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Carla Moraes

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Carla Moraes is an associate in Baker McKenzie Sao Paulo office, in partnership with Trench Rossi Watanabe.

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).