guidelines on variations to a registered pharmaceutical product

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Guidelines on Variations to a Registered Pharmaceutical Productb) only in relation to good manufacturing practices (GMP) inspections: amedicine regulatory authority that is a member of the PharmaceuticalInspection Co-operation Scheme (PIC/S) as specified at http://www.picscheme.orgWHO PQP: The WHO Prequalification of medicines ProgrammeDoc. 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 8 of 70
Guidelines on Variations to a Registered Pharmaceutical Product4. GUIDANCE FOR IMPLEMENTATION4.1 Reporting typesThe definitions outlined in the following reporting types are intended to provideguidance with respect to the classification of administrative, quality, safetyand efficacy -related changes. Specific change examples are provided in thisguideline. However, it is to be noted that a change not cited in this guideline,should be considered as a major change by default. Whenever the applicant isunclear about the classification of a particular change, NDA should be contacted.It remains the responsibility of the applicant to submit relevant documentation tojustify that the change will not have a negative impact on the quality, safety andefficacy of the product.Individual changes normally require the submission of separatevariations. Grouping of variations is acceptable only when variations areconsequential to each other, e.g. introduction of a new impurity specificationthat requires a new analytical procedureFor the purpose of classification, an application involving two or more types ofvariations will be considered as the highest risk type, e.g. a variation groupingboth a minor change and a major change will be classified as a major change.Applicants are also advised to exercise caution whenever several changes tothe same FPP are envisaged. Although individual changes may be classifiedas a particular reporting type, classification at a higher risk category may bewarranted as a result of the composite effect of these changes. In all suchcases, applicants are advised to contact NDA prior to submission of the variationapplication in order to obtain guidance in classifying such changes.4.2 NotificationsNotifications are changes that could have minimal or no adverse effects on theoverall safety, efficacy and quality of the FPP. Such notifications do not requireprior acceptance, but must be notified to NDA immediately after implementation(immediate notification (IN)), or within 12 months following implementation(annual notification (AN)) of the change.It should be highlighted that an IN or AN may be rejected in specific circumstanceswith the consequence that the applicant must cease to apply the alreadyimplemented variation.Doc. 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 9 of 70
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