Only the low-risk category of over-the-counter (OTC) drugs was permitted to be sold via the Internet, which was stipulated by the ordinance of the Minister of Health, Labour and Welfare under the Pharmaceutical Affairs Law in Japan. Two Japanese retailers of OTC drugs, who want to retail OTC drugs via the Internet, launched proceedings against the rule, and the Supreme Court gave a decision that the ministerial ordinance is illegal and invalid. The Ministry of Health, Labour and Welfare immediately started discussion to make rules for Internet retailing of OTC drugs. Finally, a bill designed to enable Internet retailing of OTC drugs was passed by the Diet on December 5, 2013, and the act was promulgated on December 13. The act was enforced on June 12, 2014. This article briefly touches on the decision process and also illustrates the key points of the new rules for Internet retailing.
Keywords: OTC drugs; Pharmaceutical Affairs Law; retailing via Internet.