DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)16.3.9 FLOWCHART FOR THE CHANGE OF PRODUCT REGISTRATION HOLDERCompany (Existing PRH)1. Manual application for QUEST product2. Payment of processing feeFinance DepartmentConfirmation of payment and issuance of receiptSecretariatReceived documentations & evaluation of application1. LOA from product owner certified by Notary Public foroverseas company or Commissioner For Oath for localcompany2. Company/ Business Registration Certificate of proposed newholder3. Statement of Acceptance As Product Registration Holder;BPFK-430.5(3)4. Resolution by Company Board of Directors of local productowner5. Certified by Commissioner for Oath of the latest documentissued by Companies Commissioner of Malaysia indicatingdetails of director/s and shareholder/s of local product owner6. Resolution by Company Board of Directors of existing PRH7. Certified by Commissioner for Oath of the latest documentissued by Companies Commissioner of Malaysia indicatingdetails of director/s and shareholder/s of existing PRH* ALL SUPPORTING ORIGINAL DOCUMENTS SHALL BESUBMITTED TO NPCBSatisfactoryNon-satisfactorySecretariatProcessing of evaluated application1. Satisfactory:a) Table to DCA meeting for approval2. Non-satisfactory:b) Table to DCA meeting for rejection (processing feeis NON REFUNDABLE in the event that applicationis being rejected)DCA MeetingSecretariatProcessing of DCA meeting outcome1. Notification of transfer approval to new proposed PRH andtermination notification to existing PRH for approvedapplication; OR2. Notification of transfer rejection to existing PRH for rejectedapplicationNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 122
Drug Registration Guidance Document (DRGD)16.4 NEW/ ADDITIONAL INDICATIONNew/ additional indication is defined as an indication which is not initially approvedfor a registered pharmaceutical product. This shall include new therapeutic indicationor indication for new age group, such as usage in children, and shall not includechanging/ rephrasing of sentences.There are two (2) types of evaluation process available for a new/ additionalindication application:16.4.1 FULL EVALUATION PROCESSFor new indication which has been registered in any one of the Authority‟s eight (8)reference countries (United Kingdom, Sweden, France, United States of America,Australia, Canada, Japan and Switzerland).This application will require specialists‟ comments.16.4.2 VERIFICATION PROCESSFor new indication which has been registered in European Countries (UnitedKingdom, Sweden and/or France) and one of the other Authority‟s referencecountries (United States of America, Australia, Canada, Japan and Switzerland).Note:The approved new indication in these countries should be the same as that of theproposed new indication.Other supporting documents that are deemed necessary shall be submitted uponrequest to support the efficacy and safety of the proposed additional indication.The supporting documents may include but not limited to the following:a) Approval of Additional Indication(s) in country of origin;b) Approval status in reference countries, its corresponding approval letter andapproved Package Insert;c) Approval Indication status in ASEAN Member States and its approvedcorresponding package insert;d) Revised Package Insert;National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 123
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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