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ANVISA IN

IN 290/2024

Leveraging Foreign Regulatory Authorizations (AREE)
BrazilANVISARegistrationEffective June 3, 2024
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What this code is

IN 290/2024 is ANVISA Normative Instruction 290/2024. A Normative Instruction details how an RDC is applied — procedures, timelines, or documentary requirements. It does not replace the parent RDC.

Instrument
IN
Full name
Instrução Normativa
Category
Registration
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English
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ANVISA-hosted English text; confirm legal effect against the current official Portuguese publication.
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17 articles · 2 language versions
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Dates
Published
April 8, 2024
Effective
June 3, 2024
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Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

English full text17 articles · English — ANVISA translationRead HTML →Portuguese full text17 articles · Portuguese — official textRead HTML →
About this regulation

Leveraging Foreign Regulatory Authorizations (AREE)

Establishes an optimized analysis procedure for Class III/IV marketing authorization petitions by using assessments from Equivalent Foreign Regulatory Authorities (AREE/EFRA), including FDA, Health Canada, Japan, and Australia TGA.

A Normative Instruction details how an RDC is applied — procedures, timelines, or documentary requirements. It does not replace the parent RDC. Always confirm the current consolidated text and transition provisions with the official source before filing.

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