RIO DE JANEIRO, BRAZIL – A resolution published by the Brazilian Health Regulatory Agency (ANVISA) aims to optimize the evaluation process for importing cannabis-based products for medical purposes.
According to the regulator, the goal of Collegiate Directive Resolution (RDC) 570/2021 is to reduce the time needed to approve the registration and enable patients to have faster access to these products.
To this end, it amends the wording of a previous RDC, number 335/2020, which had improved the population’s access to these products by defining criteria and procedures for imports by individuals “for their own use, under prescription from a legally qualified professional, for medicinal purposes.”
The growing demand for the importation of these products has led to a delay in ANVISA’s decisions, which, according to the agency, may impact patients’ health.
The number of requests has increased by over 2,400% in 6 years, corresponding to an average growth of 400% per year. In 2015 there were 896 requests. In 2020, the total stood at 19,074.
“And by mid-September 2021, there were 22,028 requests to import cannabis-based products by patients for therapeutic purposes,” ANVISA adds while reporting that the Covid-19 pandemic “aggravated the scenario, causing an even greater increase in requests to import these products.”
In a note, ANVISA explains that the new resolution establishes that approval of registration will occur “by simplified analysis in the case of cannabis-based products contained in a Technical Note issued by ANVISA’s Controlled Products Management and published on the agency’s website.”
Therefore, upon registration, only the product’s compliance will be assessed. “That is, if the product to be imported is produced and distributed by establishments duly regulated by the relevant authorities in their countries of origin for the activities of production, distribution or marketing,” the health regulator says.
ANVISA is also working on updating the systems, in order to enable the automatic approval of registration in the case of products included in a list pre-defined by the agency.
The qualified professional’s prescription term was also altered to 6 months. However, the rule provides that the product’s prescription will be valid indefinitely until the normative order issued by the Ministry of Health recognizing that the Public Health Emergency is no longer in effect.
“Imports remain subject to inspection by health authorities at ports, airports, borders, and customs areas prior to clearance,” ANVISA adds.
Among the documents required for import are the application form; bill of lading; commercial invoice; product prescription; and proof of the patient’s address.