Lucas Calabria is a member of the firm’s Life Sciences team and has wide experience in regulatory sanitary law, pharmaceutical industry compliance, and administrative litigation before the National Health Surveillance Agency (Anvisa) and other health authorities.
He provides legal counseling to clients in the pharmaceutical, food, medical devices, and cosmetics sectors.
- Post-graduate degree in Sanitary Regulatory Impact Analysis from Universidade Presbiteriana Mackenzie – 2021;
- Post-graduate degree in Sanitary Law from Faculdade Global (FG) – 2020;
- Post-graduate degree in Administrative Law from Fundação Getulio Vargas (FGV) – 2018;
- Professional Certificate in Healthcare Compliance by Colégio Brasileiro de Executivos da Saúde (CBEXs) – 2018;
- Bachelor of Laws from the Pontifical Catholic University of São Paulo (PUC-SP) – 2016.
- Chapter “Brazil” (coauthor) in: Getting the Deal Through – Life Sciences. London: Pharma & Medical Device Regulation, 2021.
Brazilian Telehealth act Comes Into Force
On December 28, 2022, Law No. 14,510/2022 (Telehealth Act), which authorizes the practice of Telehealth throughout the Brazilian territory, came into force. After lengthy discussion and approval by Congress, the President sanctioned the final wording of the Bill of Law 1,998/2020 without vetoes.
Anvisa opens a Public Consultation to propose authorization for the skinny label practice
As previously informed in the client alert sent on December 23, Anvisa opened a Public Consultation (PC 1,137/2022) to amend Resolution-RDC 47/2009 - which sets forth rules for the elaboration, harmonization, updating, publication, and availability of labels of medicines for patients and health care professionals.
Anvisa’s Board of Directors approved the opening of a Public Consultation to propose authorization for the skinny label practice
At the last meeting of 2022, held on December 22, Anvisa’s Board of Directors approved a Public Consultation to amend Resolution-RDC 47/2009 - which sets forth rules for the elaboration, harmonization, updating, publication, and availability of labels of medicines for patients and health care professionals.