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Guidance, Law & Regulations

Announcement of "Implementation items and transition periods of the Western Pharmaceuticals Good Distribution Practice (GDP) Regulations " and takes effect from its issue date. 【Date:2019-07-19】 unit:品質監督管理組

Ministry of Health and Welfare Official Announcement Issue Date: September 11, 2018 Issue No.: MOHW1071104588 Subject: Announcement of "Implementation items and transition periods of the Western Pharmaceuticals Good Distribution Practice (GDP) Regulations " and takes effect from its issue date. Legal basis: Paragraph 2 of Article 53-1 of Pharmaceutical Affairs Act Announcement elements: 1.From the date of this announcement, drug dealers applying for the first product license of western pharmaceuticals shall comply with the GDP regulations. 2.All the product license holders of western pharmaceuticals before the date of this announcement shall comply with the GDP regulations as of January 1, 2019. 3.Also, by taking the diversification and complexity of western pharmaceutical product distribution modes into consideration, for special cases such as transportation to remote or offshore regions or other situations, drug dealers shall report the details of the case to the Ministry for approval.