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Previous News
13-09-2023
Planned maintenance of the PSUR Repository (NCA and Industry) on 16 September 2023
Due to planned maintenance, the PSUR Repository (both NCA and Industry portals) will not be available on Saturday, 16 September 2023, between 9:00 and 17:00. For any further information, please contact EMA Service Desk
29-08-2023
Planned maintenance of the PSUR Repository (NCA and Industry) on 2 September 2023
Due to planned maintenance, the PSUR Repository (both NCA and Industry portals) will not be available on Saturday,2 September 2023, between 9:00 and 17:00. For any further information, please contact EMA Service Desk
22-06-2023
Planned maintenance of the eSubmission systems on 24 June 2023
Due to planned maintenance, the following eSubmission systems will not be available on Saturday 24 June 2023, between 8:00 and 18:00: Common Repository (Interface and API), PSUR Repository, Gateway FileHandler. For any further information, please contact EMA Service Desk.
21-06-2023
Planned maintenance of the PSUR Repository on 22 June 2023
Due to planned maintenance, the PSUR Repository will be available intermittently on Thursday 22 June 2023, between 17:00 and 20:00. For any further information, please contact EMA Service Desk.
19-06-2023
Planned maintenance of the PSUR Repository on 19 June 2023
Due to planned maintenance, the PSUR Repository will be available intermittently on Monday 19 June 2023, between 18:00 and 22:00. For any further information, please contact EMA Service Desk.
15-06-2023
Planned maintenance of the eSubmission systems on 17 June 2023
Due to planned maintenance, the eSubmission systems (including eAF and PLM Portal eAF) will not be available on Saturday 17 June 2023, between 8:00 and 16:00. For any further information, please contact Service Desk.
11-04-2023
PSUR unavailable this Tuesday evening
Due to essential maintenance, PSUR will be unavailable on Tuesday 11 April 2023 between 18:00 and 20:30 (CET). For any questions or concerns, please log a ticket via the EMA Service Desk
17-03-2023
Planned maintenance of the eSubmission systems on Saturday 25 March 2023
The eSubmission systems are unavailable for planned maintenance and will be unavailable from Saturday 25th of March 2023 08:00 until 18:00 due to essential maintenance. For any further information, please contact Service Desk
28-02-2023
PSUR unavailable this Wednesday evening
Due to essential maintenance, PSUR , will be unavailable on Wednesday 01 March 2023 between 18:00 and 20:00 (CET). For any questions or concerns, please log a ticket via the EMA Service Desk.
14-06-2022
A new version of the PSUR Repository Industry UI (xml delivery file UI) is now available
An updated version of the PSUR Repository Industry UI (xml delivery file user interface) is now available here. The new version provides an update of the framework for the delivery file user interface the PSUR Repository UI. The update is mainly technical, providing a slightly different look and feel.
Additionally, the only technical change is to limit the submission format to eCTD which was done in the view of the mandatory use of eCTD since January 2019.
10-06-2022
PSUR Repository MAH user interface - technical update go-live postponed until Tueday 14th June 2022
The PSUR Repository team has been working on an update of the framework for the user interface.
This updated user interface will be deployed in production on 14th of June 2022.
08-06-2022
PSUR Repository MAH user interface - technical update go-live 10th June 2022
The PSUR Repository team has been working on an update of the framework for the user interface. This is a technical update only providing a slightly different look and feel, however, there are no major functional changes to the MAH user interface.
This updated user interface will be deployed in production on 10th of June 2022.
24-05-2022
PSUR Repository MAH user interface - technical update
The PSUR Repository team has been working on an update of the framework for the user interface. This is a technical update only providing a slightly different look and feel. It should also be noted that the option to select submission format NeeS has been disabled in the view of mandatory use of eCTD for all procedure types since 1st January 2019. There are no other functional changes to the MAH user interface.
The updated user interface will be deployed in production once the internal user acceptance testing has been finalised (exact date TBC).
An updated user guide and release notes will be published at the time of the go live.
16-01-2021
Due to the end of the Brexit transitional period on 31st of December products authorised in the UK are no longer available for selection in the PSUR Repository delivery file. More information is available in the guidance to applicants with regards to impact of Brexit;
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/practical-guidance-procedures-related-brexit-medicinal-products-human-veterinary-use-within_en.pdf
Please note that all data submitted for single assessment of periodic safety update reports (PSUSA), including data submitted before the withdrawal date on UK nationally approved products, will be considered during the assessment. However, after the transition period, UK products will formally no longer be part of any ongoing PSUSA procedure. Therefore, after the transition period assessment reports will no longer be shared with marketing authorisation holders for UK products that were previously concerned by the PSUSA procedure. The outcome of the PSUSA procedure will only concern products authorised in the Union (EEA).
As the products that can be included in the PSUR procedures (irrespective of whether they are part, or not, of an EU single assessment procedure), are retrieved from the Art. 57 database, only those UK nationally authorised products for which the authorisation country in the Art. 57 entry has been updated to 'United Kingdom (Northern Ireland)' will be available for selection.
Those UK nationally authorised products that have not been updated in the Art. 57 database and still refer to authorisation country 'United Kingdom', are not be available for selection in the product lists from 1 January 2021. Therefore, the marketing authorisation holders must update their entries in art. 57 database in line with the new status of the products after 31 December 2020 before submitting a PSUR for an UK nationally authorised product with respect to Northern Ireland, irrespective of whether the PSUR is part or not of an EU single assessment procedure.
If you wish to submit a PSUR or responses and the product is not available in the PSUR Repository, the following changes must be made in the Art. 57 database:
- The product authorisation country code must be updated to UK (Northern Ireland) with new country code XI for UK(NI)
- The MAH country needs to be in EEA or UK (Northern Ireland)
15-12-2020
A new version of the PSUR Repository (industry and NCA user interfaces) is now available. Minor changes have been introduced to both industry and NCA user interfaces due to the end of the Brexit transitional period on 31st of December.
The changes relate to use of terms United Kingdom (Northern Ireland) and new country code XI for UK(NI) in the product selection tables in the industry user interface.
09-06-2020
A new version of the PSUR Repository (industry and NCA user interfaces now available
An updated version of the PSUR Repository (v1.17.0.0) is now available. This release provides minor changes to the MAH and NCA user interfaces, new features for EMA users and number of new notifications for all users. Details of the changes are available in the updated NCA and MAH User Guides, the PSUR Repository Training Guide for MAHs and NCAs and the updated Release Notes.
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, PSUR will be unavailable to users between 18:30hrs on Friday, 27th March and 08:00hrs on Monday, 30th March 2020
09-10-2019
Updated version of the PSUR Repository
Updated versions of the PSUR Repository Industry and NCA User Interfaces are now available in conjunction with a release of the eSubmission Gateway Delivery file UI. There is a very minor change to the industry UI where the product EV code is now displayed in the product selection window.
There is a minor change to the NCA user interface for super admin user only giving ability to delete versions of the Assessment Reports and the Assessment Report templates.
25-09-2019
Formatted Table Template implementation in the XML delivery files
An updated version of the eSubmission Gateway XML delivery file user interface will be made available in early October 2019.
Following this release the use of the Formatted Letter Template will become obsolete as of 1st January 2020. This will concern all EMA Human and Veterinary submission (including PSUSA procedures) and after this it will be optional for applicants to provide the Formatted Template as a part of the Cover Letter in Module 1 of eCTD sequences or Part 1 of VNeeS dossier.
From 1 January 2020, the Formatted Letter Template will no longer be maintained by EMA and the document and references will be removed from EMA corporate website.
Users are required to fill in all the submissions attributes correctly through eSubmission Web UI by creating an XML delivery file, since all attributes in the XML delivery file are used to support important searches in Common Repository. The use of XML delivery files will also support EMA internal processes by significantly reducing the time required for receiving, processing and validating incoming applications and it ensures continuous and immediate access to up-to-date dossiers.
Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release may not work following the deployment of the new version. It is always recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues. The updated system release notes detailing the changes will be made available at the time of the release.
22-07-2019
Essential maintenance to computer applications
The PSUR Repository will be impacted by essential maintenance to SPOR data services between 19:00hrs (CEST) and 20:00hrs (CEST) on Tuesday, 23 July 2019 for industry users sending non-EU single assessment PSURs and for NCA users performing searches in the non-EU single assessment area of the PSUR Repository. Additionally, on the PSUSA module, the search attribute ‘MA authorisation type’ will also be unavailable during this period. Other searches will be unaffected.
19-7-2019
The PSUR Repository 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 for industry users sending non-EU single assessment PSURs and for NCA users performing searches in the non-EU single assessment area of the PSUR Repository. Additionally, on the PSUSA module, the search attribute ‘MA authorisation type’ will also be unavailable during this period. Other searches will be unaffected
MAHs should please note that if you have submission deadline for non-EU single assessment PSUR on Friday, 19th July, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.
26-06-2019
Essential maintenance to computer applications
The PSUR Repository will be impacted by essential maintenance to SPOR data services between Saturday and Sunday, 29-30 June 2019 for industry users sending non-EU single assessment PSURs and for NCA users performing searches in the non-EU single assessment area of the PSUR Repository.
Additionally, on the PSUSA module, the search attribute ‘MA authorisation type’ will also be unavailable during this period. Other searches will be unaffected. MAHs please note that if you have a submission deadline for non-EU single assessment PSUR on Friday, 28th June, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.
12-12-2018
Essential maintenance to computer applications
The PSUR Repository will be impacted by essential maintenance to SPOR data services between Saturday and Sunday, 15-16 December 2018 for industry users sending non-EU single assessment PSURs and for NCA users performing searches in the non-EU single assessment area of the PSUR Repository. Additionally, on the PSUSA module, the search attribute ‘MA authorisation type’ will also be unavailable during this period. Other searches will be unaffected.
MAHs should please note that if you have submission deadline for non-EU single assessment PSUR on Friday, 14 December, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.
02-10-2018
The main enhancements provided in PSUR Repository versions 1.14.00 and v.1.15.00 are as follows:
- For newly uploaded Assessments (both EU & Non-EU) in the PSUR Repository – must be in word format. PDFs are longer accepted.
- Users can now view all historic versions of the Assessment Report along the submitter and date received for each version.
- When performing a search for any PSUSA for a particular procedure the Document Types are displayed with a hyperlink to the physical location of the document.
- The ‘period covered’ is now shown in the system, calculated based on the data lock point and frequency.
23-08-2018
Essential maintenance to computer applications
The PSUR Repository will be impacted by essential maintenance to SPOR data services between 08:00-18:00 hrs on Saturday, 25 August 2018 for industry users sending non-EU single assessment PSURs and for NCA users performing searches in the non-EU single assessment area of the PSUR Repository. Additionally, on the PSUSA module, the search attribute ‘MA authorisation type’ will also be unavailable during this period. Other searches will be unaffected
16-05-2018
Essential maintenance to computer applications
The PSUR Repository will be impacted by essential maintenance to SPOR data services between 18:00-19:00hrs on Thursday, 17 May 2018 for industry users sending non-EU single assessment PSURs and for NCA users performing searches in the non-EU single assessment area of the PSUR Repository. Additionally, on the PSUSA module, the search attribute ‘MA authorisation type’ will also be unavailable during this period. Other searches will be unaffected
07-03-2018
Essential maintenance to computer applications
The PSUR Repository will be impacted by essential maintenance to SPOR data services between Saturday and Sunday, 10-11 March 2018 for industry users sending non-EU single assessment PSURs and for NCA users performing searches in the non-EU single assessment area of the PSUR Repository. Additionally, on the PSUSA module, the search attribute ‘MA authorisation type’ will also be unavailable during this period. Other searches will be unaffected
MAHs should please note that if you have submission deadline for non-EU single assessment PSUR on Friday 9 March, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.
30-01-2017
Essential maintenance to computer applications
PSUR and Gateway File Handler will be affected between 07:00 and 08:00 on Wednesday, 31 January 2018 due to essential maintenance to EMA’s computer systems.
27-11-2017
Essential maintenance to computer applications
The PSUR Repository will be impacted by essential maintenance to SPOR data services between Wednesday evening 29th November and Friday, 1 December 2017 for industry users sending non-EU single assessment PSURs and for the NCA users performing searches in the non-EU single assessment area of the PSUR Repository. Additionally, on the PSUSA module, search attribute ‘MA authorisation type’ is also unavailable during this period. Other searches should work.
MAHs should please note that if you have submission deadline for non-EU single assessment PSUR on Friday 1 December, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.
09-10-2017
The PSUR Repository will be impacted by essential maintenance to SPOR data services on Thursday evening 12th and Friday 13th October 2017 for industry users sending non-EU single assessment PSURs and for the NCA users performing searches in the non-EU single assessment area of the PSUR Repository. Additionally, on the PSUSA module, search attribute ‘MA authorisation type’ is also unavailable during this period. Other searches should work.
MAHs should please note that if you have submission deadline for non-EU single assessment PSUR on Friday 13th October, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.
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 the PSUR Repository as the product selection for the PSUR submissions is linked to Art. 57. It will not be possible to update/amend product data for the creation of the XML delivery files during this downtime period.
The EMA strongly recommends that MAHs, with a PSUR submission date falling during the scheduled downtime (8 to 21 November 2017), carefully review the list of products available through the PSUR Repository xml delivery file user interface to ensure availability of the products included in the relevant procedures and make plans to create the xml delivery file and submit their PSUR prior to the 8 November. Alternatively, if an earlier submission cannot be accommodated MAHs are encouraged to review the availability of products and correctness of the entries in the XML delivery file user interface.
The MAHs should contact the EMA service desk to request a late submission ID in order to submit initial PSUSAs after the due date. There is no need to request late submission ID for subsequent submissions, such as responses.
27-06-2017
Essential maintenance to computer applications on Tuesday afternoon
PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 15:00 and 17:00 on Tuesday, 27 June 2017. Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release on 27th June 2017 will not work following the deployment of the new version.
20-06-2017
Essential maintenance to EMA computer applications affecting PSUR Repository on Saturday, 24 June
PSUR/eSubmissions Web User Interface (to create the delivery file) will be intermittently unavailable between 09:00 and 19:00 on Saturday, 24 June due to essential maintenance. EMA’s gateway will remain available for all communities throughout and any files submitted during that time will be put in a queue for processing once the deployments have been completed.
If you have any questions, please contact the EMA Service Desk.
20-02-2017
An updated version of the PSUR Repository is now available. This release provides ability to indicate if RMP is included in the submission for Centrally Authorised Products. Additionally defect fixes and improvements to the PSUR Repository notifications have also been implemented. Details are available in the updated NCA and MAH User Guides and the updated Release Notes.
16-02-2017
Essential maintenance to PSUR Repository.
PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07.00 and 09.00hrs on Monday, 20 February 2017. However, the 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.
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. More details on the release can be found from the updated release notes.
25-07-2016
An updated version of the PSUR Repository to create XML delivery files for submissions via the eSubmission Gateway and the Web Client is now available. This new version will introduce changes in line with the updated EU Module 1 Specification v3.0 and v3.0.1. The updated delivery files are also used for eCTD submissions created using eCTD specification version 2.0.
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.
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