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Guide Manual for Adverse Event Reporting
Local Title:
Annex I, part 15 GUIDE MANUAL FOR ADVERSE EVENT REPORTING
Country/Region:
Malaysia
Competent Authority:
National Pharmaceutical Regulatory Agency
Type:
Regulation
Status:
In force
Release Date:
2022-07-19
Implementation Date:
2022-08-01
Document
Language Source Title Access
EN
 Official Annex I, Part 15 Guide Manual for Adverse Event Reporting
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Summary

This is a guide for cosmetic notification holders (CNH) to report to the NPRA when an adverse event occurs, regardless of the source of the report (consumer, healthcare professional, etc.).

Main Content

  1. DEFINITIONS AND TERMINOLOGIES

  2. WHO SHOULD THE INDUSTRY REPORT TO?

  3. WHAT SHOULD BE REPORTED?

  4. WHEN TO REPORT AN ADVERSE EVENT?

  5. APPENDIX 1

History
2022-07-19
Guide Manual for Adverse Event Reporting
In force
Release Date: 2022-07-19
Implementation Date : 2022-08-01
2017-02-01
Guide Manual for Adverse Event Reporting
Invalid
Release Date: 2017-02-01
Implementation Date : 2017-02-01
Noteworthy Information
User Guide