eCTD Format Mandatory for EU National Procedures

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23 January 2019


After CP, DCP/MRP Procedures, and according to the eSubmissions Roadmap Timelines, eCTD format is now mandatory for all National Procedures in Europe

  • CP Procedure -> eCTD Mandatory from 2010
  • DCP / MRP Procedures -> eCTD Mandatory from January 2018
  • NP – all new applications -> eCTD Mandatory from July 2018
  • All Regulatory activities, including those for nationally registered products -> eCTD Mandatory from 1st January 2019

According to “Annex 2 to the HMA eSubmission Roadmap: Implementation of Mandatory use of eCTD Format for Regulatory Submission”:

  • It refers to all submissions types such as Variations, Renewals, PSURs, ASMF and so on…
  • The requirement is applicable for all Submissions from that date whatever the current format of the concerned dossier.
  • If no Baseline submission is officially required, it is recommended to consider a submission of a baseline for Module 3

In this context, and based on our strong experience within this domain, BlueReg can provide you with support regarding:

  • Publishing activities (more than 65 EU National Baselines & Switch dossiers published during 2018)
  • Strategic decisions & Planning (Prioritise your products and your submissions)
  • Documents Management / Formating
  • CMC Writing
  • Regulatory Support



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