Anvisa rectifies RDC No. 1,015 and adjusts labeling rules for cannabis products

The National Health Surveillance Agency (Anvisa) published this Tuesday (4) in the Official Gazette of the Union (DOU), a rectification of the Collegiate Board Resolution (RDC) No. 1,015, which had been disclosed on Monday (3) and reported yesterday by the Sechat portal. The correction makes specific adjustments to the wording of provisions related to labeling of cannabis products and magistral manipulation of cannabidiol (CBD) preparations.

The rectification does not alter the substance of the standard or its regulatory objectives, but clarifies formal obligations, especially regarding the information that must appear on the primary and secondary packaging of the products.

Changes in labeling requirements

In the original version of RDC No. 1,015, articles 21 and 22 stipulated that both the primary and secondary packaging must include, mandatorily, the name of the product and the name of the company holding the Health Authorization.

With the rectification, Anvisa removed the requirement to identify the company at these stages, establishing that only the name of the product should appear on the primary packaging and on the front face of the secondary packaging. This measure reduces regulatory redundancies and aligns the standard with other labeling guidelines already in force in the pharmaceutical sector.

Magistral manipulation of CBD remains authorized

Another point adjusted was article 72, which deals with the manipulation of magistral preparations. Anvisa maintained the authorization for compounding pharmacies to use, as the active pharmaceutical ingredient (API), exclusively the phytomedicine CBD obtained from Cannabis sativa L., in accordance with specific regulations to be issued by the agency.

The change was of a formal nature, involving punctuation, with no practical impact on the regulatory content already established.

Legal certainty and regulatory predictability

The publication of the rectification reinforces Anvisa's commitment to legal certainty, normative clarity, and predictability for companies, healthcare professionals, and patients who depend on medicinal cannabis-based products in Brazil.

The corrected text does not replace the certified version of the Official Gazette, but officially becomes part of RDC No. 1,015, consolidating the new regulatory framework announced this week.