KOR/761
WTO/TBT
KR South Korea
  • 11 - Health care technology
2018-06-26
2018-05-02

Narcotics

Proposed amendments to the "Enforcement Regulations of the Narcotics Control Act" (27 page(s), in Korean)

The proposed amendments seek to:

- Establish a legal basis in order to include information required to be provided on containers/ packaging under the Pharmaceutical Affairs Act in the Enforcement Rules of Narcotics Controls Act such as the indication of all ingredients, usage, dosage, direction for use, warning signs, and prescription drug labels (if applicable).

 - Specify persons responsible for providing required information of narcotics drugs or psychoactive substances on containers and packaging as follows: manufacturers, importers, exporters, and users of raw materials thereof.   - Establish a legal basis in order to allow the omission of certain information provided on containers/packaging of standard preparations or reagents for medical use containing narcotic drugs or psychoactive substances while indicating item codes, generated through Narcotics Information Management System, on the containers/packaging thereof.