Notice: Publication of the Guidance Document: Certificates of Supplementary Protection

May 12, 2023
Our reference number: 23-102693 - 530

Health Canada is pleased to announce the fifth publication of the Guidance Document: Certificates of Supplementary Protection.

Since September 21, 2017, the Office of Patented Medicines and Liaison (OPML), within the Office of Submissions and Intellectual Property, has administered sections 104 to 134 of the Patent Act and the Certificate of Supplementary Protection Regulations (CSP Regulations).

The definition of "authorization for sale" in subsection 1(2) of the CSP Regulations has been amended. The Guidance Document: Certificates of Supplementary Protection has now been amended to reflect this change and to reflect current administrative practices, such as aligning the definition of a filing date with the Management of Drug Submissions and Applications Guidance Document and how to provide a Certificate of Supplementary Protection application and related correspondence.

Questions or concerns related to this Guidance Document should be directed to the OPML at: E-mail: opml-bmbl@hc-sc.gc.ca