DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)No. ParametersOuter Carton(Unit Carton)ImmediateLabelsBlister/Strips16.17.18.19.20.21.Name & content of alcohol,where presentTo declare source ofingredients derived from animalorigin, including gelatin (active,excipient, and/or capsule shell)Recommended daily allowance(RDA) for vitamins/multivitamins/ mineralpreparations used as dietarysupplementsThe words “Keep medicine outof reach of children” or wordsbearing similar meaning in bothBahasa Malaysia & EnglishOther country specific labellingrequirements(if applicable)The words “ControlledMedicine/ Ubat Terkawal”(For scheduled poison only) NA NA NA * NA * NA * NA22. Security Label (Hologram) * NANA : Not Applicable* Exempted for small labels such as used in ampoules/ cartridge and vials** For multi-vitamins and minerals preparations it is suggested to label as multivitaminsand mineralsNo. 15, 19, 21 & 22 of the above are country specific requirements for Malaysia.Additional Information:a) If the product is without an outer carton, the inner label shall bear all theinformation that is required.b) Official website of the company or website for any purpose of product promotionfrom the PRH/ product owner/ manufacturer is not allowed to be printed on theproduct label (applicable to all categories of products inclusive of importedNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 348
Drug Registration Guidance Document (<strong>DRGD</strong>)products). However, the email address of the company is permissible on thelabel.c) The colours of labels shall be differentiated between strengths of products aswell as between products containing different active ingredients which belong tothe same holder.d) Only a single label artwork is permitted for all pack sizes of a registeredproduct.e) No stick-on label is permitted. Any usage of stick-on label shall have priorapproval by the Authority. The Authority will only consider the followingsituations:i) Stick-on label of such information and printing of registration number for labelredressing of a registered product is permitted:Words with “Controlled Medicine”/ Ubat Terkawal, Jauhi daripada kanakkanak,information of Product Registration Holder, Malaysia SpecificLabelling Requirements shall be printed in a single label.ii) The label shall be made from good quality material and not easy to be tornout.iii) However, registration number shall be printed permanently on the product(ink-jet) and it is not allowed to be printed on the stick-on label.f) Please refer to Figure 1 as an example of a product label which in accordanceto the labelling requirements.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 349
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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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