Brazil Issues Its First Authorization For The Manufacturing Of A Cannabis-Based Product

By Sylvia Muñoz Campo and Marian Venini via El Planteo.

On Wednesday, Brazil announced in its DOU (Federal Official Gazette), that ANVISA, Brazil's National Health Surveillance Agency,  will allow the manufacturing and marketing of the first cannabis-containing phytopharmaceutical product, with up to 0.2% of THC content.

While ANVISA had approved the creation of a new classification for cannabis products in December, the law only took effect on March 10. And, it was only this Wednesday that the DOU (Federal Official Gazette) disclosed the first manufacturing and marketing permit.

The new proposal speeds up the manufacturing and marketing of cannabis products. Prior to this measure, their import could take a long time, with a high expense for patients.

The measure represents Brazil’s big entrance in the South American legal cannabis market, andalso means the country could position itself as one of the big players in the region.

A Step Forward

It took ANVISA 35 days to evaluate and finally pass the first product approval. The measure represents a great achievement, and a sign of the impact Brazil has in the region: in spite of not getting there first and of the difficult times the country is facing due to the COVID-19 pandemic.

Brazil does allow the prescription of cannabidiol when there are no other therapeutic options available on the market. Its use falls under the responsibility of the prescribing physician, who must inform the patient of all risks and regulation conditions. According to the Brazilian government, the physician must also clarify that cannabis is not a medicine.

According to ANVISA’s website, it is also mandatory that either the patient or their legal representative sign an Informed Consent Form about the use of the cannabis product in question.

Why Is Cannabis Not Considered Medicine Under The Law?

Under current regulations for new and breakthrough drugs, cannabis is not considered as medicine in Brazil. This is due to the fact that these regulations demand the implementation of clinical trials to prove the efficacy of the potential drug, among other requisites.

As we all know, there still isn’t much information and research about the subject. In such a new legal landscape, this type of data is unavailable. Brazil remains, like many other nations, in a technical and scientific stage. This implies that the current data is not enough for cannabis to be legally classified as medicine. The creation of a new classification aims for quicker access and lower costs for patients (these costs could go up to 2000 reales, or about USD$360).

The import of cannabidiol products is still in effect. Patients must apply for licensing through the Federal Government Services’ webpage, as an exceptional import.

This news not only reaffirms Brazil’s presence as a big player in the industry. It also proves that, despite difficulties, the cannabis industry is undeniably essential.

The preceding article is from our Spanish language partner, El Planteo. It does not represent the opinion of Benzinga and has not been edited.