Description

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.

Resources

Name	Format	Description	Link
Submitting risk management plans draft guidance document: Opioid products	HTML		https://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices/submitting-risk-management-plans/opioid-products.html
Submitting risk management plans draft guidance document: Opioid products	HTML		https://www.canada.ca/fr/sante-canada/programmes/consultation-projet-reglementation-souple-lignes-directrices-homologation-medicaments-instruments-medicaux/presentation-plans-gestion-risques/produits-opioides.html

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