DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)16.3.6 SUPPORTING DOCUMENTSAll supporting documents shall be produced in ORIGINAL copies as listed below.16.3.6.1 LIST OF REQUIRED SUPPORTING DOCUMENTS1. Letter of Authorization (LOA) issued by overseas product owner certified byNotary Public from the country of origin of the product owner; or MalaysiaCommissioner for Oath for local product owner and shall consists of thefollowing information:a. The registered name and registration number of the product(s) concerned.b. Company name, business registration number and address of theproposed new PRH.c. Company name, business registration number and address of the existingPRH.d. Effective date of the appointment and termination given by the productowner. If the effective date is not mentioned, the date of the LOA issuedwill be considered as the effective date.e. Signature of the Managing Director/ Director/ President/ Chief ExecutiveOfficer/ General Manager who has overall responsibility for the companyor organization.f. Full and complete address, email address (if available), telephone and faxnumber (if available) of the Product Owner.Note: LOA format example (Please refer 16.3.8 Supporting Document Format Example)2. Resolution by Company Board of Directors of local product owner to verifythat ALL Board of Directors/ Partners have given their consent to the Changeof PRH.3. Certified by Commissioner for Oath of the latest document indicating detailsof director/s and shareholder/s of local product owner; e.g. Form 24 andForm 49.4. Resolution by Company Board of Directors of existing PRH to verify that ALLBoard of Directors/ Partners have given their consent to the Change of PRH.5. Certified by Commissioner for Oath of the latest document indicating detailsof director/s and shareholder/s of existing PRH; e.g. Form 24 and Form 49.6. A certified true copy of the Company/ Business Registration Certificate ofproposed new PRH; e.g. Form 9 and/ or Form 13.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 118
Drug Registration Guidance Document (DRGD)7. Statement of Acceptance as Product Registration Holder, BPFK-430.5(3) tobe completed by proposed new PRH.16.3.6.2 OTHER INFORMATION1. Date of the documents must be recent, i.e. not exceeding six (6) months fromthe date of application.2. Each page of attachment of product list (if any) with any of the supportingdocuments must be endorsed by the signatory.3. The Secretariat, if necessary, has the right to request for furthersupplementary information or documentation. Failure to do so may result inthe rejection of the transfer application.16.3.7 APPLICATION FORM BPFK-430.5 AND FORM BPFK-430.5(3)a) For application for Change of Product Registration Holder, please use FormBPFK-430.5.b) For Statement of Acceptance as Product Registration Holder, please use formBPFK-430.5(3).16.3.8 SUPPORTING DOCUMENT FORMAT EXAMPLEThis format example is suggested for the applicant in order to produce the requiredsupporting document i.e. Letter of Authorization (LOA).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 119
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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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