Newsletter
The Ministry of Health and Welfare Promulgated the Implementation Details of Good Distribution Practice (GDP) for Pharmaceuticals
To ensure the quality of storage and transportation of pharmaceutical products after they leave the manufacturing facility and to prevent counterfeit and prohibited drugs from entering the pharmaceutical supply chain, the Ministry of Health and Welfare (MOHW) announced the “Implementation Details of Good Distribution Practice (GDP) Regarding the Pharmaceuticals and the Pharmaceutical Vendors, Matters, Methods, and Schedule ” (the “Latest Announcement”) on July 26, 2023, requiring designated pharmaceutical firms to comply with the GDP by a specified deadline, pass the inspection of the central health authority and obtain a permit for the distribution of pharmaceuticals (the “GDP Approval”).
I. Implementation Status of the GDP
According to Paragraph 1, Article 53-1 of the Pharmaceutical Affairs Act (the “PAA”), “Operators engaging in the wholesale, import and export of western pharmaceuticals shall comply with the GDP, pass inspection by the central health authority and obtain a GDP approval with respect to the quality management, organization and personnel, operation sites and equipment, documents, operating procedures, customer complaints, returns and recalls, outsourced operations, self-inspection, transportation and other western pharmaceuticals distribution operations relating to the procurement, storage and supply of products.” Furthermore, Paragraph 2 thereof provides that, “The preceding paragraph may be implemented in stages. The types of pharmaceuticals and vendors, matters, methods and schedule for the phased implementation may be announced by the central health authority.”
The MOHW promulgated the GDP in 2017 and announced the preliminary implementation notification of the GDP on September 11, 2018, stating that (i) starting from the announcement date, the pharmaceutical vendors that apply for market approvals (the “MA”) for western pharmaceutical preparations for the first time should comply with the GDP and (ii) other pharmaceutical vendors that had obtained the MA for western pharmaceutical preparations prior to the announcement date should comply with the GDP by January 1, 2019. The MOHW further issued notifications requiring wholesalers, importers and exporters of western pharmaceutical preparations that require cold chain storage and transportation to comply with the GDP by December 31, 2021, and vendors engaging in the wholesale, import or export of western pharmaceutical raw materials to comply by December 31, 2022.
II. Pharmaceutical Vendors that should Obtain a GDP approval in Phases
According to the Latest Announcement, pharmaceutical vendors engaging in any of the following businesses must comply with the GDP and obtain a GDP approval before the respective specified deadlines in order to conduct such businesses. Starting from the date of this Latest Announcement, applications for GDP approval required to be obtained by the following types of pharmaceutical vendors will also be accepted:
1. “Pharmaceutical vendors authorized by the MA holders of western pharmaceutical products to import or export preparations” and “wholesale pharmaceutical vendors of blood derivatives, vaccines or botulinum toxins as announced in accordance with Article 6-1 of the PAA that do not require cold chain storage and transportation” must obtain a GDP approval by June 30, 2024.
2. “Wholesale pharmaceutical vendors of those pharmaceutical products as announced in accordance with Article 6-1 of the PAA that are not blood derivatives, vaccines or botulinum toxins”, “pharmaceutical vendors engaging in the wholesale of preparations as announced in accordance with Paragraph 2, Article 3 of the Controlled Drugs Act” and “pharmaceutical vendors engaging in the wholesale of necessary medicines as announced in accordance with Article 27-2 of the PAA” must obtain a GDP approval by December 31, 2024.
3. “Pharmaceutical vendors engaging in the wholesale of prescription medicines as defined in Paragraph 2, Article 8 of the PAA and Article 3 of its enforcement rules” and “wholesale pharmaceutical vendors that will distribute preparations to more than 10 other wholesale pharmaceutical vendors between October 1, 2024 and December 31, 2024” must obtain a GDP approval by December 31, 2025.
4. All other pharmaceutical vendors engaging in the wholesale, import or export of western pharmaceutical preparations must obtain a GDP approval by December 31, 2026.
If you have any questions on the implementation of the GDP, please feel free to contact our Pharma and Life Sciences Practice Group.