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Previous eAF news

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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