DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)10.1 PURPOSETo provide guidance on the implementation of patient dispensing pack ororiginal dispensing pack for pharmaceutical products in Malaysia.10.2 OBJECTIVEImprove patient‟s safety by:maintaining product integrity;prevent unnecessary exposure of the product;avoid product contamination due to handling especially in non-GMPpremise; andFewer steps in dispensing process hence less possibility for errors andimprovement in efficiency.10.3 DEFINITIONPatient dispensing pack or original dispensing pack is a ready-to-dispensepack with sufficient quantity equivalent to an amount not more than one monthsupply or per treatment for one patient‟s use.10.4 BENEFITSKey benefits identified:Ensuring patients on how to take medications and the importance of it,which will eventually increase patient‟s compliance.Clear identification of the medicine, by whom and where it wasmanufactured.Providing complete instructions on the use of the medicine.Original packing will maintain the integrity of the pack therefore ensuringthe stability of the product.Original packing will carry batch number and expiry date.Prevent mix-ups (or contamination) during repacking and dispensing.Facilitate recall of products since the required information can only befound on the original pack.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 424
Drug Registration Guidance Document (<strong>DRGD</strong>)10.5 CRITERIA FOR IMPLEMENTATION OF PATIENT DISPENSING PACKThe patient dispensing pack size should be based on the medication,intended use, recommended dosage and dosage form sufficient for onemonth supply or per treatment for one patient‟s use.This requirement does not apply for blister or strip pack.Maximum permitted supply is one month but may be less depending onthe intended use of the medication.The Product Registration Holder (PRH) is responsible to justify theproposed patient dispensing pack size based on these criteria as thedosing regimen for certain medication may equate to high numbers oftablets/ capsules. Justification should also address the definition of onemonth i.e. 28, 30 or 31 days.Blister or strip pack are strongly recommended for solid oral dosageforms (e.g. tablets and capsules) and bulk loose pack for supply morethan one month are not permitted unless justified by the PRH.Oral chemotherapeutics in tablet or capsule must be packed in blister toreduce personnel exposure and presumably risk which can minimise thetoxic effect of the chemotherapeutics.10.6 PRODUCTS EXEMPTED FROM THIS REQUIREMENTSThe requirements do not apply to the following products:Injectables, eye, ear and nasal drops, suppositories and pessaries.Products for export only (FEO).Drug where the risk of issuing more than the amount required by thepatient outweigh the benefits of the patient dispensing pack e.g. productscontaining substances with potential for abuse or cytotoxic agents whereprecise dosing are required.Drugs where the dosing needs to be tailored according to patient‟s bodyweight e.g. drugs used in oncology, HIV etc.Medically critical products and hospital packs for rare diseases with verylow volumes where it is not viable to produce special packs for a singlemarket.Products sold with devices with a fixed number of dosesSituations where a patient dispensing pack is not appropriate will beconsidered on a case to case basis.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 425
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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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