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 Product2. BACKGROUNDThe requirements specified in the Guidelines have been adapted from the currentWHO Guidance <strong>on</strong> Variati<strong>on</strong>s <strong>to</strong> a Prequalified Product, the European Uni<strong>on</strong>Instituti<strong>on</strong>s and Bodies Commissi<strong>on</strong>’s Guideline <strong>on</strong> the details of the variouscategories of variati<strong>on</strong>s <strong>to</strong> the terms of marketing authorizati<strong>on</strong>s for medicinal<strong>product</strong>s for human use and veterinary medicinal <strong>product</strong>s and Health Canada’sGuidance Document Post-Notice of Compliance (NOC) Changes: Quality. It isintended <strong>to</strong> provide supportive informati<strong>on</strong> <strong>on</strong> how <strong>to</strong> present an applicati<strong>on</strong> <strong>to</strong>implement a change <strong>to</strong> a <strong>product</strong>.An applicant is resp<strong>on</strong>sible for the safety, efficacy and quality of a <strong>product</strong>throughout its life-cycle. Necessarily, therefore, the applicant is required <strong>to</strong>make changes <strong>to</strong> the details of the <strong>product</strong> in order <strong>to</strong> accommodate technicaland scientific progress, or <strong>to</strong> improve or introduce additi<strong>on</strong>al safeguards for theprequalified <strong>product</strong>. Such changes, whether administrative or substantive, arereferred <strong>to</strong> as variati<strong>on</strong>s and may be subject <strong>to</strong> acceptance by NDA prior <strong>to</strong>implementati<strong>on</strong>.Technical requirements for the different types of variati<strong>on</strong>s are set out in thisguideline in order <strong>to</strong> facilitate the submissi<strong>on</strong> of appropriate documentati<strong>on</strong> byapplicants and their assessment by NDA and <strong>to</strong> ensure that variati<strong>on</strong>s <strong>to</strong> themedicinal <strong>product</strong> do not give rise <strong>to</strong> public and animal health c<strong>on</strong>cerns.1.1 Objectives1.2 ScopeThis guideline is intended <strong>to</strong>:a) assist applicants with the classificati<strong>on</strong> of changes made <strong>to</strong> a <strong>registered</strong>FPP;b) provide guidance <strong>on</strong> the technical and other general data requirements <strong>to</strong>support changes <strong>to</strong> the quality, safety and efficacy attributes of the active<strong>pharmaceutical</strong> ingredient (API) or FPP.This guideline applies <strong>to</strong> applicants intending <strong>to</strong> make changes <strong>to</strong> the differentsecti<strong>on</strong>s of <strong>product</strong> dossiers for an API or an FPP of a <strong>registered</strong> <strong>pharmaceutical</strong><strong>product</strong>. This guideline should be read in c<strong>on</strong>juncti<strong>on</strong> with other applicable<str<strong>on</strong>g>guidelines</str<strong>on</strong>g> including the Guidelines <strong>on</strong> submissi<strong>on</strong> of Documentati<strong>on</strong> forDoc. 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 3 of 70