DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)8.1.3 REQUIREMENTS FOR PRODUCT REGISTRATION ............................... 738.1.4 CONDITIONS APPLIED ON PRODUCT REGISTRATION ....................... 748.1.5 MULTIPLE APPLICATIONS ...................................................................... 758.1.6 SECOND OR THIRD SOURCE ................................................................. 758.1.7 VARIANTS ................................................................................................. 768.1.8 LANGUAGE ............................................................................................... 778.2 SUBMISSION OF APPLICATION ................................................................. 778.3 SCREENING OF APPLICATION ..................................................................... 788.3.1 SATISFACTORY ....................................................................................... 788.3.2 NON-SATISFACTORY .............................................................................. 788.4 EVALUATION OF APPLICATION.................................................................... 798.4.1 INITIATION OF REVIEW ........................................................................... 798.4.2 CORRESPONDENCE ............................................................................... 798.4.3 STOP CLOCK ........................................................................................... 798.4.4 TIMELINE FOR PRODUCT REGISTRATION ........................................... 808.5 REGULATORY OUTCOME ............................................................................. 818.5.1 DECISIONS OF THE AUTHORITY ........................................................... 818.5.2 PRODUCT REGISTRATION NUMBER..................................................... 818.5.3 CERTIFICATE OF REGISTRATION ......................................................... 818.6 POST-REGISTRATION PROCESS ................................................................. 828.7 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 AN APPEAL LETTER .................................................... 85SECTION C: QUALITY CONTROL9. GUIDELINE FOR THE SUBMISSION OF PROTOCOL OF ANALYSIS.………87National Pharmaceutical Control BureauFirst Edition, January 201320