Spring Intro 2023

16/02/2023

Why Important?

• Once approved – “Full” MA valid for 5 years and is renewable upon application by MAH • Once renewed, MA validity unlimited unless the Competent Authority decides to mandate an additional 5-yr renewal (safety reasons) – Possibility of additional commitments from assessment – Update to PI  Reminder: Conditional MAs are exempt– only valid for 1 year

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Top Tips

• Renewal application must be submitted between 11 and 9 months prior to the MA expiry date (5 th year anniversary of MA) • Timing, total process: ~4 to 8 months – Initial agency review = 90 days – Questions (clock stop) = up to 30 days – MRP/DCP – may be referred to CMDh – CP: EC decision = 67 days • Pre-renewal data-check initiated ~1 yr in advance of MA expiry – Facilitates timely start & finish, ensure a full and complete list of commitments and PAMs • Content of submission: – Module 1 : Application form + Annex 1-10 (renewal specific), PI, RMP, Mock-ups and specimens, Information about experts – Module 2.3 to 2.5: Quality Overall Summary, Non-clinical & Clinical Overviews

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