Regulations for Registration of Medicinal Products Article 104-1

Except for the situations mentioned in the preceding article, a domestically manufactured Chinese medicine demanded for exporting which of any its “export only” label, package insert, or packing may be allowed to be changed without prior application and approval in any of the following circumstances where the originally approved text is changed without affecting the drug quality or medication safety:1.Changing or deleting the manufacturer’s name or designation of the dosage form included in the product name;2.The name of the Chinese medicine is changed to the approved name for “export-only” by the central health competent authority;3.Changing the labeling method of the formula or deleting the excipient without changing the original formula proportion;4.Deleting the domestic drug license number or adding license number approved by the destination country for export;5.Changing or deleting the administration and dosage, but the changed administration and dosage shall not exceed the originally approved ones;6.Deleting or simplifying the efficacy and indications;7.Translating into a foreign language for the destination country for export;8.Adding the trademark;9.Adding precautions, warnings, or other text for ensuring drug quality and medication safety;10.Other items as announced by the central health competent authority.The changes or addition of an “export only” label, package insert, or packing set forth in the preceding paragraph shall conform to the Good Manufacturing Practices for Pharmaceuticals specified in the Pharmaceutical Good Manufacturing Practice Regulations, and records shall be made and retained by the manufacturers for future reference.