DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)5. TYPES OF APPLICATION5.1 REGISTRATION OF PRODUCTS5.1.1 APPLICATION FOR PRODUCT REGISTRATION FOR THEFOLLOWING CATEGORIES:a) New Drug Products;b) Biologics;c) Generic;d) Health supplements; ande) Natural Products.For details, please refer to Section A, 1.2 Categories of Product and SectionB: Product Registration Process.5.1.2 REGISTRATION OF COMBINATION PACK (COMBO PACK)a) Refers to products which are packed together in combination for atherapeutic regimen such as for the treatment of Helicobacter Pylori,Hepatitis C, etc.).b) Shall be registered as a single product.c) Must consist of registered products only:i. Where a combination pack consists of registered and unregisteredproducts, the unregistered product needs to be registered first, priorto submission of the application;ii.Where a combination pack consists of registered products fromdifferent product owners/ PRH, letters of authorization whichinclude product name and product registration number from eachproduct owner shall be submitted.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 58
Drug Registration Guidance Document (DRGD)d) A product which is packed together with diluent(s)/ adjuvant(s) is NOTconsidered as a combination pack.e) Labelling requirement specifically for combination pack is shown inTable IV:No. Outer Label Immediate Label1. Name of combination packIndividual name for each productsOR name of combination pack2.3.4.5.Registration number for thecombination packName and address ofmanufacturer and productregistration holderBatch number of thecombination pack productExpiry date(according to the shortestexpiry date from the individualproducts)Individual registration number foreach products OR registrationnumber for combination packName and address ofmanufacturer and productregistration holderIndividual batch number for eachproductsIndividual expiry date for eachproductsNote:These labeling requirements for a combo pack shall as well be subjectedto other labelling requirements as stated in Appendix 9.1: Label (mock-up)for Immediate Container, Outer Carton and Proposed Package Insert)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 59
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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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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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