Regulations for Registration of Medicinal Products Article 6
The FSC (Free Sales Certificate) from the country of origin mentioned in this Chapter means the original document issued by the highest health competent authority of the country of origin, therein justifies the manufacture and sale of the product in that country. The following conditions should be met:1.If the required document is in neither Chinese nor English, a Chinese or English translation should be provided additionally.2.The document is effective for two years from the issuance date, and it should be authenticated by the embassy, representative office or agencies authorized by the Ministry of Foreign Affairs of R.O.C (hereafter the R.O.C foreign affairs offices).The authentication requirement is waived for documents issued by A10 countries, which include Germany, US, UK, France, Japan, Switzerland, Canada, Australia, Belgium, and Sweden.3.Information of the product name, manufacturer’s name and address, drug formulation, dosage form and contents stated on the document should be consistent with the information on the application form. The product name of exporting drug should be stated in this document; otherwise, a letter issued by the original manufacturer should be provided to explain and to give the product name of exporting drug, as well as to certify that the product is consistent with every description on the CPP (Certificate of Pharmaceutical Product) except for the product name. For capsules, in addition to the full formulation of the drug, the full formulation of soft capsule, or the coloring agents of hard capsule should be described accordingly. In cases where the CPP does not state the coloring agents of hard capsule, the original manufacturer should issue a letter to explain.4.The CPP should specify the drug manufacturer and state the fact that the product has been approved for free sale in that country. The description of manufacturing and free sale should be clear.The following documents can substitute for the above-mentioned FSC from the country of origin:1.FSC issued by the selling countries approved by the central health competent authority;2.For drugs listed in the United States Pharmacopeia Drug Information (USPDI) or in the Approved Prescription Drug Product with Therapeutic Equivalence Evaluations (Orange Book) published by the US FDA, applicants may submit a photocopy of the pages of the product (printouts from the Internet or the electronic version are acceptable), as well as the FSC issued by the health authority of the State Government as a replacement for the one issued by the US FDA;3.For products manufactured in Germany, the FSC can be issued by the health authority of a state government. Notarization from the Federal Government would not be necessary;4.For products manufactured in any of the EU countries, the FSC issued by the European medicinal Agency (EMA) is acceptable; and5.For toll-manufactured products that have not been sold in the country where the toll-manufacturers are located, the FSC from the country where the commissioner is located together with the manufacturing license from the country where the manufacturing takes place are acceptable substitute. Another acceptable alternative is the FSC from the country where the commissioner is located, on which states the manufacturer’s name and address.Except as otherwise regulated in the Regulations, Paragraph 1 Item 1 to Item 4 are applicable to the above-mentioned alternative documents and the certificate of changes issued by the country of origin.
中文原文 藥品查驗登記審查準則第6條
本章所稱出產國許可製售證明，係指出產國最高衛生主管機關出具之許可製造及准在該國自由販賣之證明文件正本，且符合下列規定者：
一、應檢附之證明文件如非中文或英文者，應另附中文或英文譯本。
二、限出具日起二年內有效，並應經中華民國駐外使領館、代表處、辦事處或外交部授權之駐外機構（以下簡稱我國駐外館處）文書驗證。
但為德國、美國、英國、法國、日本、瑞士、加拿大、澳洲、比利時、瑞典等十國（以下簡稱十大醫藥先進國家）衛生機關出具者，得免驗證。
三、記載之產品名稱、製造廠名稱、地址及處方內容、劑型、含量，應與申請書相符。
其產品名稱應刊載外銷品名於許可製售證明上；未能刊載者，應有原廠函說明未能刊載之理由及其外銷品名，並說明除品名外，其餘內容均與許可製售證明所刊載者相符。
如係膠囊劑者，除應載明其內容物之全處方外，軟膠囊應載明軟膠囊殼之全處方，硬膠囊應載明膠囊殼之色素名稱；其製售證明無法載明硬膠囊殼之色素名稱者，應以原廠函說明。
四、其內容應載明該藥品之製造廠及准在該國自由販售，且記載之製造及販售情形應明確。
前項出產國許可製售證明，得以下列文件替代之：
一、中央衛生主管機關認可之販售國核准販售證明。
二、申請之藥品係列載於美國藥典藥物資訊（UnitedStatesPharmacop-eiaDrugInformation；USPDI）、或美國食品藥物管理局（以下簡稱美國FDA）出版之處方藥品核准名冊ApprovedPrescriptionDr-ugProductWithTherapeuticEquivalenceEvaluations（OrangeBook）者，得影印刊載之頁數或其網路版或電子書版，並檢附美國州政府衛生主管機關核發之許可製售證明，替代美國FDA出具之許可製售證明。
三、藥品出產國係德國者，其許可製售證明得由德國邦政府衛生主管機關出具，免其聯邦政府簽章。
四、藥品出產國係歐洲聯盟（EuropeanUnion，以下簡稱歐盟）會員國之一者，得以歐盟藥品審核機關EuropeanMedicinalAgency（以下簡稱EMA）出具核准製售證明替代之。
五、輸入藥品係委託製造且未於受託製造廠所在國家上市者，得以委託者所在國出具自由販賣證明及受託製造廠所在國出具製造證明替代之，或以委託者所在國出具有載明製造廠名、廠址之自由販賣證明替代之。
前項替代文件內容及出產國核准變更證明，除本準則另有規定外，準用第一項第一款至第四款規定。
一、應檢附之證明文件如非中文或英文者，應另附中文或英文譯本。
二、限出具日起二年內有效，並應經中華民國駐外使領館、代表處、辦事處或外交部授權之駐外機構（以下簡稱我國駐外館處）文書驗證。
但為德國、美國、英國、法國、日本、瑞士、加拿大、澳洲、比利時、瑞典等十國（以下簡稱十大醫藥先進國家）衛生機關出具者，得免驗證。
三、記載之產品名稱、製造廠名稱、地址及處方內容、劑型、含量，應與申請書相符。
其產品名稱應刊載外銷品名於許可製售證明上；未能刊載者，應有原廠函說明未能刊載之理由及其外銷品名，並說明除品名外，其餘內容均與許可製售證明所刊載者相符。
如係膠囊劑者，除應載明其內容物之全處方外，軟膠囊應載明軟膠囊殼之全處方，硬膠囊應載明膠囊殼之色素名稱；其製售證明無法載明硬膠囊殼之色素名稱者，應以原廠函說明。
四、其內容應載明該藥品之製造廠及准在該國自由販售，且記載之製造及販售情形應明確。
前項出產國許可製售證明，得以下列文件替代之：
一、中央衛生主管機關認可之販售國核准販售證明。
二、申請之藥品係列載於美國藥典藥物資訊（UnitedStatesPharmacop-eiaDrugInformation；USPDI）、或美國食品藥物管理局（以下簡稱美國FDA）出版之處方藥品核准名冊ApprovedPrescriptionDr-ugProductWithTherapeuticEquivalenceEvaluations（OrangeBook）者，得影印刊載之頁數或其網路版或電子書版，並檢附美國州政府衛生主管機關核發之許可製售證明，替代美國FDA出具之許可製售證明。
三、藥品出產國係德國者，其許可製售證明得由德國邦政府衛生主管機關出具，免其聯邦政府簽章。
四、藥品出產國係歐洲聯盟（EuropeanUnion，以下簡稱歐盟）會員國之一者，得以歐盟藥品審核機關EuropeanMedicinalAgency（以下簡稱EMA）出具核准製售證明替代之。
五、輸入藥品係委託製造且未於受託製造廠所在國家上市者，得以委託者所在國出具自由販賣證明及受託製造廠所在國出具製造證明替代之，或以委託者所在國出具有載明製造廠名、廠址之自由販賣證明替代之。
前項替代文件內容及出產國核准變更證明，除本準則另有規定外，準用第一項第一款至第四款規定。