DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)8.1.5 MULTIPLE APPLICATIONS ...................................................................... 758.1.6 SECOND OR THIRD SOURCE ................................................................. 758.1.7 VARIANTS ................................................................................................. 768.1.8 LANGUAGE ............................................................................................... 768.2 SUBMISSION OF APPLICATION .................................................................... 778.3 SCREENING OF APPLICATION ..................................................................... 778.3.1 SATISFACTORY ....................................................................................... 778.3.2 NON-SATISFACTORY .............................................................................. 788.4 EVALUATION OF APPLICATION.................................................................... 788.4.1 INITIATION OF REVIEW ........................................................................... 788.4.2 CORRESPONDENCE ............................................................................... 788.4.3 STOP CLOCK ........................................................................................... 798.4.4 TIMELINE FOR PRODUCT REGISTRATION ........................................... 798.5 REGULATORY OUTCOME ............................................................................. 808.5.1 DECISIONS OF THE AUTHORITY ........................................................... 808.5.2 PRODUCT REGISTRATION NUMBER..................................................... 808.5.3 CERTIFICATE OF REGISTRATION ......................................................... 818.6 POST-REGISTRATION PROCESS ................................................................. 818.7 REJECTED APPLICATION ............................................................................. 828.7.1 PROCESS OF APPEAL FOR QUEST 2 PRODUCT ................................. 838.7.2 PROCESS OF APPEAL FOR QUEST 3 PRODUCT ................................. 848.7.3 TEMPLATE FOR APPEAL LETTER ......................................................... 85SECTION C: QUALITY CONTROL9. GUIDELINE FOR THE SUBMISSION OF PROTOCOL OF ANALYSIS ......... 879.1 GENERAL REQUIREMENTS .......................................................................... 879.2 SPECIFIC REQUIREMENTS .......................................................................... 88National Pharmaceutical Control BureauFirst Edition, January 201320