CRED Practical Document Writing and Management

Where we are now

NeeS (Non eCTD electronic Submission): - (Current NeeS validation criteria v4.1) ● Electronic submissions since August 2009 – Most NCA submissions via CESP – The CTD structure is used and conforms with the ICH Granularity Document – No xml or util folder (where DTD stylesheets sit) submitted & no special software required to create – Validation of the submission is required before dispatch ● National Procedure - should be actively planning move to full eCTD submissions

VNeeS (Veterinary NeeS): - ● Electronic submissions since 2009

● The use of the Common Repository is mandatory since 1 st June 2018 ● VNeeS only for New MAAs in DCP and CP - Completed Q1 2016 ● VNeeS only for New MAAs in National Procedures by Q3 2018 ● VNeeS only for all submissions in National Procedures by Q1 2019