guidelines on variations to a registered pharmaceutical product

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Guidelines on Variations to a Registered Pharmaceutical ProductDescription of changeConditions to befulfilledDocumentationrequiredReportingtype3 Change in the name and/or addressof a manufacturer of the finishedpharmaceutical productConditions to be fulfilled1 1,2 IN1. No change in the location of the manufacturing site and in the manufacturing operations.Documentation required1. Copy of the modified manufacturing authorization or a formal document from a relevant official body(e.g. NMRA) in which the new name and/or address is mentioned.2. Samples of the productDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype4 Deletion of a manufacturing site or manufacturer involving:4a production of the API starting material 1 1 AN4b4cproduction or testing of the APIintermediate or APIproduction, packaging or testing of theintermediate or FPPConditions to be fulfilled1-2 1 IN1-2 1,2 IN1. At least one other site continues to perform the same function(s) as the site(s) intended to be deleted.2. The deletion of site is not a result of critical deficiencies in manufacturing.Documentation required1. Clear identification of the manufacturing, packaging and/or testing site to be deleted, in the letteraccompanying the application.2. Samples of the product required ONLY if deleted manufacturing site appears on registered productlabelDoc. No.: DAR/GDL/005 Revision Date: 8 th July 2013 Review Due Date: 16 th July 2016Revision No.: 1 Effective Date : 16 th July 2013 Page 14 of 70
Guidelines on Variations to a Registered Pharmaceutical ProductDescription of changeConditions to befulfilledDocumentationrequiredReportingtype5 Change of LTR None 1-3 VmajDocumentation required1. Power of attorney from the MAH revoking the previous power of attorney, and appointing the newLTR. (Same procedure of notarizing and registering the new power of attorney as at the time ofpharmaceutical product registration shall apply)2. Letter of acceptance from the proposed LTR3. List of affected products, including registration numbers. Affected products should appear on thecurrent Drug RegisterDescription of changeConditions to befulfilledDocumentationrequiredReportingtype6 Change of product name (brand name) None 1,2 VminDocumentation required1. Revised product information2. Samples of the product5.2 Changes to a CEP or to a confirmation of active pharmaceuticalingredient-prequalification documentDescription of changeConditions tobe fulfilledDocumentationrequiredReporting type7 Submission of a new or updated European Pharmacopoeia Certificate of Suitability for an activepharmaceutical ingredient or starting material or intermediate used in the manufacturing processof the active pharmaceutical ingredient:7a.1 from a currently prequalified WHO API 1-5 1-5 AN7a.2manufacturer1-4 1-6 IN7a.3 1, 3-4 1-6 Vmin7b.1 from a new manufacturer 1-4 1-6 IN7b.2 1, 3- 4 1-6 VminDoc. No.: DAR/GDL/005 Revision Date: 8 th July 2013 Review Due Date: 16 th July 2016Revision No.: 1 Effective Date : 16 th July 2013 Page 15 of 70
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