MS / ANRP ArrêtéArrêté n°2013-542/MS/CAB
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
Arrêté n°2013-542/MS/CAB is the official MS / ANRP identifier for “Organisation du circuit de notification des effets indésirables des produits de santé à usage humain”. Arrêté n°2013-542/MS/CAB is the official identifier MS / ANRP uses for this instrument.
- Instrument
- Arrêté
- Full name
- Arrêté n°2013-542/MS/CAB
- Category
- Vigilance
- Source publication
- French
- Readable HTML
- 1 language version
- Published
- —
- Effective
- —
Open a language version
Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Organisation du circuit de notification des effets indésirables des produits de santé à usage humain
Complete substantive text on physical pages2–7 of a seven-page scan; physical page1 is visually blank and retained in the audit. Article1 expressly implements Decree2012-1033, whose Article2 includes medical devices and reagents. Defines notifiers, health-service notification routing and vigilance functions. Article14 requires specified research/health bodies to report relevant study events within7days for serious unexpected death/life-threatening cases,15days for other serious unexpected cases/new facts, and annual safety reports otherwise. Article15 separately addresses any enterprise or organization exploiting health products:15days serious events regardless predictability,90days unexpected nonserious events, and periodic safety reports otherwise. These actor categories and medicinal terminology are preserved as written, without converting them into a blanket duty for every device manufacturer. Signed4June2013; no latest-currentness conclusion. Later2020-160/275 expressly name different predecessor numbers543/544, not this542.
Arrêté n°2013-542/MS/CAB is the official identifier MS / ANRP uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.