When the Minister of Health, Labour and Welfare finds that the supply of a specified pharmaceutical (meaning a specified pharmaceutical prescribed in Article 2, paragraph (17) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices; the same applies hereinafter) is in shortage, or is likely to be in shortage as reasonably judged from the state of supply and demand of the specified pharmaceutical and other circumstances, and that, as a result, the provision of appropriate medical care will become difficult, which may affect the lives and health of the people, the Minister may request marketing authorization holders (meaning persons who have obtained a license for the business of marketing pharmaceuticals under Article 12, paragraph (1) of that Act; the same applies hereinafter), manufacturers (meaning persons who have obtained a license for the business of manufacturing pharmaceuticals under Article 13, paragraph (1) of that Act; the same applies hereinafter), wholesale distributors (meaning persons who have obtained a license for the wholesale distribution business under Article 34, paragraph (1) of that Act; the same applies in Article 38-4) and other related parties to provide the cooperation necessary to ensure the provision of that specified pharmaceutical or an alternative pharmaceutical (meaning an alternative pharmaceutical prescribed in Article 18-5 of that Act; the same applies hereinafter in this Article) to medical institutions that need it, such as increasing the production of, and adjusting the sale of, that specified pharmaceutical or alternative pharmaceutical.
厚生労働大臣は、特定医薬品(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第二条第十七項に規定する特定医薬品をいう。以下同じ。)について、その供給が不足し、又はその特定医薬品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あると認められるため、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影響を与えるおそれがあると認める場合は、製造販売業者(同法第十二条第一項の医薬品の製造販売業の許可を受けた者をいう。以下同じ。)、製造業者(同法第十三条第一項の医薬品の製造業の許可を受けた者をいう。以下同じ。)、卸売販売業者(同法第三十四条第一項の卸売販売業の許可を受けた者をいう。第三十八条の四において同じ。)その他の関係者に対し、当該特定医薬品又は代替薬(同法第十八条の五に規定する代替薬をいう。以下この条において同じ。)の増産、販売の調整その他の当該特定医薬品又は代替薬を必要とする医療提供施設に対する当該特定医薬品又は代替薬の提供を図るために必要な協力を求めることができる。
In the case prescribed in the preceding paragraph, the Minister of Health, Labour and Welfare may request pharmacy establishers (meaning pharmacy establishers prescribed in Article 1-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices), the establishers of hospitals or clinics, and other related parties to provide the cooperation necessary to ensure the provision of medical care to persons who need that specified pharmaceutical or alternative pharmaceutical, such as consideration in dispensing or prescription.
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