On September 7 2017 the government published the final pharmaceutical regulations resulting from the Comprehensive Economic and Trade Agreement (for further details please see "Publication of final regulations on patent linkage and term restoration relating to CETA").(1)
The final regulations comprise:
- the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations 2017 (PMNOC regulations amendments); and
- the Certificate of Supplementary Protection (CSP) Regulations.
Both sets of regulations came into force on September 21 2017.
Health Canada has since published:
- a notice regarding the application of the PMNOC regulations amendments; and
- a guidance document outlining the application process under the CSP Regulations.
In addition, the Federal Court has published a practice notice regarding actions brought under the PMNOC regulations amendments.
For further information on this topic please contact Urszula Wojtyra or Nancy Pei at Smart & Biggar/Fetherstonhaugh's Toronto office by telephone (+1 416 593 5514) or email ([email protected] or [email protected]). Alternatively, please contact Daphne Lainson at Smart & Biggar/Fetherstonhaugh's Ottawa office by telephone (+1 613 232 2486) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
Endnotes
(1) A webinar on the new regulations is available here.