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Article 38-4

第三十八条の四

A marketing authorization holder, manufacturer or wholesale distributor of supply security pharmaceuticals, etc., or another person specified by Order of the Ministry of Health, Labour and Welfare, must, in line with the guidelines for securing stable supply and as provided by Order of the Ministry of Health, Labour and Welfare, report to the Minister of Health, Labour and Welfare the status of manufacture, importation, sale or provision of supply security pharmaceuticals, etc. and other necessary particulars.

供給確保医薬品等の製造販売業者、製造業者又は卸売販売業者その他厚生労働省令で定める者は、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、供給確保医薬品等の製造、輸入、販売又は授与の状況その他必要な事項を厚生労働大臣に報告しなければならない。

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