If less than 0.2%, it will be type B revenue, requiring 60-day revenue renewal.
Products with a concentration greater than 0.2% THC may only be prescribed to terminally ill patients or those who have exhausted therapeutic alternatives. In this case, the recipe is a more restricted type A, similar to the standard applied to morphine, for example.
In addition, the indication and use of the products will be up to the attending physician. Patients must sign an informed consent form.