Anvisa incorporates RDC 327 rules into Ordinance 344 and formalizes veterinary prescription of cannabis

The National Health Surveillance Agency (Anvisa) published, on Wednesday (26), the Resolution of the Collegiate Board of Directors (RDC) No. 999/2025. The measure updates Annex I of Ordinance SVS/MS No. 344/1998 and comes into effect on the date of its publication.

The rules for inspection and prescription, previously defined externally by RDC 327/2019, are now consolidated within the official lists of controlled substances. According to the text, the rules have been established in the official lists, ensuring greater legal certainty.

Among the main changes, new guidelines on the classification of products derived from Cannabis sativa and explicit permission for veterinary prescription stand out.

Veterinary prescription formalized by Anvisa

The new Annex 12 of List E (Proscribed Plants and Fungi) brings a significant change. The rule explicitly allows veterinarians authorized by the Federal Council of Veterinary Medicine (CFMV) to prescribe cannabis products and medications.

For this, it is necessary for the items to have Sanitary Authorization and to be regularized for commercialization in Brazil. According to Anvisa, the prescription must comply with the requirements for special control prescription notification, in accordance with current legislation and Decree No. 5,053/2004.

The resolution paves the regulatory way for the future market of specific veterinary products. The text includes in List A3 (Psychotropic Substances) veterinary products for medicinal purposes based on cannabis derivatives that are to be regularized with the Ministry of Agriculture and Livestock (MAPA).

Anvisa classification by THC content

Anvisa formalized in Ordinance 344 the control distinction based on Tetrahydrocannabinol (THC) concentration. This action "mirrors" what is already practiced in RDC 327:

List A3 (Yellow Prescription): Includes cannabis products with THC above 0.2%;

List B1 (Blue Prescription): Includes cannabis products with THC up to 0.2%.

Anvisa's determinations for inputs and other substances
A crucial point of attention for the industry and importers is the classification of pharmaceutical inputs. Anvisa determines that inputs in the forms of plant derivative, phytopharmaceutical, and bulk intended for the manufacture of cannabis products are subject to List A3 controls.

This rule applies to both human and veterinary products. The measure directly impacts the safety requirements for the storage and transportation of these loads.

Cannabidiol (CBD) remains on List C1 (Special Control). However, Anvisa's rule reiterates that this classification specifically applies to CBD obtained synthetically and free of other controlled components, except impurities.

In addition to the provisions on cannabis, RDC 999/2025 made other important movements. The substance Carisoprodol (muscle relaxant) was included in List B1 (Psychotropics), giving establishments a 60-day deadline for compliance. Meanwhile, Stiripentol (anticonvulsant) was included in List C1.