Guidance to market authorization holders on issuing health product risk communications: Submission checklist for market authorization holders

Phase 1: Request and submission

• First draft of the HPRC
• Any graphics (for example, images, figures) to be included in the HPRC
• Copies of any medical or scientific literature referenced in the HPRC
• Copies of any risk communications issued within Canada or foreign jurisdictions that are related to the issue
• HPRC dissemination strategy (distribution list and method of dissemination)

Phase 2: Review and approval

• Subsequent draft HPRCs with MAH edits
• Translation of Health Canada approved HPRC
• Signed and dated copies of the final HPRC in both official languages (PDF format)

Phase 3: Dissemination, notification and evaluation

• Notification of dissemination including distribution list, method of distribution, date of issuance and dissemination results
• Recommended: Evaluation of the effectiveness of the HPRC (for example, reach, comprehension, usefulness)