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Previous eAF news

11-09-2020

Version 1.24.0.0 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 v1.24.0.0 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).

20-07-2020

An updated release milestone plan and release schedule for the electronic Application Forms (eAF) is available below.

Version 1.24.0.0 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 v1.24.0.0 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 

 

29-06-2020

There is a short delay in the start of the UAT for the eAF v1.24.0.0 – new dates will be communicated very soon. If you wish to participate in the UAT, please register by email with eSubprogofficer@ema.europa.eu 

11-06-2020

eAF v1.24.0.0 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 below.

Version 1.24.0.0 of the variation and renewal electronic Application Forms (eAFs) is planned for release in September 2020 with a 2 months transitional period and mandatory use from November 2020. The release v1.24.0.0 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). User Acceptance Testing (UAT) is planned to support the release of this next version of the forms:

The testing by Industry and NCAs is planned to take place as follows:

    • Industry: from Mon 29/06/20 to Fri 03/07/20
    • NCAs*: from Mon 06/07/20 to Fri 10/07/20 (*Based on the eAFs received from Industry)

Please note that these dates are subject to change depending on the outcome of internal UAT. If you wish to participate in the UAT, please register by email with eSubprogofficer@ema.europa.eu 

Further details on the release scope and the confirmed dates for the UAT will be provided soon.

31-03-2020

In the view that many applicants and MAHs are now working from home due to the Covid-19 situation, we would like to remind the users of the eAF functionality which may facilitate working during exceptional circumstances with variable internet bandwidths.

The electronic Application Forms can be saved directly from the eSubmission website to the users local machine and most fields can be filled in off-line, without access to internet. Only those fields that require substance/term related searches, and the use of OMS for address details requires connection to the internet. Validation feature and most dropdown lists are loaded to the form at the time when the form is opened and can be used even when the user is not connected to the internet enabling most of the form to be filled in without internet connection.

The performance of the forms with regards to the speed is unfortunately not optimal, mainly due to the technology used and the multiple business rules built in to the form, and hence, the network is working hard on the replacement of the PDF format forms with a web-based forms. The new web based forms for human and veterinary MAAs are planned for release later this year (timelines subject to change due to Covid-19 situation).

The eAFs are submitted as a part of the dossier which, for centralised procedure applications, must be submitted via the eSubmissions Gateway. In case the users are experiencing issues with the eAFs or preparing and sending submissions via the eSubmission Gateway or Web Client, we strongly recommend raising a ticket with detailed description of the issue via the EMA service desk portal.

It is important to include as many details as possible of the issue and, for example attaching screenshots or the form in question to aid investigation for the reasons of the issue.

04-06-2020

Computer application maintenance – Sunday 7 June 2020

Essential maintenance work will be carried to eSubmission applications as part of EMA’s computer application maintenance work this weekend. As a result, eSubmission applications will be intermittently unavailable to users between 13:00 – 17:00hrs on Sunday, 7 June 2020.

24-03-2020

Computer application maintenance weekend 28-29 March 2020

Essential maintenance work will be carried out to all Telematics applications as part of EMA’s computer application maintenance work during the last weekend in March.  As a result, eAF will be unavailable to users between 18:30hrs on Friday, 27th March and 08:00hrs on Monday, 30th March 2020

09-12-2019

Version 1.23.1.4 of the Human Marketing authorisation Application (maa) electronic Application Form (eAF) is now available. The release v1.23.1.4 is a bug fix release to correct business rules implementation in sections 1.4 and 1.5. Further details are available on the release notes. This bug fix release does not affect the Data Exchange Standard (DES). Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

10-10-2019

Version 1.23.1.3 of the 4 electronic Application Forms (eAF) is now available. This release (v1.23.1.3) is a bug fix release to correct a number of issues which affect the forms. Further details are available in the release notes. This bug fix release does not affect the Data Exchange Standard (DES).
Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

01-10-2019

Version 1.23.1.3 of the 4 electronic Application Forms (eAF) will be available 10 October 2019. The release v1.23.1.3 is a bug fix release to correct a number of issues affecting the forms. More details on the fixes will be available in the release notes which will be published together with the updated forms. This hotfix release does not affect the Data Exchange Standard (DES).

Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

22-07-2019

Essential maintenance to computer applications

The eAF will be impacted by essential maintenance to SPOR data services on Tuesday, 23 July 2019. 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 will continue to work during this maintenance activity.

19-07-2019

Essential maintenance to computer applications

The eAF will be impacted by essential maintenance to SPOR data services 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. 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 will continue to work during this maintenance activity.

26-06-2019

Essential maintenance to computer applications 

The eAF will be impacted by essential maintenance to SPOR data services on Saturday, 29 June and Sunday, 30 June 2019. 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 will continue to work during this maintenance activity.

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.

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 availble here.

10-04-2019

The applicants are reminded that eAFs should be edited and signed using Adobe Reader. Using Adobe Acrobat Pro may lead to issues when the regulators review the applications using Adobe Reader and this may lead to validation issues and delays in processing the applications. More information can be found in the eAF Q&A document.

28-03-2019

The release notes for MAA Human and Veterinary electronic Application Forms (eAF) and the Renewal eAF have been updated to reflect new known issues.

26-03-2019

eAF dropdown lists not working?

Users are reminded that the eAFs will need to be ‘trusted’ in order for the dropdown lists to work. To ‘trust’ the forms, please click the exclamation mark on the top of the left hand pane and select ‘options’ to open the trust options. Select ‘trust this document always’ to proceed.

15-03-2019

Version 1.23.1.2 of the 4 electronic Application Forms (eAF) is now available. This release v1.23.1.2 is an unplanned hotfix release to fix 3 issues that affected the functioning of the forms. More details on the fixes are available on the release notes. This hotfix release does not affect the Data Exchange Standard (DES).

This new version (v1.23.1.2) of the forms will fully replace the versions 1.23.1.0 and 1.23.1.1 after transitional period, on 4 April 2019. The version of the form should not be changed during an ongoing procedure.

04-02-2019

Version 1.23.1.1 of the 4 electronic Application Forms (eAF) is now available. This release v1.23.1.1 is a bug fix release providing usability improvements and technical defect fixes. This bug fix release does not affect the Data Exchange Standard (DES).

This new version (v1.23.1.1) of the forms will fully replace the version 1.23.1.0 after transitional period, on 4 April 2019. The version of the form should not be changed during an ongoing procedure.

01-02-2019

Update of the eAF user guidance Q&A

The eAF user guidance Q&A has been updated and can be found in the“Guidance documents / Q&A” section.

12-12-2018

Essential maintenance to computer applications

The eAF will be impacted by essential maintenance to SPOR data services on Saturday, 15 December and Sunday, 16 December 2018. 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 will continue to work during this maintenance activity.

03-10-2018

The eAF User Guidance Human & Vet Q&A has been updated and can also be found under the section “Guidance documents / Q&A”.

02-10-2018

New versions of the 4 electronic Application Forms (eAF v. 1.23.1.0) and the related release notes are now available. This new version is a hotfix release of the forms and can be used as of 28th September 2018.

The current versions (v1.23.1.0) of the forms can be used and will fully replace the version 1.22.0.1 after a transitional period, on 15 October 2018 as detailed in the eAF Release Milestone plan. The version of the form should not be changed during an ongoing procedure.

23-08-2018

Essential maintenance to computer applications

The eAF will be impacted by essential maintenance to SPOR data services on between 08:00-18:00 hrs (UK time) Saturday, 25 August 2018. 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 will continue to work during this maintenance activity.

06-08-2018

The regulatory user guides for the electronic application form  for a marketing authorisation (Human and Veterinary) have been updated, see section Guidance documents / Regulatory.

13-07-2018

New versions of the 4 electronic Application Forms (eAF v. 1.23) and the related release notes are now available.

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 1.22.0.1 after transitional period, on 15 October 2018. The version of the form should not be changed during an ongoing procedure.

01-06-2018

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).

Essential maintenance to computer applications

The eAF will be impacted by essential maintenance to SPOR data services on between 18:00-19:00hrs on Thursday, 17 May 2018. 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 will continue to work during this maintenance activity.

15-05-2018

The updated DES documents and XSD files are now available for all 4 forms under the Technical Documents section below. This is in preparation for the scheduled go live of eAF Version 1.23.

13-04-2018

The eAF guidance for how to request new substances and terms has been updated. Please refer to the eAF Term Request Form section below.

07-03-2018

Essential maintenance to computer applications

The eAF will be impacted by essential maintenance to SPOR data services on Saturday, 10 March and Sunday, 11 March 2018. 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 will continue to work during this maintenance activity.

16-02-2018

New versions of the 4 electronic Application Forms (eAF v. 1.22.0.1) and the related release notes are now available. This new version is a hotfix release v1.22.0.1 of the forms and can be used as of today, 16th February 2018. The version of the form should not be changed during an ongoing procedure.

15-02-2018

As of 15 February 2018 version 1.22 of the four electronic Application Forms (eAFs) are mandatory. Older versions of the forms will no longer be supported.

15-12-2017

New versions of the 4 electronic Application Forms (eAF v. 1.22) and the related release notes are now available.

This release includes integration with OMS for organisation data and RMS for reference data.
OMS will provide standardised organisation and location data. (For information, eAF has been integrated with RMS since June 2017.)

This new version, 1.22 of the forms can be used as of today (15th December 2017) and will fully replace the version 1.21 after transitional period, on 15 February 2018. The version of the form should not be changed during an ongoing procedure.

13-12-2017

Please see below the summary of post User Acceptance Testing for eAF v1.22 outcome.
In total 247 comments were received.

We have fixed 62 defects (remaining defects will be assessed and prioritised in future releases).
All submitted change requests will be analysed and prioritised.

    Change Requests Defects Defects Addressed
eAF MAA(Human)
19
38
33
  MAA(Vet)
2
6
5
  Renewal
9
16
11
  Variation
27
22
13
   
57
82
62

27-11-2017

Essential maintenance to computer applications

The eAF will be impacted by essential maintenance to SPOR data services on Wednesday evening 29th November and Friday 1 December 2017. This maintenance work affects the ATC code field in the MAA human & vet forms and the renewal form. All other dropdown menus for controlled terminology continue working during this maintenance activity. There is no impact to the Variation application form.

22-11-2017

A webinar on the use of OMS and RMS data in eAF will be held on 28 November 2017 at 14:00-16:00 UK time. If you would like to participate in this webinar, please register by email to SPOR-Change-Liaisons@ema.europa.eu. Please note that participation in this webinar is on first come first serve basis as the maximum capacity of the virtual room is 200 participants. The webinar will be recorded and published on the eAF website.

19-10-2017

Version 1.22 of the electronic Application Forms (eAFs) will become available on 15 December 2017. The release v1.22 will provide integration with OMS from SPOR (Organisational/address data), usability improvements and technical defect fixes. 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 13/11/17 to Fri 17/11/17
    • NCAs*: from Mon 20/11/17 to Fri 24 /11/17   (*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. A kick-off meeting is planned to take place on 13th November 2017 to explain the new features.

05-10-2017

The EMA is launching an updated version of the EudraVigilance on 22 November 2017. In preparation for this update, there will be a downtime period for the Article 57 database (EXVDMP). During the scheduled downtime from 8th-21st of November 2017 it will not be possible to amend or add product/substance data in Article 57. This will impact eAF use as the substance selection for the Initial MAA is linked to EXVDMP. It will not be possible to update substance data for the creation of eAF dataset during this downtime period. The EMA strongly recommends that MAHs, with a MAA date falling during the scheduled downtime (8 to 21 November 2017), carefully review relevant data and ensure that the required substances are available via the eAFs.

12-07-2017

A defect in section 1.4 of the MAA veterinary eAF, affecting the MRL substances has been detected and subsequently fixed. New version v.1.21.0.1 of the MAA veterinary form and the updated release notes are now available.

Defects in section 1 and 3 of the Renewal eAF, affecting the MA Numbers fields and the overages field respectively, have been detected and subsequently fixed. New version v.1.21.0.1 of the Renewal form and the updated release notes are now available.

30-06-2017

A defect in section 1.1 of the MAA human eAF, affecting the PRAC rapporteur field (Centralised Procedure applications) has been detected and subsequently fixed. New version v.1.21.0.1 of the MAA human form and the updated release notes are now available.
Applicants are reminded that for Centralised Procedure a single application form per product should be used – it is not acceptable to provide separate application forms for different strengths/presentations.

20-06-2017

Version 1.21 of the 4 eAFs is now available. The release v1.21 provides usability improvements and technical defect fixes. Details of the changes are available on the updated Release notes. This release implements changes in the Data Exchange Standard (DES) of the MAA-Human and MAA-Vet forms. The updated DES and XSD documents are available under Technical Documents.

15-06-2017

Version 1.21 of the eAFs will be available on 20 June 2017. The release v1.21 provides usability improvements and technical defect fixes. Following a successful User Acceptance Testing (UAT) the release schedule is now available to provide more information on the mandatory use of version 1.21.

08-03-2017

Users of the variation form who are wishing to import data from v1.20.0.3 or earlier are reminded to remove all the scopes in section 3 before exporting the xml in to v1.20.0.5. as the format of the numbering has changed and will cause issue if not deleted before importing to the new version of the form. There is no need to untick the scopes if importing from v1.20.0.4 to v1.20.0.5.

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01-10-2016

Applicants are reminded that the section 2 of the electronic Application Form (eAF) should be filled in with product details. The use of the footnote is only allowed for those applications that contain complex form and strength data where it may be impossible to enter details in the provided fields, for example complex vaccines. Footnote should not be used for applications where the product details can be entered in section 2. Convenient ‘clone’ function is now available reducing need to type similar information multiple times.

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