DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)2. Non-scheduled Poison(Known as Non-Poison or “Over-the-Counter”, OTC)Products containing active ingredients which are not listed in theFirst Schedule under Poisons Act 1952; and is excluding activeingredient which is categorized under health supplements or naturalproducts or cosmetics.1.2.4 HEALTH SUPPLEMENTSA Health Supplement (HS) means any product that is used to supplement a dietand to maintain, enhance and improve the health function of human body. It ispresented in small unit dosage forms (to be administered) such as capsules,tablets, powder, liquids and shall not include any sterile preparations (i.e.injectables, eyedrops). It may contain one or more, or the following combination:i) Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, andother bioactive substances;ii) Substances derived from *natural sources, including animal, mineral andbotanical materials in the forms of extracts, isolates, concentrates,metabolite;iii) Synthetic sources of ingredients mentioned in (i) and (ii) may only be usedwhere the safety of these has been proven.For details, please refer to Appendix 4: Guidelines for Registration of HealthSupplements1.2.5 NATURAL PRODUCTSa) Traditional medicine (as defined under the Control of Drugs and CosmeticsRegulations 1984):Any product used in the practice of indigenous medicine, in which the drugconsist solely of one or more naturally occurring substances of a plant, animalNational Pharmaceutical Control BureauFirst Edition, January 201335