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Home Coronavirus STF authorizes import without Anvisa registration

STF authorizes import without Anvisa registration


The STF (Supreme Federal Court) formed a majority to maintain the injunction of Minister Ricardo Lewandowski that allows states and municipalities to buy international vaccines even though the immunizers have not yet registered with Anvisa (National Health Surveillance Agency).

Lewandowski’s preliminary injunction was issued in December. In the understanding of the minister, states and municipalities can import and distribute vaccines if Anvisa does not approve, within 72 hours, after requesting the laboratories responsible for the drugs. The minister emphasizes in his decision that this applies to “immunizers that have registered (approved for use on a large scale) in renowned health organizations”.

At the beginning of last year, Congress passed a law that established a 72-hour deadline for Anvisa to comment on the use of vaccines that were registered with regulatory health agencies such as the American, European, Japanese and Chinese.

In Anvisa’s evaluation, 72 hours is a short period for analysis. Today, the agency approved the registration of the first vaccine in the country, by Pfizer, but the federal government has been negotiating for the purchase of the immunizer stuck since last year and has no doses to apply.

In the preliminary injunction, the minister had considered that states and municipalities can import and distribute immunizers “in the case of non-compliance with the National Plan for Operationalization of Vaccination against covid-19, recently made public by the Union, or in the event that it does not provide coverage timely and sufficient immune system against the disease “.

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The minister’s decision is a response to two questions made to the court: one sent by the Brazilian Bar Association (OAB) and the other by the state of Maranhão. The process is on virtual trial and each minister can express his decision until 11:59 pm today.

As of today, Minister Edson Fachin, Alexandre de Moraes, Marco Aurélio, Gilmar Mender, Dias Toffoli and Cármen Lúcia followed the rapporteur’s understanding.

The rapporteur considered that the pandemic killed hundreds of thousands of people in the country and revealed “the weaknesses and virtues of our form of governance”, especially in the public system responsible for ensuring fundamental rights to life and health.

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“It is in this context, amplified by the magnitude of the pandemic resulting from Covid-19, that it is required, more than ever, a strongly proactive performance of public agents at all levels of government, especially through the implementation of universal vaccination programs”, he wrote Lewandowski in his vote.

Lewandowski had considered, in the preliminary injunction, that the command of the Ministry of Health over the National Immunization Plan does not exclude the powers of states and municipalities to adapt vaccination to local realities.






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Source link
https://noticias.uol.com.br/saude/ultimas-noticias/redacao/2021/02/23/maioria-do-stf-autoriza-importacao-de-vacinas-sem-registro-da-anvisa.htm


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