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eCTD Industry Update (10th January 2023)

January 10, 2023
/
onix

EMA

  • European Medicines Agency post-authorisation procedural advice for users of the Centralised Procedure Clean Version / Tracked Version (updated)
  • European Medicines Agency Pre-authorisation guidance - Clean Version / Tracked Version (updated)
  • Regulatory and procedural guideline: Validation checklist for Type II (non) clinical variations (updated)

CMDh

  • UPDATE - Chapter 2: Procedure for automatic validation of Mutual Recognition Procedures for Variations - Clean Version / Tracked Version
  • UPDATE - Chapter 3: CMDh BPG for the processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure - Clean Version / Tracked Version
  • UPDATE -Chapter 4: CMDh BPG for the processing of Type IB Minor Variations (Notifications) in the Mutual Recognition Procedure - Clean Version / Tracked Version
  • UPDATE -Chapter 5: CMDh BPG for the handling of Type II Variations in the Mutual Recognition Procedure - Clean Version / Tracked Version
  • UPDATE - Chapter 6: CMDh BPG for the processing of Grouped Applications in the Mutual Recognition Procedure - Clean Version / Tracked Version
  • UPDATE -Chapter 7: CMDh BPG on Worksharing - Clean Version / Tracked Version
  • UPDATE - CMDh Best Practice Guide on the processing of renewals in the MRP/DCP - Clean Version / Tracked Version
  • UPDATE - Cover letter for Variation Applications in the Mutual Recognition Procedure
  • UPDATE - Position Paper concerning Applicants’ request of submission of multiple applications during ongoing DCPs or inclusion of new CMS or additional strength(s) in an already ongoing DCP - Clean Version / Tracked Version
  • UPDATE -Applicant's response template
PreveCTD Industry Update (21st December 2022)
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