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:

• the seriousness of the risk assessed
• the role of the HPRC in relation to other activities planned to manage the risk
• the nature of the product, in terms of the extent of its use in the general population and the size of the population that is impacted
• the information gaps or inadequate reach of previous communications or parallel risk management activities (for example, product recall)
• the general awareness, familiarity or existing information related to the risk being communicated and any social sensitivities (for example, deaths involved, impact on vulnerable populations, actions taken by other regulators)

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

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