DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)PRODUCT OWNER LETTER HEAD(full and complete address, email address, telephone and fax number)(Please state) Date of LOA(the existing PRH shall submit an application within 6 months from this date)Drug Control Authority,Lot 36, Jalan Universiti,46200 Petaling Jaya,Selangor, Malaysia.Dear Sir/ Madam,LETTER OF AUTHORIZATION FOR TRANSFER OF PRODUCT REGISTRATION HOLDERThe above subject matter is referred.Due to (please state) reason of the transfer,2. We, Name of registered Product Owner, the undersigned as the product owner for the saidproduct(s) listed below:Name of Product(s)Registration Numberhereby authorize(If number of product > 10, endorsed attachment is allowed.)Company name with business registration number and full address of the proposed new PRHto be the Product Registration Holder and to act on our behalf/ responsible for all matters pertainingto the registration of the listed product(s) including obtaining approval for any subsequent productvariation and maintenance of the product(s) registration.3. Therefore, we hereby terminate marketing authorization of the existing Product RegistrationHolderCompany name with business registration number and full address of the existing PRHfor the listed product(s) effectively on date of authorization/ termination.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 120
Drug Registration Guidance Document (DRGD)4. We shall confirm that the entire dossier of the listed product(s) includes all the data insupport of the original application, together with all correspondence with the Drug Control Authority(DCA)/ National Pharmaceutical Control Bureau concerning the listed product(s), to be transferredfrom Company name of the existing PRH to Company name of the proposed new PRH upon theapproval from DCA.Thank you.Sincerely,*Company officer‟s signature(s)*Full name & Title/ PosititionCompany stampcc:Company of proposed new PRHCompany of existing PRHProduct Manufacturer(A copy of LOA shall be sent tothese companies by the ProductOwner)(**Certified by Notary Public/ Commissioner for Oath)IMPORTANT NOTICE:1. *LOA shall be signed by Managing Director/ Director/ President/ Chief ExecutiveOfficer/ General Manager who has overall responsibility for the company ororganization.2. **LOA shall be certified by Notary Public of the country of origin for overseas companyor Malaysia Commissioner for Oath for local company.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 121
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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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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