Description

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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Name	Format	Description	Link
Guidance Document: Tamper-resistance Formulations of Opioid Drug Products	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/tamper-resistance-formulations-opioid-drug-products.html
Guidance Document: Tamper-resistance Formulations of Opioid Drug Products	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/proprietes-resistance-alteration-produits-pharmaceutiques-opioides.html

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