MDD GN-03GN-03
GN-03 is the official MDD identifier for “Guidance Notes GN-03 - Guidance Notes for Adverse Event Reporting by Local Responsible Persons”. GN-03 is the official identifier MDD uses for this instrument.
- Instrument
- GN-03
- Full name
- GN-03
- Category
- Vigilance
- Authority source
- English
- Readable HTML
- 27 articles · 1 language version
- Published
- 2005
- Effective
- —
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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.
Guidance Notes GN-03 - Guidance Notes for Adverse Event Reporting by Local Responsible Persons
Adverse event reporting guidance for Local Responsible Persons under the MDACS, English expression GN-03:2025(E), edition 6.0 dated 2 January 2025 per the printed revision history. Covers the three basic reporting criteria, reportable use errors, exemption rules with serious-public-health override, reporting timeframes (10/30 elapsed calendar days by severity, follow-up final report within 30 days), and the reporting form; Appendices 1-3 carry worked reportable/non-reportable examples, exemption explanations, and the adverse event report form. Ingested from the exact official PDF including the revision-history table; sections 1-9 and Appendices 1-3 carry stable anchors.
GN-03 is the official identifier MDD uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.