• June 23, 2023
  • WTO

Japan Proposes Designation of Three Substances as "Specified Controlled Substances"


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Japan has proposed the additional designation of three substances as Shitei Yakubutsu (i.e. "Specified Controlled Substances") under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

The Minister of Health, Labour and Welfare of Japan has put forth this proposal, which entails strict controls on the manufacture, import, sale, ownership, and use of these substances, except for specific purposes.

The proposed substances to be designated as Shitei Yakubutsu are as follows:

(*) N-(1-Adamantyl)-1-(4-fluorobutyl)-1H-indazole-3-carboxamide [4F-ABINACA, 4F-ABUTINACA]

(*) 2-(4-Ethoxybenzyl)-5-nitro-1-[2-(piperidin-1-yl)ethyl]benzimidazole [N-Piperidinyl Etonitazene, Etonitazepipne]

(*) 2-(3-Chlorophenyl)-3-methylmorpholine [3-CPM, 3-Chlorophenmetrazine]

Under the proposed regulations, the manufacture, import, sale, simple ownership, and use of these designated substances would be strictly prohibited, with exceptions for specific proper uses. The proper uses for these Shitei Yakubutsu are outlined as follows:

(*) Research and testing purposes at government institutions, local governments, associated agencies, technical colleges, inter-university research institutes, independent administrative agencies, and local independent administrative agencies.

(*) Testing conducted under the provisions of the Act.

(*) Forensic use.

The intention behind this proposal is to establish a robust framework to mitigate potential risks associated with substances that have probable effects on the central nervous system. By designating these substances as Shitei Yakubutsu, the Japanese government aims to ensure their proper handling, control, and appropriate use.

NotificationG/TBT/N/JPN/774

Document: 23_10470_00_e.pdf


                   

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