DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)c) A proper record of product supplied stating the product name, productregistration number, name, address and contact number of purchaser(prescriber) shall be kept and submitted to the Authority upon request.5. MIDAZOLAMProducts containing midazolam are restricted for use in government andprivate hospitals and specialist clinics only.6. PARACETAMOL IN COMBINATION WITH CAFFEINEa) For products containing a combination of paracetamol and caffeine,dose unit of caffeine for adults is 65mg and maximum dose of caffeineis 520mg per day, meanwhile, dose unit for paracetamol is 500mg withthe maximum dose of 4,000mg per day or 8 tablets daily.b) Products containing caffeine for pediatrics are not allowed.c) Allowable packing size should not exceed 20 tablets/ capsules.7. VACCINESa) Each batch of the product must comply with WHO requirements for theproduct.b) Each batch of the product imported into Malaysia must be accompaniedwith a batch release certificate.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 322
Drug Registration Guidance Document (<strong>DRGD</strong>)APPENDIX 8:LIST OF PERMITTED, PROHIBITED AND RESTRICTEDSUBSTANCESIMPORTANT NOTES:The following lists are by no means exhaustive.Outline:8.1 List of Prohibited and Restricted Active Ingredients and Combination8.1.1 List of Prohibited Active Ingredients and Combinationsa) Specific Active Ingredientsb) Combinations8.1.2 List of Restricted Active Ingredients and Combinationsa) Specific Active Ingredientsb) Combinations8.2 List of Prohibited and Restricted Excipients8.2.1 List of Prohibited Excipients8.2.2 List of Restricted Excipients8.3 List of Permitted and Restricted Colouring Agents8.3.1 List of Permitted Colouring Agents8.3.2 List of Restricted Colouring AgentsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 323
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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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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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