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Post-Market Safety Management Standards for Pharmaceuticals, Quasi Drugs, Cosmetics and Medical Devices: Report on Side Effects of Quasi-Drugs and Cosmetics
Local Title:
薬事法施行規則及び医薬品、医薬部外品、化粧品及び医療機器の製造販売後安全管理の基準に関する省令の一部を改正する省令の施行について(医薬部外品及び化粧品の副作用等の報告について)
Country/Region:
Japan
Competent Authority:
Ministry of Health, Labour and Welfare
Type:
Regulation
Status:
In force
Release Date:
2014-02-26
Implementation Date:
2014-04-01
Document
Language Source Title Access
JA
 Official Post-Market Safety Management Standards for Pharmaceuticals, Quasi Drugs, Cosmetics and Medical Devices: Report on Side Effects of Quasi-Drugs and Cosmetics
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Summary

On Feb. 26, 2014, Japan MHLW revised some provisions of the Post-Market Safety Management Standards for Pharmaceuticals, Quasi Drugs, Cosmetics and Medical Devices: Report on Side Effects of Quasi-Drugs and Cosmetics.

The standards specify the legal basis, terminologies, deadline, format and etc. of adverse reaction reports.

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