Regulations for the Issuance of Medicinal Products and Medical Devices Manufacturing Licenses and Evidentiary Documents for Good Manufacturing Practices Article 3
A medicament manufacturing license shall include registration of the following items:1. The name of the medicament manufacturing factory.2. The address of the medicament manufacturing factory.3. The license number.4. The full time resident drug administrator or manufacturing supervisor.5. The items or the operations for which the license has been granted.6. The period for which the license is valid.If there is any change in the registration matters under subparagraphs 1 or 4 of the preceding paragraph, an application for amendment of registration, along with the required fee and the information set out in Appendix 1, shall be submitted to the central competent health authority within 30 days from the date of the occurrence of the change.If there is to be any change in the matter under paragraph 1, subparagraph 5, 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