Resolution from Anvisa for the manufacture and sale of Cannabis products published in the Official Gazette

The Resolution of the Collegiate Board of Anvisa regarding the production and sale of Cannabis-based products in Brazil (No. 327) was published in the Official Gazette of the Union this Wednesday (11). The rules will come into effect 90 days from this date.

The regulation will be reviewed within 3 years due to the technical-scientific stage of Cannabis-based products worldwide, the agency reported.

The text outlines the procedures for granting Sanitary Authorization for manufacturing and importing, and establishes requirements for the commercialization, prescription, dispensing, monitoring, and inspection of Cannabis products for medicinal purposes.

Lawyer Giovanni Prudente Sorbello, a specialist in Public and Regulatory Law, considered the published regulation restrictive, both in terms of usage and product disclosure:

"Although it is a significant advancement for the country, the published regulation is somewhat restrictive; for example, only products administered orally or nasally will be authorized for regularization, excluding all other forms."

"Additionally, cosmetics, smoking products, health products, and food based on Cannabis and its derivatives have been excluded from the scope of regulation. There is also a restriction on any type of advertising and promotion of products formulated with Cannabis."

Understand the new regulation  

How will it work? 

A category called “Cannabis-derived products” has been created. These products will receive a Sanitary Authorization from Anvisa to be marketed in Brazil, exclusively in pharmacies and drugstores. 

Furthermore, such products cannot be prepared in compounding pharmacies, and their indication will be exclusively by a medical professional. 

What forms will be accepted for these products? 

Cannabis derivatives may be produced for oral and nasal administration, in immediate-release forms. 

Why product and not medication? 

The rule for registering new or innovative medications requires clinical research capable of proving the efficacy of these products, in addition to other requirements for their classification as medication. 

The current technical-scientific stage of Cannabis-based products worldwide would not be sufficient for their approval as medications.

The new category will allow patients in Brazil to access these products. 

When does it take effect? 

The regulation will come into effect 90 days after its publication. Only after this period will Anvisa begin to receive requests from companies interested in marketing Cannabis-derived products in Brazil. 

What type of prescription will be made? 

The rules vary according to the concentration of tetrahydrocannabinol (THC). In formulations with THC concentrations of up to 0.2%, the product must be prescribed using a type B prescription, with numbering provided by the local Health Surveillance and renewal of the prescription within 60 days. 

Products with THC concentrations above 0.2% may only be prescribed to terminal patients or those who have exhausted therapeutic treatment alternatives. In this case, the prescription will be type A, valid for 30 days, provided by the local Health Surveillance, similar to the standard for morphine, for example. 

What about exceptional imports? 

Imports of Cannabis-derived products, such as cannabidiol, remain authorized. To request this authorization, it is necessary to access the Federal Government's service page. Check the electronic form to request authorization for exceptional import of cannabidiol. 

Who will be able to produce? 

National or foreign companies will be able to explore this market. National manufacturers may import semi-finished raw materials for manufacturing in national territory. 

Companies wishing to request Sanitary Authorization for Cannabis products must meet nine specific requirements: 

1. Operating Authorization (AFE) issued by Anvisa with the activity of manufacturing or importing medication. 
2. Special Authorization (AE). 
3. Good Manufacturing Practices Certificate (CBPF) for medications for the manufacturing company of the product. 
4. Good Distribution and Storage Practices for medication. 
5. Technical and scientific rationale justifying the formulation of the Cannabis product and the route of administration. 
6. Technical documentation of the product's quality. 
7. Operational conditions to perform quality control analyses in Brazilian territory. 
8. Capacity to receive and address notifications of adverse effects and technical complaints about the product. 
9. Knowledge of the concentration of the main cannabinoids present in the formulation, including CBD and THC, and the ability to justify the development of the Cannabis product.