DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)f) Conditions for application:i) Individual registered products proposed to be packed together as aconvenient pack shall be sourced from the same product owner/ PRH;ii) Submission of the application shall be made by the same PRH.iii) The manufacturing site for the convenient pack shall be a GMP certifiedfacility.g) Approved indication of each individual registered product in the convenientpack remains unchanged. There is no common specific indication for theconvenient pack.h) Labelling requirement specifically for convenient pack:Table XVII:Outer LabelContents in the labelling of eachindividual registered product have tobe included in the outer label of theconvenient pack.Immediate LabelAs per labelling requirements forregistered products.Note:For the purpose of application submission, if the individual registered productis also marketed independently, outer label of the packaging soldindependently and outer label of the convenient pack shall be submittedtogether.i) Additional information on differentiation from Combination Pack(Combo Pack):Table XVIII:No.ParticularsConvenientPackCombinationPack(Combo Pack)1.New registration number(MAL No.) to be assignedupon approvalNoYesNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 116
Drug Registration Guidance Document (DRGD)No.ParticularsConvenientPack2. Mode of application Variation Type IICombinationPack(Combo Pack)Application forregistration as anew product3. Purpose of productFor convenienceof the consumerFor therapeuticregimen4. New indication No Yes5. Sale of product6. ExampleCan be soldindividually or asa packConfinement Setor Set JamuBersalinOnly to be soldas a packKlacid HP7(for treatment ofpeptic ulcerdiseasesassociated withH. pyloriinfection)17. POST-MARKETING ACTIVITIES17.1 PHARMACOVIGILANCE17.1.1 ADVERSE DRUG REACTION REPORTING AND SAFETY UPDATESIn accordance with Regulation 28 : Reporting adverse reaction under Control ofDrugs and Cosmetics Regulations 1984, Sale of Drugs Act 1952 (amendment 2006),the product registration holders or any person who possesses any registeredproduct shall inform immediately the Director of Pharmaceutical Services of anyadverse reaction arising from the use of the registered product.All product registration holders must ensure that a pharmacovigilance system is inplace by the company and appropriate action is taken, when necessary.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 117
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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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