DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)8.7.1 PROCESS OF APPEAL FOR QUEST 2 PRODUCTFigure 5:* Applicants may confirm toappeal for rejected application ofany product within 14 daysfrom the date of notificationfrom the Authority, via theQUEST systemApplicant shall print a copy ofappeal letter generated by theQUEST system on thecompany‟s letterhead* Note:For suspended/ cancelled registration of aproduct, applicant may confirm to appealmanually by sending an appeal letter to NPCBwithin fourteen (14) days from the receipt ofnotification letter from the Authority, and itshall be subjected to the same process ofappeal.Applicant shall send the signedappeal letter to NPCB as peraddress stated in the letter** 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 Healtha) ** 90 Days is a timeframe given to applicantapplicable for rejected application of theseproduct categories: generic (scheduled poison& non-scheduled poison), health supplementand natural product. Additional information/supplementary data/ documents shall besubmitted via QUEST system.b) ** 180 Days is a timeframe given to applicantapplicable for rejected application of new drugproduct and biologics; and cancelledregistration of an adulterated product.Additional information/ supplementary data/documents shall be submitted manually toSection of Regulatory Coordination, Centre forProduct Registration, NPCB.Regulatory outcomeRejectedAppeal rejectedApprovedPost-Registration ProcessNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 83