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Instructions for Accreditation of Foreign Pharmaceuticals/Quasi-drug Manufacturers
Local Title:
医薬品及び医薬部外品に関する外国製造業者の認定及び登録申請等の取扱いについて
Country/Region:
Japan
Status:
In force
Type:
Regulation
Release Date:
2021-04-28
Implementation Date:
2021-04-28
Competent Authority:
Ministry of Health, Labour and Welfare
Document:
Summary

A foreign manufacturer intending to manufacture quasi-drugs in foreign countries and export them to Japan is required to be accredited by the MHLW as an “Accredited Foreign Manufacturer”.

On April 28, 2021, MHLW updated the Instructions for Accreditation of Foreign Pharmaceuticals/Quasi-drug Manufacturers (hereafter referred to as "the Instructions"), which mainly deals with prompt accreditation approval.

This Instructions came into force upon issuance, and the original Instructions which was implemented on Oct. 8, 2010 became invalid automatically.

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History
Instructions for Accreditation of Foreign Pharmaceuticals/Quasi-drug Manufacturers
Date of Release: 2021-04-28
Date of Implementation : 2021-04-28
Status : In force
Standards for Accreditation of Foreign Quasi-drug Manufacturers
Date of Release: 2015-06-26
Date of Implementation : 2015-06-26
Status : In force