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:No.Section A: Product Particulars1. Product Name2. Product Description3. Dosage Forma) Source of Capsule Shellb) Certificate to verify the source of the capsule shellc) Coloring agent used in capsule shell(Please attach COA of the capsule shell)4. Product Indication/ Usage5. Dose/ Use Instruction6. Contraindication7. Warning and Precautions8. Drug Interaction9. Side Effects/ Adverse reaction10. Signs and Symptoms of Overdose and Treatment11. Storage Condition12. Shelf LifeNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 138
Drug Registration Guidance Document (<strong>DRGD</strong>)Step II:13. Therapeutic Code/ ATC CodeNo.1.2.3.Section B: Product FormulaBatch Manufacturing Formulaa) Batch Sizeb) UnitActive Ingredientsa) Active Ingredients Nameb) Quantityc) Sourced) Form of Substancee) Overage (%)f) RemarksExcipientsa) Active Ingredients Nameb) Quantityc) Functiond) Sourcee) Overage (%)f) Remarks4. Attachment of Batch Manufacturing Formula Documentation5. Manufacturing Process6. Attachment of Manufacturing Process Documentation7. In-Process Quality Control8. Attachment of Finished Product Specification Documentation9.No.1.Attachment of Stability Data Documentation(For two batches) - Compulsory for imported productSection C: Particulars of Packing- Please refer Appendix 10: Guide for Implementation of Patient DispensingPack for Pharmaceutical Products in MalaysiaPack Size(Fill details by weight/ volume/ quantity)Measurement TypeNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 139
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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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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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