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Minister Lewandowski’s decision applies to immunizers who do not have the analysis performed by the regulator 72 hours after registration.
STF authorizes the purchase and supply of vaccines without the approval of Anvisa
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12/17/2020 – 5:34 PM (Updated 12/17/2020 – 6:03 PM)
Minister Ricardo Lewandowski, of the STF (Supreme Federal Court), authorized this Thursday (17) that the States buy and supply vaccines against covid-19 even without the authorization of Anvisa (National Health Surveillance Agency).
The minister’s order is only valid for immunizers who do not have the analysis carried out by the regulator 72 hours after their official registration.
Read more: Barroso votes so that parents do not stop vaccinating children
“If this governmental agency does not issue the competent authorization within 72 hours, it will be able to import and distribute vaccines registered by at least one of the foreign health authorities and released for commercial distribution in the respective countries,” the minister wrote.
In his decision, Lewandowski cites Federal Law 13,979, signed in February, which provides for the granting of authorization by Anvisa within 72 hours after submitting the request to the agency. The norm does not require authorization from any other body of the Public Administration and determines the automatic authorization of the immunizer if the term expires without manifestation.
To date, no company has requested authorization for the emergency use of the covid-19 vaccine. The modality differs from the medical history, which establishes a series of restrictions. Last Monday (14), Anvisa said that it will analyze requests for emergency use of immunizers within ten days.
The National Plan for the Operationalization of Vaccination against covid-19 launched by the Ministry of Health foresees the immunization of 51.4 million people in the first half of 2021. The expectation is that the entire Brazilian population will be immunized in 16 months.
