Article 6-4-4

①If the supply of pharmaceuticals, medical device or regenerative medicine products (meaning the pharmaceuticals, medical device and regenerative medicine products prescribed respectively in Article 2, paragraphs (1), (4) and (9) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960), excluding those intended to be used exclusively for animals; the same applies hereinafter in this paragraph and paragraph (3)) is short or is likely to become short due to a decrease in production or other circumstances, and there is therefore a risk that the interests of medical care recipients will be significantly harmed, the Minister of Health, Labour and Welfare may request a person who has obtained approval for marketing prescribed in Article 14, paragraph (1) of that Act, a person who has obtained approval for marketing prescribed in Article 23-2-5, paragraph (1) of that Act, or a person who has obtained approval for marketing prescribed in Article 23-25, paragraph (1) of that Act (hereinafter referred to as "marketing authorization holder" in this Article) to report on the status of production, import, sale or lending of those pharmaceuticals, medical device or regenerative medicine products.

②A marketing authorization holder must comply with a request from the Minister of Health, Labour and Welfare pursuant to the provisions of the preceding paragraph.

③If the Minister of Health, Labour and Welfare has received a report from a marketing authorization holder, based on the provisions of paragraph (1), on the status of production, import, sale or lending of pharmaceuticals, medical device or regenerative medicine products, the Minister is to make public information on that status.