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Guidance, Law & Regulations

Announcement of the “Implementation Items and Schedule of the Guide to Good Manufacturing Practice for Medical Products (Part III: Distribution)” 【Date:2019-07-19】 unit:品質監督管理組

Ministry of Health and Welfare Official Announcement Issue Date: February 18, 2016 Issue No.: MOHW1041106197A Subject: Announcement of the “Implementation Items and Schedule of the Guide to Good Manufacturing Practice for Medical Products (Part III: Distribution)” Legal basis: Article 57 of the Pharmaceutical Affairs Act and Article 3 of the Pharmaceutical Good Manufacturing Practice Regulations Announcement elements: 1.As of July 1, 2016, pharmaceutical manufacturers of western pharmaceutical products (including medical gas manufacturers) as newly established, relocated and business resumption and logistics companies engaging in labeling and packaging operations of western pharmaceutical products shall comply with the aforementioned Guide’s requirements in their application for inspection of the good manufacturing practice for pharmaceutical products. 2.Approved pharmaceutical manufacturers of western pharmaceutical products (including medical gas manufacturers) and logistics companies engaging in labeling and packaging operations of western pharmaceutical products not condition mentioned in the preceding paragraph, shall comply with the aforementioned Guide’s as of January 1, 2019. 3.Also, by taking the diversification and complexity of western pharmaceutical products distribution modes into consideration, for special cases such as transportation to remote or off-shore regions or other individual situations, the companies shall report the case’s detail condition to the Ministry for approval. 4.Please also refer to the following websites: (1)The Ministry’s website (http://www.mohw.gov.tw/): “Health and Welfare Regulations > Inquiry system of Laws and Regulations”. (2)The website Food and Drug Administration of the Ministry’s (http://www.fda.gov.tw/): “Announcement > TFDA Announcement”.