DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)9.1.2 PROPOSED PACKAGE INSERTPackage insert (PI) is required for products containing scheduled poison. PI mayalso be submitted for OTC products. The draft copy of the PI shall be submitted forevaluation.Sharing of PI is only allowed for products having the same active ingredient(s) butwith different strengths.The following information is required to be included in the PI:a) Brand or Product Nameb) Name and Strength of Active Substance(s)c) Product Descriptiond) Pharmacodynamics/ Pharmacokineticse) Indicationf) Recommended Dosageg) Route of Administrationh) Contraindicationsi) Warnings and Precautionsj) Interactions with Other Medicamentsk) Statement on usage during pregnancy and lactationl) Adverse Effects/ Undesirable Effectsm) Overdose and Treatmentn) Incompatibilities (For injections only)o) Storage Conditions (may be omitted if the information is stated on the labelor outer carton labels)p) Dosage forms and packaging availableq) Name and address of manufacturer/ product registration holderr) Date of revision of PINational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 342
Drug Registration Guidance Document (DRGD)9.1.3 PATIENT INFORMATION LEAFLETPatient Information Leaflet (PIL) or in Bahasa Malaysia known as RisalahMaklumat Ubat Pesakit (RiMUP), is compulsory for products which are selfadministeredby patients, including:a) Scheduled poisons (Category A);b) Over-the-Counter, OTC products (Category X);c) Health supplements with high claims (disease risk reduction).For details, please refer to:i) Direktif Penguatkuasaan Keperluan Mengemukakan Risalah Maklumat Ubatuntuk Pengguna (RiMUP) Bil. 5 Tahun 2011 Bil (15) dlm BPFK/PPP/01/03 Jld 1ii) Garispanduan Pelaksanaan Risalah Maklumat Ubat untuk Pengguna (RiMUP)The draft copy of the PIL in both English and Bahasa Malaysia shall be submitted forevaluation.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 343
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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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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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