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Henrique Kruger Frizzo

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His area of expertise is Public Law, Government Affairs and Regulatory, with focus on consultancy matters. Mr. Frizzo is recognized by Chambers & Partners as a leading Individual in Public Law. He elaborates legal opinions and responds to consultations on the areas of expertise, including public tenders and contracts with the government, concession and public-private partnership contracts. Has experience in complex negotiations with the government and in the alignment of strategies to meet the local content requirements in public tenders. Assist clients in the regulatory area, especially pharmaceutical, medical devices and health areas. Also acts in procurements in the defense area, including the negotiation of offset arrangements. He is a speaker in events related to compliance in contracts with the government and regulatory.

The National Health Surveillance Agency published Resolution RDC No. 625/2022, which provides the minimum requirements related to the marketing authorization holders’ obligation to communicate the implementation of a drug recall to the competent authorities and consumers. This is in case there is sufficient evidence or proof of quality deviation resulting in risks or consequences to health, as well as due to the cancellation of registration related to safety and efficacy.

How do life sciences companies intend to leverage new and existing sources of growth? Explore the trajectory of life sciences transactions in our latest report.

As digital transformation reshapes business models with different emphases across regions, digitally enabled strategies are helping companies transition from product-only offerings to product-service hybrids, orient to patient mapping, pre-diagnostics solutions and enhancing treatment administration.

The Brazilian National Health Surveillance Agency (“Anvisa”) published Resolution RDC No. 497/2021 (“RDC 497/2021”) setting forth the new administrative procedure for obtaining the Good Manufacturing Practices Certificate, as well as the Good Distribution and/or Storage Practices Certificate. RDC 497/2021 modifies the general conditions for certification, as provided for in its Chapter II, to facilitate the certification process.

The Brazilian federal government published on 10 March: (a) Federal Law No. 14,124/2021, for providing for exceptional measures related to the acquisition of vaccines and other services related to COVID-19; and (b) Federal Law No. 14,125/2021, for providing for liability and adverse events of post-vaccination against COVID-19, and for the acquisition and distribution of vaccines by private entities and federative entities (state or municipality).