DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)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 | 178
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 | 179
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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