eCTD Industry Update (5th September 2022)

September 5, 2022

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EMA

IRIS guide for applicants - How to create and submit scientific applications for industry and individual applicants (updated)

CMDh

Update: Step 2 - No nitrosamine detected response template
Update: EMA/CMDh explanatory notes on Variation Application Form - Human medicinal products only (Clean Version / Tracked Version)
Update: Chapter 7: CMDh BPG on Worksharing (Clean Version / Tracked Version)
Update: Procedural advice on Validation of MR/Repeat-use/DC Procedures (Clean Version / Tracked Version)
Update: Recommendations on Informed Consent Applications in Mutual Recognition and Decentralised Procedures (Clean Version / Tracked Version)
Update: Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing Procedure (Clean Version / Tracked Version)