guidelines on variations to a registered pharmaceutical product

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Authorization of these <strong>guidelines</strong>Authorized byTitleExecutive Secretary/RegistrarNameGordon K. SematikoSignatureDate 8 th July 2013
Guidelines on Variations to a Registered Pharmaceutical ProductCONTENTS1. INTRODUCTION........................................................................................................... 12. BACKGROUND............................................................................................................ 31.1 Objectives.................................................................................................................................... 31.2 Scope .......................................................................................................................................... 33. GLOSSARY.................................................................................................................. 64. GUIDANCE FOR IMPLEMENTATION.......................................................................... 94.1 Reporting types..........................................................................................................................94.2 Notifications................................................................................................................................94.3 Annual notification (AN)...........................................................................................................104.4 Immediate notification (IN) ......................................................................................................104.5 Minor variation (Vmin)..............................................................................................................104.6 Major variation (Vmaj)..............................................................................................................104.7 New applications/extension applications............................................................................... 114.8 Labelling information............................................................................................................... 114.9 Conditions to be fulfilled.......................................................................................................... 114.10 Documentation required.......................................................................................................... 115. SUMMARY OF CHANGES......................................................................................... 135.1 Administrative changes...........................................................................................................131a Change in the name and/or corporate address of the supplier of the finished pharmaceuticalproduct .......................................................................................................................................132 Change in the name or address of a manufacturer of an active pharmaceutical ingredientthat is not a supplier of a WHO prequalified active pharmaceutical ingredient or that is notsupported by a CEP ...................................................................................................................133 Change in the name and/or address of a manufacturer of the finished pharmaceuticalproduct........................................................................................................................................144 Deletion of a manufacturing site or manufacturer involving:.......................................................145 Change of LTR............................................................................................................................156 Change of product name (brand name) .....................................................................................155.2 Changes to a CEP or to a confirmation of active pharmaceutical ingredientprequalificationdocument ......................................................................................................157 Submission of a new or updated European Pharmacopoeia Certificate of Suitability for anactive pharmaceutical ingredient or starting material or intermediate used in themanufacturing process of the active pharmaceutical ingredient:................................................15Doc. 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 iii of 70
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