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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
Expert Translation AI Translation View Official Documents

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

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