guidelines on variations to a registered pharmaceutical product

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Guidelines on Variations to a Registered Pharmaceutical Productsigned. Electronic versions of the application form, both as a Worddocument and a scanned signed PDF file, should be provided;b) an updated quality information summary (QIS) (if applicable);c) replacement of the relevant sections of the dossier as per CTD format;d) copies of SmPC, PIL and labels, if relevant.It is to be noted that NDA reserves the right to request further information notexplicitly described in this guideline.The QIS provides a summary of the key quality information from the productdossier. For FPPs that have an agreed-upon QIS, the QIS should be revisedand submitted (in word format only) with every variation application. Any revisedsections within the QIS should be highlighted. If there is no change to the QISas a result of the variation, the current QIS should still be submitted and astatement made in the covering letter that there has been no change made tothe QIS.Alternate approaches to the principles and practices described in this documentmay be acceptable provided they are supported by adequate scientificjustification. It is also important to note that NDA may request information ormaterial, or define conditions not specifically described in this guidance, in orderto adequately assess the safety, efficacy and quality of an FPP.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 12 of 70
Guidelines on Variations to a Registered Pharmaceutical Product5. SUMMARY OF CHANGES5.1 Administrative changesDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype1aChange in the name and/or corporateaddress of the supplier of the finishedpharmaceutical productConditions to be fulfilled1 1 IN1. Confirmation that the supplier of the product remains the same legal entity.Documentation required1. A formal document from a relevant official body (e.g. the national medicines regulatory authority(NMRA)) in which the new name and/or address is mentioned.Description of changeConditions tobe fulfilledDocumentationrequiredReportingtype2 Change in the name or address of amanufacturer of an active pharmaceuticalingredient that is not a supplier of a WHOprequalified active pharmaceutical ingredientor that is not supported by a CEPConditions to be fulfilled1 1 IN1. No change in the location of the manufacturing site and in the manufacturing operations.Documentation required1. A formal document from a relevant official body (e.g. NMRA) in which the new name and/or addressis mentioned.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 13 of 70
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