ANVISA published today in the Official Gazette the expected Resolution for authorizing the manufacturing and importation, as well for establishing the requirements for the commercialization, prescription, dispensation, monitoring and supervision of Cannabis based products for medicinal purposes.
According to the Resolution, a new category of products was created, namely “Cannabis based products”. Interested companies must obtain a “Sanitary Authorization” in order to be commercialize and/or import the product (ANVISA did not use the wording “marketing authorization”, as applicable for other category of regulated products).
The Sanitary Authorization shall be valid for five years and, after this period, the product must be regularized through the same procedure applicable for drugs’ registration. This five-years period is not renewable.
Cannabis based products may only be prescribed when there is no other therapeutic option available in the Brazilian market.
Only pharmacies without manipulation can do the dispensation of these products, upon submission of prescription by legally qualified physician.
Other rules applicable to such products (such as information which should be included in the labelling, packaging and leaflet of products, rules for importation, control and supervision of products) are also provided for in the Resolution. There are several applicable requirements.
Advertising is prohibited, among other particularities.
The regulations enters into force in 90 days, and will be reviewed within three years by ANVISA.
The Public Law, Government Relations and Regulatory team of Trench, Rossi and Watanabe is available to provide any clarification.