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eSubmission expert group documents

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External Links

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Systems:

Common Repository

eAF

eASMF
ePMF
CESP

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

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PSUR Repository

Industry access

NCA access
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Projects:

eCTD v4.0

CESSP

Paediatric submissions

SPOR

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Introduction

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.

For technical support, 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 details on how to find us please click here.

eSubmission eAFRSS news feed


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What's New in eSubmission Today?

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09-08-2019

Vendor Readiness Survey 

The ICH M8 EWG would like to assess the readiness of eCTD v4.0 Vendors and their development and/or readiness to deliver a production ready eCTD v4.0 solution. We request that the eCTD v4.0 Vendor Readiness Survey be completed by September 15, 2019.

More information about eCTD v4.0 including the EU IG package can be found here.

Updated reminder on the working documents provided within the eCTD submissions

As per the structure of the eCTD, the product information should be provided in PDF format within Module 1.1.3. However, occasionally it is necessary to provide, in addition to the PDF requirement, product information or the Module 2 documents in Word format. These files should be provided outside of the eCTD structure, in a separate folder called xxxx-workingdocuments on the same submission zip package as the eCTD.

For PMF certification submissions the ePMF should be provided within the working documents folder. This folder should be called “xxxx-workingdocuments” as for all other documents.
Other documents that can be provided as working documents outside of the eCTD structure include for example the RMP, (validation) checklists or any document specifically requested to be provided as a working document by the Health Authorities.

Please note: the Agency strongly recommends that applicants only include as part of the working documents folder applicable documents. Providing additional documents e.g. entire modules may cause delays in processing the application.

Please note: the eCTD validation report should not be included in the working documents folder. More information on the working documents can be found from the Harmonised Technical Guidance for eCTD Submissions in the EU.

22-07-2019

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 between 19:00hrs (CEST) and 20:00hrs (CEST) on Tuesday, 23 July 2019.  Applications consuming real-time RMS data (PSUR Repository, MMS-e, EudraGMDP, EudraCT, EU PAS (ENCepp), and eAF) will be affected intermittently 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. Please note that if you have submission deadline for non-EU single assessment PSUR on Friday, 26th July, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.

 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.

19-07-2019

Essential maintenance is scheduled to be carried out to SPOR data services: Referential Management Services (RMS) and Organisations Management Services (OMS) between 18:00hrs (CEST) and 19:00hrs (CEST) on Friday, 19 July 2019 and between 21:00hrs (CEST) and 22:00hrs (CEST) on Sunday 21 July 2019.  Applications consuming real-time RMS data (PSUR Repository, MMS-e, EudraGMDP, EudraCT, EU PAS (ENCepp), and eAF) will be affected intermittently 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. Please note that if you have submission deadline for non-EU single assessment PSUR on Friday, 26th July, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.

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.

04-07-2019

The CESSP essentials document has been updated and can be found here

03-07-2019

Updated version 2.2 of the eSubmission roadmap published

An updated version of the eSubmission Roadmap has been published. The Roadmap has been updated to reflect achieved milestones and to include new and amended timelines for implementation of various telematics systems/standards. The updated Roadmap v2.2 and the visual representation of the steps are available here.

26-06-2019

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 08:00hrs(CEST) on Saturday, 29 June and 16:00hrs (CEST) on Sunday, 30 June 2019.  

Applications consuming real-time RMS data (PSUR Repository, MMS-e, EudraGMDP, EudraCT, EU PAS (ENCepp), and eAF) will be affected intermittently 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.

Please note that if you have submission deadline for non-EU single assessment PSUR on Friday, 28th June, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.

 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.

05-06-2019

The milestones for the CESSP phase 1 project has been updated and can be found here.

03-06-2019

A webinar providing an update of the CESSP phase 1 project (converting the current eAFs MAA human and veterinary into web based forms) will be held on 5 June 2019. This webinar is aimed for Regulators and instructions on how to connect have been sent out by email to representatives of National Competent Authorities.

23-05-2019

The presentation and recording from the webinar providing an update to Industry about  the CESSP phase 1 project held on 7th of May 2019 is now available here.

24-04-2019

A Q&A document on how to handle eCTD for ASMF submissions has been published on the eASMF page.

15-04-2019

A webinar providing an update of the CESSP phase 1 project (converting the current eAFs into web based forms) will be held on 7 May 2019 from 10:00 to 11:30 CET. This webinar is aimed for applicants (from pharmaceutical industry). A separate session aimed for regulators will be be organised in near future.

Please note that participation in this webinar is on first come first serve basis as the maximum capacity of the virtual meeting room is limited to 200 participants. If multiple users from your organisation are attending, please share the connection with your colleagues.

The webinar will be recorded and the recording will be made available on the CESSP webpage after the webinar.

How to login is available here.

Previous news is available here

 

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