Anvisa discusses review of regulation of medicinal cannabis products

The National Health Surveillance Agency (Anvisa) has included in the agenda of its next meeting of the Collegiate Board (Dicol), scheduled for December 19, the analysis of a public consultation proposal aimed at revising Collegiate Board Resolution (RDC) No. 327/2019. This norm establishes procedures for granting health authorizations, manufacturing, importing, commercializing, and prescribing cannabis products for medicinal purposes.

Review aims to meet sector advancements

The review of RDC No. 327/2019 is part of the 2024-2025 Regulatory Agenda, classified as theme No. 8.28. The objective is to update current requirements, aligning regulations with scientific advancements and the needs of the medicinal cannabis market. Among the aspects being evaluated are the simplification of procedures for companies and the expansion of access to products for patients who depend on this therapy.

According to the process (25351.912833/2022-80), reported by director Rômison Rodrigues Mota, the proposal also includes the revision of criteria for monitoring and inspecting these products, ensuring greater safety and efficacy.

How to participate in the public consultation

The meeting will be held at Anvisa's headquarters in Brasília at 9:30 a.m. Those interested in participating in the collegiate board meeting with any contributions on the topic have until December 16, 2024, at 11:59 p.m. to register.

Manifestations can be sent by:

• Companies and associations in the regulated sector;
• Health professionals, such as doctors and pharmacists;
• Patients and representatives of civil organizations;
• Researchers and experts in the field;
• Any citizen interested in the topic.

Detailed instructions for submitting contributions are available in item VIII of the meeting agenda, published in Anvisa's official document. Click here to access: