Court orders Anvisa to allow entry of cannabis-based product from company based in Curitiba

In the latest decision issued by Judge Vera Lúcia Feil, from the 4th Federal Court of Curitiba (PR), it was determined that the National Health Surveillance Agency (Anvisa) should allow the entry of a cannabis-based product for medicinal purposes. The company that made the request, based in the capital of Paraná and responsible for marketing the cannabidiol Mahara in Brazil, obtained the injunction on February 7.

The judge emphasized in her decision that the import authorization for the product should occur automatically, according to the regulations of RDC 660/2022, and that the company only became aware of the product's exclusion from Anvisa's system through a patient. This patient, when searching for the name in the form, did not find it.

The company claims to have a commercial agreement for the manufacturing of the product in the United States, being marketed in Brazil under the commercial name. It also argues that the importation procedure is regulated by Technical Note 65/2023 from Anvisa, which allows for the automatic issuance of the import authorization for products included in it. However, since December 2023, Anvisa has been denying all requests without providing justifications.

The company stated that it had submitted the documents requested by Anvisa regarding the manufacturing company in the USA, proving all necessary licenses. Nevertheless, it did not receive a response from the regulatory agency. Faced with this situation, the company sought the recognition of its right to import the product through a judicial request.

Judge Vera Lúcia Feil considered that the company pointed out illegal abuse by Anvisa, in denying the Mahara authorization requests without initiating a formal procedure or previously communicating the need to submit documents. She highlighted that the product is listed in Technical Note 65/2023, with no news of its revocation, and that the delay in analyzing the company's request constitutes abuse.

"The judicial decision only restored the possibility for Mahara patients to issue the import authorization automatically, as since 2020 the company has been included in Anvisa's technical note that allows for the immediate issuance of the authorization for the import of its product," says Ana Paula Rossi, CEO of Mahara.