# 医療法 / Medical Care Act — 第六条の四の四 (Article 6-4-4) - Law: 医療法 (Medical Care Act), 昭和二十三年法律第二百五号 - English title "Medical Care Act": Ministry of Justice translation - Kind: Act — the distinction between 法律 (Act), 政令 (Cabinet Order), 省令 (Ministerial Order) and 条例 (local ordinance) decides who may issue it and what it may say. - Provision: 第六条の四の四 (Article 6-4-4) — address `art-6-4-4` - Text in force since: 2026-10-01 - URL (the page that opens at this provision): https://japanlaw.org/en/medical-care-act/art-6-4-4 - Permanent URL (e-Gov law ID, never renamed): https://japanlaw.org/l/323AC0000000205/art-6-4-4 - Every provision below carries its address and both URLs on the line under it. - Japanese text: e-Gov 法令検索, Digital Agency (デジタル庁). English: as marked on each line below. Only the Japanese as published by the government has legal effect; the text below is a copy of it. Every English rendering below is a translation and says which kind: the Ministry of Justice's translation, or this site's machine translation, whose model and date the Sources list names. They are never merged and never substituted for one another. --- ### 第六条の四の四 art-6-4-4 · https://japanlaw.org/en/medical-care-act/art-6-4-4 · https://japanlaw.org/l/323AC0000000205/art-6-4-4 **第一項** 厚生労働大臣は、医薬品、医療機器又は再生医療等製品（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（昭和三十五年法律第百四十五号）第二条第一項、第四項及び第九項にそれぞれ規定する医薬品、医療機器及び再生医療等製品をいい、専ら動物のために使用されることが目的とされているものを除く。以下この項及び第三項において同じ。）について、生産の減少その他の事情によりその供給が不足し、又は不足するおそれがあるため、医療を受ける者の利益が大きく損なわれるおそれがある場合には、当該医薬品、医療機器又は再生医療等製品について、同法第十四条第一項に規定する製造販売の承認を受けた者、同法第二十三条の二の五第一項に規定する製造販売の承認を受けた者又は同法第二十三条の二十五第一項に規定する製造販売の承認を受けた者（以下この条において「製造販売業者」という。）に対して、当該医薬品、医療機器又は再生医療等製品の生産、輸入、販売又は貸付けの状況について報告を求めることができる。 art-6-4-4/par-1 · https://japanlaw.org/en/medical-care-act/art-6-4-4/par-1 · https://japanlaw.org/l/323AC0000000205/art-6-4-4/par-1 If the supply of pharmaceuticals, medical device or regenerative medicine products (meaning the pharmaceuticals, medical device and regenerative medicine products prescribed respectively in Article 2, paragraphs (1), (4) and (9) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960), excluding those intended to be used exclusively for animals; the same applies hereinafter in this paragraph and paragraph (3)) is short or is likely to become short due to a decrease in production or other circumstances, and there is therefore a risk that the interests of medical care recipients will be significantly harmed, the Minister of Health, Labour and Welfare may request a person who has obtained approval for marketing prescribed in Article 14, paragraph (1) of that Act, a person who has obtained approval for marketing prescribed in Article 23-2-5, paragraph (1) of that Act, or a person who has obtained approval for marketing prescribed in Article 23-25, paragraph (1) of that Act (hereinafter referred to as "marketing authorization holder" in this Article) to report on the status of production, import, sale or lending of those pharmaceuticals, medical device or regenerative medicine products. machine translation, not official **第二項** 製造販売業者は、厚生労働大臣から前項の規定による求めがあつたときは、その求めに応じなければならない。 art-6-4-4/par-2 · https://japanlaw.org/en/medical-care-act/art-6-4-4/par-2 · https://japanlaw.org/l/323AC0000000205/art-6-4-4/par-2 A marketing authorization holder must comply with a request from the Minister of Health, Labour and Welfare pursuant to the provisions of the preceding paragraph. machine translation, not official **第三項** 厚生労働大臣は、第一項の規定に基づき製造販売業者から医薬品、医療機器又は再生医療等製品の生産、輸入、販売又は貸付けの状況について報告を受けた場合には、当該状況に関する情報を公表するものとする。 art-6-4-4/par-3 · https://japanlaw.org/en/medical-care-act/art-6-4-4/par-3 · https://japanlaw.org/l/323AC0000000205/art-6-4-4/par-3 If the Minister of Health, Labour and Welfare has received a report from a marketing authorization holder, based on the provisions of paragraph (1), on the status of production, import, sale or lending of pharmaceuticals, medical device or regenerative medicine products, the Minister is to make public information on that status. machine translation, not official --- ## Cites - art-6-4-4/par-1: 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（昭和三十五年法律第百四十五号）第二条第一項 → e-Gov law 335AC0000000145, 第二条第一項 (Article 2, paragraph (1)), art-2/par-1 — not held in this collection - art-6-4-4/par-1: 第四項 → e-Gov law 335AC0000000145, 第二条第四項 (Article 2, paragraph (4)), art-2/par-4 — not held in this collection - art-6-4-4/par-1: 第九項 → e-Gov law 335AC0000000145, 第二条第九項 (Article 2, paragraph (9)), art-2/par-9 — not held in this collection - art-6-4-4/par-1: この項 → 医療法 第六条の四の四第一項 (Article 6-4-4, paragraph (1)), art-6-4-4/par-1 — https://japanlaw.org/en/medical-care-act/art-6-4-4/par-1 · https://japanlaw.org/l/323AC0000000205/art-6-4-4/par-1 - art-6-4-4/par-1: 第三項 → 医療法 第六条の四の四第三項 (Article 6-4-4, paragraph (3)), art-6-4-4/par-3 — https://japanlaw.org/en/medical-care-act/art-6-4-4/par-3 · https://japanlaw.org/l/323AC0000000205/art-6-4-4/par-3 - art-6-4-4/par-1: 同法第十四条第一項 → e-Gov law 335AC0000000145, 第十四条第一項 (Article 14, paragraph (1)), art-14/par-1 — not held in this collection - art-6-4-4/par-1: 同法第二十三条の二の五第一項 → e-Gov law 335AC0000000145, 第二十三条の二の五第一項 (Article 23-2-5, paragraph (1)), art-23-2-5/par-1 — not held in this collection - art-6-4-4/par-1: 同法第二十三条の二十五第一項 → e-Gov law 335AC0000000145, 第二十三条の二十五第一項 (Article 23-25, paragraph (1)), art-23-25/par-1 — not held in this collection - art-6-4-4/par-1: この条 → 医療法 第六条の四の四 (Article 6-4-4), art-6-4-4 — https://japanlaw.org/en/medical-care-act/art-6-4-4 · https://japanlaw.org/l/323AC0000000205/art-6-4-4 - art-6-4-4/par-2: 前項 → 医療法 第六条の四の四第一項 (Article 6-4-4, paragraph (1)), art-6-4-4/par-1 — https://japanlaw.org/en/medical-care-act/art-6-4-4/par-1 · https://japanlaw.org/l/323AC0000000205/art-6-4-4/par-1 - art-6-4-4/par-3: 第一項 → 医療法 第六条の四の四第一項 (Article 6-4-4, paragraph (1)), art-6-4-4/par-1 — https://japanlaw.org/en/medical-care-act/art-6-4-4/par-1 · https://japanlaw.org/l/323AC0000000205/art-6-4-4/par-1 ## Cited by 4 provisions cite this one. No official source publishes this direction. - 医療法 第六条の四の四第一項 — https://japanlaw.org/en/medical-care-act/art-6-4-4/par-1 · https://japanlaw.org/l/323AC0000000205/art-6-4-4/par-1 - 医療法 第六条の四の四第二項 — https://japanlaw.org/en/medical-care-act/art-6-4-4/par-2 · https://japanlaw.org/l/323AC0000000205/art-6-4-4/par-2 - 医療法 第六条の四の四第三項 — https://japanlaw.org/en/medical-care-act/art-6-4-4/par-3 · https://japanlaw.org/l/323AC0000000205/art-6-4-4/par-3 - 医療法 第九十二条第一項 — https://japanlaw.org/en/medical-care-act/art-92/par-1 · https://japanlaw.org/l/323AC0000000205/art-92/par-1 --- ## Sources - e-Gov 法令検索, Digital Agency (デジタル庁) — 医療法 — the text in force from 2026-10-01 (https://laws.e-gov.go.jp/law/323AC0000000205/20261001_507AC0000000087), retrieved 2026-10-19 - Japanese Law Translation Database System, Ministry of Justice (法務省) — Medical Care Act — Ministry of Justice translation (https://www.japaneselawtranslation.go.jp/en/laws/view/4006/tb), retrieved 2026-10-19 - claude-sonnet-5-5 — Machine translation, batch medical-care-act-20261019T144711-001, translated 2026-10-20 - This site's parser, version 210 — 医療法 — structure, counts, cross-references and defined terms, computed 2026-10-19