The Ministry of Health reported that the new Decree 7761/22, issued by the Executive Power, on licenses for the production and marketing of medicinal cannabis, does not eliminate the current requirements to request said license.
Dr. Mercedes Da Silva, coordinator of the National Program for the Study and Medical and Scientific Research of the Medicinal Use of the Cannabis Plant and its Derivatives (PROINCUMEC), dependent on the National Directorate of Sanitary Surveillance (DINAVISA), explained about said decree.
The specialist indicated that, with the new provisions, the limit of 13 permits was eliminated, and it can now be issued to any applicant who meets the prerequisites already established.
To acquire medicinal oil for free through the state program, both the treating physician and the patient must be registered in the National Registry of Cannabis Derived Products.
This registry covers citizens who suffer from: refractory epilepsy or multiple sclerosis, and to date, 110 beneficiaries are registered nationwide.
Requirements for requesting production licenses
The requirements for those interested in having a controlled production and industrialization license can be found in DINAVISA Resolution No. 309/22, and cover several requirements, such as the installation of a pharmaceutical laboratory for the manufacture of medicines authorized by DINAVISA.
In addition, the certificate of good practices, a Pharmaceutical Chemist professional who will act as regent; cultivation, industrialization and export plans, in case you want to export the product, among others.
