# 医療法 / Medical Care Act — 第三十八条の二 (Article 38-2)

- 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: 第三十八条の二 (Article 38-2) — address `art-38-2`
- Text in force since: 2026-10-01
- URL (the page that opens at this provision): https://japanlaw.org/ja/medical-care-act/art-38-2
- Permanent URL (e-Gov law ID, never renamed): https://japanlaw.org/l/323AC0000000205/art-38-2
- 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.

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### 第三十八条の二
<sup>art-38-2 · https://japanlaw.org/ja/medical-care-act/art-38-2 · https://japanlaw.org/l/323AC0000000205/art-38-2</sup>

  **第一項**  厚生労働大臣は、重要供給確保医薬品等について、需要の増加又は製造数量の減少その他の事情により、現にその供給が不足し、又は重要供給確保医薬品等の需給の状況その他の状況から合理的に判断して、その供給が不足する蓋然性が特に高く、かつ、その供給の不足により、適切な医療の提供が困難になり、国民の生命及び健康に重大な影響を与えるおそれがあると認めるときは、当該重要供給確保医薬品等の製造販売業者又は製造業者に対し、安定供給確保指針に即して、厚生労働省令で定めるところにより、当該重要供給確保医薬品等の製造又は輸入に関する計画（以下この条において「製造等計画」という。）を作成し、厚生労働大臣に届け出るべきことを指示することができる。
  <sup>art-38-2/par-1 · https://japanlaw.org/ja/medical-care-act/art-38-2/par-1 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-1</sup>
  When the Minister of Health, Labour and Welfare finds that, due to an increase in demand, a decrease in the quantity manufactured or other circumstances, the supply of important supply security pharmaceuticals, etc. is actually in shortage, or the likelihood of its being in shortage is particularly high as reasonably judged from the state of supply and demand of the important supply security pharmaceuticals, etc. and other circumstances, and that, due to the shortage of supply, the provision of appropriate medical care would become difficult, which may seriously affect the lives and health of the people, the Minister may instruct the marketing authorization holders or manufacturers of the important supply security pharmaceuticals, etc., in line with the guidelines for securing stable supply and as provided by Order of the Ministry of Health, Labour and Welfare, to prepare a plan concerning the manufacture or importation of the important supply security pharmaceuticals, etc. (hereinafter referred to as a "plan for manufacturing, etc." in this Article) and to notify the Minister of Health, Labour and Welfare of it.
  <sup>machine translation, not official</sup>

  **第二項**  厚生労働大臣は、前項に規定する事態に対処するため特に必要があると認めるときは、同項の規定による指示に従つて届出をした製造販売業者又は製造業者に対し、安定供給確保指針に即して、その届出に係る製造等計画（次項の規定による変更の届出があつたときは、その変更後のもの。以下この条において同じ。）を変更し、厚生労働大臣に届け出るべきことを指示することができる。
  <sup>art-38-2/par-2 · https://japanlaw.org/ja/medical-care-act/art-38-2/par-2 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-2</sup>
  When the Minister of Health, Labour and Welfare finds it particularly necessary to deal with the situation prescribed in the preceding paragraph, the Minister may instruct a marketing authorization holder or manufacturer that has made a notification in compliance with an instruction under that paragraph, in line with the guidelines for securing stable supply, to change the plan for manufacturing, etc. relating to the notification (where a notification of change has been made pursuant to the provisions of the following paragraph, the plan after the change; the same applies hereinafter in this Article) and to notify the Minister of Health, Labour and Welfare of it.
  <sup>machine translation, not official</sup>

  **第三項**  前二項の規定による指示に従つて届出をした製造販売業者又は製造業者は、その届出に係る製造等計画を変更したときは、厚生労働省令で定めるところにより、変更した事項を厚生労働大臣に届け出なければならない。
  <sup>art-38-2/par-3 · https://japanlaw.org/ja/medical-care-act/art-38-2/par-3 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-3</sup>
  A marketing authorization holder or manufacturer that has made a notification in compliance with an instruction under the preceding two paragraphs must, when it has changed the plan for manufacturing, etc. relating to the notification, notify the Minister of Health, Labour and Welfare of the changed particulars, as provided by Order of the Ministry of Health, Labour and Welfare.
  <sup>machine translation, not official</sup>

  **第四項**  第一項又は第二項の規定による指示に従つて届出をした製造販売業者又は製造業者は、その届出に係る製造等計画に沿つて当該製造等計画に係る重要供給確保医薬品等の製造又は輸入を行わなければならない。
  <sup>art-38-2/par-4 · https://japanlaw.org/ja/medical-care-act/art-38-2/par-4 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-4</sup>
  A marketing authorization holder or manufacturer that has made a notification in compliance with an instruction under paragraph (1) or (2) must manufacture or import the important supply security pharmaceuticals, etc. relating to the plan for manufacturing, etc., in line with the plan relating to the notification.
  <sup>machine translation, not official</sup>

  **第五項**  厚生労働大臣は、第二項の規定による指示を受けた製造販売業者若しくは製造業者が正当な理由がなくその指示に従わなかつたとき、又は前項に規定する製造販売業者若しくは製造業者が正当な理由がなくその届出に係る製造等計画に沿つて当該製造等計画に係る重要供給確保医薬品等の製造若しくは輸入を行つていないと認めるときは、その旨を公表することができる。
  <sup>art-38-2/par-5 · https://japanlaw.org/ja/medical-care-act/art-38-2/par-5 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-5</sup>
  When the Minister of Health, Labour and Welfare finds that a marketing authorization holder or manufacturer that received an instruction under paragraph (2) has not complied with the instruction without justifiable grounds, or that a marketing authorization holder or manufacturer prescribed in the preceding paragraph has not, without justifiable grounds, manufactured or imported the important supply security pharmaceuticals, etc. relating to the plan for manufacturing, etc., in line with the plan relating to the notification, the Minister may make public that fact.
  <sup>machine translation, not official</sup>

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## Cites
- art-38-2/par-1: この条 → 医療法 第三十八条の二 (Article 38-2), art-38-2 — https://japanlaw.org/ja/medical-care-act/art-38-2 · https://japanlaw.org/l/323AC0000000205/art-38-2
- art-38-2/par-2: 前項 → 医療法 第三十八条の二第一項 (Article 38-2, paragraph (1)), art-38-2/par-1 — https://japanlaw.org/ja/medical-care-act/art-38-2/par-1 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-1
- art-38-2/par-2: 次項 → 医療法 第三十八条の二第三項 (Article 38-2, paragraph (3)), art-38-2/par-3 — https://japanlaw.org/ja/medical-care-act/art-38-2/par-3 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-3
- art-38-2/par-2: この条 → 医療法 第三十八条の二 (Article 38-2), art-38-2 — https://japanlaw.org/ja/medical-care-act/art-38-2 · https://japanlaw.org/l/323AC0000000205/art-38-2
- art-38-2/par-3: 前二項 → 医療法 第三十八条の二第一項 (Article 38-2, paragraph (1)), art-38-2/par-1 — https://japanlaw.org/ja/medical-care-act/art-38-2/par-1 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-1
- art-38-2/par-3: 前二項 → 医療法 第三十八条の二第二項 (Article 38-2, paragraph (2)), art-38-2/par-2 — https://japanlaw.org/ja/medical-care-act/art-38-2/par-2 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-2
- art-38-2/par-4: 第一項 → 医療法 第三十八条の二第一項 (Article 38-2, paragraph (1)), art-38-2/par-1 — https://japanlaw.org/ja/medical-care-act/art-38-2/par-1 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-1
- art-38-2/par-4: 第二項 → 医療法 第三十八条の二第二項 (Article 38-2, paragraph (2)), art-38-2/par-2 — https://japanlaw.org/ja/medical-care-act/art-38-2/par-2 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-2
- art-38-2/par-5: 第二項 → 医療法 第三十八条の二第二項 (Article 38-2, paragraph (2)), art-38-2/par-2 — https://japanlaw.org/ja/medical-care-act/art-38-2/par-2 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-2
- art-38-2/par-5: 前項 → 医療法 第三十八条の二第四項 (Article 38-2, paragraph (4)), art-38-2/par-4 — https://japanlaw.org/ja/medical-care-act/art-38-2/par-4 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-4

## Cited by

9 provisions cite this one. No official source publishes this direction.

- 医療法 第三十八条の二第一項 — https://japanlaw.org/ja/medical-care-act/art-38-2/par-1 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-1
- 医療法 第三十八条の二第二項 — https://japanlaw.org/ja/medical-care-act/art-38-2/par-2 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-2
- 医療法 第三十八条の二第三項 — https://japanlaw.org/ja/medical-care-act/art-38-2/par-3 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-3
- 医療法 第三十八条の二第四項 — https://japanlaw.org/ja/medical-care-act/art-38-2/par-4 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-4
- 医療法 第三十八条の二第五項 — https://japanlaw.org/ja/medical-care-act/art-38-2/par-5 · https://japanlaw.org/l/323AC0000000205/art-38-2/par-5
- 医療法 第三十八条の三第一項 — https://japanlaw.org/ja/medical-care-act/art-38-3/par-1 · https://japanlaw.org/l/323AC0000000205/art-38-3/par-1
- 医療法 第三十八条の六第一項 — https://japanlaw.org/ja/medical-care-act/art-38-6/par-1 · https://japanlaw.org/l/323AC0000000205/art-38-6/par-1
- 医療法 第八十九条第一項第四号 — https://japanlaw.org/ja/medical-care-act/art-89/par-1/item-4 · https://japanlaw.org/l/323AC0000000205/art-89/par-1/item-4
- 医療法 第八十九条第一項第五号 — https://japanlaw.org/ja/medical-care-act/art-89/par-1/item-5 · https://japanlaw.org/l/323AC0000000205/art-89/par-1/item-5

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## 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-20261019T151250-007, translated 2026-10-20
- This site's parser, version 210 — 医療法 — structure, counts, cross-references and defined terms, computed 2026-10-19