Regulatory Submission For Post Approval Variations in SEurope To Maintain Product Life Cycle Via Software

Abstract

Post-approval variations play a vital role in maintaining the product life cycle of any pharmaceutical product commencing from the approval up until the product has been withdrawn. Types of variation for the particular submission and the documents to be submitted along with the variation is one of the competent works which is done with compliance. The comprehensive study has been illustrated via case studies for different types of post-approval variations in Europe. Filing of the variation is conducted via a decentralized procedure. Various criteria’s to be taken care of while uploading the document is also mentioned. It demonstrates variation type, dossiers to be submitted through CTD structure electronically. Pharmaready software is utilized to upload the files in eCTD format and is then published. The validation of the uploaded documents is performed and the validation report is attached henceforth. The regulatory aspect has been provided in form of guidelines and directives which are available for all the software’s, to comply with the respective agency’s criteria for regulatory submission, document management, and structured product label management.