International

Brazil: Anvisa authorizes the import of 249 cannabis derivatives. 5 are THC

Published

4 years ago

October

Photo: Marcelo Camargo - Agência Brasil

The National Health Surveillance Agency (Anvisa) has approved 249 cannabis derivatives for importation into Brazil, of which five have THC and the remaining CBD. The authorized products follow a new resolution, with simpler rules for individual importation by Brazilian patients, but Anvisa clarifies that "it did not evaluate the effectiveness, quality or safety of the products", referring to the legislation of the countries of origin. See the complete list of authorized brands at the end of the news.

The list of authorized cannabis products was sent by Anvisa exclusively to the portal Cannabis & Health, in early October, and includes the brands that will have automatic agency approval for individual importation by patients in Brazil. There are 249 products from dozens of different brands, most from Europe and the United States, but also from brands operating abroad. Of these, only 5 products have THC. Almost all products are oils and extracts, but there are also some creams, lotions and a spray.

The new rules were motivated by the demand of patients, which has skyrocketed in recent times. In six years, there was an increase of more than 2.400% in the number of requests, or 400% per year. If in 2015 there were 900 requests, last year that number was 20 thousand. Currently, the waiting list is around three thousand patients. For automatic approval, the products must appear on the list published by Anvisa.

The new directive defines criteria and procedures that become automatic for importation by individuals “for their own use, upon medical prescription”. The automation of cadastral approval, however, has not yet been implemented and will be published on the Anvisa website.

Anvisa clarifies that it has not evaluated the effectiveness, quality or safety of the products
In the document, it can be read that “it should be clarified that the products listed here were analyzed by Anvisa only with regard to minimum criteria of regularity of the producer and distributor establishment with the competent authority in their country of origin for production activities, distribution or marketing, as determined by Art. 4 of RDC No. 335/2020, transcribed below. It is noteworthy that these are products without registration at Anvisa and that have not seen their efficacy, quality or safety evaluated by the Agency”.

The Resolution of the Collegiate Board of Directors RDC 570/2021 should reduce the time for approval of the registration by up to 5 days. According to the text, the registration approval will take place through a simplified analysis and only by the Controlled Products Management and no longer by other departments.

According to the text, new companies may enter this list, if approved by the agency. “The product to be imported must be produced and distributed by establishments duly regulated by the competent authorities in their countries of origin for production, distribution or marketing activities”, the document reads.

SEI_ANVISA - 1630517 - Cannabis Technical Note (1)

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[Disclaimer: Please note that this text was originally written in Portuguese and is translated into English and other languages using an automatic translator. Some words may differ from the original and typos or errors may occur in other languages.]

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