The following items shall be registered in the approval document under the preceding article:1. The name of the medicament manufacturing factory.2. The address of the medicament manufacturing factory.3. The approval number.4. The items or operations for which approval has been granted.5. The period for which the approval is valid.6. The pharmaceutical firm that is the agent for import.If there is any change in the registration matters under subparagraphs 1, 2, 4, or 6 of the preceding paragraph, the pharmaceutical firm that is the agent for import shall submit an application for amendment of registration, along with the required fee and the information set out in Appendix 1, to the central competent health authority within 90 days from the date the change occurs.A change under paragraph 1, subparagraph 2 may be made only for the cause of address plate renumbering. In the event of any relocation, an application for inspection shall be submitted under the Regulations of Medicament Manufacturer Inspection.If there is any application for a change in the matter under paragraph 1, subparagraph 4, it shall be inspected by the central competent health authority to ensure it meets the requirements of the Regulations of Medicament Manufacturer Inspection before it may be approved.Appendix 1.pdf