The purpose of this Act is to prescribe matters necessary to deal with pharmaceutical affairs smoothly, thereby contributing to the improvement of the national public health. It regulats pharmaceutical affairs, pharmacists, pharmacies, drugs, and related public health activities. The Act defines key concepts such as drugs, quasi-drugs, herbal preparations, prescription drugs, over-the-counter drugs, clinical trials, and national essential drugs. It establishes the overall legal basis for pharmaceutical manufacturing, distribution, dispensation, safety management, and professional regulation in order to protect public health and ensure the safe use of medicines. The Act further regulates the qualifications, licensing, duties, education, and disciplinary conditions applicable to pharmacists and Korean medicine pharmacists. It establishes the Korean Pharmaceutical Association and the Oriental Pharmacy Association, prescribes rules concerning pharmacy establishment and management, and creates advisory and supervisory mechanisms under the Ministry of Health and Welfare and the Ministry of Food and Drug Safety. The legislation also defines ethical obligations, reporting requirements, and restrictions intended to prevent illegal pharmaceutical practices and conflicts of interest. More specifically, the Act prescribes detailed rules governing the dispensation of drugs, operation of pharmacies, medication counseling, drug information systems, public late-night pharmacies, prescription management, and exceptional circumstances allowing direct drug dispensation by physicians or pharmacists. It also includes provisions on pharmaceutical safety, clinical and non-clinical studies, protection of pharmacy users, supervision, inspections, penalties, and administrative enforcement measures designed to ensure the safe, transparent, and effective operation of the pharmaceutical sector.
Republic of Korea · 2007-04-11