XEVMPD and Article 57
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Articles in this section
4- Maintaining XEVMPD Through the Product Lifecycle: Variations, Transfers, Renewals, Suspensions and Withdrawals How regulatory lifecycle events should be translated into XEVMPD maintenance activities, with practical examples of variations, transfers, renewals, suspensions, withdrawals and changes to QPPV and PSMF information. Read Article →
- XEVMPD Data Quality: Reconciliation, Completeness and Detecting Hidden Errors How to assess whether XEVMPD data accurately represent the medicinal-product portfolio, investigate discrepancies, identify systemic errors and maintain reliable product data throughout the regulatory lifecycle. Read Article →
- XEVMPD Lifecycle Maintenance: Managing Variations, Transfers, Renewals and Withdrawals Learn how to connect regulatory lifecycle events to XEVMPD maintenance, identify which product information may require updating, control transfers and withdrawals, and prevent lifecycle data from becoming inconsistent. Read Article →
- XEVMPD Data Quality: Common Errors, Validation and Maintenance How MAHs can maintain accurate and current XEVMPD data, identify common Article 57 data-quality problems, understand EMA validation, and build practical controls around submission and maintenance. Read Article →