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ANVISA RDC

RDC 497/2021

GMP and Distribution/Storage Certification Procedures
BrazilANVISAGMP/QMSEffective June 1, 2021
Official source linked
What this code is

RDC 497/2021 is ANVISA Collegiate Board Resolution 497/2021. A Collegiate Board Resolution is ANVISA’s primary binding regulation. The number is sequential within the year (RDC 751/2022 is resolution 751 issued in 2022).

Instrument
RDC
Full name
Resolução da Diretoria Colegiada
Category
GMP/QMS
Source links
Authority source
Portuguese
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Authority publication; confirm whether a later amendment or consolidated version applies.
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44 articles · 1 language version
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Direct citations can link to an article, for example /data/regulations/brazil/rdc-497-2021.pt.html#art-1.
Dates
Published
May 26, 2021
Effective
June 1, 2021
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Portuguese full text44 articles · Portuguese — official textRead HTML →
About this regulation

GMP and Distribution/Storage Certification Procedures

Administrative procedures for granting Good Manufacturing Practices certificates and Good Distribution and/or Storage Practices certificates. Article 8 amended by RDC 850/2024 to extend MDSAP-linked certificates from 2 to 4 years.

A Collegiate Board Resolution is ANVISA’s primary binding regulation. The number is sequential within the year (RDC 751/2022 is resolution 751 issued in 2022). Always confirm the current consolidated text and transition provisions with the official source before filing.

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