DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)8.3 SCREENING OF APPLICATIONAfter an online submission of the product registration application has been done, theapplication shall be undergone an initial evaluation (or known as screening process) whichshall ensure the required data/ information of the submitted application are complete.Further evaluation shall be done after payment for the application has been made.8.3.1 SATISFACTORYOnly complete application shall be accepted and approved for payment.Upon approval from the screening process, applicant shall print three (3) copies of paymentvoucher and submit two (2) copies of payment voucher together with correct fees toFinance Department, NPCB for payment confirmation. Applicant shall keep a copy of thepayment voucher for future reference. A product reference number shall be given to theapplication upon payment confirmation.Applicant shall make payment within thirty (30) days from the date of approval for payment.The application form shall be deleted from the system if payment has not been made withinthe specified timeframe.8.3.2 NON-SATISFACTORYIf the application is found incomplete during the screening process, the application shall berejected and the applicant shall be notified via the system.Note:If there is any decision made by the applicant/ required by the Authority in certain casesto withdraw a submitted application for registration of a product, at any stage ofevaluation prior to its approval, the applicant shall notify the Authority and shall state thereasons for the decision.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 78
Drug Registration Guidance Document (DRGD)8.4 EVALUATION OF APPLICATION8.4.1 INITIATION OF REVIEWUpon confirmation of payment, the application with the submitted data shall be evaluated.Review of applications shall follow a queue system. There shall be separate queues for thedifferent categories of products and/or according to level of claims i.e. general, medium orhigh claim.Priority review may be granted for product which is intended for treatment of a serious orlife-threatening disease, where the likelihood of death is high unless the course of thedisease is interrupted.8.4.2 CORRESPONDENCECorrespondence via the system shall be sent to the applicant if there is any clarification andfurther supplementary data/ information, documentation or samples pertaining to theapplication, if deemed necessary by the Authority.Application shall be rejected if the applicant fails to respond to the correspondence fromNPCB to submit the required supplementary data/ information, documentation or sampleswithin six (6) months from the first correspondence date. (Reference: Circular Bil (08) dlm.BPFK/PPP/01/03)8.4.3 STOP CLOCKUnder review.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 79
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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