To facilitate the submission of regulatory information concerning marketing authorisations application for medicinal products to National Competent Authorities and EMA as well as to streamline the business process, standards for electronic submissions have been developed.
For human medicinal products, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed an electronic exchange standard called electronic Common Technical Document (eCTD). This standard is based on “M4: The Common Technical Document (CTD)” in its various parts.
The current electronic version was developed by the eCTD Implementation Working Group and released as version 3.2 in February 2004. The European Union applies the eCTD Specification in the European region and has completed it with the European Module 1.
Preparation of the next major version (version 4.0) is now ongoing within the ICH.
For technical support, please visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here.
For more information, please refer to the eCTD v.3.2, eCTD EU M1 specification and eCTD v.4.0 webpages.
For veterinary medicinal products, a specific EU standard, Veterinary Non-eCTD electronic Submissions (VNeeS), that is based on the EU Notice to Applicants format for veterinary applications, has been developed.
For more information, please refer to the Veterinary eSubmission webpage.
The EU standards and related guidance documents are developed and maintained by the different key user groups and approved by the eSubmission expert group before publication.
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Reminder concerning the Common Repository for Veterinary medicinal products: applicants are reminded that for procedures involving only Centrally Authorised products, submission should be done only once, via the EMA eSubmission Gateway. No additional submission should be done via CESP, CD or DVD, as National Competent Authorities have now access to the Common repository. For further details, please consult the Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for Medicinal Products for Veterinary use (CVMP) (EMA/466102/2007)
The regulatory user guides for the electronic application form for a marketing authorisation (Human and Veterinary) have been updated, and the links can be found on the eAF website.
New versions of the 4 electronic Application Forms (eAF v. 1.23) and the related release notes are now available here.
This release includes further integration with OMS for organisation data in proposed and present part of Variation form and other NTA changes. This new version, 1.23 of the forms can be used as of today (13th July 2018) and will fully replace the version 126.96.36.199 after transitional period, on 15 October 2018. The version of the form should not be changed during an ongoing procedure.
An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce an additional business rule to help users correctly select PASS 107 procedures types. Also,a Purchase Order number attribute for PASS 107 procedure was introduced.
This release of the eSubmission Gateway delivery file UI also fixes the known issue related to Veterinary submissions, users can now select from a predefined list of procedure numbers to reference their ASMF submissions. This is aligning with how Human procedure numbers can be linked to ASMF submission.
Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release on 6st of July 2018 should work following the deployment of the new version. It is however, recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues. The updated system release notes detailing the changes are available here.
Essential maintenance to computer applications on Friday
Common Repository, PSUR, Gateway File Handler and eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07:00 and 09:00 on Friday, 6 July 2018.However, the EMA gateway will remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete. If you have any questions, please contact the IT Service Desk.
eSubmission CMB and CMB documents have been renamed eSubmission expert group and eSubmission expert group documents. The eSubmission CMB changed its name in June 2018 to better reflect its current status and tasks.
Previous news is available here