Guide Manual for Adverse Event Reporting

Local Title

Annex I, part 13 GUIDE MANUAL FOR ADVERSE EVENT REPORTING

Country/Region

Malaysia

Competent Authority

National Pharmaceutical Regulatory Agency

Type

Regulation

Status

Invalid

Release Date

2017-02-01

Implementation Date

2017-02-01

Expert Translation

AI Translation

View Official Documents

Summary

History

Noteworthy Information

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

DEFINITIONS AND TERMINOLOGIES
WHO SHOULD THE INDUSTRY REPORT TO?
WHAT SHOULD BE REPORTED?
WHEN TO REPORT AN ADVERSE EVENT?
APPENDIX 1

Guide Manual for Adverse Event Reporting

In force Release Date: 2022-07-19 Implementation Date: 2022-08-01
Guide Manual for Adverse Event Reporting

Invalid Release Date: 2017-02-01 Implementation Date: 2017-02-01