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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Title (French) Ligne directrice : Propriétés de résistance à l'altération de produits pharmaceutiques opioïdes
Update Frequency as_needed
Geographic Scope []
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Sensitivity Level unrestricted
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Data Dictionary
Open Canada Date Published 2017-05-18 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["document d'orientation", "formulations inviolables", "médicament opioïde", "inviolabilité", "produits opioïdes à libération contrôlée", "pré-commercialisation", "présentations de drogue"], "en": ["guidance document", "tamper-resistance formulations", "opioid drug", "tamper-resistance", "controlled-release opioid products", "pre-market", "drug submissions"]}
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