Regulations for Registration of Medicinal Products Article 44

When applying for licenses for export products, the applicant should submit the original copy and a duplicate copy of the application form, assurance statement A, assurance statement B, assurance statement for the export-only product, form for sticking package inserts and labels (two copies), form for sticking licenses, the testing specifications, methods and certificate of analysis of API and final product respectively, and a photocopy of GMP compliance certificate. The manufacturer should retain the Manufacturing and Control Standards (including the actual amount or materials used as specified in batch records), batch record, the testing specifications, methods and certificate of analysis of excipients, stability study data, and validation of analytical methods and validation of critical manufacturing processes for future inspection. If necessary, the central health competent authority may request the applicant to provide samples for testing. Such requests should be answered.When applying for an export license, if the applicant imports semi-products to manufacture export-only final products, and has obtained a license for importing the semi-products, then in addition to the above mentioned documents, the applicant should also provide the original copy of a commission letter, therein authorizing the applicant to register the product in Taiwan and export them to other countries. If the applicant does not hold a license for importing semi-products, then the CPP or the FSC from the manufacturing country of the semi-products should also be provided.