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Article 36

第三十六条

When the Minister of Health, Labour and Welfare finds that the supply of a specified pharmaceutical (meaning a specified pharmaceutical prescribed in ; 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 ; the same applies hereinafter), manufacturers (meaning persons who have obtained a license for the business of manufacturing pharmaceuticals under ; the same applies hereinafter), wholesale distributors (meaning persons who have obtained a license for the wholesale distribution business under ; 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 ; 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、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(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(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(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(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 ), 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.

厚生労働大臣は、前項に規定する場合には、薬局開設者(医薬品、医療機器等の品質、に規定する薬局開設者をいう。)又は病院若しくは診療所の開設者その他の関係者に対し、調剤又は処方に関する配慮その他の当該特定医薬品又は代替薬を必要とする者に対する医療の提供を図るために必要な協力を求めることができる。

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