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.
- Publisher - Current Organization Name: Health Canada
- Licence: Open Government Licence - Canada
Data and Resources
-
Guidance Document: Tamper-resistance Formulations of Opioid Drug ProductsHTMLEnglish publication HTML
-
Guidance Document: Tamper-resistance Formulations of Opioid Drug ProductsHTMLFrench publication HTML
Similar records