Submitting risk management plans draft guidance document: Canadian-specific addendum template

Name: Submitting risk management plans draft guidance document: Canadian-specific addendum template
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

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.