DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)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 importedproducts). 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 | 346
Drug Registration Guidance Document (<strong>DRGD</strong>)Figure 1:PRHNote:Numerical notations shown in the above figure are in line with the numberingfor the parameters, shown in Table 1 above, to be included in the product label(as identified and adopted by the ACCSQ-PPWG).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 347
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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