Following this year’s announcements of Certificates of Supplementary Protection (CSP) in Canada, the first transitional period has ended. Applicants had a transition period of two years to submit for their CSP in Canada. This period is now closed (as of 21 September 2018), meaning a CSP for a New Drug Submission (NDS) must now take place within 12 months.
Additionally, a CSP application must be submitted within 120 days of marketing authorisation being awarded by Health Canada.
A report on these updates is available from Smart & Biggar Fetherstonhaugh.