Regulations for the Issuance of Medicinal Products and Medical Devices Manufacturing Licenses and Evidentiary Documents for Good Manufacturing Practices Article 8
A pharmaceutical firm that has obtained a medicament manufacturing license may fill out an application form with the information set out in Appendix 2 attached, and pay a fee to apply to the central competent health authority to receive a certificate showing conformity in good manufacturing practices for medicaments (“ certificate ” ).When a foreign manufacturer of imported medicaments has been found through an on-site inspection by the central competent health authority to meet the requirements of the Pharmaceutical Good Manufacturing Practice Regulations, the pharmaceutical firm that is the agent for import may apply for a certificate in accordance with the preceding paragraph.Appendix 2.pdf