DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)d) The following records shall be maintained for the product and well keptfor auditing by the Authority.3. HUMAN GROWTH HORMONE (Somatotropin, Somatropin)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.4. ISOTRETENOIN/ TRETINOINa) The product shall only be sold or supplied to:i) Dermatologist (Skin Specialist) who are gazetted with the Ministryof Health, Malaysia, or registered with the Academy of Medicine,Malaysia, and National Specialist Registry.ii)A hospital or institution maintained by the government, having theservices of a skin specialist or registered medical practitioner withexperience in dermatology.b) The container of the product shall be labelled in a conspicuous anddistinct manner, with the following statements:i) “Isotretinoin/ tretinoin is highly teratogenic.ii) Pregnancy must be avoided during treatment and for at least 1month after completing treatment.”National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 330
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 | 331
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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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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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