Description

A Canadian-specific addendum should address: risks or uncertainties that are unique to the Canadian context, and measures that the manufacturer intends to take that are unique to the Canadian context.

Resources

Name	Format	Description	Link
Submitting risk management plans draft guidance document: Canadian-specific addendum template	HTML		https://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices/submitting-risk-management-plans/canadian-specific-addendum-template.html
Submitting risk management plans draft guidance document: Canadian-specific addendum template	HTML		https://www.canada.ca/fr/sante-canada/programmes/consultation-projet-reglementation-souple-lignes-directrices-homologation-medicaments-instruments-medicaux/presentation-plans-gestion-risques/modele-addenda-propre-contexte-canadien.html

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