DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)11. GUIDELINE FOR THE SUBMISSION OF PRODUCTSAMPLES FOR LABORATORY TESTINGThe submission of sample for laboratory testing is as part of the registration process. Thisguideline consists of the general and specific requirements for the submission of samplesto the Centre for Quality Control for laboratory testing. The general requirements define thecondition of the samples to be submitted whereas the specific requirements illustrate theadditional details needed according to the category of product.The sample shall be submitted to the Centre for Quality Control within 14 days after thepayment has been confirmed. Application for product registration shall be rejected by theAuthority if the sample is not submitted within 30 days from the date of confirmed payment.The applicants shall comply with these requirements and failure to meet any of theserequirements may cause rejection of the samples.11.1 GENERAL REQUIREMENTSa) After the registration payment has been approved, applicants must makeappointment with the Laboratory Services Unit for the submission of registrationsamples for laboratory testing.b) Requirements for samples:i) Samples submitted must be in their original packaging & labeling.ii)iii)Samples submitted must be from the same manufacturing premise as statedin the application for registration.Samples submitted must have an expiry date of least one (1) year from thedate of submission.c) For imported products, applicants are required to submit the original import permittogether with the samples for laboratory testing. The import permit will be issued bythe Centre for Registration and Centre for Quality Control for natural product andpharmaceutical products, respectively. The applicant should ensure that the importpermit is endorsed by the enforcement officer at the entry point.d) The payment voucher and approved payment application status should also besubmitted together with the samples.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 97