DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 114
Drug Registration Guidance Document (DRGD)16.3 CHANGE OF PRODUCT REGISTRATION HOLDER16.3.1 INTRODUCTIONA transfer procedure shall be used where a product registration for the purpose ofmarketing authorization to be transferred from the existing product registrationholder (PRH) to another holder. This speedy administrative procedure allows thesame product to maintain the same registration number.Upon receipt of complete application, the application shall be processed within fortyfive(45) working days.16.3.2 CONDITIONSThe conditions for the PRH transfer procedure are as follows:1) An application to transfer the marketing authorization of a product shall besubmitted by the existing PRH.2) The new PRH shall be a registered company/ business with CompaniesCommissioner of Malaysia and a registered QUEST user with NationalPharmaceutical Control Bureau (NPCB).3) The existing product registration shall have a remaining validity period of atleast six (6) months. If the period is less than six (6) months, productregistration renewal shall be made before the transfer application is submitted.4) No change/s can be made to the technical data or approved pharmaceutical /pharmacological information, including the texts of the product label and leaflet,except the name and address of the approved PRH, unless made throughvariation procedure.5) In the interim, the existing PRH is still vested with the marketing authorization ofthe said registered product.6) The transfer shall come into effect on the day the DCA makes its decision on theapplication. Upon the transfer of product registration to the new PRH, theauthorization issued to the previous PRH will be cancelled as the product cannotbe marketed simultaneously by two different PRHs. The new PRH shall bearresponsibility for the said product.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 115
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PART III: NON-CLINICAL DATADrug Reg
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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