埃塞俄比亚注要求.docVIP

G U I D E L I N E S ? ON THE REQUIREMENTS ? FOR THE REGISTRATION OF ? HUMAN DRUGS ? ? ? ? ? P A R T I ? ? ? ? ? ? ? ? ? Section I Requirements for Abbreviated New Drug Application (ANDA) ? 1.???? Application form ? The pre-marketing application (PMA) form for New Drug Application is as indicated in Annex I. The date of application should correspond to the date of submission of the application to the Drug Administration and Control Authority of Ethiopia. ? 2.???? Agency Agreement ? 2.1.? An agency agreement should be made between the manufacturer of the drug