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 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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What's New in eSubmission Today?

13-09-2018

Gateway submission of veterinary applications in VNeeS version 2.6.

Please note that the EMAeSubmission Gateway web UI is being updated to reflect in the field “Submission
format” the VNeeS version 2.6 for Pharmaceutical and Immunological products.

For the time being, therefore, please submit your applications in VNeeS version2.6 using the submission format 2.5.

And

Essential maintenance to computer applications on Friday, 14 September

PSUR and eSubmission Web User Interface (to create the delivery file) will be unavailable between 17:30-19:30hrs (UK time) on Friday, 14  September 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.  

05-09-2018

Essential maintenance to computer applications on Thursday, 6 September

PSUR and eSubmission Web User Interface (to create the delivery file) will be unavailable between 17:30-19:30hrs (UK time) on Thursday, 6 September 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.  

03-09-2018

Guideline on eSubmissions for Veterinary products – version 2.6 now in force.

Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council came into force on 27 January 2017.

With VNeeS version 2.6 now in force, the structure of the electronic dossier has been brought in line with structure described in the Commission Implementing Regulation.

30-08-2018

Essential maintenance to eAF Web App
Electronic Application Form web application (eAF Web App) will be unavailable between 07:00 and 09:00 (UK time) on Friday, 31 August 2018 due to essential maintenance 

29-08-2018

Human domain

The new eCTD validation criteria  (v7.1) will come into force by 1 September 2018. There is no transition period.  See this and further eSubmission information on the eSubmission webpage – eCTD v.3.2.
In addition, the NeeS validation criteria (v4.3) are updated as well. However, in line with the eSubmission Roadmap, they should now be applicable for National Procedures only, and normally only for other NP submissions than new MAA.

Veterinary domain

Guideline on eSubmissions for Veterinary products – version 2.6 entering into force on 1 of September 2018. Please see relevant documents on the Veterinary webpage.

Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council came into force on 27 January 2017.

With VNeeS version 2.6, the structure of the electronic dossier has been brought in line with structure described in the Commission Implementing Regulation.
For further information, please consult the VNeeS guideline or the VNeeS Q&A relating to eSubmission for Veterinary.

And

Reminder concerning the Common Repository for EMA coordinated procedures for Human Medicinal Products: applicants are reminded that from 1st of September for EMA coordinated procedures involving both Centrally and Nationally Authorised products, submission should be done only once, via the EMA eSubmission Gateway. No additional submission should be done via CESP.

The Dossier Requirements for referral, NAP and ancillary medicinal substances in medical devices document will be updated soon.

23-08-2018

Essential maintenance to computer applications

Essential maintenance is scheduled to be carried out to SPOR data services: Referential Management Services (RMS) and Organisations Management Services (OMS) between 08:00 and 18:00hrs (UK time) on Saturday, 25 August 2018. Applications consuming real-time RMS data (PSUR Repository, MMS-e, EudraGMDP, EudraCT, EU PAS (ENCepp), and eAF) will be affected during this time. Should you have any questions please contact the EMA IT Service Desk.

The PSUR Repository will be impacted for industry users sending non-EU single assessment PSURs only and the NCA users using performing searches in the non-EU single assessment area of the PSUR Repository. Search attribute MA authorisation type is also unavailable during this period.

The eAF will be impacted for the ATC code field (MAA human and vet and the renewal form) and for the areas where Organisations and Locations are used (however manual input of data is allowed for these areas). There is no impact to the Variation application form. All other dropdown menus for controlled terminology continue working during this maintenance activity

17-08-2018

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)

06-08-2018

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.

Previous news is available here