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 ProductC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> be fulfilled1. No change in the functi<strong>on</strong>al characteristics of the <strong>pharmaceutical</strong> form e.g. disintegrati<strong>on</strong> time,dissoluti<strong>on</strong> profile etc.2. Any minor adjustment <strong>to</strong> the formulati<strong>on</strong> <strong>to</strong> maintain the <strong>to</strong>tal weight is made by an excipient whichcurrently makes up a major part of the FPP formulati<strong>on</strong>.3. Specificati<strong>on</strong>s for the FPP are updated <strong>on</strong>ly with respect <strong>to</strong> appearance/odour /taste or if relevant,deleti<strong>on</strong> or additi<strong>on</strong> of a test for identificati<strong>on</strong>.4. Any new comp<strong>on</strong>ent must comply with the relevant secti<strong>on</strong> of NDA “Guidelines <strong>on</strong> Submissi<strong>on</strong> ofDocumentati<strong>on</strong> for Marketing Authorizati<strong>on</strong> of a Registered Pharmaceutical Product for Human Use“,and ‘Guidelines for registrati<strong>on</strong> of Veterinary drugs’5. Any new comp<strong>on</strong>ent does not include the use of materials of human or animal origin for whichassessment is required of viral safety data, or is in compliance with the current WHO Guideline <strong>on</strong>Transmissible Sp<strong>on</strong>giform Encephalopathies in relati<strong>on</strong> <strong>to</strong> Biological and Pharmaceutical Products orEMA’s Note for Guidance <strong>on</strong> Minimizing the Risk of Transmitting Animal Sp<strong>on</strong>giform EncephalopathyAgents via Human and Veterinary Medicinal Products or an equivalent guide of the ICH regi<strong>on</strong> andassociated countries.6. For paediatric <strong>product</strong>s, the change does not require submissi<strong>on</strong> of results of palatability studies.Documentati<strong>on</strong> required1. Samples of the <strong>product</strong>2. Discussi<strong>on</strong> <strong>on</strong> the comp<strong>on</strong>ents of the FPP (e.g. compatibility of API and qualitative compositi<strong>on</strong> of thecolouring or flavouring system if purchased as a mixture, with specificati<strong>on</strong>s, if relevant).3. Either a CEP for any new comp<strong>on</strong>ent of animal origin susceptible <strong>to</strong> TSE risk or where applicable,documented evidence that the specific source of the TSE risk material has been previously assessedby an NMRA in the ICH regi<strong>on</strong> or associated countries and shown <strong>to</strong> comply with the scope of thecurrent guideline in the countries of the ICH regi<strong>on</strong> or associated countries. The following informati<strong>on</strong>should be included for each such material: name of manufacturer, species and tissues from which thematerial is derived, country of origin of the source animals and its use.4. Copies of revised FPP release and shelf-life specificati<strong>on</strong>s and certificates of analysis for a minimumof two pilot or <strong>product</strong>i<strong>on</strong> scale batches.5. If applicable, data <strong>to</strong> dem<strong>on</strong>strate that the new excipient does not interfere with the analyticalprocedures for the FPP.6. Results of stability testing generated <strong>on</strong> at least two pilot or <strong>product</strong>i<strong>on</strong> scale batches with a minimumof three (3) m<strong>on</strong>ths of accelerated (and intermediate, as appropriate) and three (3) m<strong>on</strong>ths of l<strong>on</strong>gtermtesting.7. Copies of relevant secti<strong>on</strong>s of blank master <strong>product</strong>i<strong>on</strong> documents with changes highlighted as well asrelevant pages of the executed <strong>product</strong>i<strong>on</strong> documents for <strong>on</strong>e batch and c<strong>on</strong>firmati<strong>on</strong> that there are nochanges <strong>to</strong> the <strong>product</strong>i<strong>on</strong> documents other than those highlighted.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 36 of 70