Medicinal Cannabis Review: Public Consultation 1.316/2025 open

The Public Consultation (CP) No. 1.316/2025, which aims to initiate the review process of Collegiate Board Resolution (RDC) No. 327/2019 from the National Health Surveillance Agency (Anvisa), remains open until June 3, 2025. This resolution establishes the procedures for granting Sanitary Authorization for the manufacture and import of Cannabis products for medicinal purposes, in addition to defining the requirements for their commercialization, prescription, dispensation, monitoring, and inspection.

RDC No. 327/2019 defined, on a transitory basis, the regulatory category of Cannabis products, encompassing industrialized products for human medicinal use that contain active ingredients obtained from the Cannabis sativa plant species. Article 77 of this Resolution stipulated a period of three years, following its publication, for the revision of the normative text.

In this context, Anvisa conducted a Regulatory Impact Analysis (AIR), identifying the need for adjustments to improve the clarity and effectiveness of the regulations. As a result, it was decided to maintain the transitional category for these products, while implementing new requirements to ensure transparency throughout the process, as well as the safety and quality of the products.
Thus, the main objective of the CP is to update and improve the regulations related to prescription, good manufacturing practices, dispensing, monitoring, advertising, inspection, and labeling of Cannabis products for medicinal purposes. This initiative aims to ensure a significant increase in the safety and quality of these products.

The Public Consultation will be available for contributions from April 4th to June 3rd, 2025. During this period, all interested parties may submit their suggestions and comments regarding the presented proposals. Public participation is considered essential for the improvement of the regulation, ensuring that the new rules adequately meet the needs of the sector.

For more content related to Anvisa and other developments regarding Public Consultation No. 1.316/2025, do not hesitate to contact us at the email: regulatorio@kasznarleonardos.com.