DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)No. Types of COS Descriptioni) Transfer of manufacturing of an asepticallyprocessed sterile product to a:a) newly constructed or refurbished asepticprocessing facility or area;4. Type IV5. Type VChange ofmanufacturingsite for sterileproductsChange ofmanufacturingsite in crisissituationb) an existing processing facility or area that doesnot manufacture similar approved products.(For example, transferring the manufacture of alyophilized product to an existing asepticprocess area where there is no approvedlyophilized product is manufactured).ii) Transfer of a finished product sterilized by terminalprocesses to a newly constructed facility at adifferent manufacturing site.Once this change has been approved, subsequentsite changes to the facility for similar types ofproduct and processes will not be categorized as aType IV COS.i) Change of location of the site of manufacture thatis deemed necessary due to certain circumstancessuch as natural disasters, closure or suspension ofpremise (revocation of manufacturing license) andmatters related to breach of product quality, safetyand efficacy ONLY.ii) Prior to submission of Type V COS, approval letterissued by the secretariat of the Authority shall beobtained.iii) Application for Type V COS must be made withinthree (3) months from the date of the crisis.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 112
Drug Registration Guidance Document (DRGD)16.2.4 MODE OF SUBMISSIONa) Complete application for COS with supporting documents shall be submittedmanually to Variation Section, Centre of Post-Registration, NPCB.b) For submission of COS Type II to Type V, applicant can download Form BPFK415.3 from NPCB‟s website www.bpfk.gov.my under Industry - Forms.Submission of completed application form with supporting documents shall bemade together with processing fees, according to category of product, asstipulated in the form.16.2.5 OTHER INFORMATIONa) Application for COS will be rejected if applicant failed to submit required datawithin six (6) months from the first correspondence date;b) All supporting documents in accordance to the specified conditions laid down foreach type of COS should be submitted. For details, please refer to Appendix 13:Supporting Documents Required for Change of Manufacturing Site Application.c) If deemed necessary, NPCB reserves the right to request for additionalsupporting documents.d) For further information pertaining to COS, please refer these circulars.i) Bil (59) BPFK/17/VF/9.2ii) Bil (22) dlm. BPFK/PPP/01/03iii) Bil (31) dlm. BPFK/PPP/01/03iv) Bil (39) dlm. BPFK/PPP/01/03v) Bil (10) dlm BPFK/PPP/01/03 Jld 1National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 113
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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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