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.
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。
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.
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.
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.
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.
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