Spring Intro 2023

16/02/2023

Why Important?

• Large, comprehensive document including detailed description of the PV system • Not submitted to health authorities BUT required within 7 days of a request – regular updates therefore required • Key document checked by PV inspectors Key Regulatory Input: • Worldwide Marketing Status document – approval & launch dates (overlap with PSUR) • PV system performance: – PSUR submission record – check submission compliance – Description of variation submissions (internally and externally triggered) – Adherence to RMP commitments or other PV obligations

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Conclusion

• Regulatorywork doesn’t stop at MAA approval • Work closely with cross functional team • Build a good relationshipwith the agency • Regulatory play a key role in being strategic (not just operational!)

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