The Latini Group began in 2017 Latini consolidation of a group of companies that offer a range of services to identify and meet the needs of the world market strategically. Today is world reference in the development of regulatory processes, manufactures, nationalizes, import and export products according to the best use and needs of each client with efficiency and agility.
Our expertise allows minimizing market risks to the commercial ticket through quality and regulatory standards for highly trained professionals and in tune with the technological innovations supported by research, publications, works with institutions and important national and international partnerships. This initiative was created to Copacabana Holding: multi-service company with a proposal to offer the world market solutions to promote the commercial ticket between Nations and add value to products and services sold.
The Brazilian Regulatory Authority (ANVISA) published the regulation RDC 327/2019, determining the technical requirements that technical dossiers for Cannabis-based Products should contain for future analysis by the Agency. This new legislation should be in force in 90 days from the date of publication in the Brazilian Official Gazette. This approval by ANVISA creates a class of products, i.e. those based on Cannabis spp. Read more...
After the Meeting of the Collegiate Board (DICOL) of the National Health Surveillance Agency (ANVISA), on Dec/03/19, the medicinal use of Cannabis sp. products was approved. The next step is the publication by ANVISA of the Collegiate Board Resolution (RDC), which will standardize the rite of registration of these products, determining the technical requirements that technical dossiers should contain for future analysis by the Agency. Once published, the Collegiate Board Resolution (a.k.a. RDC) should be in force in 90 days from the date of publication in the Brazilian Official Gazette. This approval by ANVISA creates a class of products, i.e. those based on Cannabis sp.
Regulatory Requirements for Companies to Hold the Market Approval
Companies that will submit the registration processes to market Cannabis sp. products in the future, must meet the following regulatory requirements:
Regulatory Requirements for Cannabis sp. based Products:
Regulatory Requirements for the Prescription of Cannabis sp. Products:
Handling of Cannabis sp. Products:
Planting Cannabis Sativa L. :
It is forbidden to plant Cannabis sativa L. throughout the Brazilian territory, according to Ordinance SVS/MS no. 344/98, List E, adhering, Item 1.
Ordinance SVS/MS no. 344/98 (Prescription Products Controlled by ANVISA)
Ordinance SVS/MS no. 344/98 was updated on Dec/03/19, through RDC no. 325/19. Cannabidiol is listed in List C1 (item 23) and Tetrahydrocannabinol is listed in List F2 (item 139).
Technical annotations on these pharmaceutical active ingredients are described as follows:
Want to register Cannabis sp.-based products in Brazil? Contact us:
The World Health Organization (WHO) has warned countries neighbouring Brazil of the risk of yellow fever. The occurrence of the disease in animals in the states of Roraima (which borders Venezuela), Mato Grosso do Sul (which has a border with Argentina) and Paraná (close to Argentina and Paraguay) "represents a virus circulation risk to these countries, especially in the areas with the same ecosystem," says the bulletin released last Friday (3 February).