DPML DocumentDirectives pour le système national de pharmacovigilance au Burundi, décembre 2015
Système national de pharmacovigilance : directives et annexes de notification is published by Ministère de la Santé Publique et de la Lutte contre le Sida — Département de la Pharmacie, du Médicament et des Laboratoires. This document is identified by its title; no separate official document code is recorded.
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- Document
- Full name
- Directives pour le système national de pharmacovigilance au Burundi, décembre 2015
- Category
- Vigilance
- Source publication
- French
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- 1 language version
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Système national de pharmacovigilance : directives et annexes de notification
Complete 68-page ministry guidance supplied on ABREMA’s current vigilance-text page, with its seven annexes and reporting tools. Its pharmaceutical-product definition includes laboratory/IVD reagents, dressings, devices and consumables, and section II.5 expressly includes medical-device incidents. Much of the clinical material remains medicine-specific. The original DPML-era institutional names and December 2015 edition are retained; read responsibilities with the 2021 ABREMA decree. Diagram and form pages are preserved as original figures, with OCR where the PDF contains image-only form fields. The misleading source filename 'texte_vigilance_publicite' is not a separate advertising regulation or a new 2026 edition.
This document is identified by its title; no separate official document code is recorded. Always confirm the current consolidated text and transition provisions with the official source before filing.