Amendment to Ordinance on Designated Substances and Medical Uses under the Pharmaceuticals and Medical Devices Act

AI summary

Generated by AI from the Japanese source metadata. It is an unofficial monitoring aid, not legal advice, and may contain errors. The area, stage, and impact labels are preliminary keyword-based triage labels. Confirm every point in the original Japanese source.

Summary

This is a Ministry of Health, Labour and Welfare ordinance (Reiwa 8 MHLW Ordinance No. 131) that partially amends the ordinance defining designated substances under Article 2, Paragraph 15, and medical uses under Article 76-4 of Japan's Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, and Other Products. According to the provided metadata, the amending ordinance has a promulgation date of 2026-08-18 and an enforcement date of 2026-08-28. The original ordinance is Heisei 19 MHLW Ordinance No. 14.

Business Impact

Businesses handling pharmaceuticals or regulated substances may need to check whether the amended list of designated substances or permitted medical uses affects their products or activities.

Recommended Action

Review the official Japanese ordinance via the e-Gov source to confirm the specific changes and their effective date.

Timeline of related official records

Related official records are linked only when names and instrument numbers match exactly, so this timeline may be incomplete. Dates are as stated by the official sources. It is a monitoring aid, not legal advice; the original Japanese sources are authoritative.

1. 2026-08-18 — Promulgated (instrument recorded by e-Gov Law Search) 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第二条第十五項に規定する指定薬物及び同法第七十六条の四に規定する医療等の用途を定める省令の一部を改正する省令（令和八年厚生労働省令第百三十一号） (this update) Original Japanese source
2. 2026-08-28 — Effective date stated by e-Gov Law Search 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第二条第十五項に規定する指定薬物及び同法第七十六条の四に規定する医療等の用途を定める省令 (this update) Original Japanese source