DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)4.2 ACTIVE INGREDIENTSListed active ingredients can be checked trough http://www.bpfk.gov.my of product search.4.3 MAXIMUM DAILY LEVELS OF VITAMINS AND MINERALS FORADULTS ALLOWED IN HEALTH SUPPLEMENTSNO. VITAMINS & MINERALS UPPER DAILY LIMIT1. Vitamin A 5000 IU2. Vitamin D 1000 IU3. Vitamin E 800 IU4. Vitamin K (K1 and K2) 1 0.12mg5. Vitamin B1 (Thiamine) 100 mg6. Vitamin B2 (Riboflavine) 40 mg7. Vitamin B5 (Panthothenic Acid) 200 mg8. Vitamin B6 (Pyridoxine) 100 mg9. Vitamin B12 (Cyanocobalamin) 0.6 mg10. Vitamin C (Ascorbic Acid) 1000 mg11. Folic Acid 0.9 mg12. Nicotinic Acid 15 mg13. Niacinamide (Nicotinamide) 450 mg14. Biotin 0.9 mg15. Boron 6.4 mg16. Calcium 1200 mg17. Chromium 0.5 mg18. Copper 2 mg19. Iodine 0.3 mg20. Iron 2 20 mg21. Magnesium 350 mgNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 176
Drug Registration Guidance Document (<strong>DRGD</strong>)NO. VITAMINS & MINERALS UPPER DAILY LIMIT22. Manganese 3.5 mg23. Molybdenum 0.36 mg24. Phosphorus 800 mg25. Selenium 0.2 mg26. Zinc 15 mgNote:1. Vitamin K (K1 and K2) is restricted only for combination with other vitamins andminerals in oral preparations. Vitamin K (K1 and K2) as a single ingredient in anoral preparation is not allowed.2. For pre and antenatal use, as part of a multivitamin and mineral preparation,levels higher than the 20mg limit established for adults may be permitted at thediscretion of the Authority.3. Any form of fluoride as an ingredient is not permitted in formulation of healthsupplement products.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 177
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Page 126 and 127: Drug Registration Guidance Document
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Page 220 and 221: 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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