Module 18 2021

07/02/2021

1. Validation: 20 working days 2. 1 st round review by NB: 40 working days 3. CLOCK STOP 4. 2 nd round review by NB: 60 working days 5. CLOCK STOP 6. 3 rd round review by NB: 70 working days 7. CLOCK STOP 8. NB finalises report and makes submission for decision making 9. Final decision issued: 80 working days Timelines – Example NB review timelines

Up to 250 working days : 13 months

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Medicines aspects

Jason will present these aspects…

• Quality

• Safety

• Efficacy

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