DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Step II:16. Storage Condition17. Shelf Life18. Therapeutic Code/ ATC CodeNo.Section B: Product Formula1. Batch Manufacturing Formula2. Attachment of Batch Manufacturing Formula DocumentationNo.Section C: Particulars of Packing- Please refer Appendix 10: Guide for Implementation of Patient DispensingPack for Pharmaceutical Products in Malaysia1.2.Pack Size(Fill details by weight/ volume/ quantity)Immediate Container Type(Container Type and Description)e.g. Aluminium/ Glass/ Metal/ Paper/ Plastic/ Others3. Barcode/ Serial No. (Optional)4. Recommended Distributor‟s Price (RM) (Optional)5. Recommended Retail‟s Price (RM) (Optional)No.Section D: Label (Mock-up) For Immediate Container, Outer Carton,Proposed Package Insert- Please refer Appendix 9: Labelling Requirements1. Proposed Label Mock-up for Immediate Container2. Proposed Label Mock-up for Outer Carton3. Proposed Package InsertNo.Section E: Supplementary Documentation1. Product Owner2. Letter of Authorization from Product Owner3.Letter of Appointment of Contract Manufacturer from Product Owner (ifapplicable)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 140
Drug Registration Guidance Document (<strong>DRGD</strong>)Step II:4.5.Letter of Acceptance from Contract Manufacturer(if applicable)Is the active ingredient(s) patented in Malaysia?(Yes/ No)(If yes, please attach the related document)6. Certificate of Pharmaceutical Product (CPP)7. CPP Issuing Body8.Is this product licensed to be placed on the market for use in the exportingcountry? (Yes/ No)(If no, please state the reason)9.Is the product on the market in the exporting country? (Yes/ No)(If no, please state the reason)10. Date of Issue of CPP11. Date of Expiry of CPP12. Certificate of Free Sale (CFS)13. CFS Issuing Body14. Date of Issue of CFS15. Date of Expiry of CFS16. Certificate of Good Manufacturing Practice (GMP)17. Certificate of GMP Issuing Body18. Date of Issue of Certificate of GMP19. Date of Expiry of Certificate of GMP20.Summary of Product Characteristics(Product Data Sheet)21. Patient Information Leaflet (PIL)22. *Attachment of Protocol Analysis23. *Attachment of Analytical Validation24. *Certificate of Analysis (CoA)25. Other Supporting Document (if any)26. Manufacturer (Name and address)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 141
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PART III: NON-CLINICAL DATADrug Reg
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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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