Health Canada has issued the first Certificates of Supplementary Protection (CSPs) against the following approvals: neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily A/neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily B (Pfizer’s TRUMENBA), letermovir (Merck’s PREVYMIS), and guselkumab (TREMFYA)(see: Register of Certificates of Supplementary Protection). In addition, the CSP application fee as of April 1, 2018 is $9,192.
Related Publications & Articles
-
Health Canada releases its Statistical Report 2024/2025 for PMNOC Regulations, data protection and CSPs
On July 25, 2025, the Office of Patented Medicines and Liaison of Health Canada released its Statistical Report 2024/2025 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection...Read More -
Health Canada aims to reduce red tape by increasing international collaboration, alignment and reliance
In July 2025, the Government of Canada launched a “Red Tape Review” across all federal departments to modernize regulatory frameworks and support economic growth.Read More -
Medical devices updates: new Health Canada guidance for determining medical device application type and Medical Devices Directorate performance reports released
In August 2025, Health Canada released the Guidance for determining medical device application type.Read More