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Guidance, Law & Regulations

Announcement of the “Implementation details and transition periods of the Western Pharmaceuticals Good Distribution Practice (GDP) Regulations for drug dealers engaged in cold chain storage and trans 【Date:2019-07-19】 unit:品質監督管理組

Ministry of Health and Welfare Official Announcement Issue Date: May 10, 2019 Issue No.: MOHW1081102148 Subject: Announcement of the “Implementation details and transition periods of the Western Pharmaceuticals Good Distribution Practice (GDP) Regulations for drug dealers engaged in cold chain storage and transportation” and takes effect from its issue date. Legal basis: Paragraph 2 of Article 53-1 of Pharmaceutical Affairs Act Announcement elements: 1.Apart from the drug dealers specified in the MOHW1071104588 (announcement dated September 11, 2018), from the date of this announcement, the dealers whose business undertakings engaged in wholesaling, importing and exporting western pharmaceutical products requiring cold chain storage and transportation can apply for GDP inspection to Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW) and shall comply with the GDP regulations by December 31, 2021. 2.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, the Ministry will depend on the details of the case for approval.