Paulo Rosito has more than 25 years of experience acting as an in-house counsel in legal departments of big companies of the pharmaceutical, agribusiness and aviation areas, with time spent on private practice in the intellectual property area. He acts strategically in consultive and litigation cases of the Life Sciences area, especially in governmental interactions and relations with a variety of authorities, for example, ANVISA (Brazilian regulatory agency), CMED (Brazilian pharmaceutical price authority) and CONITEC (the Brazilian health technology assessment instrumentality). Due his vast experience, he has worked in a number of negotiation, drafting and review of agreements and contracts both strategic or routine and has an extensive experience in all areas of compliance, such as structuring of policies and procedures (SOPs), investigations and multidisciplinary legal advice.
- Specialist in Corporate Law by PUC-SP (2000);
- Law Decree by PUC-SP (1998).
- Member of the Board of Directors of Blue Health Participações S.A.
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.