guidelines on variations to a registered pharmaceutical product

Guidelines on Variations to a Registered Pharmaceutical Product5.4.2 Veterinary Pharmaceutical Products - specific changesDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype59 Variations concerning a change to or addition of a non-food producing target speciesVmajDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype60 Deletion of a food producing or non-food producing target species60a Deletion as a result of a safety issue Vmaj60b Deletion not resulting from a safety issue 1,2 VminDocumentation required1. Justification for the deletion of the target species2. Revised product informationDescription of changeConditions to befulfilledDocumentationrequiredReporting type61 Change to the withdrawal period for a Veterinary pharmaceutical productVmajDescription of changeConditions to befulfilledDocumentationrequiredReporting type62 Changes to the labelling or the package leaflet which are not connected with the summary ofproduct characteristicsVminDoc. 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 60 of 70