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 Product4.7 New applicati<strong>on</strong>s/extensi<strong>on</strong> applicati<strong>on</strong>sCertain changes are so fundamental that they alter the terms of the accepteddossier and c<strong>on</strong>sequently cannot be c<strong>on</strong>sidered as changes. For these casesa new dossier must be submitted. Examples of such changes are listed inAppendix 1.4.8 Labelling informati<strong>on</strong>For any change <strong>to</strong> labelling informati<strong>on</strong> (SmPC, PIL, labels) not covered bythe variati<strong>on</strong> categories described in this document, NDA must be notified andsubmissi<strong>on</strong> of the revised labelling informati<strong>on</strong> is expected as per the Guidelines<strong>on</strong> Submissi<strong>on</strong> of Documentati<strong>on</strong> for Marketing Authorizati<strong>on</strong> of a RegisteredPharmaceutical Product for Human Use.4.9 C<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> be fulfilledFor each variati<strong>on</strong>, attempts have been made <strong>to</strong> identify particular circumstanceswhere lower reporting requirements (IN, AN or Vmin) are possible. A change thatdoes not meet all of the c<strong>on</strong>diti<strong>on</strong>s stipulated for these specific circumstances isc<strong>on</strong>sidered <strong>to</strong> be a major variati<strong>on</strong>.In some circumstances Vmaj categories have been specifically stated for a givenvariati<strong>on</strong>. This has been d<strong>on</strong>e <strong>to</strong> indicate <strong>to</strong> applicants what documents shouldbe c<strong>on</strong>sidered <strong>to</strong> be provided. This is for informati<strong>on</strong>al purposes <strong>on</strong>ly. The list ofdocumentati<strong>on</strong> is not intended <strong>to</strong> be comprehensive and further documentati<strong>on</strong>may be required. For all changes it remains the resp<strong>on</strong>sibility of the applicant <strong>to</strong>provide all necessary documents <strong>to</strong> dem<strong>on</strong>strate that the change does not havea negative effect <strong>on</strong> the safety, efficacy or quality of the FPP.4.10 Documentati<strong>on</strong> requiredExamples of variati<strong>on</strong>s are organized according <strong>to</strong> the structure of the comm<strong>on</strong>technical document (CTD) and the corresp<strong>on</strong>ding modules have been identifiedfor supporting data.For each variati<strong>on</strong> certain documents have been identified and organizedaccording <strong>to</strong> CTD structure as supporting data. Regardless of the documentsspecified, applicants should ensure that they have provided all relevantinformati<strong>on</strong> <strong>to</strong> support the variati<strong>on</strong>.a) a variati<strong>on</strong> applicati<strong>on</strong> form (a template can be downloaded from thewebsite). All secti<strong>on</strong>s of this form should be completed and the documentDoc. 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 11 of 70