DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)7. Statement of Acceptance as Product Registration Holder, BPFK-430.5(3) tobe completed by proposed new PRH.16.3.6.2 OTHER INFORMATION1. Date of the documents must be recent, i.e. not exceeding six (6) months fromthe date of application.2. Each page of attachment of product list (if any) with any of the supportingdocuments must be endorsed by the signatory.3. The Secretariat, if necessary, has the right to request for furthersupplementary information or documentation. Failure to do so may result inthe rejection of the transfer application.16.3.7 APPLICATION FORM BPFK-430.5 AND FORM BPFK-430.5(3)a) For application for Change of Product Registration Holder, please use FormBPFK-430.5.b) For Statement of Acceptance as Product Registration Holder, please use formBPFK-430.5(3).16.3.8 SUPPORTING DOCUMENT FORMAT EXAMPLEThis format example is suggested for the applicant in order to produce the requiredsupporting document i.e. Letter of Authorization (LOA).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 119