Module 6

03/10/2024

Submission of PSURs

For each scheduled PSUR, only one PSUR will be prepared regardless if it is submitted to the EU and/or non-EU. To the EU – within 70 calendar days of the data lock point (DLP) for PSURs covering intervals up to 12 months (including intervals of exactly 12 months); – within 90 calendar days of the DLP for PSURs covering intervals in excess of 12 months; – the timeline for the submission of ad hoc PSURs requested by competent authorities will normally be specified in the request, if not ad hoc PSURs should be submitted within 90 calendar days of the DLP . To non-EU countries – within 60 calendar days of the data lock point for PSURs To ensure timely submissions, Novartis will conservatively prepare all PSURs based on a 60 day submission timeframe.

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High-level responsibilities & requirements for data management

• GVP Module I defines the requirements for the Quality Management System (QMS) for the PV system • Cornerstone of safety data management is the preservation of data integrity and quality • This is applicable to the full data lifecycle • Good Documentation Practices must be followed • Deviations must be investigated & reported

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