The Minister of Health, Labour and Welfare is to establish guidelines for securing the stable supply of supply security pharmaceuticals and the raw materials or materials recognized as indispensable for their manufacture (hereinafter referred to as "supply security pharmaceuticals, etc.") (hereinafter referred to as the "guidelines for securing stable supply").
厚生労働大臣は、供給確保医薬品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「供給確保医薬品等」という。）の安定的な供給の確保を図るための指針（以下「安定供給確保指針」という。）を定めるものとする。
The guidelines for securing stable supply are to prescribe the following particulars:
安定供給確保指針においては、次に掲げる事項を定めるものとする。
the basic direction concerning securing the stable supply of supply security pharmaceuticals, etc.;
供給確保医薬品等の安定的な供給の確保に関する基本的な方向
particulars concerning measures to prevent the occurrence of supply shortages of supply security pharmaceuticals, etc.;
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の施策に関する事項
particulars concerning manufacture or importation in the case where a supply shortage of supply security pharmaceuticals, etc. occurs; and
供給確保医薬品等の供給不足が発生した場合における製造又は輸入に関する事項
other important particulars concerning securing the stable supply of supply security pharmaceuticals, etc.
その他供給確保医薬品等の安定的な供給の確保に関する重要事項
When the Minister of Health, Labour and Welfare has established or amended the guidelines for securing stable supply, the Minister is to publish them without delay.
厚生労働大臣は、安定供給確保指針を定め、又はこれを変更したときは、遅滞なく、これを公表するものとする。
"Supply security pharmaceutical" in paragraph (1) means a specified pharmaceutical that the Minister of Health, Labour and Welfare, after hearing the Health Sciences Council, designates as having a high necessity of securing its stable supply, in consideration of the following particulars:
the degree of severity of the symptoms in the case of contracting the disease for which it is used;
その用途に係る疾病にかかつた場合の病状の程度
the existence or non-existence of a specified pharmaceutical or treatment method that can substitute for the specified pharmaceutical;
当該特定医薬品と代替性のある特定医薬品又は治療方法の有無
the existence or non-existence of special technology required for its manufacture, the supply situation of raw materials or materials, and other particulars to be noted regarding its manufacture or supply; and
その製造に要する特別の技術の有無、原料又は材料の供給事情その他の製造又は供給に関して留意すべき事項
other particulars specified by an Order of the Ministry of Health, Labour and Welfare.
その他厚生労働省令で定める事項
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