DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)11.3 APPEAL FOR RETESTINGa) Applicants are allowed only one (1) appeal for any sample that fails laboratorytesting (except if found to be adulterated) the Centre for Quality Controlsubjected to approval by the Deputy Director, Centre for Quality Control.b) Appeal for retesting must be submitted through the on-line registration systemwithin 30 days from the date of result being released.c) If no appeal within 30 days or appeals received after 30 days or the appeal isrejected, the original test result is final and the sample will be considered asfailed laboratory testing.d) Upon approval of appeal for retesting, an applicant needs to submit newsample, reference standards (if required), and other relevant materials (ifrequired) as requested earlier. They should also submit the payment voucherand approval letter for the appeal. This sample shall be treated as a newregistration sample and the applicant will be endured all the cost on the sampleanalysis.(Reference: Circular Bil (67) dlm BPFK/02/5/1.3)e) The result of the re-tested sample is final and there is no provision for a secondappeal.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 99