DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)m) Importer and Store AddressPlease key in (where applicable).n) Other Supporting DocumentPlease attach (if any).PART II, III & IV – QUALITY , NONCLINICAL DOCUMENT & CLINICALDOCUMENTIn order to complete these parts, please refer the main DRGD as well as ASEANCommon Technical Requirements Guidance Documents, and the followingdocuments (where applicable):a) Appendix 2: Requirements for Product Registrationb) Appendix 3: Guidelines on Registration of Biologicsc) Appendix 4: Guideline on Registration of Health Supplementsd) Appendix 5: Guideline on Registration of Natural Productse) Appendix 6: Guideline on Regulatory Control of Active PharmaceuticalIngredients (API)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 446