EU Telematics PIM _
  CMB Documentation
_

Home

_

Human eSubmission

_
Veterinary esubmission
_

eSubmission CMB

_
CMB Documents
_

Documentation

_

Projects:

_

Common Repository

_
CESP
_

eAF

_
eASMF
_
ePMF
_

eSubmission Gateway & eSubmission Web Client

_

Delivery file UI

_

eSubmission Gateway

_
PSUR Repository
_

Industry access

_
NCA access
_

eCTD

_

eCTD v4.0

_

EU Module 1

_

eSignatures

_
_

 

These documents have been created/adopted by the eSubmission CMB or by the TIGes.

HMA eSubmission Roadmap

  • Final HMA eSubmission Roadmap (adopted) The final version eSubmission Roadmap v.1.0 was endorsed by the EUTMB on the 1st of October 2014. Further details on the implementation of the Roadmap will be published at a later stage by the eSubmission CMB.
  • eSubmission Roadmap (powerpoint presentation) The final version of the eSubmission Roadmap v.2.0 has been endorsed by the EUTMB on the 1st of October 2014. Further details on the implementation of the Roadmap will be published at a later stage by the eSubmission CMB.
  • Annex I to the HMA eSubmission Roadmap on the implementation of eCTD version 4.0.This initial version of the Annex I to the roadmap was adopted by the eSubmission CMB on 17th December 2014.
  • Annex II to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for regulatory submissions. Revised version of the Annex II to the roadmap has been adopted by the eSubmission CMB on 26th August 2016.
  • Annex III to the HMA eSubmission Roadmap on Transitioning to the mandatory use of the Common Repository for eCTD format Centralised Procedure submissions (June 2015)
  • Annex V to the HMA eSubmission Roadmap on the implementation of mandatory use of electronic application forms (eAFs)
  • Annex VI to the HMA eSubmission Roadmap on the implementation of mandatory VNeeS format for Veterinary regulatory submissions. This initial version of the Annex VI to the roadmap was adopted by the eSubmission CMB on 28th August 2015. (October 2015)

TIGes/CMB Harmonised eCTD Guidance

TIGes/CMB Harmonised NeeS Guidance

  • The TIGes Harmonised NeeS guidance document version 4.0 can be found here and Release notes here (Note: The guidance is not applicable to centralised procedure)
  • NeeS Validation Criteria v4.1 and Release notes - The use of validation criteria v6.1 is mandatory as of 1st October 2016.

EMA eSubmission Guidance for the Centralised Procedure

  • All EMA guidance documents, both practical and strategic, as well as Statements of Intent relating to eCTD and electronic submissions, can be found on the EMA external website here

Best Archiving Practice

 

EMA
©1995-2016 European Medicines Agency | Disclaimer| For technical support, visit the EMA Service Desk portal: https://servicedesk.ema.europa.eu