Pharmaceutical Affairs Act Enforcement Rules Article 12

When a drug manufacturer engages in the wholesaling and exporting of its own products, the importing of raw materials for its own use, or the concurrent retailing of its own products in accordance with Article 16 of the Act, and does so at the same location at which it manufactures and processes drugs, those businesses may be concurrently managed by its manufacturing supervisor. When the pharmaceutical firm, however, concurrently engages in the sale of products other than its own products or establishes a separate place of business to engage in any of the foregoing businesses, it shall employ separate management personnel for those respective purposes, and shall register as a pharmaceutical firm that is a seller of drugs or medical devices.When a drug manufacturer, in accordance with Article 58 of the Act, contracts another manufacturer to manufacture drugs, the wholesaling, exporting, and retailing of those drugs may take place in accordance with the fore part of the preceding paragraph.