Notifying Health Canada of Foreign Actions - Guidance Document for Industry - Summary
From Health Canada
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
- The guide is intended for regulated parties (industry) who are affected by the regulation.
In this guide
- 1 Introduction
- 2 Interpretation
- 2.1 What kinds of foreign actions require authorization holders to notify Health Canada?
- 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?
Details and history
Published: July 12, 2018
Consulted: Canada Gazette Part I - 2017
Contact the Marketed Health Products Directorate to the attention of “Foreign Action Notifications”
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