Anvisa has approved new regulations concerning products derived from cannabis for medical use. The regulation lists the legal requirements that companies must meet in order to receive marketing authorization. While the 0.2% Anvisa THC restriction mainly affects patients, it is necessary to register both 0.3% and 0.2% – a challenge that must be met by the cannabis industry that can be overcome.
Among the rules approved by the National Health Surveillance Agency for the production and sale of cannabis derivatives in Brazil, the Anvisa THC limit of 0.2% was highlighted. This is because the largest supply of THC products come from the United States where the restriction is 0.3%.
That little variation makes a big difference. Above 0.2%, a type-A prescription (yellow prescription) will be required with a 60-day renewal and numbering provided by the National Health Surveillance Agency.
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The Anvisa THC limit meets European standards
“The 0.3% limit questioned is related to the psychoactive effect of the cannabis plant. Generally, products that meet the 0.3% limit in North America are considered to have a non-psychoactive effect, while in the European community it would be 0.2%, as available in the World Health Organisation (WHO) document,” Anvisa clarified.
“As the norms for herbal medicines in Brazil have been in convergence process for some time with those of the European Community, it was decided as pertinent to follow the specification of the 0.2% Anvisa THC limit, considering that in that economic block the herbal medicines are regulated,” the Brazilian regulatory agency continued.
The agency pointed out that the Anvisa THC limit applied in the Brazilian standard does not constitute a prohibitive limit for products to be made available in the domestic market containing a higher concentration of THC.
The Anvisa THC limit could restrict the effectiveness of cannabis medication
“My son takes an oil with 0.22% THC. It will fall into the “yellow” category. Our family will remain hostages of authorization from Anvisa or, in the worst case, the manufacturer will decrease the THC in the oil that is actually working,” said filmmaker Rita Carvana, mother of a 13-year-old boy with epilepsy.
For Camila Teixeira, CEO of Indeov, a representative of North American medical cannabis companies in Brazil, there is a challenge regarding access to products from these two categories.
“The restriction is not absolute because the regulation also allows products with higher THC concentration. There is a need for an adequate concentration of products in order to keep the concentration below 0.2% so that the required prescription is blue for easier access instead of yellow,” said Teixeria.
Regulations affect patients
Viviane Sedola, CEO of Dr. Cannabis, believes that the Anvisa THC limit is a challenge that must be met by the industry.
“The 0.2% restriction mainly affects patients. Of course, 0.2% is a different percentage from other countries, so it’s something peculiar, but it’s a challenge that can be overcome,” said Sedola.
For HempMeds Brazil, the determination is not restrictive and does not generate commercial impacts. According to Medical Marijuana Inc., the company already produces products that meet this determination including 0% THC.
“We already have products that meet the Anvisa THC limit. Therefore, it is only a matter of adapting other requirements to take our cannabis-derived products to pharmacies,” HempMeds stated.
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