Guidance Document: Tamper-resistance Formulations of Opioid Drug Products

This guidance document is specific to the "tamper-resistance" feature of controlled-release opioid products. It is intended for the pre-market review of drug submissions when sponsors seek to obtain approval for controlled-release opioid drug formulations with tamper-resistant properties and wish to include, in product monographs, scientific statements and claims regarding tamper-resistance.

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Champ Valeur
Dernière modification avril 17, 2026, 17:29 (TU)
Créé le avril 17, 2026, 17:29 (TU)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2016-03-30 00:00:00
open_canada_keywords {"fr": ["Document d'orientation", "formulations inviolables", "propriétés d'inviolabilité", "produits médicamenteux opioïdes", "formulations médicamenteuses opioïdes à libération contrôlée", "produits opioïdes à libération contrôlée", "présentations de drogue", "monographies de produits"], "en": ["Guidance document", "tamper-resistance formulations", "tamper-resistant properties", "opioid drug products", "controlled-release opioid drug formulations", "controlled-release opioid products", "drug submissions", "product monographs"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Ligne directrice : Propriétés de résistance à l'altération de produits pharmaceutiques opioïdes
update_frequency as_needed