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

May 15, 2019

Our reference number: 19-105716 - 691

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

Since September 21, 2017, the Office of Patented Medicines and Liaison, within the Office of Submissions and Intellectual Property (OSIP), has administered sections 104 to 134 of the Patent Act and the Certificate of Supplementary Protection Regulations (“CSP Regulations”). OSIP continues to administer these provisions, and meanwhile has undergone an organizational reporting change. Effective October 1, 2018, OSIP has joined the Resource Management and Operations Directorate (RMOD) within the Health Products and Food Branch at Health Canada. This organizational change has been reflected in the publication of this Guidance Document.

A new third version of the Certificate of Supplementary Protection (CSP) application form is now available for use effective immediately, which reflects changes described in this notice.

Please note that the “Method of Payment” field on the CSP application form has now been deleted. The Advance Payment Details form is required to provide a description of the method of payment used to pay the prescribed fee.

Accordingly, Fee Payment Instructions have been updated on the CSP application form and in the Guidance Document.

We take this opportunity to remind applicants of the three requirements for filing a CSP application, which is also provided in amended section 2.2.1 of the Guidance Document:

  1. complete the CSP application form online and submit the information from the form saved in .xml format
  2. complete and submit the “Advance Payment Details for Drug Submissions and Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protection Applications” form (“Advance Payment Details” form), and
  3. pay the required fee

Questions or concerns related to this Guidance Document should be directed to the Office of Patented Medicines and Liaison at:

E-mail: hc.opml-bmbl.sc@canada.ca

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