Pharmaceutical Affairs Act Article 53-1

Business undertakings engaged in wholesaling, importing, and exporting western pharmaceuticals, their product procuring, holding, and supplying related to the quality management, organization and personnel, premises and equipment, documentation, operation procedures, customer complaints, returns and recalls, outsourced activities, self-inspections, transportation, and other pharmaceuticals distribution practice, shall meet the standard of Western Pharmaceuticals Good Distribution Practice Regulations and shall obtain the western pharmaceuticals distribution license upon the inspection and approval from the central competent health authority.The contents from the previous paragraph shall be enforced in several phases. The enforcement of pharmaceuticals, the types of pharmaceutical firms, requirements, methods, and schedules shall be announced by the central competent health authority.Business undertakings that meet the standard of Paragraph 1 in obtaining the western pharmaceuticals distribution license may pay the corresponding application fees to apply for certificates with the central competent health authority.Western Pharmaceuticals Good Distribution Practice Regulations and western pharmaceuticals distribution licenses of paragraph 1, the application requirements, review procedures, and criteria, approval and issuance, validity period, revocation, return, and cancellation of the license of the previous paragraph and other matters requiring compliance shall be prescribed by the central competent health authority.