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

November 16, 2023
Our reference number: 23-102693 - 530

Health Canada is pleased to announce the sixth 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).

Changes to the Certificate of Supplementary Protection (CSP) application process have been made in light of a new payment option available to CSP applicants. As a result of the changes, the use of the Advance Payment Details for Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protections Applications form (Advance Payment Details Form) has been discontinued. In order to continue to meet regulatory requirements, applicants must pay the fee and include both their unique CSP Customer Number and the method of payment on the CSP application form.

To this end, a new version of the CSP application form is now available for use effective immediately, which reflects the changes described in this notice.

The CSP application form has been amended to remove references to the Advance Payment Details Form, to include the mandatory "Method of Payment" drop-down field, and to include a mandatory "CSP Customer Number" field. CSP Customer Numbers are used to reconcile payments made with related CSP applications. In order to ensure the Minister has sufficient information to process the CSP application, applicants must include their CSP Customer Number in the new field of the CSP application form. Applicants should contact the OPML in advance of their CSP application filing deadline in order to obtain a CSP Customer Number or to confirm their existing CSP Customer Number, if it is not known. It may take up to five business days to provide CSP Customer Number information.

Application filing instructions have been updated on the CSP application form and in the Guidance Document. Health Canada takes this opportunity to inform applicants of the two requirements for filing a CSP application, which are also provided in section 2.2.1 of the Guidance Document:

1. Pay the required fee
2. Complete the CSP application form online, including the description of the method of payment used to pay the fee, and submit the information from the form saved in.xml format

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