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 Product4. Any new analytical procedure does not c<strong>on</strong>cern a novel, n<strong>on</strong>-standard technique or a standardtechnique used in a novel way.5. The deleted analytical procedure is an alternate method and is equivalent <strong>to</strong> a currently acceptedmethod.Documentati<strong>on</strong> required1. Descripti<strong>on</strong> of the method and comparative validati<strong>on</strong> results dem<strong>on</strong>strating that the currently acceptedand proposed methods are at least equivalent.2. Documentati<strong>on</strong> dem<strong>on</strong>strating that c<strong>on</strong>diti<strong>on</strong> #5 is met.Descripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> befulfilledDocumentati<strong>on</strong>requiredReportingtype49 Change in any part of the (primary)packaging material not in c<strong>on</strong>tact withthe finished <strong>pharmaceutical</strong> <strong>product</strong>formulati<strong>on</strong> (e.g. colour of flip-offcaps, colour code rings <strong>on</strong> ampoules,change of needle shield)C<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> be fulfilled1 1-2 IN1. The change does not c<strong>on</strong>cern a fundamental part of the packaging material, which affects the delivery,use, safety or stability of the FPP.Documentati<strong>on</strong> required1. Informati<strong>on</strong> <strong>on</strong> the proposed packaging material (e.g. descripti<strong>on</strong>, materials of c<strong>on</strong>structi<strong>on</strong>,specificati<strong>on</strong>s etc.).2. Samples of the <strong>product</strong>.Descripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> befulfilledDocumentati<strong>on</strong>requiredReportingtype50 Change <strong>to</strong> an administrati<strong>on</strong> or measuring device that is not an integral part of the primarypackaging (excluding spacer devices for metered dose inhalers) involving:50a additi<strong>on</strong> or replacement 1,2 1-2 IN50b deleti<strong>on</strong> 3 3 INC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> be fulfilled1. The proposed measuring device is designed <strong>to</strong> accurately deliver the required dose for the <strong>product</strong>c<strong>on</strong>cerned, in line with the posology and results of such studies are available.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 55 of 70