With a growing demand for regularization and availability in the Brazilian market of various products obtained from the Cannabis sativa plant and because there is not enough data to prove the safety, efficacy and quality of most of the products obtained from this plant, the National Health Surveillance Agency ( ANVISA) started to create regulatory paths to make cannabis products available in Brazil.
As Cannabis products do not fit into any of the categories provided for in Brazilian health legislation, a new regulatory category was created, where the requirements for authorization, manufacture, import, dispensation, control, among others for Cannabis products were established.
The Sanitary Authorization for Cannabis products was created in order to make available, in the quickest way to the Brazilian population, safe and quality products containing Cannabis derivatives, but which did not complete the necessary studies for registration as a medicine.
The manufacturer or importer that wishes to commercialize Cannabis products must, prior to requesting Sanitary Authorization, have municipal and federal health licenses for the activities of manufacturing or importing medications and medications subject to special control. Federal health licenses are issued by ANVISA, and are called “Authorization of Business Operation – AFE” and “Special Authorization – AE”, for drugs subject to special control. In addition, it is necessary that the national or international manufacturer company has the Certificate of Good Manufacturing Practices for medicines issued by ANVISA and that it complies with the Good Distribution and Storage Practices of medicines.
To request Sanitary Authorization of Cannabis products, technical and scientific documents must also be sent to ANVISA containing the justifications, technically based, regarding the development of the Cannabis product, in addition to other documents and information, such as the labelling and packaging model, information leaflet, stability studies, among others.
It is important to note that Cannabis products can only be approved for use orally or nasal, in forms of immediate release and that the asset consists of plant derivatives or phytopharmaceuticals. In addition, Cannabis products are not allowed to be marketed in the form of a plant drug from the Cannabis spp plant. or its parts. In addition, cosmetics, smoke, health products and food will not be considered cannabis products, regardless of their status in the country of origin, when it comes to imported products.
Finally, it is important to clarify that the rule dealing with Sanitary Authorization for Cannabis products is temporary and will be revised in 3 years, which means that companies that are interested in obtaining authorization, have until December 2022 to adapt and request the granting of this authorization.