Pharmaceutical companies holding the Western Pharmaceutical Product Licenses shall comply with the “Guide to Good Manufacturing Practice for Medical Products (Part III: Distribution)”. The details are
【Update Date：2016-04-08】unit：品質監督管理組
Ministry of Health and Welfare Official Letter
Issue Date: February 18, 2016
Issue No.: MOHW1041106197D
Subject: Pharmaceutical companies holding the Western Pharmaceutical Product Licenses shall comply with the “Guide to Good Manufacturing Practice for Medical Products (Part III: Distribution)”. The details are explained as follows.
Explanations:
1. The Good Distribution Practice (GDP) management system is promoted to ensure themaintenance of good quality and packaging integrity of all of the western pharmaceutical products delivered to patients during of manufacturing, storage and transportation. Hence the Ministry announced the “Guide to Good Manufacturing Practice for Medicinal Products (Part III: Distribution)” on July 16, 2015 via the Announcement MOHW1041102778, and the Implementation Items and Schedule of the “Guide to Good Manufacturing Practice for Medicinal Products (Part III: Distribution)” on February 18, 2016 via the Announcement MOHW1041106197A.
2. The pharmaceutical companies holding the Western Pharmaceutical Product Licenses and pharmaceutical manufacturers are equally important in ensuring the product quality, therefore, special precaution shall be paid to the daily operations in storage and distribution of the products to prevent the products from adulteration so to protect the public’s safety in drug consumption. In order to elevate the management level and provide more consumer protections, the aforesaid pharmaceutical companies shall follow the “Guide to Good Manufacturing Practice for Medicinal Products (Part III: Distribution)” as announced by the Ministry on July 16, 2015 via the Announcement MOHW1041102778.
3. Pharmaceutical companies holding the Western Pharmaceutical Product Licenses shall meet the aforementioned Guide’s requirements by the dates listed below:
(1) For pharmaceutical companies applying for their first Western Pharmaceutical Product Licenses: July 1, 2016.
(2) Pharmaceutical companies already hold the Western Pharmaceutical Product Licenses and not in the condition mentioned in the preceding paragraph: January 1, 2019
4. Taking the diversification and complexity of distribution types of western pharmaceutical product into consideration, for special cases such as transportation to remote or offshore regions or other individual situations, the companies shall report the case’s detail condition to the Ministry for approval.
5. Prior to the dates stated in the above explanation 3, the aforesaid companies shall exercise its consumer protection obligation as equipping good product storage and distribution operations, the Ministry will also conduct non-periodical inspections.