DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)The Authority reserves the right to conduct an inspection on anymanufacturing site.Unless otherwise supported by justifications acceptable to the Authority, thefollowing products are unlikely to be registered:i) products not licensed/ certified for sale in the country of manufacture/product owner;ii) products manufactured for export only (imported products).g) Is this product licensed to be placed on the market for use in the exportingcountry?If no, please state the reason.h) Is the product on the market in the exporting country?If no, please state the reason.i) Summary of Product Characteristics (SPC)Please attach (where applicable).j) Patient Information Leaflet (PIL)Please attach (where applicable).k) Attachment of Protocol Analysis, Analytical ValidationPlease attach (where applicable).l) Certificate of Analysis (CoA) for Finished ProductFor two (2) batches.Compulsory for imported product.Please attach the certificate (which must be complete with the productspecification and results).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 454
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 | 455
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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