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11-01-2017

Version 1.21 of the eAFs will become available on 7 February 2017. The release v1.21 will provide mainly technical defect fixes and usability improvements.
We are organising a User Acceptance Testing (UAT) to support the release of this next version of the forms:

  • The testing by Industry and NCAs will take place
    • Industry: from Mon 16/01/17 to Thu 19/01/17
    • NCAs*: from Tue 23/01/17 to Fri 27/01/17   (*Based on the eAFs received from Industry)

If you wish to participate, please email Beatriz.Calvo@ema.europa.eu.  A feedback form for consolidated comments will be provided to you following your registration.

Please use the Service Desk portal https://servicedesk.ema.europa.eu to raise any queries related to the eAFs. Procedural queries related to MRP, DCP and National procedures should be directed to the relevant National Competent Authority.

13-12-2016

New versions of the VNeeS Guideline v2.5 and the related Validation checklist v2.5 have been published under the Current Guidance section on the Vet eSubmission website. The new VNeeS Guideline and the checklist will enter into force on 1 June 2017. Rules for technical validation remain unchanged and therefore the current VNeeS Checker v.2.4b (validation tool) will remain valid from 1 June 2017.

The release schedule for the update of the electronic Application Forms (eAFs) is now available and can be found here. The next release, version 1.21 will deliver defect fixes and usability improvements and is planned for user acceptance testing in January 2017 and for deployment in February 2017.

The User guide to the XML delivery file creation has been updated and is available here.

Support to eSubmissions during EMA holidays: Please note that all EMA eSubmission systems are running as per normal during the EMA holiday. Submissions received via the eSubmission Gateway during the EMA closure are automatically uploaded to the Common Repository and the PSUR Repository as relevant. In case of technical issues, the EMA IT service desk is open until 6:30pm UK time on 22nd of December 2016. The service desk will reopen for external users for 4 half days between 27th and 30th December 2016, please note that if the queries are complex or require specific expertise they may not be solved until the service desk returns to normal service on Tuesday 3rd January 2017. There will be no procedural support available during the EMA closure from 23rd December until 2nd of January 2017 inclusive.

05-12-2016

An updated version of the eSubmission Gateway XML delivery file web UI is now available. This version delivers new functionality to create delivery files for MRL and veterinary PSUR submissions as well as functionality to create delivery files for human PASS 107o submissions, PASS 107n, PASS 107o and PASS 107q submissions for Nationally Authorised Products and submissions for Ancillary Medicinal Products in medical devices.  

The User guide to the XML delivery file creation and the Release notes have been updated and are now available here.

The use of eSubmission Gateway / Web Client will become mandatory for all Veterinary submissions on 1 January 2017. The procedural announcement and presentation from the training held on 1 December 2016 are available here.

The use of XML delivery files for all Veterinary submissions will become mandatory on 1 April 2017. The Statement of Intent is available here.

The Common Repository will be extended to all veterinary submissions in the centralised procedure. The Statement of Intent is available here.

The use of VNeeS format for all veterinary submissions in European procedures (CP, DCP and MRP) will become mandatory as of 1 January 2017. Details are available in the Annex to the eSubmission roadmap.

01-12-2016

Essential maintenance to computer systems during the weekend

Please note that the following computer systems will be unavailable on Sunday, 4th December 2016 between 9.00hrs and 19.00hrs (UK Time) due to essential maintenance:

  • PSUR and eSubmission Web User Interface – affecting parts of DREAM*
  • Axway Gateway – affecting EudraVigilance and eSubmissions

(* Due to essential folder re-structuring, colleagues working in the cabinet 01 /H-PUSA area might receive warning messages. Please avoid working in this area on Sunday 4th Dec, if possible. All other areas of DREAM will be available as usual.)

22-11-2016

A statement of intent is published regarding the replacement of electronic Application Forms by CESSP. More information on the CESSP project is available here.

11-11-2016

As of 1 January 2017 it will be mandatory for applicants to make all veterinary procedural submission to EMA via the eSubmission Gateway/Web Client portal. In preparation, a training Webinar for Industry – Mandatory Use of eSub Gateway for veterinary submissions to EMA will be held on 1 December 2016 from 13:00 to 15:00 UK time. For details see the Veterinary esubmission website.

09-11-2016

An updated version of the Common Repository is now available for the NCAs. The Common Repository contains all Centralised Procedure eCTD format submissions and is accessible to all NCAs. The update user guide is now available for NCAs. The updated Q&A document is now available here.

And

The Practical User Guide for Electronic Application Forms (eAF) for human and veterinary medicinal products in the EU has been updated and is available here.  

07-11-2016

Essential maintenance to replace the Common Repository web user interface

The European Medicines Agency will be carrying out essential maintenance activities on the Common Repository system during the period specified below. Users may therefore find the application being intermittently unavailable during this time.

Tuesday, 8 November 2016 18:00hrs - 20:00hrs (UK time)

This maintenance activity will introduce a new web application to users which will replace the existing Common Repository web user interface. The new version of the system provides access to the word version working documents via the user interface and introduces a new look and feel with EMA branding. An updated user guide has been circulated to Common Repository contact points and is also available on the Telematics website.

We apologise for any inconvenience caused. If you have any questions, please contact the IT Service Desk.

18-10-2016

Updated versions of 4 electronic Application Forms (eAF v. 1.20.0.3) have been published following reported issues. The updated forms and related release notes are now available here.

The User guide to the XML delivery file creation has been updated and is now available here.

14-10-2016

The Annex1 - A Guide to the EMA filenaming convention for eSubmission has been updated and is available here.

Essential maintenance to PSUR Repository and eSubmission Gateway this weekend

Due to essential maintenance the PSUR Repository and the eSubmission Gateway are unavailable this weekend from 18:00 UK time on Friday, 14 October until 06:00 AM UK time on Monday 17 October 2016.

EMA IT systems unavailable from 18:00 Friday 28 October to 06:00 Tuesday 1 November 

All European Medicines Agency (EMA) IT systems will be temporarily unavailable from 18:00 on Friday 28 October to 6:00 on Tuesday 1 November (UK time), due to an essential exercise to test the Agency’s IT recovery capacity in case of a major event.

During this period, it will not be possible to access the EMA public website, www.ema.europa.eu, or any other EMA-hosted website or online application, including the systems used to send and receive applications for EMA regulatory procedures. MAHs should plan their submissions around the availability of the systems.
Emails sent to EMA email addresses during this period will be queued and delivered to recipients on 1 November.
Normal service will resume on 1 November.

The EMA product emergency hotline and phone number for notifying suspected quality defects or product recalls will operate as usual. While the EMA public website is unavailable, a holding page will be displayed with details of these emergency numbers. We would like to thank you in advance for your patience and cooperation during this essential IT maintenance work.

If you require more information, please contact the IT Service Desk ITServiceDesk

10-10-2016

An updated version of the PSUR Repository has been made available on Thursday 6th October 2016. This release improves the product availability for the submission of responses. The updated release notes are available here.

An updated version of the eSubmission Gateway XML delivery file web UI is now available. This version improves the availability of Referral and ASMF procedures as well as fixing known defects. The updated release notes are available here.

04-10-2016

Essential maintenance to PSUR Repository on Thursday evening.

PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 18:00 and 19:00hrs on Thursday, 6 October 2016. However, Axway gateway will be available for all communities and any files submitted during that time will be put in a queue for processing when the deployments will be completed.

If you have any questions, please contact the EMA IT Service Desk

03-10-2016

Essential maintenance to Gateway - 14-17 October 2016

The European Medicines Agency will be carrying out essential maintenance activities on the Gateway during the period specified below. Users may therefore find the Gateway unavailable during this time.

  • Friday, 14th October from 20.00hrs (UK time) to Monday, 17th October, 6.00hrs (UK time)

During this period, it will not be possible to send messages via the Agency’s Gateway. Depending on the routing, either there will be a failure to connect and the message will not reach the Agency, or the message will be queued and delivered once services have been restored. Only in the second case will an MDN be received and the message processed once the service has been restored. Users should therefore plan their submissions around the availability of the systems.

Normal service will resume at 6.00hrs (UK time) on Monday, 17 October 2016.
We would like to thank you in advance for your patience and co-operation during this essential IT maintenance work and we apologise for any inconvenience this may cause. Should you have any questions please contact the EMA IT service desk at https://servicedesk.ema.europa.eu

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01-10-2016

The use of the updated EU Module 1 Specification v3.0 and/or v3.0.1 is now mandatory for all eCTD format submissions in the EU. The specification and related documents are available here.

The use of the XML delivery files for submissions via the eSubmission Gateway and the Web Client is now mandatory. The use of XML delivery files has replaced the use of filenaming conventions for majority of human and veterinary submissions to the EMA. More information on the use of the delivery files for submissions via the eSubmission Gateway and the Web Client is available here. The Annexes describing the filenaming conventions have been updated.

Applicants are reminded that the section 2 of the electronic Application Form (eAF) should be filled in. The use of the footnote is only allowed for form and strength information for complex vaccines/combination products. The eAFs and related user guides are available here.

Applicants are reminded that eCTD validation reports must not be provided in the working documents folder in the submissions to EMA. More information on the use of the working documents folder is available in the Harmonised Technical Guidance for eCTD Submissions in the EU document.

19-09-2016

A further update to the revised Annex II to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for regulatory submissions is available here.

The use of the eAF v1.20 will become mandatory on Monday 19th September 2016. Use of previous versions is accepted only for ongoing applications – the version of the form should not be changed in the middle of the procedure. The latest version of the forms and relevant guidance is available here.

Essential maintenance to PSUR Repository and the eSubmission Gateway on Tuesday evening 20th September 2016

Please note that the PSUR Repository will be unavailable for Member State and industry users between 18.00-19.00hrs UK time on Tuesday, 20th September due to essential maintenance.  The EMA eSubmission Gateway/Web Client will not be available during this time.

 If you have any questions or issues, please contact the EMA IT Service Desk

19-08-2016

Updated versions of 4 electronic Application Forms (eAF v. 1.20.0.2) have been published following reported issues. The updated forms and related release notes are now available here. Version 1.20 of the forms has been available for use since 14th June 2016 and will fully replace version eAF v. 01.19 after an extended transitional period on19 August 2016. Version 1.19 of the forms may be used until 18 September 2016.

18-08-2016

Recordings from the webinar training on the use of the updated XML delivery files for submissions via the eSubmission Gateway held on 21st July and the interactive Q&A sessions held on 25 and 26th July are now available here.

The recording of the PSUR Repository v1.07 webinar training held on 25 July and recordings from the webinars on the Mandatory use are now available here

27-07-2016

Common Repository unavailable on Thursday evening 28 July 2016 for scheduled maintenance.
The Common Repository will be unavailable on Thursday 28 July 2016 from 18.00 until 21.00 UK time while scheduled upgrade work is carried out. This upgrade introduces changes to bring the Common Repository into line with eCTD EU Module 1 specification v3.0.

And

The updated release schedule for the hotfix version 1.20.0.2 for electronic Application Forms has been published here. The acceptability of the v1.19.0.2 of the eAF has been extended until 19 September 2016 when the updated versions of all 4 forms plan to be published.

The updated eSubmission Gateway error codes list is now available here. The error codes listing provides problem descriptions for errors experienced by users when sending packages using the eSubmission Gateway / Web Client.

The updated formatted table template is now available here. The main changes in this cover letter template reflect changes in the updated eCTD EU Module 1, the usage of the template for non-EU single assessment submissions and the discontinued use of Annex I for product listing for PSUSA procedures (product listing is created when products are selected on the xml delivery file).

Updated Annex II to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for regulatory submissions is available here.

The presentation from the training session on the use of the updated version of the PSUR Repository held on 25 July 2016 is available here.

The presentation from the interactive Q&A sessions held on 25 and 26 July 2016 on the use of the updated version of eSubmission Gateway XML delivery file user interface is now available here.

25-07-2016

Updated versions of the PSUR Repository and the eSubmission Gateway user interfaces to create XML delivery files for submissions via the eSubmission Gateway and the Web Client are now available. These new versions will introduce changes in line with the updated EU Module 1 Specification v3.0 and v3.0.1. The updated delivery files should also be used for eCTD submissions created using eCTD specification version 2.0. The changes are implemented to the Gateway XML delivery files also for Veterinary submissions to align the submission process and provide more information on the submission.

Updated user guides and system release notes are available for PSUR Repository users here and for Gateway users here. Slides from the training session held on 21 July 2016 on the use of the updated delivery files are now available here.

Issues have been reported with the latest versions of the electronic Application Forms v1.20.0.1 and, while the issues are fixed the acceptability of the v1.19.0.0 of the eAF has been extended until 15 September 2016. The new versions of all the 4 forms are planned to be published within the coming weeks, exact date of this new release is yet to be confirmed.

If you are experiencing issues with the forms, please contact the EMA IT service desk via the online portal: https://servicedesk.ema.europa.eu.

The formatted table template cover letter has been updated and is now available here.

22-07-2016

Please Note Monday, 25 July 2016 07:00hrs – 09:00hrs (UK time):

The European Medicines Agency will be carrying out essential maintenance activities on the PSUR/eSubmissions Web/Gateway File Handler during the period specified below. Users may therefore find the application being unavailable during this time. However, Axway gateway will be available for all communities and any files submitted during that time will be put in a queue for processing when the deployments will be completed.     

14-07-2016

Updated versions of the PSUR Repository and the eSubmission Gateway user interfaces to create XML delivery files for submissions via the eSubmission Gateway and the Web Client will become available by 1st of August 2016. These new versions will introduce changes in line with the updated EU Module 1 Specification v3.0. The changes are implemented to the Gateway XML delivery files also for Veterinary submissions to align the submission process and provide more information on the submission.

Invitations to training sessions and interactive Q&A sessions have been sent to registered Gateway users and contact points who have previously attended PSUR Repository training. If you have not received an invitation and would like attend, please register by contacting eSubProgOfficer@ema.europa.eu by Wednesday 20th July noon UK time.

The maximum capacity of the virtual meeting rooms is 200 participants and spaces will be allocated on a first come first serve basis. There are 2 separate Q&A sessions to allow as many participants as possible to attend this interactive session. The participants should select one of the sessions only.

If multiple users from your organisation intend to attend, please consider sharing the connection with your colleagues. Sessions will be recorded and the recordings will be made available on the eSubmission website.

Session

Date

Time

Training on the use of XML delivery files for submissions via the eSubmission Gateway – update reflecting the updated EU M1.

Thursday 21 July 2016

09:00 UK time

Training and Interactive Q&A on the v1.07 of the PSUR Repository

Monday 25 July 2016

10:00 UK time

Interactive Q&A session on the use of the XML delivery files for submissions via the eSubmission Gateway (session 1)

Monday 25 July 2016

12:00 UK time

Interactive Q&A session on the use of the XML delivery files for submissions via the eSubmission Gateway (session 2)

Tuesday 26 July 2016

10:00 UK time

Updated Release Notes and Implementation Guide have been published to clarify the changes and requirements related to the update of the eCTD EU Module 1 Specification v3.0 and v3.0.1. Both documents can be found from here.

Updated Release Notes have been published to provide clarification on the changes and the use of the eCTD Validation Criteria v6.1. The updated document can be found here.

Issues have been reported with the latest versions of the electronic Application Forms v1.20.0.1 and, while the issues are being investigated and fixed, new versions of all the 4 forms are planned to be published within the next coming weeks, exact date of this new release is yet to be confirmed. If you are experiencing issues with the forms, please contact the EMA IT service desk via the online portal: https://servicedesk.ema.europa.eu.

04-07-2016

ASMF: It is now mandatory to use eCTD format for all ASMF submissions for human use in the centralised procedure.

eCTD: The EUM1 Specification v3.0 and v3.0.1 have entered into force on 1st July 2016 and may be used for all eCTD format submissions within Europe.Submissions in v2.0 will be accepted until 30th September 2016.

VNeeS: An updated version of the VNeeS checker version 2.4.b has been published on the websites of the French and Belgian competent authorities. More information on the update and information on the veterinary eSubmissions can be found here.

eSubmission Gateway: Presentation and recording from the webinar training on the use of XML delivery files for Veterinary submissions via the eSubmission Gateway, held on 3 June 2016, are now available here.

The recordings from the training session and the interactive Q&A session on the use of XML delivery files for submissions via the eSubmission Gateway are now available here.

30-06-2016

eAF: Updated versions of all 4 electronic Application Forms (eAF v. 1.20.0.1) have been published following reported issues with the proof of payment section and entering quantities in the initial human MAA form. The updated forms and related release notes are now available here. Version 1.20 of the forms may be used from 14th June 2016 and will fully replace the current version of eAF v. 01.19 after a transitional period on1 August 2016. Version 1.19 of the forms may be used until 1 August 2016.

PSUR Repository: In some cases, when submitting a package to the PSUR Repository, the zip manager did not create a specific entry for the top level sequence directory. This caused the system to generate an error since it could not match the sequence number provided in the xml delivery file with the top level directory of the zip file.
This issue has now been resolved and, in all cases, the zip manager creates a specific entry for the top level sequence directory. More information on the mandatory use of the PSUR Repository can be found here.

24-06-2016

Variation eAF: Due to an unexpected technical issue the publication of the updated version of the form is postponed to early next week. The hotfix version will be made available as soon as possible during the week commencing 27th June 2016.

ASMF: Updated draft version of the Practical Guidance on the use of the eCTD format for ASMFs for Active Substance Master File Holders and Marketing Authorisation Holders has been released for public consultation and is available here. Please send your comments to EUM1Spec@ema.europa.eu by 29 July 2016.

21-06-2016

Variation eAF: Two issues have been detected with the new version of the variation application form (eAF v. 1.20) affecting the use of the form in its current state for MRP/DCP applications. EMA is currently fixing these defects affecting selection of Reference Member State (MRP/DCP procedures) and the Proof of Payment section. The form may continue to be used for Centralised Procedure applications and National Procedure applications. A new version of the form will be published later this week. If you have already started to fill in the application form v. 1.20 and you are submitting an application prior to the publication of the hotfix version, please provide the information from Proof of Payment section as a separate annex to the application form. Alternatively, you may use version 1.19. Please note that once the hotfix version becomes available the information already filled in v. 1.20 can be imported to the new version.  We would like to thank those users who have reported the issues with the forms.

Important Notice to all PSUR Repository users and MAHs:

The PSUR Repository will be temporarily unavailable from 09:00 – 12:00 (UK time) on Saturday 25  June 2016  due to essential maintenance. All submissions sent to the PSUR repository during the downtime are queued and will be made available in the system once normal service is returned.

14-06-2016

New versions of the electronic Application Forms (eAF v. 1.20) and the related release notes are now available here. This version of the forms provides usability improvements and defect fixes and aims to improve the user experience for all users. Version 1.20 of the forms may be used from 14th June 2016 and will fully replace the current version of eAF v. 01.19 after a transitional period on1 August 2016. Version 1.19 of the forms will be withdrawn from the eAF website on 1 July 2016 however it may be used until 1 August 2016. The use of the eAFs is mandatory for all human and veterinary submissions.

10-06-2016

The use of the PSUR Repository is mandatoryas of 13 June 2016.  All PSURs for products authorised in Europe must now be submitted to the PSUR Repository (PSURs for products authorised under Art. 58 are excluded). There should be no PSUR submissions directly to the National Competent Authorities from Monday 13th June 2016 onwards. More information on the mandatory use of the PSUR Repository as well as the updated user guidance is now available here.

07-06-2016

The Data Exchange Standard (DES) for the variation eAF has been updated reflecting changes implemented in the upcoming release of all electronic Application Forms (eAFs) version 1.20 on 14th June 2016. The variation DES and the DES change summary are now available here.

06-06-2016

The interactive Q&A session on the use of the xml delivery files for submissions via eSubmission Gateway scheduled for 6th of June at 10am has been cancelled due to technical issues with Adobe connect tool. A new date will be organised and all registered users will be invited to the session.

01-06-2016

  • An error has been detected in the published md5 checksum and the update is now available here.
  • Updated release notes for the eCTD validation criteria v6.0 and v6.1 are now available here.
  • Updated release notes for the eCTD EU M1 specification v3.0.1 are now available here.
  • All questions, queries and issues on the use of the PSUR Repository should now be reported via the EMA service portal: https://servicedesk.ema.europa.eu. Please indicate in your query that the issue concerns PSUR repository. The introduction of the EMA service portal aims to harmonise the process to report and track queries sent to EMA. The PSURrepository@ema.europa.eu email address should be to submit change requests related to PSUR repository system.
  • Interactive Questions and Answers sessions are being organised on the use of the XML delivery files for all submissions via eSubmission Gateway/Web Client. Please note that both sessions; 1.6.2016 at 12:00 – 13:30 UK time and 6.6.2016 at 10:00-11:30 UK time are on a first come first serve basis, and only the first 200 participants are able to connect to the sessions.

Wherever possible, please share the connection with your colleagues and if you are unable to attend the recordings for both of these Q&A sessions will be published on the eSubmission Gateway website.
Further training and interactive Q&A sessions are planned for July 2016 once a new version of the system is released to reflect the updated EU Module 1 specification.

  • Presentation from the training on the use of the XML delivery files for eSubmission Gateway / Web Client is now available here.
  • The user guide on XML delivery file creation has been updated and is available here.

23-05-2016

An eSubmission Gateway user interface to create XML delivery files for submissions via the eSubmission Gateway and the Web Client is now available. The use of the delivery files is initially introduced as a pilot, covering the majority of submission types for both human and veterinary domains. Use of the delivery files will become mandatory for Human Centralised Procedure submissions in line with the mandatory use of the updated eCTD EU M1 in October 2016. The use of filenaming conventions will be phased out after a transitional period for all other procedure types. The user guide to XML delivery files and the release notes are available here.

A webinar on the Introduction to new Gateway User Interface for Veterinary Applicants will be held on 3 June 2016 from 11.30 to 13:00.00 UK time. This webinar is dedicated to Veterinary Industry. Please contact eAFwebinar-registration@ema.europa.eu by 1 June 2016 to register and to send any queries you would like to addressed during this webinar.

19-05-2016

A new release of eSubmission Gateway user interface will introduce use of XML delivery files for submissions via the eSubmission Gateway and the Web Client, replacing currently used filenaming conventions. The use of the delivery files is initially introduced as a pilot, covering the majority of submission types for both human and veterinary domains.

A webinar on the use of the new Gateway User Interface for Applicants for Human medicinal products and PIP sponsors will be held on 23 May 2016 from 10:00 to 11:30 UK time. A meeting invitation to the session with connection details will be sent to all registered Gateway users.

A webinar on the Introduction to new Gateway User Interface for Veterinary Applicants will be held on 3 June 2016 from 11.30 to 13:00.00 UK time. This webinar is dedicated to Veterinary Industry. Please contact eAFwebinar-registration@ema.europa.eu by 1 June 2016 to register and to send any queries you would like to be addressed during this webinar.
Should several participants from the same company wish to attend, it is advised to send only one registration request and attend from the same room. Both sessions will be recorded and the recording will be made available on the eSubmission website.

17-05-2016

Due to am error in the EU M1 specification v3.0, a new version (3.0.1) with the updated md5 checksums is now available here.

13-05-2016

Version 01.06 of the PSUR Repository will be made available for both MAHs and NCAs on 14th of May 2016. This release provides improvements to the system prior to the start of the mandatory use on 13th June 2016. The release also provides fixes for defects that have been identified during simulated mandatory use. While the new version is being made available the system will not be able to process new submissions. The PSUR Repository will be unavailable for MAH and NCA users between 9:00 am and 9:00 pm UK time on Saturday 14th May 2016. The updated system release notes and MAH and NCA user guides can be found here.

12-05-2016

A series of trainings and Q&A sessions have been scheduled in preparation for the upcoming PSUR Repository release v1.06.00 and for the mandatory use.
The industry representatives are encouraged to register for the training by sending contact details to eSubprogofficer@ema.europa.eu. NCA representatives will receive an invitation from EMA without a need to register.

11-05-2016

The PSUR Repository bulletin has been updated and can be found here.

10-05-2016

Version 01.06 of the PSUR Repository will be made available for both MAHs and NCAs on 14th of May 2016. The new release provides change requests and defect fixes further enhancing the system in preparation for the mandatory use starting on 13th June 2016. While the new version is made available the system will not be able to process new submissions. Submissions will be received via the eSubmission Gateway however will only be made available in the PSUR repository once the deployment is finalised. The PSUR Repository will be unavailable for both, MAH and NCA users between 9:00 am and 9:00 pm UK time on Saturday 14th May 2016. More information on the PSUR Repository can be found here.

03-05-2016

The EU Harmonised technical eCTD guidance has been updated.  The updated document is available here.

Due to the high volume of feedback received for the eAF UAT, the release date has been revised. The updated release schedule is available here.

Annex 1 – A guide to the filenaming convention for eSubmission describing the detailed filenames for submission via the eSubmission Gateway / Web Client has been updated and can be found here.

From 23 May 2016 it will be possible to use XML delivery files instead of existing filenaming conventions for submissions via the eSubmission Gateway / Web Client. Results of the user acceptance testing (UAT) in April were successful and more information on the pilot launch of the XML delivery files for all types of procedures will be published this month.

12-04-2016

Publication of eAF version 1.20: Please note that following a very high number of testing feedback for the new version of the eAF, we are revising the publication date and the related release plan to ensure that a user friendly robust form will be released. The new date will be communicated as soon as possible. We apologise for any inconvenience.

A second webinar for NCAs on eAF: Overview and best practices how to automatically import data from eAFs into NCA IT-systems will be held on 15 June 2016, from 10:00 to 11:30 CET. Registrations are accepted until 13 June 2016. For more information and to register, please visit the NTC website.

11-04-2016

Important Notice to MAHs:
All EMA IT systems temporarily unavailable from 06:00 on Saturday 16 April to 06:00 on Sunday 17 April 2016 (UK time) due to essential maintenance. More information is available here.

The Annex 1 – A guide to the filenaming convention for eSubmission document  describing the detailed filenaming conventions for submissions via eSubmission Gateway has been updated with new, additional filenaming conventions for ancillary medicinal substances, PASS 107, Signal Detection, NAPs included in a worksharing procedures and Clinical Trial Publication submissions. The updated Annex 1 can be found here.  

The PSUR Repository bulletin has been updated and can be found here.

04-04-2016

EU M1 v3.0 Implementation Guide is now finalised and is available here.  Minor changes (deleting words ‘county specific’ in 11.9, ordering of 11.BP1/BP2 and 14.1/14.5) have been implemented in the published eCTD validation criteria available here.

29-03-2016

An error had been detected in the eCTD published validation criteria. The updated version with correct md5 checksums is available here.

22-03-2016

From 23 May 2016 it will be possible to use XML delivery files instead of the existing  filenaming conventions for number submission types via eSubmission Gateway/Web Client. We would like to involve industry representatives in the upcoming User Acceptance Testing (UAT) which is planned to take place with human and veterinary industry representatives:

  • From Monday 18/04/16 to Friday 22/04/16

If you wish to participate in the testing of the new functionality, please email turi.salami@ext.ema.europa.eu. Detailed information package for testing and a feedback form for comments will be provided to you following your registration.

15-03-2016

MAHs are advised that due to system maintenance work the product refresh for the PSUR Repository will be stopped during the following planned dates, which are currently:

  • 11th March to 18th March 2016
  • 22nd March to 29th March 2016

As a consequence MAHs that make changes to data in Article 57 during these periods will be affected when searching for their products during the XML delivery file creation process.

If you encounter issues with the submission of your initial PSUR we recommend that you wait until these days have passed; there are no planned submission deadlines until 20.04.2016 therefore a slight delay in submission will not impact your procedure start.

If you encounter issues submitting supplementary information please await until the period is over and attempt to resubmit. Please inform your procedure manager (PM) of this and we will communicate with the assessment team accordingly. In those cases where you have an extensive response please highlight this to your PM in order to consider whether an alternative route of submission to the NCA should be considered.

09-03-2016

Version 1.20 of the eAFs will become available on 15 April 2016. To support the release of this next version of the forms:

  • New versions of the eAF Data Exchange Standards (DES) and schemas have been released and can be found here.
  • We are organising User Acceptance Testing (UAT) of version 1.20 of the eAFs. The testing by Industry and NCAs will take place
    • Industry: from Mon 21/03/16 to Thu 24/03/1
    • NCAs*: from Tue 29/03/16 to Fri 01/04/16   (*Based on the eAFs received from Industry)

If you wish to participate, please email turi.salami@ext.ema.europa.eu.  A feedback form for consolidated comments will be provided to you following your registration.

A webinar for NCAs on eAF: Overview and best practices how to automatically import data from eAFs into NCA IT-systems has been moved from 23 February 2016 to 16 March 2016, from 13:00 to 14:30 CET. This webinar is dedicated to National Competent Authorities and is organised in collaboration with the Network Training Centre. Further registrations are accepted until 14 March 2016. For more information and to register, please visit the NTC website.

The Service Desk portal (https://servicedesk.ema.europa.eu) should be used to raise any queries related to the eAFs.

07-03-2016

The EMA is extending the use of XML delivery files for all submissions excluding the Veterinary PSURs and Maximum Residue Limit (MRL) from 23 May 2016. A Statement of Intent on the extended use of XML delivery files for all submissions via the eSubmission Gateway/Web Client is now available here.

29-02-2016

The eSubmission Change Management Board and the Human Harmonisation Maintenance Group (HHMG) have adopted the updated eCTD validation criteria. The eCTD criteria have been updated in line with published EU Module 1 v3.0 following public consultation. The NeeS validation criteria have been updated to align to the updated eCTD validation criteria. The eCTD validation criteria v6.0, the NeeS validation criteria v4.1 and related release notes are available here.

If you have any questions regarding further development or require clarification on these documents, please contact: EUM1spec@ema.europa.eu

23-02-2016

Version 01.19.0.2 of the eAFs has been made available to fix technical issue related to the locking of the variation form and issues with the availability of the controlled terminologies in all forms.  If you have already started to fill in version 1.19.0.1 of the variation form please import the user filled data to the new version to ensure that the variation form is fully locked. This can be done using the functionality to export the user filled data from 1.19.0.1 and import it into 1.19.0.2. The updated release notes and the forms are now available here.

12-02-2016

As of the 11 February 2016 all ongoing procedures with PSURs available in the PSUR Repository will “switch-on”.

This covers all procedures, whether previously in the pilot or not. The circulation of assessment reports and comments via email is no longer in place and the PSUR Repository enhanced notification system will alert National Competent Authorities (NCAs) to document uploads into the system. The enhanced notifications contain relevant information which was originally circulated by assessment teams by email. All procedures starting from February onwards will run in switch-on mode only.

During the switch-on phase the EMA will also manually upload all the PSURs that are received by NCAs only, during the so called “reconciliation process”.  This process applies to nationally authorised medicines only. The manual upload is the second pillar of the “switch-on” phase as it will allow the system to host full data sets for all procedures, thereby allowing the NCAs to fully test complete download capability. In order to support this phase of the project, and in addition gain further experience with the system, MAHs are strongly encouraged to submit all PSURs and supplementary information for nationally authorised medicines to the PSUR repository in addition to the submissions to the relevant NCAs. This will allow the EMA to rely less on the reconciliation process with the Member States, ensuring timely inclusion of PSURs in the system and better adherence to the procedural timetable; ultimately ensuring that no PSUR is left unassessed or assessed late.

Please be reminded that for centrally authorised medicines submission to the PSUR Repository is already mandatory. MAHs for nationally authorised medicines are also reminded that PSUR submissions both to the PSUR Repository and NCAs must be structured electronic submissions, i.e. eCTD or NeeS. PSURs submitted as pdf documents cannot be uploaded into the PSUR Repository, and will entail follow up with the relevant MAH.

The PSUR Repository will become mandatory on the 13 June 2016; from this moment on all PSUR submissions across Europe will be submitted to the EMA only via this channel.

Users should continue to report any issues they may have with the system through the PSUR Repository mailbox psurrepository@ema.europa.eu .

05-02-2016

A webinar on the Introduction to VNeeS 2.4 will be held on 24 February 2016 from 10.00 to 11.00 UK time, in collaboration with Topra.This webinar is dedicated to Industry.
This session will focus on changes in VNeeS 2.4 which will come into force on 1 July 2016, its rationale and impact on applicants. There will also be an opportunity to address other vet-specific queries relating to eSubmissions.

For more information and to register, please visit the Topra webinars webpage.

01-02-2016

As of today, 1 February 2016 the EMA is introducing a new Service Desk portal (https://servicedesk.ema.europa.eu) through which users can raise IT system related questions, issues and requests for services. This portal will improve the efficiency and effectiveness of technical support by allowing users to report issues, track progress of their queries and obtain answers to frequently asked questions – all in one place.

This new web based portal replaces the eAF@ema.europa.eu email address which is currently used for all eAF related queries.

The new portal also replaces the gatewaysupport@ema.europa.eu mailbox which is used for all technical queries concerning Web Client/Gateway set-up, registration details or the transmission failures of files in the production or test environment.

During 1 month transitional period until 1 March 2016, both the old mailbox system and the Service Desk portal may be used, however, we strongly recommend the use of the Service Desk portal for all relevant queries. Until 1 March 2016, any requests submitted by email to the functional mailboxes above will be transferred by EMA to the EMA Service Desk portal on the requestor’s behalf. The requestor will receive an email with a reference number for their enquiry. Please see the EMA Service Desk portal presentation.

Things to remember as of 1 February 2016:

To use this new portal, you will need to register (a one-time, automated self-registration process) if you are not already registered for any of the Agency’s other systems (e.g. Eudralink, MMS, EudraCT);

All requests and issues in relation to the electronic Application Forms (eAF) will be dealt through this portal;

Relevant issues with eSubmission Gateway registration and transmission failures using the eSubmission Gateway will be dealt through this portal;

Any ongoing incidents or service requests logged before 1 February will be handled using the existing process i.e. you will not receive a new query number and credentials to access the self-service portal;

Instead of reporting issues/questions on the eAF via email as previously, please select ‘Report an Issue with business applications/software’ option from the service desk menu and select the relevant application/system from the menu e.g. ‘electronic Application Form – eAF’;

Emails to the above addresses will receive an automated response that include a link to the new portal, however the existing eAF@ema.europa.eu and Gatewaysupport@ema.europa.eu email addresses will continue to be monitored until 1 March 2016;

eCTD@ema.europa.eu and the eSubmission@ema.europa.eu as well as registration to the eSubmission Gateway remain as a separate processes for now. Queries related to eCTD submissions can continue to be sent to eCTD@ema.europa.eu. To register to use eSubmission Gateway/Web Client please follow the guidance on the eSubmission Gateway webpage;

PSURrepository@ema.europa.eu mailbox used for all PSUR Repository related business and procedural queries will also remain outside the service portal. All technical questions related to transmission failures via the eSubmission Gateway should be addressed to the service portal;

As of 1 March 2016, all enquiries you wish to raise related to the electronic Application Forms and the eSubmission Gateway support will have to be logged via the EMA Service Desk portal (https://servicedesk.ema.europa.eu).

27-01-2016

The PSUR Repository bulletin has been updated and can be found here.

25-01-2016

The use of eCTD format for centralised procedure human ASMF submissions will become mandatory from 1 July 2016. The Statement of Intent can be found here.

22-01-2016

Version 01.05 of the PSUR Repository was made available on 6th January 2016. This release is a major milestone in the PSUR Repository project marking the completion of the delivery of all post-audit functionalities in line with the plan approved by the EMA Management Board in June 2015. The updated system release notes can be found here.

Updated ‘util folder package’ reflecting the changes in the updated EU M1 v3.0 specification v.3.0 is now available here.

21-01-2016

The PSUR Repository bulletin has been updated and can be found here.

12-01-2016

Version 01.19.0.1 of the eAFs now replace versions 1.18 and 1.19.0.0. More information can be found here.

21-12-2015

  • The new version of the Guideline on eSubmissions for Veterinary Products - version 2.4 together with eSubmission Validation checklist - version 2.4 and tools is published under the Current Guidance section here.The new VNeeS Guideline, checklist and checker will come into force on 01/07/2016.

16-12-2015

  • The PSUR Repository bulletin has been updated and can be found here.

15-12-2015

  • The updated eAF release schedule is now available and can be found here.
  • Presentation and recording from the training session on eAF to Industry users held on 1 December 2015 is available here. Updated
  • A second webinar on the eAFs (initial, variation, renewal) for Human and Veterinary procedures will be held on 11 January 2016 from 13.00 to 14.30 UK time. This webinar is dedicated to Industry.

This session will provide information where to find relevant documents and will address the most common issues and workaround solutions faced by industry when filling the forms. Please contact eAFwebinar-registration@ema.europa.eu by 6 January 2016 to register.

Should several participants from the same company wish to attend, it is advised to send only one registration request and attend from the same room.
The session will be recorded and posted on the eAF eSubmission website shortly after. If your registration for the session on 1 December 2015 has been unsuccessful, you will receive an invitation to this webinar automatically by 11 December 2015.


Please note: There will be no scope for live questions on 11 January 2016. If you have questions not addressed in the training session held on 1 December 2015, please email them to eAFwebinar-registration@ema.europa.eu by 6 January 2016.

  • Recordings from the eAF webinar sessions with National Competent Authorities are now available for NCA users and can be found here.

25-11-2015

Important to Note for Friday, 27 November 2015, 07:00-09:00 hrs

  • Due to essential maintenance to our systems, the PSUR Repository will be unavailable available on Friday, 27 November 2015, 07:00-09:00hrs. The NCA user interface will not be available during this period.  The user interface for the generation of the XML delivery file will not be available during this period. The eSubmission Gateway will continue to be available throughout this period for sending previously created submissions.

23-11-2015

  • A number of defects have been reported in the release v.1.19 of the eAFs. The EMA is working hard to fix these issues as soon as possible and a hotfix release will be deployed as soon as possible. Meanwhile if you are experiencing issues with any of the electronic application forms v.1.19 as published on 9th of November 2015 please inform the EMA as soon as possible via eAF@ema.europa.eu and continue using v.1.18 which remains available. The date of v 1.19 coming into force will be delayed to allow applicants who are experiencing issues with the new versions to continue submitting using v. 1.18. The new date of mandatory use of v. 1.19 will be published with the hotfix release of the forms.

20-11-2015

  • The PSUR Repository bulletin has been updated and can be found here.

16-11-2015

  • The eCTD validation criteria has been updated in line with published EU Module 1 v3.0 and has been released for public consultation until 14.December.2015. The validation criteria v.6.0 and related release notes and the comments template can be found here. The eSubmission Change Management Board and the Human Harmonisation Maintenance Group (HHMG) would like to invite all pharmaceutical companies, vendors of eCTD building and reviewing tools, and competent authorities to review and comment on the updated validation criteria. Please provide your comments, using the comments form, to EUM1spec@ema.europa.eu no later than 14 December 2015.
    If you have any questions regarding further development or require clarification on these draft documents, please contact: EUM1spec@ema.europa.eu.

09-11-2015

  • New versions of the electronic Application Forms (eAF v. 01.19) are now available and can be found here. These versions provide usability improvements to the existing forms and reflect the changes in the NtA application forms as published by the European Commission in September 2015. These versions replace the current version of eAF v. 01.18 after a transitional period of 1 month on 30 November 2015 and should be used after this date. The use of the eAFs is mandatory for all centralised procedure for human and veterinary submissions since 1 July 2015 and will become mandatory for all European procedures covered by the eAFs including Mutual Recognition, Decentralised Procedure and the national applications from 1 January 2016 as per the HMA eSubmission Roadmap.
  • A webinar on the eAFs (initial, variation, renewal) for Human and Veterinary procedures will be held on 01 December 2015 from 13.00 to 14.30 UK time.
    This webinar is dedicated to Industry.

    This session will not demonstrate how to fill in the forms but will rather provide information where to find relevant documents and will address the most common issues and workaround solutions faced by Industry when filling the forms. It will also explain the support structure to be followed for business related queries for MRP/DCP/National applications and Centralised ones.

    Please contact eAFwebinar-registration@ema.europa.eu by 26 November 2015 to register and to send any queries you would like to be addressed during this webinar.
    Should several participants from the same company wish to attend, it is advised to send only one registration request and attend from the same room.
    The session will be recorded and posted on the eAF eSubmission website shortly after.

03-11-2015

  • The recording of the PSUR Repository v.1.04 training with the MAHs is now available along with the updated presentation from the follow-up interactive Q&A session here.
  • The CAP Dossier Requirements document has been updated and is available here.    

27-10-2015

  • The Annex I – Guide to EMA filenaming convention for eSubmission document has been updated and can be found here.
  • The PSUR Submission requirements during the transitional period document has been updated and can be found here.

21-10-2015

  • The PSUR Repository bulletin has been updated and can be found here.

19-10-2015

  • Version 3.0 of the EU Module 1 eCTD v.3.2.2 specification is now available. This EU M1 update sees an introduction of a new submission attribute containing a Universally Unique Identifier (UUID), introduction of the concept of ‘submission unit’ as well as a number of new regulatory activities among other updates. Details of the changes can be found in the Release notes. The updated EU M1 Specification and related Annex can be found here. The Human Harmonisation Group would like to thank all parties for input and comments to the draft specification.
  • The eAF Technical Guidance document and the Q&A document have been updated and are now available here. Further updates will be provided to both documents following the release of the new version of the eAFs.

14-10-2015

  • Version 01.04 of the PSUR Repository is available for both MAHs and NCAs. This new release provides change requests further enhancing the system for example the completely new product selection functionality for MAHs in the delivery file creation screen and the deduplication functionality for NCAs. The release also provides fixes for defects that have been identified during the pilot phase. The updated system release notes and MAH and NCA user guides can be found here.

09-10-2015

  • The PSUR Repository bulletin has been updated and can be found here.

05-10-2015

  • Annex VI to the HMA eSubmission Roadmap on the implementation of mandatory VNeeS format for Veterinary regulatory submissions document is available here.  
  • Training sessions and a follow-on interactive Q&A sessions for MAHs and other industry users as well as NCA (member states) users concentrating on the new features of the PSUR repository v1.04.00 will be organised in October 2015. These sessions will be recorded and the recordings will be made available on the PSUR Repository webpage. Dates and times for these sessions and more information about the sessions can be found here. Email PSURrepository@ema.europa.eu to book your place.

17-09-2015

  • Forthcoming User Acceptance Testing (UAT) of version 1.19 of the eAFs. This will be the last UAT before the use of the eAF becomes mandatory for all EU procedures (vet and human) from January 2016, so it is important that participation is high in order to ensure that all remaining defects are identified and fixed and any change requests are prioritised appropriately. Please see the eAF page for more information.
  • The PSUR Repository bulletin has been updated and can be found here.

01-09-2015

  • From 1 September 2015 all PSUR submissions via the eSubmission Gateway / Web Client should be submitted with an xml delivery file. It will no longer be possible to use filenaming conventions for PSUR submissions in future. Annex 1 describing the detailed filenaming conventions for all eSubmission Gateway / Web Client submissions has been updated and can be found from the eSubmission Gateway / Web Client webpage.

14-08-2015

  • PSUR recorded webinar training sessions and updated presentation slides for Marketing Authorisation Holders and National Competent Authorities users are available here.

06-08-2015

  • Version 01.03 of the PSUR Repository is now available for both MAHs and NCAs. This new release provides change requests further enhancing the system and fixes defects identified during the pilot phase. The updated system release notes and MAH and NCA user guides can be found here.
  • The PSUR Repository bulletin has been updated and can be found here.

03-08-2015

  • Release 01.18 of the electronic Application Forms (eAF v. 01.18) now replaces the previous forms. These new versions provide usability improvements and improved functionality. The eAFs and all supporting documents can be found here. The use of the eAFs is mandatory for all centralised procedure human and veterinary submissions since 1 July 2015 and will become mandatory for all other procedures (MRP/DCP/National) from January 2016 as per the HMA eSubmission Roadmap.

24-07-2015

  • The Common Repository Q&A document has been updated and can be found here.
  • Training sessions and a follow-on interactive Q&A sessions for MAHs and other industry users as well as NCA users concentrating on the new features of the PSUR repository v1.03.00 will be organised in August and September 2015. These sessions will be recorded and the recordings will be made available on the PSUR Repository webpage. Dates and times for these sessions and more information about the sessions can be found here. Email PSURrepository@ema.europa.eu to book your place.

21-07-2015

  • The eCTD EU Module 1 v3.0 has been released for public consultation until 14.9.2015 and the updated version can be found here. The eSubmission Change Management Board and the Human Harmonisation Maintenance Group (HHMG) invites all pharmaceutical companies, vendors of eCTD building and reviewing tools, and competent authorities to send comments. Please complete the relevant tab(s) on the comments form and return it to EUM1spec@ema.europa.eu no later than 14 September 2015.

    If you have any questions regarding further development or require clarification on these draft documents, please contact: EUM1spec@ema.europa.eu.

13-07-2015

  • The User Guides for the electronic Application Forms for Marketing Authorisation for Human and Veterinary use have been updated and are now available on the CMDh website and CMDv website and can also be found here.

06-07-2015

  • New versions of all electronic Application Forms (eAF v. 01.18) are now available and can be found here. These versions provide usability improvements to the existing forms. The new versions of the forms replace the current version of eAF v. 01.17 after a transitional period of 1 month on 3 August 2015 and should be used this date. The use of the eAFs is now mandatory for all centralised procedure human and veterinary submissions since 1 July 2015 as per the HMA eSubmission Roadmap.

01-07-2015

  • The use of the Common Repository for Human Centralised Procedure submissions is now mandatory for all National Competent Authorities. Submissions sent to EMA via eSubmission Gateway/Web Client will be considered delivered to all National Competent Authorities’ representatives and alternates. Submissions for Centralised Procedure should be made via EMA eSubmission Gateway/Web Client only. Additional copies should not be submitted directly to the NCAs on CD/DVD or via CESP as this might lead to validation issues and cause delays. More information on the Common Repository can be found here.
  • The use of the electronic Application Forms (eAF) is now mandatory for all Human and Veterinary Centralised Procedure submissions. The forms for Initial, variation and renewal applications as well as a User Guidance document and an updated Q&A document are also available on the eAF webpage.

23-06-2015

  • On 11 June 2015 the EMA Management Board, based on a positive PRAC Recommendation and an independent audit report, announced that the PSUR repository meets the functional specifications as agreed in the ‘PSUR Repository functionalities to be audited’ document and concluded that it has achieved its full functionality. The legislation foresees that 12 months after the EMA Management Board announcement , the use of the repository for the submission, storage and retrieval of all PSURs and related documents (assessment reports) in the European Union will become mandatory (13 June 2016).

Full news item can be found on the EMA public website

  • The scope for release v.1.03.00 has been agreed, and scheduled for early August 2015. The NCA and Industry user acceptance testing (UAT) will take place between the 17th and 23rd July. NCAs and industry representatives interested in participating in the UAT should contact Turi Salami (turi.salami@ext.ema.europa.eu) by the 25th June.

The main enhancements provided in this version are:

  • Improvements to the product search functionality;
  • Additional search criteria for PSURs and supplemental information within the non-EU Single assessment screen;
  • Addition of national authorisation numbers to facilitate searches when uploading Non EU single assessment documents, and
  • The addition of information regarding silent adoption/plenary discussion in the assessment report upload screen.
The “Kick-off” meeting with PSUR Repository Advisory Group to prepare the UAT will take place on the 26th June 2015.

10-06-2015

  • France has joined the Common Repository to receive Centralised Procedure submissions on 3 June 2015. The large majority of the NCAs are now using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. In compliance with the HMA eSubmission Roadmap, it will be mandatory for all NCAs to use the Common Repository from 1st July 2015. Please see details on the Common Repository page. The CAP Dossier Requirements document has been updated.
  • Annex III to the HMA eSubmission Roadmap on Transitioning to the mandatory use of the Common Repository for eCTD format Centralised Procedure submissions document is available here.

 

08-06-2015

  • The PSUR Repository bulletin has been updated and can be found here.

01-06-2015

  • Version 01.02 of the PSUR Repository is now available. This release provides change requests enhancing the system and fixes defects since the start of the pilot phase. In particular, this release provides solutions for all remaining findings from the audit carried out by PwC Luxembourg in Feb-Mar 15.

  • Industry associations and NCAs are invited to take part in a User Acceptance Testing of the eAF v.01.18. The industry testing will take place 1.-5.6.2015 and the NCA testing will take place 8.-12.6.2015. If you would like to participate in the UAT, please contact Turi.Salami@ext.ema.europa.eu

  • New versions of the eAF DES and schemas have been released and can be found here.

  • The use of the eAFs will become mandatory for all Centralised procedure Initial Marketing authorisation applications, Variations and Renewals from 1 July 2015. More information on the mandatory use can be found here.

28-05-2015

The PSUR Repository Project team organised a Q&A webinar on 21 May to assist NCAs in preparing for usage of the API for automated exchange of information between the NCA IT systems and the PSUR Repository. Both IT aspects and business process aspects were addressed. As the overall feedback was that this initiative was useful, similar webinars will be organised in the near future. The slides of the webinar and the Q&A can be found here.

22-05-2015

  • Due to essential maintenance to our systems, the PSUR Repository will not be fully available on Sat 23 May 15 09:00-15:00

    Due to essential maintenance to our systems, the PSUR Repository will not be fully available on Sat 23 May 15 09:00-15:00.
    The impact of this will be:
    - The NCA user interface will not be available during that period.
    - The user interface for generation of the XML delivery file will not be available during that period.
    - The eSubmission Gateway will continue to be available throughout this period so MAHs can send PSUR submissions.
  • An eAF benchmark response times document is now available and can be found here.

22-04-2015

  • Draft specifications of the PSUR Repository API and Supplementary Specification are available here.

16-04-2015

  • A new PSUR Bulletin is now available and can be found here.

13-04-2015

  • The meetings page has been updated and can be viewed here.

31-03-2015

  • The Guideline on eSubmissions for Veterinary Products - version 2.3 has been updated and can be found here.
  • The eSubmission Validation checklist - version 2.3 has been updated and can be found here.
  • The Change request tracking table has been updated and can be viewed here.

24-03-2015

  • Version 01.01 of the PSUR Repository is now available. This release provides change requests enhancing the system and fixes defects identified after the UAT end 2014 or since the start of the pilot phase

23-03-2015

20-03-2015

  • PSUR Repository version 01.01 will be available for MAH and NCAs on 24 March 2015. This release provides change requests enhancing the system and fixes defects identified after the UAT or since the start of the pilot phase. The updated system release notes and links to both, MAH and NCA user interfaces can be found here.
  • The use of the XML delivery file for all PSUR submissions via the eSubmission Gateway/Web Client will become mandatory from 1 September 2015. Please see the statement of intent here.
  • The new versions of all electronic Application Forms (eAF) will be available on 23 March 2015 and can be found here. The new versions provide improvements to the existing forms in preparation for the mandatory use of the eAFs for all centralised procedure human and veterinary submissions from 1 July 2015 as per the HMA eSubmission Roadmap and the related annex to the roadmap describing the steps to the mandatory use.
  • A new PSUR Bulletin is now available and can be found here.

17-03-2015

  • Please Note: eAF will be unavailable on Monday, 23rd March 2015 from approx. 07.00 to 07.30 GMT. We apologise for any inconvenience this may cause.

12-03-2015

  • The eCTD version 4.0 EU M1 Implementation Guide is now available for public consultation. The eSubmission Change Management Board invites all pharmaceutical companies, vendors of eCTD building and reviewing tools and competent authorities to take part in this consultation and provide comments by 22 May 2015. Please provide your comments using the comment template; and any questions regarding further development and clarifications of the released draft documents to: eCTD4consultation@ema.europa.eu. The Implementation Guide and relevant documents can be found here.

27-02-2015

  • A new PSUR Bulletin is now available and can be found here.
  • Interactive Q&A sessions are being organised by the PSUR Repository team to support the use of PSUR Repository in the view of the ongoing pilot. There will be a short demo of the system after which we will answer your questions about the repository. In the NCA session there will be a short demo of the search and retrieval functionality as well as how to submit your assessment reports and comments to the repository. After the demo NCAs will have an opportunity to ask questions on the use of the repository. Please see here to book your place.
  • Updated Variations in eCTD format Q&A document has been updated by the Harmonisation Group and can be found here.

20-02-2015

  • The next version of the eAFs is now available for User Acceptance Testing until 5th of March 2015 for limited number of testers. If you are interested to participate in this exercise, please see more information from here
  • Recordings from the webinar trainings on the use of PSUR Repository for new and existing Gateway users and recording from the MAH pilot training are now available here

16-02-2015

  • New versions of the eAF DES and schemas have been released and can be found here.

13-02-2015

  • A new PSUR Bulletin is now available and can be found here.
  • Presentations from the webinar training sessions for existing and new Gateway users have been updated and are available here.
  • Annex V to the HMA eSubmission Roadmap on the implementation of mandatory use of electronic application forms (eAFs) is now available and can be found here.

10-02-2015

  • A communication leaflet concerning the mandatory use of the eAF has been published and can be found here.

09-02-2015 - Please Note

  • eAF will be unavailable on Wednesday 11th February 2015 from approx. 17.30 to 18.30 GMT. We apologise for any inconvenience caused.

06-02-2015

  • A new PSUR Bulletin is now available and can be found here.

02-02-2015

  • The EMA PSUR Repository team is introducing a regular news bulletin with the intention of keeping the EU Regulatory Network and Industry up to date with the most relevant repository related activities and milestones.Our intention is to facilitate continuous engagement and enhance the dialogue and collaboration between stakeholders and the project. The new bulletin is available here.
  • Updated Annex II to the HMA eSubmission Roadmap on the implementation of mandatory eCTD format for regulatory submissions is now available here.

29-01-2015

  • Please Note Due to essential maintenance to our database systems, the PSUR Repository will not be available on Sat 31 Jan 15 09:00-18:00. The eSubmission Gateway will continue to be available throughout this period so MAHs can send PSUR submissions.

26-01-2015

  • The PSUR Repository is available and it is now possible to submit PSURs to the PSUR Repository. The delivery files required for the submissions can be created here. The system is also available to all registered NCAs for pilot use here. More information on the PSUR Repository can be found from the PSUR Repository page here.

20-01-2015

  • Annex I to the HMA eSubmission Roadmap on the implementation of eCTD version 4.0 and Annex II to the HMA eSubmission Roadmap on the implementation of mandatory eCTD format for regulatory submissions is now available and can be found here

23-12-2014

  • Romania will join the Common Repository to receive Centralised Procedure submissions from 1st January 2015. The majority of the NCAs are now using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. In compliance with the HMA eSubmission Roadmap, it will be mandatory for all NCAs to use the Common Repository from 1st July 2015.  Please see details on the Common Repository page. The CAP Dossier Requirements document has been updated

10-12-2014

  • A dedicated webpage for PSUR Repository is now available here. News and announcements related to the system availability including all user guidance documents will be published on this page.

26-11-2014

Malta has now joined the Common Repository to receive Centralised Procedure submissions. 18 NCAs are now using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. In compliance with the HMA eSubmission Roadmap, it will be mandatory for all NCAs to use the Common Repository from 1st July 2015.  Please see details on the Common Repository page. The CAP Dossier Requirements document has been updated

21-11-2014

HMA eSubmission Roadmap

The Final HMA eSubmission Roadmap was adopted by the EUTMB on 1st of October 2014. The common agreed vision for the objectives on eSubmissions in Europe are outlined in the eSubmission Roadmap which can be found here

27-10-2014

eAF

The eAF term request process has been updated and the relevant documents can be found here

Veterinary Submissions

The filenaming conventions for Veterinary Submissions have been simplified. It is now easier to submit Veterinary submissions using the eSubmission Gateway and the Web Client. Updated Annex 2 can be found here

Deadline approaching - Referral Procedures to be sent via eSubmission Gateway / Web Client from 1st of November 2014

From 1 November 2014 all submissions for Referral Procedures for human medicinal products should be sent via the eSubmission Gateway or the Web Client. After 1 November 2014, the EMA is no longer accepting electronic submissions for referrals on CD or DVD.

The European Medicines Agency (EMA) strongly recommends using the electronic submission channels (eSubmission Gateway or Web Client) and the electronic Common Technical Document (eCTD) or NeeS (Non-eCTD electronic Submission) formats for submission of referrals. For Referral submissions related to Centrally Authorised products, it is mandatory to use the eCTD format.

The EMA's strategy for the electronic submission of applications aims to improve efficiency and decrease costs for applicants. Applicants who wish to use the eSubmission Gateway or Web Client are encouraged to register to use the eSubmission Gateway/Web Client on the EMA’s eSubmission Gateway website as soon as possible.

13-10-2014

Portugal has now joined the Common Repository to receive Centralised Procedure submissions. More than half of the NCAs are now using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. In compliance with the HMA eSubmission Roadmap, it will be mandatory for all NCAs to use the Common Repository from 1st July 2015.  Please see details on the Common Repository page. The CAP Dossier Requirements document has been updated

08-10-2014

Hungary has now joined the Common Repository to receive Centralised Procedure submissions. More than half of the NCAs are now using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. In compliance with the HMA eSubmission Roadmap, it will be mandatory for all NCAs to use the Common Repository from 1st July 2015.  Please see details on the Common Repository page. The CAP Dossier Requirements document has been updated.

02-10-2014

eAF 1.16.0.1 hot fix has been deployed and can be found here

26-09-2014

New versions of the eAF forms, release notes, DES and schemas have been released, and can be found here

11-09-2014

Italy and Spain have now joined the Common Repository to receive Centralised Procedure submissions. There are currently 15 NCAs that are using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. Please see details on the Common Repository page. The CAP Dossier Requirements document has been updated

01-09-2014

Regulatory information - Referral Procedures to be sent via eSubmission Gateway / Web Client from 1st of November 2014

From 1 November 2014 all submissions for Referral Procedures for human medicinal products should be sent via the eSubmission Gateway or the Web Client. After 1 November 2014, the EMA is no longer accepting electronic submissions for referrals on CD or DVD.

The European Medicines Agency (EMA) strongly recommends using the electronic submission channels (eSubmission Gateway or Web Client) and the electronic Common Technical Document (eCTD) or NeeS (Non-eCTD electronic Submission) formats for submission of referrals. For Referral submissions related to Centrally Authorised products, it is mandatory to use the eCTD format.

The EMA's strategy for the electronic submission of applications aims to improve efficiency and decrease costs for applicants. Applicants who wish to use the eSubmission Gateway or Web Client need to register on the EMA’s eSubmission Gateway website.

22-08-2014

Norway has now joined the Common Repository to receive Centralised Procedure submissions. There are currently 13 NCAs that are using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. Please see details on the Common Repository page. The CAP Dossier Requirements document has been updated.

And

New versions of the eAF DES and schemas have been released and can be found here

14-08-2014

Bulgaria, Czech Republic and Luxembourg have now joined the Common Repository to receive Centralised Procedure submissions. There are currently 12 NCAs that are using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. Please see details on the Common Repository page. The CAP Dossier Requirements document has been updated

01-08-2014

Belgium, Greece and Slovakia have now joined the Common Repository to receive Centralised Procedure submissions. There are currently 9 NCAs using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. Please see details on the Common Repository page. Additionally the CAP Dossier Requirements document has been updated.

And

A further draft of the eSubmission Roadmap v.1.0 has now been endorsed by the IT Directors Executive Committee on 24 July 14 and will be on the agenda for the next EUTMB for further endorsement. More details on the implementation of the Roadmap will also be published at a later stage by the eSubmission CMB.

And

The European Medicines Agency has moved. Our new address is:
30 Churchill Place | Canary Wharf | London E14 5EU | United Kingdom

09-07-2014

Croatia is now using the Common Repository to receive Centralised Procedure submissions. The CAP Dossier Requirements document has been updated

 

 

 
 

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