EFDA EFDAEFDA/GDL/042 Version No: 003
EFDA/GDL/042 Version No: 003 is the official EFDA identifier for “Guidelines on Reliance for Medicine Marketing Authorization (EFDA/GDL/042)”. EFDA/GDL/042 Version No: 003 is the official identifier EFDA uses for this instrument.
- Instrument
- EFDA
- Full name
- EFDA/GDL/042 Version No: 003
- Category
- General
- Authority source
- English
- Readable HTML
- 20 articles · 1 language version
- Published
- 2024-12-02
- Effective
- 2024-12-02
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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.
Guidelines on Reliance for Medicine Marketing Authorization (EFDA/GDL/042)
EFDA's reliance guideline: when the Authority will take account of a decision or an assessment already made by a trusted regulator instead of assessing the application itself, the reliance pathways it recognises, and the documentation a reliance application needs. Version 003, approved 02/12/2024 and effective the same day, first issued 20/12/2021, with version 002 effective 01/01/2024. It is NOT a device instrument: it is written for medicines marketing authorization, and it is filed in this market because it is an EFDA reliance instrument in the declared set and because reliance policy is read across product lines — the batch triage note described the lead as a device text, and this record corrects that in its own summary rather than by omission. Its body prints sections 11 and 13 unnumbered where the contents numbers them, and prints "10.1. Application Submission" only in the contents; the extract follows the body.
EFDA/GDL/042 Version No: 003 is the official identifier EFDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.