Anvisa approves changes in quality control of cannabis products from two pharmaceutical companies

The National Health Surveillance Agency (Anvisa) published, in the edition of this Tuesday (18) of the Official Gazette of the Union (DOU), Resolution-RE No. 4,597, dated November 14, 2025. The document approves requests from the pharmaceutical companies Prati-Donaduzzi and Promediol do Brasil for changes in the quality control protocols of their Cannabidiol-based products.

The measure, signed by the General Management of Medicines of the agency, authorizes changes related to tests, specification limits, and analytical methods used in the quality control of the finished product.

In the case of Prati-Donaduzzi, the authorization covers various presentations of the Cannabidiol product, including oral solutions of 20 mg/mL, 50 mg/mL, and 200 mg/mL. The resolution confirms the sanitary validity of these products ranging between 18 and 24 months, depending on the concentration and specific presentation (bottles accompanied by one or more dosing syringes).

For Promediol do Brasil, the change refers to the Cannabidiol Promediol product at a concentration of 200 mg/mL (drop solution), with a validity period set at 24 months.

Both requests were registered under subject code 11542 (Cannabis Product - Change related to tests, specification limits, and analytical methods). The resolution comes into effect on the date of its publication.