Article 1
These regulations are promulgated pursuant to the Paragraph 4 of Article 53-1 of the Pharmaceutical Affairs Act.
Article 2
The quality management of business undertakings engaged in wholesaling, retailing, importing and exporting western pharmaceuticals (hereinafter referred to as the business undertakings), shall meet the regulations of quality management standards indicated in Table 1 (attached).
Article 3
The organization and personnel of the business undertakings shall meet the regulations of organization and personnel standards indicated in Table 2 (attached).
Article 4
The premises and equipment of the business undertakings shall meet the regulations of premises and equipment standards indicated in Table 3 (attached).
Article 5
The documentation of the business undertakings shall meet the regulations of documentation standards indicated in Table 4 (attached).
Article 6
The operation procedures of the business undertakings shall meet the regulations of operation procedures standards indicated in Table 5 (attached).
Article 7
The customer complaints, returns, and recalls of the business undertakings shall meet the regulations of complaints, returns, and recalls standards indicated in Table 7 (attached).
Article 8
The outsourced activities of the business undertakings shall meet the regulations of outsourced activities standards indicated in Table 7 (attached).
Article 9
The self-inspections of the business undertakings shall meet the regulations of self-inspections standards indicated in Table 8 (attached).
Article 10
The transportation of the business undertakings shall meet the regulations of transportation standards indicated in Table 9 (attached).
Article 11
The definition of terms used in this regulation indicated in Table 10 (attached).
Article 12
These regulations shall be effective as of the date of promulgation.