Japan - Proposed Shitei Yakubutsu and their "proper uses" designated under the Act

Ministry of Health, Labour and Welfare (MHLW) has issued notification proposing "Shitei Yakubutsu" (designated 6 substances), and their "proper uses" designated under the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (hereinafter referred to as the "Act") (1960, Law No.145)

Proposed date of adoption: 22 June 2016

Proposed date of entry into force: 2 July 2016

Final date for comments: Not applicable

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures, so that these can be taken up suitably.