G TBT N KOR 371 - Partial revision of Enforcement Regulation of the Pharmaceutical Affairs Act (21 pages, available in Korean).
Year Issued: 2012
Month Issued: 07
Circulation Date: 2012-06-05
Final Date for Comments: 2012-08-01
Objective: Renewal system) To evaluate safety and efficacy of pharmaceuticals in a regular and organized manner and to control pharmaceutical approval efficiently (Change in packaging unit and labelling) To prevent overuse of pharmaceuticals and to promote consumers' rights to have information on products they take.
(Renewal system) Determining application methods, documents required to be submitted, etc., pursuant to the revised Pharmaceutical Affairs Act (2012.5.14) introducing the renewal system for pharmaceuticals (Change in packaging unit and labelling) Requiring packaging unit to be one day dose and usage/dosage, warnings, etc., to be presented in brief on the external container or package in the case of certain pharmaceuticals, among OTC drugs, that are allowed to be sold besides pharmacies.
In category: KOREA, REPUBLIC OF
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Department of Trade and Industry - Bureau of Product Standards 3/F Trade and Industry Building
361 Sen. Gil Puyat Avenue, Makati City Philippines 1200, Telephone: (632) 751-4700 Fax: (632) 751-4706