DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)APPENDIX 4:GUIDELINE ON REGISTRATION OF HEALTH SUPPLEMENTSIMPORTANT NOTES:This guideline will serve as an additional reference guide for the registration ofhealth supplement products which consist of pharmaceutical active ingredients forhuman use as well as ingredients derived from natural sources.Applicants are advised to refer to Drug Registration Guidance Document for thecommon requirements for the preparation of a well-structured dossier applicationto be submitted for product registration.Outline:4.1 Definition4.1.1 Health Supplement (HS)4.1.2 Indication4.1.3 Route of Administration4.1.4 Exclusion as Health Supplement4.1.5 Exemption4.2 Active Ingredients4.3 Maximum Daily Levels of Vitamins and Minerals for Adults Allowed inHealth Supplements4.4 Health Supplement Claim4.4.1 Conditions4.4.2 Types and Evidence of Claims4.4.3 Claims Substantiation4.4.4 Illustrative Substantiation Evidence4.5 Specific Dossier Requirement for Registration of Health SupplementsAttachment 1:Attachment 2:AcknowledgementsChecklist of Dossier Requirement for Health SupplementsTable 20: Allowable Claims for Specific Active Ingredients inHealth SupplementsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 168
Drug Registration Guidance Document (DRGD)4.1 DEFINITION4.1.1 HEALTH SUPPLEMENT (HS)A Health Supplement (HS) means any product that is used to supplement a diet and tomaintain, enhance and improve the health function of human body. It is presented in smallunit dosage forms (to be administered) such as capsules, tablets, powder, liquids and shallnot include any sterile preparations (i.e. injectable, eyedrops). It may contain one or more,or the following combination:i) Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and otherbioactive substances;ii) Substances derived from *natural sources, including animal, mineral and botanicalmaterials in the forms of extracts, isolates, concentrates, metabolite;iii) Synthetic sources of ingredients mentioned in (i) and (ii) may only be used where thesafety of these has been proven.4.1.2 INDICATIONi) Used as a Health Supplement;ii) Vitamin and mineral supplements for pregnant and lactating women.4.1.3 ROUTE OF ADMINISTRATIONOral4.1.4 EXCLUSION AS HEALTH SUPPLEMENTS:Health Supplements shall NOT include:i) Any product as a sole item of a meal;ii) Any injectable and sterile preparation;iii) Any human part or substance derived from any part of the human body;iv) Any substance listed in the Schedule of the Poison Act;v) Any other route of administration other than the oral route.4.1.5 EXEMPTIONExtemporaneous preparations that have been prepared and given directly to the patient bya healthcare practitioner during the course of treatment.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 169
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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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