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Western Pharmaceuticals Good Distribution Practice Regulations
1.中華民國一百零六年十二月二十八日衛生福利部衛授食字第 106110753 9 號令訂定發布全文 12 條；並自發布日施行
資料來源：全國法規資料庫（ChOrder.json，版本 2026/7/24 上午 12:00:00）・政府資料開放授權
These regulations are promulgated pursuant to the Paragraph 4 of Article 53-1 of the Pharmaceutical Affairs Act.
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).
The organization and personnel of the business undertakings shall meet the regulations of organization and personnel standards indicated in Table 2 (attached).
The premises and equipment of the business undertakings shall meet the regulations of premises and equipment standards indicated in Table 3 (attached).
The documentation of the business undertakings shall meet the regulations of documentation standards indicated in Table 4 (attached).
The operation procedures of the business undertakings shall meet the regulations of operation procedures standards indicated in Table 5 (attached).
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).
The outsourced activities of the business undertakings shall meet the regulations of outsourced activities standards indicated in Table 7 (attached).
The self-inspections of the business undertakings shall meet the regulations of self-inspections standards indicated in Table 8 (attached).
The transportation of the business undertakings shall meet the regulations of transportation standards indicated in Table 9 (attached).
The definition of terms used in this regulation indicated in Table 10 (attached).
These regulations shall be effective as of the date of promulgation.