Regulations for Registration of Medicinal Products Article 70
The application for transferring a domestic drug license or an imported drug distributor’s license should be filed by both parties. The following documents should be provided:1.Application form for post-approval changes signed by both parties;2.Original copy of the drug license to be transferred;3.A list of drug licenses to be transferred, therein recording the license number, formula, dose and dosage form;4.The assurance statement made by the transferee to certify the responsibility. For the transfer of the license of locally manufactured drugs, the assurance statement should also certify the absence of drugs of the same formula;5.The following documents are required for the application for license transfer of locally manufactured drugs:(1) Photocopy of the transfer approvals issued by the health competent authorities of the local governments where the transferor and transferee are located;(2) A list of valid drug licenses held by the transferee, a record of the license number, formula, dose and dosage form;(3) An assurance statement (A);(4) A photocopy each of all changed certificates and licenses;(5)Manufacturing and Control Standard. This document can be exempted, if local manufacturers have no intention to initiate production at present. The certificates should be noted with the phrase: “Manufacturing is prohibited”. Manufacturers have to submit the Manufacturing and Control Standards and obtain an approval from the central health competent authority before production can be started.6.The following documents are required for the application of imported drug distributor’s license transfer:(1) A photocopy of the company license of both transferor and transferee;(2) Original copy of the transfer agreement with signets of both parties;(3) Original copy of the authorization letter issued by the original manufacturer, stating the termination of the distributing contract with the transferor and the exchange of new contract with the transferee, as well as the addresses of both parties and the drug items involved in the transfer. The authorization letter should be authenticated by the R.O.C. foreign affairs offices;(4) A statement certifies that the same manufacturer does not have any products of the same formulation as the transferred drug.When applying for domestic drug license transfer, if the product name on the old license includes a prefix of the transferor’s company name which is not authorized to be used by the transferee, then an application for a change in product name should be filed at the same time. If domestic drug license transfer includes toll-manufactured, then the application should comply with Article 46.
中文原文 藥品查驗登記審查準則第70條
國產藥品許可證移轉及輸入藥品之代理權移轉登記，應由讓與人及受讓人共同申請，並檢附下列資料：
一、雙方具名之藥品變更登記申請書。
二、移轉之藥品許可證正本。
三、移轉之藥品許可證清冊，其內容應包括許可證字號、處方、劑量、劑型。
四、受讓人對移轉藥品負責之切結書；申請國產藥品許可證移轉，並應加具對移轉藥品無相同處方之切結書。
五、申請國產藥品許可證移轉登記，應另附下列資料：
（一）讓與人及受讓人所在地之直轄市或縣（市）衛生主管機關核准移轉文件影本。
（二）受讓人現有藥品許可證清冊，其內容應包括許可證字號、處方、劑量、劑型。
（三）切結書（甲）。
（四）已完成變更之證照影本各一份。
（五）製造管制標準書。
但如藥品尚不製造者，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。
六、申請輸入藥品之代理權移轉登記，應另附下列資料：
（一）讓與人與受讓人之藥商許可執照影本。
（二）雙方讓渡書正本，並加蓋讓與人及受讓人雙方原印鑑。
（三）原廠委託書正本，詳述終止讓與人之代理權，改由受讓人取得代理權，與雙方地址及移轉藥品之品名；其委託書並應經我國駐外館處文書驗證。
（四）對移轉藥品同一製造廠無相同處方之切結書。
申請國產藥品許可證移轉登記，如移轉藥品許可證之品名有加冠廠名且未經被加冠廠名之廠商授權者，應同時辦理藥品品名變更登記；其移轉申請涉及製造廠變更者，適用第四十六條之規定。
一、雙方具名之藥品變更登記申請書。
二、移轉之藥品許可證正本。
三、移轉之藥品許可證清冊，其內容應包括許可證字號、處方、劑量、劑型。
四、受讓人對移轉藥品負責之切結書；申請國產藥品許可證移轉，並應加具對移轉藥品無相同處方之切結書。
五、申請國產藥品許可證移轉登記，應另附下列資料：
（一）讓與人及受讓人所在地之直轄市或縣（市）衛生主管機關核准移轉文件影本。
（二）受讓人現有藥品許可證清冊，其內容應包括許可證字號、處方、劑量、劑型。
（三）切結書（甲）。
（四）已完成變更之證照影本各一份。
（五）製造管制標準書。
但如藥品尚不製造者，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。
六、申請輸入藥品之代理權移轉登記，應另附下列資料：
（一）讓與人與受讓人之藥商許可執照影本。
（二）雙方讓渡書正本，並加蓋讓與人及受讓人雙方原印鑑。
（三）原廠委託書正本，詳述終止讓與人之代理權，改由受讓人取得代理權，與雙方地址及移轉藥品之品名；其委託書並應經我國駐外館處文書驗證。
（四）對移轉藥品同一製造廠無相同處方之切結書。
申請國產藥品許可證移轉登記，如移轉藥品許可證之品名有加冠廠名且未經被加冠廠名之廠商授權者，應同時辦理藥品品名變更登記；其移轉申請涉及製造廠變更者，適用第四十六條之規定。