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)
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