Decree regulates the free provision of cannabidiol-based medications by the Unified Health System of São Paulo

On December 26, 2023, Decree No. 68,233/2023 was published in the Official Gazette of São Paulo, regulating the free provision of cannabidiol (CBD)-based medications and related compounds of medicinal cannabis by the Unified Health System (SUS) of São Paulo.

This Decree establishes guidelines in accordance with Law No. 17,618, dated January 31, 2023, addressing the state policy for the distribution of formulated products containing plant-derived derivatives of cannabidiol — associated with other cannabinoid substances, including tetrahydrocannabinol — in state-owned and privately affiliated public health units under the Unified Health System – SUS.

In this context, to access cannabidiol-based medication, patients or their legal representative must submit a request. Subsequently, the Department of Health will conduct an evaluation, adhering to clinical protocols and state technical standards.

Nevertheless, as per Article 3 of the mentioned Decree, the provision of this medicinal product will only occur if the product is registered with the National Health Surveillance Agency (ANVISA). The Decree also references ANVISA’s RDC 327/2019, which must be complied with, as it outlines procedures for granting Health Authorization, manufacturing, and importing, as well as setting requirements for the commercialization, prescription, dispensing, monitoring, and inspection of Cannabis products for medicinal purposes.

In addition to regulating the provision of cannabidiol-based medications, the Decree also encompasses the establishment of a monitoring committee to oversee patients using these medications, aiming to assess information and propose the use of new medications to the National Committee for the Incorporation of Technologies in SUS (Conitec).

Decree No. 68,233/2023 came into effect upon its publication in the Official Gazette. Consequently, following the authorization of the State Health Department, the medication will be available in specialized pharmacies and can be obtained upon presentation of the required documents.

For further content related to the regulation of medicinal cannabis, do not hesitate to contact us via email at: regulatorio@kasznarleonardos.com.