Notice: ICH Guidance on Reporting Adverse Reactions to Marketed Health Products

Name: Notice: ICH Guidance on Reporting Adverse Reactions to Marketed Health Products
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

Notice: ICH Guidance on Reporting Adverse Reactions to Marketed Health Products is an open dataset from Health Canada with 2 files (HTML); catalogue record updated 2023-12-02. On CanQuery you can follow the original downloads. Files are available in English and French.

Health Canada has implemented the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance: E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting via our Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products, which took effect on March 3, 2011.

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2023-12-02

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

Notice: ICH Guidance on Reporting Adverse Reactions to Marketed Health Products (French, HTML) HTML · Download HTML
Notice: ICH Guidance on Reporting Adverse Reactions to Marketed Health Products (English, HTML) HTML · Download HTML

Related open data

Health Canada