Submitting risk management plans draft guidance document: Opioid products

Opioid products need to include specific content within their RMP to address: the risk and uncertainties of opioid-related harms in Canada and other risks and uncertainties posed by the product, where warranted.

Données et ressources

Info additionnelle

Champ Valeur
Dernière modification avril 17, 2026, 17:33 (TU)
Créé le avril 17, 2026, 17:33 (TU)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2022-12-09 00:00:00
open_canada_keywords {"fr": ["plans de gestion des risques", "PGR", "soumission du PGR", "risques", "incertitudes des produits médicamenteux", "procédures de soumission", "produits opioïdes"], "en": ["risk management plans", "RMP", "submitting RMP", "risks", "uncertainties of drug-products", "procedures to submit", "opioid products"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Ébauche ligne directrice : Présentation des plans de gestion des risques : Produits opioïdes
update_frequency as_needed