DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)GenusSpeciesPart ofPlant/AnimalProhibited(whole plant/animalunlessotherwisespecified)Constituent ofConcern Reasonsfor ProhibitionReasons for ProhibitionStrophantusAll speciesStrophantusalkaloidsCardiac effect similar todigoxinSymphytumpregrinumPyrrolizidinealkaloidReported to cause livertoxicity2.1.4 USE OF PROTECTED/ ENDANGERED INGREDIENTSa) PROTECTED/ ENDANGERED WILDLIFE SPECIESIt is the responsibility of the applicant to ensure that the ingredient(s)derived from wildlife species its parts and derivatives used in theformulation COMPLIES with the Wildlife Conservation Act 2010 (Act716) and International Trade in Endangered Species Act 2008 (Act686). Both guidelines can be downloaded through this linkhttp://www.wildlife.gov.my.The applicant shall contact the following department to obtain thenecessary permit/ license. A copy of the permit/ license shall beattached together with the application form for product registration.Department of Wildlife and National Parks, Peninsular MalaysiaKm. 10, Jalan Cheras,56100 Kuala Lumpur,Tel: +603-90866800, Fax: +603-90753873b) ENDANGERED BOTANICAL SPECIESIt is the responsibility of the applicant to declare the source of thebotanical ingredient if it is listed under the International Trade inNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 262
Drug Registration Guidance Document (<strong>DRGD</strong>)Endangered Species Act 2008 (Act 686). If the ingredient is from alocal source, a special permit/ license shall be obtained from the:Division of Protection and Quarantine of Plants,Department of Agriculture,Tingkat 1-3, Wisma Tani,Jalan Sultan Salahuddin,50632 Kuala Lumpur.Tel: +603 - 20301400, Fax: +603 - 26913550.2.2 EXCIPIENTSa) Excipients are substances used to assist in the manufacture of activesubstance into dosage forms suitable for administration to consumers. Eachexcipient ingredient included in a formulation must have a justifiable excipientrole and shall be controlled by specifications. The intended use of anexcipient shall be appropriate.b) New excipient will require safety and/or other additional data to support thefunction in the product prior to addition into the Quest 3 database.2.3 INDICATIONS2.3.1 INDICATIONS ACCEPTABLE FOR NATURAL PRODUCTSa) General Health Maintenance/ Kesihatan Am“Traditionally used…./ “Digunakan secara tradisional….“Digunakan secara homeopati untuk.../ “Homeopathically used....1. For general health/ for health/ untuk kesihatan.2. General health maintenance/ for general well being.3. For health and strengthening the body/ untuk kesihatan danmenguatkan badan.4. For relief of body heatiness/ untuk melegakan panas badan.5. For general debility, weakness after illness or childbirth/ untuk letihlesu/ kelesuan badan selepas sakit atau selepas bersalin.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 263
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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