Guidance to market authorization holders on issuing health product risk communications: Timelines

The timeline to develop and disseminate an HPRC should be based on an assessment of the risk associated with a health product. The lead directorate and the MAH should discuss the level of urgency associated with a particular risk and select an appropriate timeline before initiating the HPRC process. Some factors that contribute to determining urgency may include:

Depending on the risk issue and the urgency to communicate, the timeline for issuing an HPRC can range from 2 days for urgent issues to 25 working days for standard HPRCs.  The RCS will work with MAHs to develop a critical path for each HPRC, on a case-by-case basis, based on the level of urgency.

To help MAHs visualize the sequence and timelines associated with HPRC development, Health Canada has developed 3 HPRC timelines based on the different levels of urgency.  

Health product risk communication timelines

Table 1: Standard health product risk communication (HPRC) (20 to 25 business days)
Days 0-4 Days 5-8 Days 9-12 Days 13-16 Days 17-19 Day 20 Day 21 Days 22-25
MAH prepares and submits first draft to Health Canada (HC) HC reviews draft and requests revisions from market authorization holder (MAH) MAH incorporates revisions and submits draft for HC approval HC conducts approvals MAH translates HPRC HC verifies translation MAH provides signed copies of HPRC Dissemination
Table 2: Expedited HPRC (2 to 10 business days)
Day 1 Days 2-4 Day 5 Days 6-7 Day 8 Day 9 Day 10
MAH prepares and submits first draft to HC HC reviews draft and requests revisions from MAH MAH incorporates revisions and submits draft for HC approval HC conducts approvals MAH translates HPRC and HC verifies MAH provides signed copies of HPRC Dissemination
Table 3: Urgent HPRC (less than 48 real-time hours)
Hours 0-12 Hours 13-19 Hours 20-23 Hours 24-32 Hours 33-39 Hours 40-43 Hours 44-47
MAH prepares and submits first draft to HC HC reviews draft and requests revisions from MAH MAH incorporates revisions and submits draft for HC approval HC conducts approvals MAH translates HPRC and HC verifies MAH provides signed copies of HPRC Dissemination

Additional rounds of revision (requests and responses) may cause delays in the process.

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