Regulations of Medicament Manufacturer Inspection Article 5
For foreign manufacturers of imported pharmaceuticals mentioned in Subparagraph 1, Paragraph 1 of Article 3, the Taiwan agents (pharmaceutical companies) shall apply for inspection by submitting a fee, along with completed application materials and a Plant Master File (hereafter shortened to “PMF”) containing the items detailed in the application materials to the central competent health authority. However, for manufacturers of countries approved by the central competent health authority, the PMF may be replaced by the SMF and an inspection report from said country’s competent health authority.The PMF and SMF referred to in the preceding Paragraph shall be certified by the highest competent health authority or chamber of commerce in the country of origin. However, if documents from the highest competent health authority in the country of origin proving that the manufacturer is in compliance with local pharmaceutical GMP standards, or the original copy of a manufacturing and sales approval certificate clearly stating that said manufacturer is in compliance with local pharmaceutical GMP standards are submitted, the above certification is not required. If the country of origin is Germany, the documents may be issued by the competent health authority of a German state government, certification by the German federal government is not required.If inspection of foreign factory is required as part of the inspection mentioned in Paragraph 1, the applicant shall submit a fee to the central competent health authority, and coordinate with the foreign manufacturer in preparing the information required for the inspection process.
中文原文 藥物製造業者檢查辦法第5條
第三條第一項第一款之輸入藥品國外製造業者，應由我國代理商（藥商）繳納費用，並填具申請書表及依書表所載事項檢附該國外製造業者之工廠資料（PlantMasterFile，以下簡稱PMF），向中央衛生主管機關申請檢查。
但經中央衛生主管機關認可之國家，其製造業者之工廠資料（PMF），得以該業者之工廠基本資料（SMF）及該國衛生主管機關核發之稽查報告替代之。
前項工廠資料（PMF）及工廠基本資料（SMF），應經出產國最高衛生主管機關或商會簽證。
但如檢附出產國最高衛生主管機關出具該製造業者符合當地藥品優良製造規範之證明或載明該製造業者係符合當地藥品優良製造規範之製售證明正本者，得免簽證；如出產國係德國者，其證明文件得由德國邦政府衛生主管機關出具，免其聯邦政府簽證。
第一項檢查如有實施國外查廠之必要者，申請人應向中央衛生主管機關繳納費用，並與國外製造業者配合檢查要求，備齊相關資料。
但經中央衛生主管機關認可之國家，其製造業者之工廠資料（PMF），得以該業者之工廠基本資料（SMF）及該國衛生主管機關核發之稽查報告替代之。
前項工廠資料（PMF）及工廠基本資料（SMF），應經出產國最高衛生主管機關或商會簽證。
但如檢附出產國最高衛生主管機關出具該製造業者符合當地藥品優良製造規範之證明或載明該製造業者係符合當地藥品優良製造規範之製售證明正本者，得免簽證；如出產國係德國者，其證明文件得由德國邦政府衛生主管機關出具，免其聯邦政府簽證。
第一項檢查如有實施國外查廠之必要者，申請人應向中央衛生主管機關繳納費用，並與國外製造業者配合檢查要求，備齊相關資料。