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ANVISA RDC

RDC 850/2024

GMP Certificate Extension for MDSAP Manufacturers
BrazilANVISAGMP/QMSEffective April 1, 2024
Official source linked
What this code is

RDC 850/2024 is ANVISA Collegiate Board Resolution 850/2024. 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
English
Open the issuing-authority text
ANVISA-hosted English text; confirm legal effect against the current official Portuguese publication.
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2 articles · 2 language versions
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Direct citations can link to an article, for example /data/regulations/brazil/rdc-850-2024.en.html#art-1.
Dates
Published
March 22, 2024
Effective
April 1, 2024
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Each version has stable article 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 text2 articles · English — ANVISA translationRead HTML →Portuguese full text2 articles · Portuguese — official textRead HTML →
About this regulation

GMP Certificate Extension for MDSAP Manufacturers

Amends Article 8 of RDC 497/2021 so qualifying Good Manufacturing Practices certificates granted through MDSAP are valid for four years, subject to continued participation in MDSAP.

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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