Regulations of Medicament Manufacturer Inspection Article 10

Domestic medicament manufacturers in compliance with regulations of Article 4,Article 6, and Article 8 will be issued with medicament manufacturing licenses by the central health authority.Foreign medicament manufacturers in compliance with regulations of Article 5,Article 7, and Article 9 will be issued with approval documents by the central health authority.
中文原文 藥物製造業者檢查辦法第10條
國產藥物製造業者符合第四條、第六條及第八條規定者,由中央衛生主管機關核發藥物製造許可;國外藥物製造業者符合第五條、第七條及第九條規定者,由中央衛生主管機關發給核定文件。

English translation for reference only; the Chinese text prevails. Not legal advice.