Regulations for Registration of Medicinal Products｜第 62 條｜Food and Drug Administration｜Regulation｜In Force
第 二 章/第 三 節｜衛生福利部｜v1.0
Effective Date: 2024-01-01｜Last Amended: 2023-04-27
For post-approval change, the following documents are required for the changes of the drug manufacturer’s address: 1.If the change is due to building-numbering adjustment, then the following documents shall be submitted: (1) Application form of post-approval changes; (2) Original drug licenses; (3) A list of all drug licenses; (4) For local drug manufacturers, a photocopy of each changed license, and the documents issued by the household registration authorities to prove the implementation of building-numbering adjustment; (5) For foreign manufacturers of imported drugs, a notification letter of post-approval changes issued by the original manufacturers and documentation issued by the relevant household registration authorities. The documents should be authenticated by the R.O.C. Foreign affairs offices. The authentication requirement is waived for documents issued by A10 countries. 2.The following documents are required for site relocation or changes in the place of production: (1) Application form of post-approval changes; (2) Original drug licenses; (3) For local drug manufacturers, a list of all drug licenses, a photocopy of each changed license, and a photocopy of the GMP certificate for the new site after relocation; (4) For foreign manufacturers of imported drugs, a letter of proxy, the original notification letter of post-approval changes issued by the original manufacturer, CPP from the manufacturing country, a photocopy of the GMP compliance certificate, the Standard Manufacturing and Control Procedures and the amount of all components in the batch record or the manufacturing records of the same lot for the final products, the testing specifications, the testing methods and certificate of analysis for the final products and the raw materials of the same lot, and data of stability tests. If the holder the GMP compliance certificate is not the applicant, then this documentation can be replaced by a letter of authorization issued by the original manufacturer or the local drug company holding the certificate, therein specifying the approval number of the original certificate. (5) For foreign manufacturers of imported drug substances, a letter of proxy, the original notification letter of post-approval changes issued by the original manufacturer, the GMP compliance certificate of the active pharmaceutical ingredients, and the relevant technical documents as specified in Appendix 12. (6) Article 46 should be followed for documentation submission. (7) If renewal of license is required, the original application form shall be submitted. For imported drugs, if the foreign manufacturing site’s address remains the same, but the address of the drug company or the foreign license holder is changed, and there is no transfer of rights, then the following documents shall be submitted. 1.Application form for post-approval changes; 2.Original drug license; 3.A list of all drug licenses; 4.Notification letter of post-approval changes issued by the original manufacturer.