Module 9 2021

Early access tools – Adaptive licensing

Staggered approval from very small, restricted patient populations to increasingly wider populations Evolution of the conditional marketing application prospectively planned, iterative approach initially targeting well-defined group of patients followed by iterative phases and progressive licensing adaptations to expand its use to a wider patient population All stakeholders (including MS patient access bodies) involved ● across the life span to determine appropriateness for adaptive development ● to agree data generation plan ensure that the use of the medicines (i.e. restricted prescribing) is well monitored and managed ● to agree upfront on a plan of post-licensing knowledge generation

Novartis Pharma AG- Business use only- not for further distribution

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