Will Health Canada update the Summary Basis of Decision documents to include post-market information or new uses as they are approved?
No. The SBDs will be “frozen” to reflect the information that supported the original decision to authorize the product. Subsequent submissions reviewed for additional uses (Supplemental Drug Submissions or Application for a Medical Device Licence Amendment) will not be captured under Phase I of the SBD implementation strategy, but this may be considered for future phases. Readers seeking post-market information should also consult the MedEffect Canada Web site.
