DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)8.7.2 PROCESS OF APPEAL FOR QUEST 3 PRODUCTFigure 6:# Applicants may confirm toappeal for rejected application ofany product within 14 daysfrom the date of notificationfrom the Authority# Note:The same process of appeal is applicable toregistration of a product which has beensuspended/ cancelled by the Authority.Applicant shall submit appealletter to NPCB as per addressstated in the template appealletter*** Applicant shall submitrequired additional information/supplementary data/ documentswithin 90 or 180 days from thedate of appeal confirmationEvaluation by the AuthorityMemorandum of appealprepared by the Authority andsent to the Minister of Health*** Note:a) 90 Days is a timeframe given to applicantapplicable for rejected application of theseproduct categories: generic (scheduled poison &non-scheduled poison), health supplement andnatural product. Additional information/supplementary data/ documents shall besubmitted manually to Section of RegulatoryCoordination, Centre for Product Registration,NPCB.b) 180 Days is a timeframe given to applicantapplicable for rejected application of biologicsand new drug product; and cancelledregistration of an adulterated product. Additionalinformation/ supplementary data/ documentsshall be submitted manually to Section ofRegulatory Coordination, Centre for ProductRegistration, NPCB.c)Regulatory outcomeRejectedAppeal rejectedApprovedPost-Registration ProcessNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 84