URGENT: Anvisa to discuss regulation of medicinal marijuana on June 11

26/03/2026 09h42

The National Health Surveillance Agency has scheduled a Public Ordinary Meeting for June 11, 2019, to discuss the public consultation of two processes that could change the regulation of medicinal cannabis in Brazil.

The agency's president, William Dib, who also serves as the rapporteur on the topic, called for a debate on two public consultation proposals:

Public consultation proposal on technical and administrative requirements for the cultivation of Cannabis spp for medicinal and scientific purposes and other provisions
Public consultation proposal on the specific procedure for registration and monitoring of medicines based on Cannabis spp, its derivatives, and synthetic analogs.

Sechat had previously reported exclusively on May 14, through an interview with Anvisa's director Renato Porto, that regulations for cannabis cultivation and medicine production would be released later this year.

Porto told Sechat: "I believe there is already a foundation of studies, and I will just reconfirm that Anvisa only deals with products related to health. That is our evaluation focus. I would also like to make it clear that we do not address any legislative options - whether to decriminalize marijuana or not. Having said that, I must remind you that we started in 2013 and 2014 with this issue and had a discussion regarding the prohibition or non-prohibition of cannabidiol.

Cannabidiol is a component of a plant that has over 480 components. So, cannabis is truly a distinct plant, let's say. It is not a common plant. That is why the whole world has been studying it for a long time. Well, based on that, we concluded that this product should not be prohibited in Brazil because it was prohibited until then. So, in 2014, we removed it from the prohibition list of Ordinance 344, which evaluates drugs, controlled substances, and more. So we removed it. From then on, every Brazilian citizen can buy medications containing cannabidiol, but not manufactured in Brazil - which is a deficiency we want to address. So, those who have the prescription can import this product. Therefore, the patient would no longer be without assistance. So, the path was as follows: How do I provide assistance to people who want to import this product? Want to have access to this product that science already recommends, through various studies, and that the World Health Organization (WHO) already classifies this product as a possible therapy, if I'm not mistaken, for over 39 diseases. So, we could not neglect this product. So today, patients in Brazil are supported by a controlled process where we approve products containing substances from this plant."

Porto adds: "Every innovative regulatory path, which breaks some boundaries, starts with a more controlled process. Only after that, the product is released, but first it needs to be controlled. Understand the effects, understand if people are using it correctly. How do I introduce a new technology released to the consumer without study, control? So this generates data, information. For what? Which medications are being used the most? Anvisa is attentive and using all its means to provide Brazilians access to this type of product. What would be the next frontier? We are about to manufacture this product... What have we been discussing? How are we going to break this second barrier? Which is the barrier of production for research. Can people produce to make medications? These are questions that have already arisen for us. So when I say it can be produced, what can it be produced for? Ah... to manufacture in Brazil. But there is no one today wanting to manufacture in Brazil, so can I let the plant be grown here and then export? Maybe not the plant, but the extract, or an input?"