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 Product5.4.2 Veterinary Pharmaceutical Products - specific changesDescripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong>be fulfilledDocumentati<strong>on</strong>requiredReportingtype59 Variati<strong>on</strong>s c<strong>on</strong>cerning a change <strong>to</strong> or additi<strong>on</strong> of a n<strong>on</strong>-food producing target speciesVmajDescripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong>be fulfilledDocumentati<strong>on</strong>requiredReportingtype60 Deleti<strong>on</strong> of a food producing or n<strong>on</strong>-food producing target species60a Deleti<strong>on</strong> as a result of a safety issue Vmaj60b Deleti<strong>on</strong> not resulting from a safety issue 1,2 VminDocumentati<strong>on</strong> required1. Justificati<strong>on</strong> for the deleti<strong>on</strong> of the target species2. Revised <strong>product</strong> informati<strong>on</strong>Descripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> befulfilledDocumentati<strong>on</strong>requiredReporting type61 Change <strong>to</strong> the withdrawal period for a Veterinary <strong>pharmaceutical</strong> <strong>product</strong>VmajDescripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> befulfilledDocumentati<strong>on</strong>requiredReporting type62 Changes <strong>to</strong> the labelling or the package leaflet which are not c<strong>on</strong>nected with the summary of<strong>product</strong> characteristicsVminDoc. 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 60 of 70