Regulations for Registration of Medicinal Products Article 64
Applications for registration of pharmaceutical toll-manufacturing shall comply with the Regulations on Pharmaceutical Toll-Manufacturing and Contract Analysis and shall submit the following documents:1. Application form for toll-manufacturing;2. A photocopy of toll-manufacturing contracts, therein stating the details about the management of toll-manufacturing;3. Application form for post-approval changes;4. Original drug license;5. A list of all drug licenses categorized by dosage forms, but it is exempted for toll-manufacturing only one drug license;6. A description of each toll-manufacturing process. This requirement can be exempted, if a complete manufacturing process is commissioned to the toll-manufacturers;7. Standard Manufacturing and Control Procedures and the amount of all components in the batch record or the batch record of the same lot as the finished product. This document can be exempted if the local manufacturers have no intention to start the manufacture yet. The certificates should be noted with the phrase: “Manufacturing is not allowed”. Manufacturers are required to submit the Standard Manufacturing and Control Procedures and obtain approval from the central competent health authority prior to production;8. A photocopy of the contract giver’s company license;9. A photocopy of each of the contract acceptor’s factory registration license and drug manufacturing permit. For imported drugs, those documents can be replaced with a photocopy of the acceptor’s GMP compliance certificate. If the holder of the GMP compliance certificate is not the applicant, then this document can be replaced by a letter of authorization issued by the original manufacturer or the local drug company who holds the certificate, therein specifying the approval number of the original certificate.10. The testing specifications and methods of the finished products issued by the contract acceptor;11. Documents of rescission with previous acceptors. Those entering into a toll-manufacturing contract for the first time can be exempted from this requirement;12. If the imported drugs were toll-manufactured, a notification letter of post-approval changes issued by the original manufacturer and the CPP from the country of origin shall be submitted. For the imported drug substances, the CPP can be exempt. However, the relevant technical documents for changing toll-manufacture, specified in Appendix 12, are required.Drug license holder should comply with Article 46 when applying for pharmaceutical toll-manufacturing or changing the original pharmaceutical toll-manufacturing.The change of the licenses mentioned in Paragraph 1 will be processed by noting the original license rather than issuing another one. However, in situations where the assessment results show that an import permit is required to change into a manufacturing permit, a new license has to be issued.Under such circumstances, the applicant shall complete the checklist for toll-manufacturing dossiers, and provide all relevant documents, as well as the application form for drug registration and the Declaration (A).After the application is approved, the applicant shall, of their own accord, modify the labels, package inserts, outer boxes, aluminum blister foil, etc. Those materials should be submitted upon request for inspection.
中文原文 藥品查驗登記審查準則第64條
申請藥品委託製造登記，應符合藥物委託製造及檢驗作業準則之規定，並檢附下列資料：
一、委託製造申請函。
二、委託製造契約書影本，其內容應說明委託製造管理之規定。
三、藥品變更登記申請書。
四、藥品許可證正本。
五、藥品許可證清冊，其內容應以劑型分類。
但單張委託製造者，免附。
六、說明製程之分段委託製造情形之資料。
但全程委託製造者，免附。
七、製造管制標準書及批次製造紀錄中之下料量或同批次之批次製造紀錄。
但國產藥品如尚不製造者，得免附製造管制標準書，惟應於許可證加註「不得製造」之字樣。
如廠商其後擬實際生產該藥品者，應檢送製造管制標準書，經中央衛生主管機關審核後，始得製造。
八、委託者之藥商許可執照影本。
九、受託廠之工廠登記證及藥商製造業許可執照影本各一份。
但輸入藥品之委託製造，得檢附受託製造廠符合藥品優良製造規範之證明文件影本替代之；如證明文件之持有者非申請人時，得以原廠授權函或持有證明文件之國內藥商授權函，並載明其證明文件之核准文號替代之。
十、受託廠出具之受託藥品成品檢驗規格及方法。
十一、與前受託製造廠解約書。
但首次申請委託製造者，免附。
十二、輸入藥品委託製造，應另附原廠變更通知函及出產國許可製售證明。
其中屬輸入原料藥者，得免附出產國許可製售證明，另應依附件十二檢附製造廠變更相關資料。
已領有藥品許可證者，依前項規定申請改由委託製造或變更委託製造廠，適用第四十六條之規定。
申請第一項登記之許可證換證，以於原證加註而不換證方式為原則。
但如申請變更之案件，經核定需由輸入許可證改列製造許可證者，應予換證。
有前項但書情形者，除應填具委託製造檢附資料查檢表並依書表所載事項檢附資料外，應另附查驗登記申請書及切結書（甲）各一份。
申請人於其申請案獲准後，應自行變更其藥品標籤、仿單、外盒、鋁箔片等，必要時應提出備查。
一、委託製造申請函。
二、委託製造契約書影本，其內容應說明委託製造管理之規定。
三、藥品變更登記申請書。
四、藥品許可證正本。
五、藥品許可證清冊，其內容應以劑型分類。
但單張委託製造者，免附。
六、說明製程之分段委託製造情形之資料。
但全程委託製造者，免附。
七、製造管制標準書及批次製造紀錄中之下料量或同批次之批次製造紀錄。
但國產藥品如尚不製造者，得免附製造管制標準書，惟應於許可證加註「不得製造」之字樣。
如廠商其後擬實際生產該藥品者，應檢送製造管制標準書，經中央衛生主管機關審核後，始得製造。
八、委託者之藥商許可執照影本。
九、受託廠之工廠登記證及藥商製造業許可執照影本各一份。
但輸入藥品之委託製造，得檢附受託製造廠符合藥品優良製造規範之證明文件影本替代之；如證明文件之持有者非申請人時，得以原廠授權函或持有證明文件之國內藥商授權函，並載明其證明文件之核准文號替代之。
十、受託廠出具之受託藥品成品檢驗規格及方法。
十一、與前受託製造廠解約書。
但首次申請委託製造者，免附。
十二、輸入藥品委託製造，應另附原廠變更通知函及出產國許可製售證明。
其中屬輸入原料藥者，得免附出產國許可製售證明，另應依附件十二檢附製造廠變更相關資料。
已領有藥品許可證者，依前項規定申請改由委託製造或變更委託製造廠，適用第四十六條之規定。
申請第一項登記之許可證換證，以於原證加註而不換證方式為原則。
但如申請變更之案件，經核定需由輸入許可證改列製造許可證者，應予換證。
有前項但書情形者，除應填具委託製造檢附資料查檢表並依書表所載事項檢附資料外，應另附查驗登記申請書及切結書（甲）各一份。
申請人於其申請案獲准後，應自行變更其藥品標籤、仿單、外盒、鋁箔片等，必要時應提出備查。