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A Q&A guide to medicinal product regulation and product liability law in Brazil. The Q&A gives a high level overview of key … Medicinal product regulation and product liability in Brazil 2018

A Q&A guide to pharmaceutical IP and competition law in Brazil. The Q&A gives a high level overview of key issues including … Pharmaceutical IP and competition law in Brazil 2018

On 22 December 2017 came into force the National Sanitary Surveillance Agency’s (ANVISA) Service Orientation no. 43/2017 (OS 43/17), establishing objective and … New regulation for registration and posterior modifications of name of drugs and biological products before ANVISA

On April 17, 2018 the Superior Court of Justice had the opportunity to analyze the first Special Appeal addressing the term of … Brazilian Superior Court of Justice decides its first mailbox case

In a decision made available on the 7th of November, Judge of the Supreme Court Luiz Fux dismissed a lawsuit by which … Supreme Court dismisses lawsuit against rule that guarantees a minimum term for patent protection

The Ministry of Environment published the Ordinance # 01/2017 on the Official Gazette of October 13, which establishes November 6th as the date when SISGEN (a database that will allow parties to register their ABS activities) will start to operate. Moreover, the same ordinance established November 6th as the beginning of the deadline provided by Brazilian Biodiversity Act (Law # 13.123/2015) for parties to regularize their ABS activities.

The Ministry of Environment published on its website the new templates of Benefit Sharing Agreements in compliance with the Biodiversity Act (Law # 13.123/2015). In light of such Act, the one who carries out activities of research and development accessing Brazilian genetic resources and traditional knowledge must share the benefits arising out of such activities if they originated a finished product or reproductive resources.

The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports.

A Q&A guide to medicinal product regulation and product liability law in Brazil.

ANVISA has published, on 08/02/2017, in the Federal Register, the the Public Consultation 371/2017 to discuss the extension, from 5 to 10 … Medical Devices – ANVISA´s Public Consultation to extend the registration term