DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)10. SODIUM METABISULPHITE (Excipient)The following statement shall be included in the package insert of productscontaining Sodium metabisulphite:WARNING:This preparation contains Sodium metabisulphite that may cause seriousallergic type reactions in certain susceptible patients. Do not use if known tobe hypersensitive to bisulphites.Prohibited Visual/ Graphics on Label, as shown in Table 14 below:No. Issue Example Note1.Marketing strategyExample:“Money back guarantee”“Buy 1 free 1”“Backed by RM5 millionproduct Liability Insurance”Such statementsare prohibited onlabels, as perMedicines(Advertisementand Sale) Act1956 requirements2.Usage guide whichpromotes use ofother product(s)Example:“After consumption of thisproduct (Product A), forbetter results, it isrecommended to takeProduct B”Prohibited onproduct label3. Consumer testimonialProhibited onproduct labelNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 214
Drug Registration Guidance Document (<strong>DRGD</strong>)No. Issue Example Note4.Clinical Trial results orany information onclinical trial done onproductExample :“Clinically Tested”“Randomized Double BlindPlacebo Control ClinicalStudy”Such statementsare prohibited onlabels (as perMedicines(Advertisementand Sale) Act1956Requirement5.Reference to Hadith/ Al-Quran/ Bible/ ReligiousbooksProhibited onproduct label6.Opinion of prominentfigure(s) onproduct or its activeingredient/contentExample:Opinion ofproduct/formulation inventorProhibited onproduct label7.Label design (graphicand color) similar tolabels from anothercompanyProhibited onproduct label8.Statement on activeingredient originExample:Source from the Mountainsof AlpsAllowed if proventrue9.Introduction of founder/ManufacturerProhibited onproduct label10. Logo with certificationExample:SIRIM/ ISO / GMP/ HACCPProhibited onproduct labelbecausecertificationrenewal is on ayearly basisNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 215
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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