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The National Health Surveillance Agency (Anvisa) approved this Wednesday (10) a resolution that makes official the rules of the new Law 14,124 / 2021, approved by Congress and sanctioned by President Jair Bolsonaro (no party).
Among the changes, Anvisa confirmed that states, municipalities and the private sector can import drugs and vaccines against Covid-19, even those that are not approved for use in Brazil.
In this case, according to the agency, the interested party must demonstrate that the drug or vaccine has been classified in their country of origin as indicated to treat the new coronavirus disease. Phase 3 testing or interim results also need to be completed.
The Anvisa board also made the new term official. The agency now has to analyze within seven days a request for the emergency use of a vaccine against Covid-19 that has been approved by one agency among a list of the main ones in the world.
The legislation sanctioned by President Jair Bolsonaro also establishes the permission for the Union, the states and the municipalities to assume civil responsibility for the possible secondary effects of vaccines. This is a requirement of the pharmaceutical company Pfizer, which is negotiating the sale of the immunizer it developed with BioNTech to Brazil.
More lead time for butantan
Anvisa also approved the extension of the deadline for the Butantan Institute to complete the studies on the Coronavac vaccine and present them to the entity. The delivery of the studies is part of the requirements of Anvisa when the emergency use of the vaccine was authorized in January.
The deadline expired on February 28. Butantan requested and Anvisa authorized that the results be delivered before April 30. The institute stated that some of the tests must be repeated and that there was a delay in the importation of inputs necessary for the process.
