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ANMAT Disposición

Disposición 8194/2023

Good Technovigilance Practices
ArgentinaANMATVigilanceEffective September 28, 2023
What this code is

Disposición 8194/2023 is the official ANMAT identifier for “Good Technovigilance Practices”. Disposición 8194/2023 is the official identifier ANMAT uses for this instrument.

Instrument
Disposición
Full name
Disposición 8194/2023
Category
Vigilance
Source links
Authority source
Spanish
Authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
23 articles · 1 language version
Direct citations can link to an article, for example /data/regulations/argentina/disp-8194-2023.es.html#art-1.
Dates
Published
September 28, 2023
Effective
September 28, 2023
Readable full text

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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.

About this regulation

Good Technovigilance Practices

Post-market technovigilance duties for registration holders, including adverse-event and quality-failure definitions, reporting, and field safety actions.

Disposición 8194/2023 is the official identifier ANMAT uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.