December 4, 2019
The Brazilian Health Regulatory Agency (ANVISA) unanimously approved Brazil’s new Regulation on the use of cannabis for medicinal purposes. ANVISA’s approval includes the registration and marketing of cannabidiol-based products (CBD-based) in pharmacies. The new regulation, that will be issued as a Resolution of the Collegiate Board (RCD), shall undergo a reevaluation within three years.
The Agency, however, did not approve the cultivation of cannabis in the country, considering this as a matter of “criminal law”. This second decision was not unanimous (3 votes against the proposal and 1 in favour).
The regulatory procedure conducted by the Agency has already observed the Federal Government’s new direction on the improvement of regulation quality in Brazil. As an example, the regulatory change came after public hearings and consultations held by ANVISA in 2019. Social participation, involving the medical community, patients and public authorities were strictly observed during the procedure. One of the main concerns that was considered for the approval of the new regulation is the heavy bureaucracy previously required to import CBD-based products.
The decision creates a new class of products in the Brazilian pharmaceutical market. The CBD-based product must observe all the necessary requirements for its regularization, considering the quality parameters defined by the regulation that will soon be published by the agency. The approved regulation requires the company interested in manufacturing cannabis medicines to have specific operating permits, in addition to a certificate of good manufacturing practices issued by ANVISA.
ANVISA’s Directors, during the meeting, emphasized that those products cannot yet be defined as "drugs/medicines" because there is insufficient scientific evidence on the efficacy and safety of these products, as proposals for cannabis-based products resemble traditional drug procedures. Under the proposed regulation, companies should continue to conduct scientific research to prove the efficacy and safety of plant-based products.
The cannabis-based products are going to be sold exclusively in pharmacies or drugstores upon presentation of a prescription. Manufacturers who choose to import cannabis substrate for the manufacturing of the product should, according to ANVISA, import semi-prepared raw materials. That is, the company cannot import the plant or part of it.
The new regulation comes into force 90 days after its publication in the Official Gazette. In the next weeks, following the publication of the new regulation final text, we will highlight the requirements for product registration and the requirements provided by the Agency.