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1 Definitions The terminologies used in this Notification are defined as follows. (1) The “Act” “Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, 2 Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (Act No. 145 of 1960) (2) Amended Enforcement Regulations “Enforcement Regulations of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (MHW Ministerial Ordinance No. 1 of 1961) amended according to “Ministerial Ordinance for Partial Amendment of the Enforcement Regulations of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (MHLW Ministerial Ordinance No. 82 of 2017) (3) Amended Fee Regulations “Fee Regulations related to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (MHW Ministerial Ordinance No. 63 of 2000) amended according to the “Ministerial Ordinance for Partial Amendment of the Fee Regulations related to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (MHLW Ministerial Ordinance No. 83 of 2017) (4) Amended QMS Ministerial Ordinance