Submitting risk management plans draft guidance document: Canadian-specific addendum template

Submitting risk management plans draft guidance document: Canadian-specific addendum template A Canadian-specific addendum should address: risks or uncertainties that are unique to the Canadian context, and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. 2024-04-04 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyrisk management plansRMPsubmitting RMPrisksuncertainties of drug-productsprocedures to submitCanadian-specific addendum template Submitting risk management plans draft guidance document: Canadian-specific addendum templateHTML 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Submitting risk management plans draft guidance document: Canadian-specific addendum templateHTML 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

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.

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