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

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 (395.25 KB, 23 pages)

Details and history

Published: September 21, 2017

Updated: 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.