Notifying Health Canada of Foreign Actions - Guidance Document for Industry

Overview

This guidance document provides manufacturers, importers and other holders of instruments of market authorization under the Food and Drug Regulations (FDR) with information that may be useful in achieving compliance with the regulatory requirements of notification to Health Canada (HC) of foreign regulatory actions as outlined in sections C.01.050 (2)(a), (b) and (c) and C.01.050 (3) of the Food and Drug Regulations.

These provisions are intended to improve the collection and assessment of new relevant safety information in respect of any serious risk of injury to human health involving regulatory issues in foreign countries and help determine an appropriate response in Canada to these issues. As many drugs may be marketed years in advance or in higher volume in other countries, important safety signals may be detected earlier in a foreign jurisdiction.

Who this guide is for

1. The guide is intended for regulated parties (industry) who are affected by the regulation.

In this guide

• Foreword
• 1   Introduction
  • 1.1   Purpose
  • 1.2   Background
  • 1.3   Scope and Application
• 2   Interpretation
  • 2.1   What kinds of foreign actions require authorization holders to notify Health Canada?
    • 2.1.1   Quality-related issues examples:
    • 2.1.2   Other safety-related issues examples:
    • 2.1.3   Which foreign regulatory authorities are encompassed by the requirements?
  • 2.2   Key elements for consideration about serious risk
  • 2.3   What kind of information needs to be included?
  • 2.4   What is the process for notifying Health Canada of foreign actions?
  • 2.5   Language of notification reports
  • 2.6   Are regulated parties required to monitor foreign regulatory action?
  • 2.7   How will compliance be monitored and assessed?
  • 2.8   Will submitted information reports be publicly accessible?

View complete guide

Details and history

Published: July 12, 2018

Updated: November 20, 2018

Consulted: Canada Gazette Part I - 2017

For assistance

Contact the Marketed Health Products Directorate to the attention of “Foreign Action Notifications”