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Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (2018.12.30)
Local Title:
医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律施行令
Country/Region:
Japan
Competent Authority:
Ministry of Health, Labour and Welfare
Type:
Regulation
Status:
In force
Release Date:
2018-12-28
Implementation Date:
2018-12-30
Document
Language Source Title Access
JA
 Official Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (2018.12.30)
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ChemLinked Translation
Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (2018.12.30)
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Summary

The regulation (also known as "Implementation Order of Pharmaceutical and Medical Devices Law") contains provisions for the manufacture and marketing of cosmetics, quasi-drugs and pharmaceuticals.

The Cabinet hereby enacts this Cabinet Order pursuant to the provisions of Article 2, paragraph (4), Article 11 (including as applied mutatis mutandis pursuant to Article 38), Article 28, paragraph (2), Article 30, paragraph (3), Article 43, paragraph (2), Article 67, paragraph (1), Article 77, paragraph (3), Article 78, paragraph (1), Article 80 and Article 82 of the Pharmaceutical Affairs Act (Act No. 145 of 1960).

History
2018-12-28
Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (2018.12.30)
In force
Release Date: 2018-12-28
Implementation Date : 2018-12-30
2015-01-19
Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (English Version Available)
Invalid
Release Date: 2015-01-19
Implementation Date : 2015-04-01