DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCE6.January2013Appendix 5,Guideline onRegistration ofNaturalProducts- Amendment at 2.1.3 Prohibited/ Banned Ingredients:a) Table 1: Botanicals (and botanical ingredients) containingscheduled poisons as listed under the Poisons Act 1952,for ingredient “Valerian”, as follows:Species: Deletion of “Extract only”Constituent(s) of concern: Addition of “Valepotriates”.b) Table 4: List B: Botanicals which may be Adulterated withAristolochic Acid:Addition of botanical name starting at Cocculusorbiculatus DC. [Common or Other Names: Mokuboui(Japanese)] to the last botanical namesStephania tetrandra S. Moore and Vladimiria souliei(franch.) LingMemo from Sub-Section ofComplementary Medicine(53)dlm.BPFK/PPP/06/17Jilid 29, 18 January 2013- Amendment at 2.7.1 Statement to be stated on productlabel:“If symptoms persist, please consult a doctor.” and “This is anatural medicine/ Ini adalah ubat tradisional.” OR “This is ahomeopathy medicine/ Ini adalah ubat homeopati.” TOFor product with an indication “For general health/ wellbeing” or “Untuk kesihatan umum”, please state:- “Please consult your pharmacist / doctor before takingNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 486
Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCEthis product or Sila merujuk kepada ahli farmasi/ doktorsebelum mengambil produk ini.”For product with an indication “To relieve symptomsfor…. (any illness)” or “untuk mengurangkan tandatanda/simptom….”, please state:- “Please consult your pharmacist/ doctor if symptomspersist/ worsen or Sila merujuk kepada ahli farmasi/doktor jika simptom berlarutan/ bertambah teruk.”“This is a traditional medicine/Ini adalah ubat tradisional.”OR “This is a homeopathy medicine/Ini adalah ubathomeopati.”Unless otherwise supported, all herbal/ traditionalproducts label shall state the following generalcautionary statement, EXCEPT for product withindication for men‟s health or product for children useonly:“Pregnancy and breastfeeding: Insufficient reliabledata”- Amendment at 2.7.2 Specific Labelling Statements/ Warning& Precautions:a) For product containing Royal Jelly: Addition of “(for oraluse)” after the word of “Royal Jelly”.b) Addition of new active ingredient i.e. “For productNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 487
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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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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