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  7. About designated drugs stipulated in the Act on Ensuring Quality, Effectiveness and Safety of Pharmaceuticals, Medical Devices, etc. (Pharmaceutical Machinery Law)

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About designated drugs stipulated in the Act on Ensuring Quality, Effectiveness and Safety of Pharmaceuticals, Medical Devices, etc. (Pharmaceutical Machinery Law)

Last Updated January 29, 2024

In order to prevent substance abuse, the Law Concerning the Quality, Effectiveness and Safety of Pharmaceuticals and Medical Devices (Ministry of Health, Labor and Welfare) has a high probability of having the effect of excitement, suppression or hallucination of the central nervous system, In addition, those that may cause harm to insurance hygiene when used in the human body (excluding stimulants, cannabis, drugs, psychotropic drugs, and psychotropics, and psychotropics, and psychotropics) are designated as psychotropics). These substances are often added to products distributed as dangerous drugs at high frequency.

There are two types of designated drugs: those that specify each substance individually (individually designated) and those that comprehensively specify a specific group of substances with similar chemical structures (comprehensive designation).

As of 2019, more than 2,300 substances have been designated as designated drugs. The Pharmaceutical Machinery Law stipulates that, except for special cases, the manufacture, import, sale, advertising, etc. of these designated drugs must not be made.

Excerpt from the Pharmaceutical Machinery Law

(Prohibition of manufacturing, etc.)

Article 76-4
Designated drugs shall not be manufactured, imported, sold, awarded, or stored or displayed for purposes other than those specified by Ordinance of the Ministry of Health, Labour and Welfare (hereinafter referred to as "uses for medical care, etc." in the following Article) for the purpose of diagnosis, treatment or prevention of disease and for purposes that are not likely to cause harm to the human body.

(Restrictions on advertising)

Article 76-5
Regarding designated drugs, when conducting in newspapers or magazines for pharmaceutical personnel (meaning those engaged in research on natural sciences) who publish articles on medical affairs or pharmaceutical affairs or natural sciences, No one shall advertise such drugs except for those who use them for medical purposes.

Related link

Detailed information on dangerous drugs and designated drugs is available.

Inquiries to this page

RIKEN, Medical Care Bureau Institute of Hygiene

Telephone: 045-370-9451

Telephone: 045-370-9451

Fax: 045-370-8462

Email address: ir-eiken@city.yokohama.jp

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Page ID: 729-238-417

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