DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)No.17.Type I: Minor changeVariationType II: Major changeChange or addition of fill volumeand/or change of shape or dimensionof container or closure for a sterilesolid and liquid drug productAll supporting documents in accordance to the specified conditions laid down foreach type of variations should be submitted. For further information pertaining toconditions and supporting documents required for an application of variation, pleaserefer to Appendix 12: Conditions and Supporting Documents Required forApplication of Variation Type I & Type II.If deemed necessary, NPCB reserves the right to request for additional supportingdocuments and variation approval letters from other regulatory bodies for allcategories of product.For variations which are not covered in this guidance document, please referASEAN Variation Guideline for Pharmaceutical Product 2012.16.1.1 MODE OF SUBMISSIONTable XV:No. Variation QUEST 2 Product QUEST 3 Product1. Type IApplicant shall submit application forVariation Type I via both manual andonline QUEST 2 system.For manual submission, applicantcan download Form BPFK 416.2from NPCB‟s websitewww.bpfk.gov.my, and shall submitto the Variation Section, Centre ofPost Registration, NPCB.Applicant shall submitapplication for VariationType I and/or Type IImanually to the VariationSection, Centre of PostRegistration, until furthernotice pertaining to onlinesubmission.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 109