Regulations for Registration of Medicinal Products｜第 6 條｜Food and Drug Administration｜Regulation｜In Force
第 二 章/第 一 節｜衛生福利部｜v1.0
Effective Date: 2024-01-01｜Last Amended: 2023-04-27
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; and 5.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.