guidelines on variations to a registered pharmaceutical product
guidelines on variations to a registered pharmaceutical product
guidelines on variations to a registered pharmaceutical product
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Guidelines <strong>on</strong> Variati<strong>on</strong>s <strong>to</strong> a Registered Pharmaceutical ProductDescripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> befulfilledDocumentati<strong>on</strong>requiredReportingtype5 Change of LTR N<strong>on</strong>e 1-3 VmajDocumentati<strong>on</strong> required1. Power of at<strong>to</strong>rney from the MAH revoking the previous power of at<strong>to</strong>rney, and appointing the newLTR. (Same procedure of notarizing and registering the new power of at<strong>to</strong>rney as at the time of<strong>pharmaceutical</strong> <strong>product</strong> registrati<strong>on</strong> shall apply)2. Letter of acceptance from the proposed LTR3. List of affected <strong>product</strong>s, including registrati<strong>on</strong> numbers. Affected <strong>product</strong>s should appear <strong>on</strong> thecurrent Drug RegisterDescripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> befulfilledDocumentati<strong>on</strong>requiredReportingtype6 Change of <strong>product</strong> name (brand name) N<strong>on</strong>e 1,2 VminDocumentati<strong>on</strong> required1. Revised <strong>product</strong> informati<strong>on</strong>2. Samples of the <strong>product</strong>5.2 Changes <strong>to</strong> a CEP or <strong>to</strong> a c<strong>on</strong>firmati<strong>on</strong> of active <strong>pharmaceutical</strong>ingredient-prequalificati<strong>on</strong> documentDescripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong>be fulfilledDocumentati<strong>on</strong>requiredReporting type7 Submissi<strong>on</strong> of a new or updated European Pharmacopoeia Certificate of Suitability for an active<strong>pharmaceutical</strong> ingredient or starting material or intermediate used in the manufacturing processof the active <strong>pharmaceutical</strong> 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 Revisi<strong>on</strong> Date: 8 th July 2013 Review Due Date: 16 th July 2016Revisi<strong>on</strong> No.: 1 Effective Date : 16 th July 2013 Page 15 of 70