CHAPTER I GENERAL PROVISIONS
Article 1(Purpose) #
The purpose of this Act is to contribute to the promotion of people's health and the development of the national economy by laying a foundation for the development of the pharmaceutical industry and by creating an environment to induce investment from foreign pharmaceutical enterprises' into the Republic of Korea through the systematic fostering and support of the pharmaceutical industry, the enhancement of innovativeness of the pharmaceutical industry, and the strengthening of international cooperation in order for the pharmaceutical industry to be internationally competitive.
Article 2(Definitions) #
The terms used in this Act are defined as follows: <Amended on Dec. 11, 2018; Jan. 9, 2024>
1. The term "pharmaceutical industry" means the industry related to research, development, manufacturing, processing, storage, and distribution of drugs under subparagraph 4 of Article 2 of the Pharmaceutical Affairs Act;
2. The term "pharmaceutical enterprise" means any of the following enterprises engaged in economic activities related to the pharmaceutical industry in the Republic of Korea:
(a) An enterprise that holds a permit to manufacture drugs or a permit to manufacture and sell items or that has reported to manufacture and sell items in accordance with Article 31 of the Pharmaceutical Affairs Act;
(b) A foreign pharmaceutical enterprise that holds a permit to import items of drugs or has reported the imported items in accordance with Article 42 of the Pharmaceutical Affairs Act;
(c) An enterprise specializing in research and development of new drugs, among venture businesses under Article 2-2 of the Special Act on the Promotion of Venture Businesses;
(d) An enterprise complying with the standards prescribed by Presidential Decree in terms of organization, human resources, etc. to specialize in the research and development of new drugs, etc.;
3. The term "innovative pharmaceutical enterprise" means a pharmaceutical enterprise that falls under any of the following subparagraphs, certified by the Minister of Health and Welfare pursuant to Article 7: