Judge Vera Lucia Feil’s injunction determines release of the company’s cannabidiol after the company faces automatic denials from the regulatory agency
Published in 20/02/2024
In the last decision made by Judge Vera Lucia Feil, of the 4th Federal Court of Curitiba (PR), the, it has been determined that the National Health Surveillance Agency (Anvisa) releases the entry of a cannabis-based product for medicinal purposes. The company that made the request, based in the state capital and responsible for the commercialization of cannabidiol Mahara in Brazil, obtained the injunction on February 7.
The magistrate stressed in her decision that the issue of the import authorization of the product should occur automatically, according to the regulations of RDC 660/2022, and that the company only became aware of the exclusion of the product from the Anvisa system through a patient. The latter, when searching for the name on the form, did not find it.
The company claims to have a commercial agreement for the manufacture of the product in the United States, being marketed in Brazil under the trade name. It also argues that the import procedure is regulated by Anvisa Technical Note 65/2023, which allows the automatic issuance of import authorization for products inserted in it. However, since December 2023, Anvisa has denied all requests, without providing justification.
The company said it had sent the documents requested by Anvisa about the manufacturer in the US, proving all the necessary licenses. However, it did not receive a response from the regulatory agency. Given this situation, the company sought the recognition of its right to import the product through a judicial request.
Judge Vera Lucia Feil considered that the company pointed to illegal abuse by Anvisa, by rejecting applications for Mahara’s authorisation without opening a formal procedure or communicating in advance the need to submit documents. He pointed out that the product is listed in Technical Note 65/2023, there is no news of its revocation, and that the delay in analyzing the company’s request constitutes abuse.
“The court ruling only reinstated the possibility for Mahara patients to issue the import authorisation automatically, he said, since the year 2020 the company is inserted in the technical note of Anvisa that allows the immediate issuance of the authorization to import your product” says Ana Paula Rossi, CEO Mahara.
