When the Minister of Health, Labour and Welfare finds, as reasonably judged from the state of manufacture and other circumstances, that there is a likelihood that the supply of important supply security pharmaceuticals (meaning, among the supply security pharmaceuticals prescribed in paragraph (4) of the preceding Article, those that the Minister of Health, Labour and Welfare, after hearing the Health Sciences Council, designates as being particularly important to secure the stable supply of, in consideration of the particulars listed in the items of that paragraph) and the raw materials or materials recognized as indispensable for their manufacture (hereinafter referred to as "important supply security pharmaceuticals, etc.") will be in shortage, and that, if the supply were to be in shortage, 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. to prepare, in line with the guidelines for securing stable supply and as provided by Order of the Ministry of Health, Labour and Welfare, a plan concerning the measures necessary to prevent the occurrence of a supply shortage of the important supply security pharmaceuticals, etc. (hereinafter referred to as a "plan for measures to prevent supply shortages" 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（前条第四項に規定する供給確保医薬品のうち、同項各号に掲げる事項を勘案し、その安定的な供給の確保を図ることが特に重要なものとして、厚生労働大臣が厚生科学審議会の意見を聴いて指定するものをいう。）及びその製造に必要不可欠であると認められる原料又は材料（以下「重要供給確保医薬品等」という。）について、製造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あり、かつ、その供給が不足した場合には、適切な医療の提供が困難になることにより、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供給不足の発生を未然に防止するために必要な措置に関する計画（以下この条において「供給不足防止措置計画」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 measures to prevent supply shortages 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 measures to prevent supply shortages 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.
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、その届出に係る供給不足防止措置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。
A marketing authorization holder or manufacturer that has made a notification in compliance with an instruction under paragraph (1) or (2) must take the measures necessary to prevent the occurrence of a supply shortage of the important supply security pharmaceuticals, etc. relating to the plan for measures to prevent supply shortages, in line with the plan relating to the notification.
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、その届出に係る供給不足防止措置計画に沿つて当該供給不足防止措置計画に係る重要供給確保医薬品等の供給不足の発生を未然に防止するために必要な措置を行わなければならない。
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, taken the measures necessary to prevent the occurrence of a supply shortage of the important supply security pharmaceuticals, etc. relating to the plan for measures to prevent supply shortages, in line with the plan relating to the notification, the Minister may make public that fact.
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供給不足防止措置計画に沿つて当該供給不足防止措置計画に係る重要供給確保医薬品等の供給不足の発生を未然に防止するために必要な措置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。
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