DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)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 approvalNoYes2. Mode of application Variation Type IIApplication forregistration as anew product3. Purpose of productFor convenienceof the consumerFor therapeuticregimenNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 122
Drug Registration Guidance Document (DRGD)No.ParticularsConvenientPackCombinationPack(Combo Pack)4. 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.Product registration holders are required to monitor and report any product safetyissues that arises locally or internationally to the NPCB and comply with all safetyrelateddirectives issued by the Authority.The product registration may be cancelled if the product registration holder fails toinform the Authority of any serious adverse reactions upon receipt of such reports.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 123
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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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