DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)No.10.11.Step I: Product ValidationIs this a replacement product? (Yes/ No)If yes, please provide:a) Letter of Declaration stating that this product is a replacement productb) Registration number and product name of the replaced productIs there any other manufacturer (repacker)? (Yes/ No)a) Manufacturer (repacker) nameb) Manufacturer (repacker) addressc) Certificate of Good Manufacturing Practice (GMP)d) Packaging Process12. Is this an imported product? (Yes/ No)Step II:Part I: Administrative Data And Product InformationNo.Section A: Product Particulars1. Product Name2. Name & Strength of Active Substance and Excipient3. Dosage Form4. Product Description5. Pharmacodynamics6. Pharmacokinetics7. Indication8. Recommended Dose9. Route of Administration10. Contraindication11. Warning and Precautions12. Interaction of Other Medicaments13. Pregnancy and Lactation14. Side Effects15. Symptoms and Treatment of OverdoseNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 130
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 | 131
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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