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 ProductIf changes <strong>to</strong> the dossier <strong>on</strong>ly c<strong>on</strong>cern edi<strong>to</strong>rial changes, such changes neednot be submitted as a separate variati<strong>on</strong>, but can be included as a notificati<strong>on</strong><strong>to</strong>gether with a subsequent variati<strong>on</strong> c<strong>on</strong>cerning that part of the dossier. In sucha case, a declarati<strong>on</strong> should be provided that the c<strong>on</strong>tent of the c<strong>on</strong>cernedpart of the dossier has not been changed by the edi<strong>to</strong>rial changes bey<strong>on</strong>d thesubstance of the variati<strong>on</strong> submitted.Doc. 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 5 of 70