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 220.127.116.11 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.
The document “Exceptions to the VNeeS format” has been updated. Please see the link in the section “Current Guidance” on the Veterinary eSubmission page.
Updated documentation related to CESSP Phase 1 - i.e. Q&A, CESSP essentials project information and UAT2 results summary - have been published.
Mandatory use of the Common Repository for veterinary submissions
The use of the Common Repository by National Competent Authorities (NCAs) to retrieve veterinary submissions is now mandatory since the 1st of June 2018. Please see further details in 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 Common Repository has been extended to include EMA coordinated procedures from 8 March 2018. The use of the Common Repository for EMA coordinated procedures will become mandatory on 1st September 2018.
There should be no EMA coordinated procedures submissions sent directly to any NCAs from 1st of September 2018 as these will be considered to have been delivered to the NCAs. Please see the Statement of Intent on the mandatory use of Common Repository for EMA coordinated submissions for human medicinal products.
Version 1.23 of the electronic Application Forms (eAFs) will become available on 13 July 2018. The release v1.23 will provide further integration with OMS from SPOR (Organisational/address data) and NTA changes,
User Acceptance Testing (UAT) is planned to support the release of this next version of the forms:
- The testing by Industry and NCAs will take place
- Industry: from Mon 11/06/18 to Fri 18/06/18
- NCAs*: from Mon 19/06/18 to Fri 22/06/18 (*Based on the eAFs received from Industry)
If you wish to participate, please register by email with eSubprogofficer@ema.europa.eu. A feedback form for consolidated comments will be provided to you following your registration. Please follow Summary of changes, document which shows clearly before and after areas and changes to eAF that focus on test scenarios for current UAT. UAT version of Summary of changes will be sent via email with UAT package. Final version will be published on website later (13 July 2018).31-05-2018
Updated annexes to the eSubmission roadmap published
The following updated Annexes to the eSubmission Roadmap have been published to reflect further details on the practical implementation steps. Annex 3 to the HMA eSubmission Roadmap on the implementation of mandatory VNeeS format for Veterinary regulatory submissions, Annex 4 to the HMA eSubmission Roadmap on the replacement of the current PDF electronic application forms (eAFs) with the CESP Application Dataset Management Module (CESP Dataset Module) and Annex 5 to the HMA eSubmission Roadmap on the mandatory use of the Common Repository for EMA led procedures can be found here.
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 18:00-19:00hrs (UK time) on Thursday, 17 May 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 Organizations 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
The updated Annexes to the Roadmap are being published as they become available to reflect further details on the practical implementation steps. Annex 1 to the HMA eSubmission Roadmap on the implementation of eCTD version 4.0 and Annex 2 to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for Human regulatory submissions can be found here.
The updated DES documents and XSD files are now available for all 4 forms under the Technical Documents section. This is in preparation for the scheduled go live of eAF Version 1.23.
Previous news is available here