guidelines on variations to a registered pharmaceutical product

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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
Guidelines on Variations to a Registered Pharmaceutical Product6. Appendix 1: Examples of changes that make anew application/extension application necessaryDescription of changeConditionsto be fulfilledDocumentationrequiredReporting type1. Change of the API to a different API2. Inclusion of an additional API to amulticomponent productNone 1 New application/extensionapplication3. Removal of one API from a multicomponentproduct4. Change in the dose/strength of one or moreAPIs5. Change from an immediate-release product toan extended or delayed-release dosage formor vice versa6. Change from a liquid to a powder forreconstitution or vice versa7. Changes in the route of administrationConditions to be fulfilledNoneDocumentation required1. Documents in fulfillment of the requirements outlined in NDA Guidelines on Submission ofDocumentation for Marketing Authorization of a Registered Pharmaceutical Product for Human Use(Document No. DAR/GDL/005) and Guidelines for registration of Veterinary MedicinesDoc. 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 61 of 70
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guidelines on variations to a registered pharmaceutical product

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