Public consultation on the revision of RDC No. 327/2019 comes into effect; contributions can be submitted up to 7 days after publication

The National Health Surveillance Agency (Anvisa) has initiated a public consultation on the revision of RDC No. 327/2019, which regulates the manufacturing, importation, commercialization, prescription, and oversight of cannabis-based products for medicinal purposes. The deadline for submitting contributions will begin seven days after the official publication in the Official Gazette of the Union. Click here to access Public Consultation No. 1,316. 

The proposal will be available in full on Anvisa's portal, and suggestions can be submitted exclusively through a specific electronic form. The form will soon be accessible on Anvisa's website. Click here to follow up: 

After the deadline for submitting suggestions, Anvisa will analyze the contributions and publish the results on its official portal. The Agency may, as necessary, seek assistance from agencies and entities involved with the topic, as well as those who express interest in the matter, to enrich the technical discussions and the final deliberation of the Collegiate Board.

This revision aims to improve the procedures established in the RDC No. 327, especially regarding the authorization for the manufacturing and importation of products, as well as their commercialization and oversight, adjusting the regulation to the new demands of the medicinal cannabis market in Brazil.

See a summary of the main proposals for updating RDC 327

The proposal was developed by a competent technical team and included the rapporteur of the Acting Director-President, Rômison Rodrigues Mota. The main changes addressed in the vote are as follows:

- THC Limit: The proposal clarifies that products with more than 0.2% THC will be exclusively intended for the treatment of patients with severe or life-threatening diseases. Use in these cases will be contraindicated for individuals under 18 years of age, pregnant women, and nursing mothers. Risk assessment will be conducted by physicians for elderly patients and those with a history of cannabis dependence.

- Importation of cannabis inputs and products: The proposal also authorizes the importation of Cannabis sativa L. extract and phytopharmaceuticals such as CBD for research and manufacturing. However, compounding pharmacies are prohibited from importing CBD phytopharmaceuticals directly.

- Good Manufacturing Practices (GMP): A valid Good Manufacturing Practices Certificate (CBPF) issued by Anvisa will be required for the production line of finished products. Previously, equivalent documents from health authorities of countries recognized by Anvisa were accepted for a transition period - which has already expired.

- Routes of administration: The proposal expands the permitted routes of administration, including oral, sublingual, inhalation, and dermatological routes, in addition to those already authorized (oral and nasal). Injectable and sterile routes remain excluded, as well as the use of smoking products made from Cannabis sativa.

- Compounding of Magistral Preparations (Compounding Pharmacies): The compounding of restricted formulations containing phytopharmaceutical CBD with a minimum purity of 98% will be allowed. The CBD for compounding may be manufactured in Brazil or imported. Commercialization will be restricted to pharmacies with Special Authorization (AE), and advertising and distribution of free samples will be prohibited.

- Prescription and dispensing of products: The prescription of products with up to 0.2% THC must be made on a common prescription pad, according to Portaria SVS/MS No. 344/1998, and no longer on Notification of Prescription "B". The prescription of products with more than 0.2% THC continues to require Notification of Prescription "A".