eAF issue with webservices
An issue relating to the eAF webservice update has affected availability of terms in the ‘Pharmaceutical Form’ field in all 4 forms. We have released a fix that has partially solved the issue; however, we are aware that there are still many combined pharmaceutical forms that are currently unavailable in the eAFs. Please note that as this issue affects the webservices to the form, not the form itself, also previous versions of the form are affected. We are working on a further fix to solve this issue as soon as possible.
For any issues with the eAFs, please raise a call via the EMA service desk.
A new version of the eSubmission Gateway XML delivery file is now available
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced multiple changes ranging from new fields to changing previously optional fields to mandatory fields and a major change for Paediatric submissions by completely transforming the delivery files for these types of submissions as we are preparing to extend the Common Repository to contain Paediatric submissions.
Details on the changes are described in the release specific presentations, the updated user guide and the updated release notes which can be found here and specific details relating to the Paediatric delivery files can be found here.
Users should note that the delivery files created prior to the new release will not work after the go live.
eAF v22.214.171.124 important note to users
An updated version of the variation eAF v126.96.36.199 is now available on the eAF website. This release which does not change the form version number, provides a fix to the Adobe backwards compatibility issue and it should solve the issues some users have experienced with the scope selection dropdown list in section 3. This version also includes a change in the form validation rules for grouping of Type IA or Type IAIN variations.
Please ensure that upon opening the eAF you ‘trust’ the form by clicking the small exclamation mark at the top of the left-hand adobe pane and then selecting the trust option from the yellow banner which will open across the top of the forms. The drop-down menu’s will not work if the form has not been trusted.
The Presentations for applicants and NCAs on the release v188.8.131.52 have been updated and are available here.
For any issues with the eAFs, for example reporting missing scopes, please raise a call via the EMA service desk.
The Guideline on eSubmission for Veterinary products - version 2.7 entered into force on 01 October 2020.
The EU Change Control Process
The EU Change Control Process for Veterinary has been updated and can be found here.
eAF v184.108.40.206 now available
Version 220.127.116.11 of all four electronic Application Forms (eAFs) is now available. The release v18.104.22.168 provides a major change in section 3 of the variation form by further integrating with RMS from SPOR (scopes and conditions and documentation). Some defects have been fixed in MAA human, MAA vet and renewal (H&V forms.
The new version is implemented with 3 months transitional period. Mandatory use of v22.214.171.124 will start on 16th December 2020.
More details can be found from the release notes and the updated Practical user guide for electronic Application Forms as well as the presentation on changes available here.
Please note that due to the major change in the variation form, data imports from older versions of the variation form will not work.
Applicants are reminded that the version of the form should not be changed during an ongoing procedure.
eAF v126.96.36.199 will be released on 15th September 2020
Version 188.8.131.52 of all four electronic Application Forms (eAFs) will be made available on 15th September 2020 with a slightly longer, 3 months transitional period and mandatory use from December 2020. The release v184.108.40.206 will provide a major change in section 3 of the variation form by further integrating with RMS from SPOR (scopes and conditions and documentation). There has been minor defect fixes in the other 3 forms (MAA human, MAA vet and renewal (H&V).
We would like to thank all UAT participants for your efforts and very useful comments.
A slightly updated release milestone plan and release schedule for the electronic Application Forms (eAF) are now available.
Issue with eSubmission Gateway and its infrastructure
For the last few days, the EMA Gateway and surrounding infrastructure experienced an unplanned outage.
This has resulted in delays in acknowledgment communication as well as internal delays in submissions distribution.
The service is now available but we request you do not resubmit packages as the process of sending acknowledgments is experiencing delays.
Thank you for your patience and understanding.
eAF v220.127.116.11 - Updated UAT details, updated release milestone plan and updated release schedule for eAF now available
An updated release milestone plan and release schedule for the electronic Application Forms (eAF) are now available.
Version 18.104.22.168 of all the 4 electronic Application Forms (eAFs) is planned for release in September 2020 with a 2 month transitional period, and mandatory use from November 2020.
The release v22.214.171.124 will provide a major change into the section 3 of the variation form by further integrating with RMS from SPOR (scopes and conditions and documentation).
Please note that both MAA forms, human and veterinary, have been added into this release following a discovery of a defect in the forms.
The User Acceptance Testing (UAT) to support the release of this next version of the forms started on Friday 17th of July 2020.
Due to the delay in starting testing, we are now testing in parallel with both user groups (Industry and NCAs) and the UAT will run until Tuesday 4th of August 2020.
If you have not yet registered, however, wish to participate in the UAT, please contact us by email to eSubprogofficer@ema.europa.eu