Guidance Document: Certificates of Supplementary Protection - summary

From Health Canada

Overview

This guidance document provides an overview of the certificate of supplementary protection (CSP) application process for applicants. This includes information on

• how to provide a CSP application
• the service standard for processing applications
• the roles and responsibilities of applicants and Health Canada

Please note our new CSP application form, which has been amended in light of a new payment option available to applicants, to remove references to the Advance Payment Details for Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protections Applications form (Advance Payment Details Form), to include the mandatory “Method of Payment” drop-down field, and to include a mandatory “CSP Customer Number” field. The use of the Advance Payment Details Form has been discontinued.

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, the applicant’s CSP Customer Number must be inputted in the new field of the CSP application form.

The Office of Patented Medicines and Liaison should be contacted in advance of a CSP application filing deadline in order to obtain a CSP Customer Number or to confirm an existing CSP Customer Number if it is not known. It may take up to five business days to provide CSP Customer Number information.

An agent must use the applicant’s CSP Customer Number when paying on behalf of the applicant.

Who this guide is for

• Owners of Canadian patents
• Canadian and foreign drug companies
• Canadian and foreign regulatory bodies

In this guide

• 1 Introduction
  • 1.1 Policy Objectives
  • 1.2 Policy Statements
  • 1.3 Scope and Application
  • 1.4 Background
• 2 Guidance for Implementation
  • 2.1 General
  • 2.2 Procedures
    • 2.2.1 Filing a CSP application
    • 2.2.2 Timing requirements and time sensitive requirements
    • 2.2.3 Initial Processing of CSP applications
    • 2.2.4 Conflict/priority scheme
    • 2.2.5 Issuance and rejection procedures
    • 2.2.6 Service standard
    • 2.2.7 Eligible Medicinal Ingredients
      • 2.2.7.1 Authorization for sale
      • 2.2.7.2 First authorization for sale in Canada
      • 2.2.7.3 Previous CSP
    • 2.2.8 Eligible Patents
    • 2.2.9 Correction of errors
    • 2.2.10 Reissuance procedure
  • 2.3 Scope of CSPs
  • 2.4 CSP ownership
  • 2.5 Completing the CSP application form

View complete guide
Download PDF (459 KB, 25 pages)

Details and history

Published: September 21, 2017

Updated: December 20, 2023; November 16, 2023; May 12, 2023; January 6, 2021; May 15, 2019; September 4, 2018

Part of topic(s): Guidance on Certificates of Supplementary Protection

For assistance

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