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 Product5. SUMMARY OF CHANGES5.1 Administrative changesDescripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong>be fulfilledDocumentati<strong>on</strong>requiredReportingtype1aChange in the name and/or corporateaddress of the supplier of the finished<strong>pharmaceutical</strong> <strong>product</strong>C<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> be fulfilled1 1 IN1. C<strong>on</strong>firmati<strong>on</strong> that the supplier of the <strong>product</strong> remains the same legal entity.Documentati<strong>on</strong> required1. A formal document from a relevant official body (e.g. the nati<strong>on</strong>al medicines regula<strong>to</strong>ry authority(NMRA)) in which the new name and/or address is menti<strong>on</strong>ed.Descripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong>be fulfilledDocumentati<strong>on</strong>requiredReportingtype2 Change in the name or address of amanufacturer of an active <strong>pharmaceutical</strong>ingredient that is not a supplier of a WHOprequalified active <strong>pharmaceutical</strong> ingredien<strong>to</strong>r that is not supported by a CEPC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> be fulfilled1 1 IN1. No change in the locati<strong>on</strong> of the manufacturing site and in the manufacturing operati<strong>on</strong>s.Documentati<strong>on</strong> required1. A formal document from a relevant official body (e.g. NMRA) in which the new name and/or addressis menti<strong>on</strong>ed.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 13 of 70