DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)Section Documents Yes/ No11.Other supporting documents eg. Halal Certification of the animalderived ingredient from a competent Halal Certification Authority.12. Labelling of the animal derived materials.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 176
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 | 177
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PART III: NON-CLINICAL DATADrug Reg
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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