On May 15, 2019, Health Canada released the third publication of the Guidance Document: Certificates of Supplementary Protection. The changes reflect organizational changes at Health Canada, a third version of the Certificate of Supplementary Protection application form and updates to the fee payment instructions.
Related Publications & Articles
-
Medical devices updates: mandatory use of the regulatory enrolment process for medical devices and updated guidance documents related to the regulatory enrolment process
Health Canada released a notice to industry on April 24, 2026, outlining that manufacturers must use the Regulatory Enrolment Process (REP) and Common Electronic Submission Gateway (CESG) for medical ...Read More -
Health Canada seeks feedback on phased implementation of the incorporated by reference list for Ministerial Reliance Order
As previously reported, Health Canada has proposed a Ministerial Reliance Order that would allow Health Canada to rely on decisions of foreign regulatory authorities (FRAs). Health Canada has proposed...Read More -
Health Canada finalizes biosimilar guidance: comparative clinical efficacy studies not typically required
In Canada, biosimilar products are approved by way of a new drug submission, following Health Canada guidance first released in 2010 and significantly revised in 2016.Read More
