DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)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 | 265