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I plan to launch a product on the Brazilian market, but I don’t know if it needs to be licensed by ANVISA

Several categories of products are regulated by ANVISA: medicines, cosmetics, food, tobacco products, Cannabis-derived products, blood derivatives, pesticides, medical devices, etc. The establishments that import, manufacture, distribute, store, process and sell the products are also regulated by ANVISA.

ANVISA is the Brazilian Health Authority, whose purpose is to promote the protection of the population’s health, through the sanitary control of the production and consumption of products and services subject to sanitary surveillance, including environment, processes, inputs and related technologies, as well as the control of ports, airports, borders and customs facilities. Visit https://www.gov.br/anvisa/pt-br

Several categories of products are regulated by ANVISA: medicines, cosmetics, food, tobacco products, Cannabis-derived products, blood derivatives, pesticides, medical devices, etc.

The establishments that import, manufacture, distribute, store, process and sell the products are also regulated by ANVISA.

As one can imagine, each category holds different requirements and degrees of complexity, which must be analyzed in order to be approved by ANVISA. By analyzing the product, we can define whether it is regulated by ANVISA.

Picture of Adriana Paes Leme

Adriana Paes Leme

Adriana holds a degree in Pharmacy with Qualification in Industry from UFRJ (Rio de Janeiro, Brazil) and in Law from Universidade Estácio de Sá (Rio de Janeiro, Brazil); MBA in Business Management from IBMEC (Rio de Janeiro, Brazil); LL.M student in Data Privacy, Cybersecurity, Data Management and Leadership, at the University of Maastricht- The Netherlands (2022-2024) More than 20 years of professional experience developed in the pharmaceutical industry with focus on Regulatory Affairs.

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