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PSUR Repository
The PSUR repository is a single, central platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the EU. The PSUR Repository provides an important simplification for marketing authorisation holders allowing them to send all PSURs and related submissions to a single recipient. It also facilitates the assessment by ensuring that NCAs, EMA and its scientific committees have timely and secure access to all relevant documents. The PSUR Repository was introduced by the EU pharmacovigilance legislation to facilitate the exchange of information on the safety of authorised medicines between regulators and pharmaceutical companies and it supports both the PSUR Single Assessment Procedure (PSUSA), as governed by the EURD list, as well as the pure NAP procedures where the active substance(s) are outside of the EURD list.
As of 13 June 2016 the use of the PSUR Repository is mandatory. All PSURs for products authorised in Europe must now be submitted to the PSUR Repository (PSURs for products authorised under Art. 58 are excluded).
PSUR submissions to the Repository are made using the eSubmission Gateway/Web Client with the use of an XML delivery file. The delivery files are used to provide required metadata allowing the EMA to process the submissions. You can find the link to the tool to create the delivery file here. The XML delivery file must be included within the submission package (i.e. in the relevant ZIP file).
It is essential that all MAHs, who have not previously used the eSubmission Gateway / Web Client, register to use the eSubmission Gateway as soon as possible using the online registration form. Guidance on how to register can be found from the eSubmission Gateway and Web Client online registration guidance document. Existing eSubmission Gateway/Web Client users do not need to re-register.
News
Previous news can be found here.
29-04-2025
Planned maintenance of eSubmission systems on 30 April 2025, 18:00
CET
Due to planned maintenance, the following eSubmission systems will not be available on
Wednesday 30 April 2025, between 18:00 and 20:00: eSubmission website,
PSUR Repository,
Gateway Filehandler, Delivery File UI, Registration Gateway.
For any further information, please contact
EMA Service Desk.
28-04-2025
Reminder for PSUSA procedures: new requirement for Word version of the initial PSURs and RSI responses
When submitting initial PSUR or RSI responses for a PSUSA procedure,
the marketing authorisation holders (MAHs) are also required to systematically provide
Word versions of the submitted initial PSURs and RSI responses,
as part of the Working Documents folder.
When submitted with an eCTD, the Working Documents should always be provided in a
separate folder called "xxxx-workingdocuments" on the same submission zip package
containing the eCTD, where the number (xxxx) matches the number of the eCTD sequence being submitted.
Any deviation will lead to a failed submission, and the package will have to be
resubmitted with the correct naming. For example, if sending sequence "0007", which
contains working documents, the separate folder should be named "0007-workingdocuments".
More details can be found in chapter 2.9.10 of the
Harmonised guidance eCTD - version 6.0
16-04-2025
PSUSA procedures: new requirement for Word version of the PSURs and RSI responses
When submitting PSUR or RSI responses for a PSUSA procedure, the marketing authorisation holders (MAHs) are also required
to systematically provide Word versions of the submitted PSURs and RSI responses,
as part of the Working Documents folder.
Reminder
When submitted with an eCTD, the Working Documents should always be provided in a separate folder called "xxxx-workingdocuments" on the same submission zip package containing the eCTD, where the number (xxxx) matches the number of the eCTD sequence being submitted.
Any deviation will lead to a failed submission, and the package will have to be resubmitted with the correct naming. For example, if sending sequence "0007", which contains working documents, the separate folder should be named "0007-workingdocuments".
More details can be found in chapter 2.9.10 of the Harmonised guidance eCTD - version 6.0.
More details can be found in chapter 2.9.10 of the Harmonised guidance eCTD - version 6.0.
And
Planned maintenance of eSubmission systems on 23 April 2025, 18:00 CET
Due to planned maintenance, the Common Repository Web User Interface and API
(relevant for NCAs only) and the PSUR Repository Industry access and NCA access
will not be available on Wednesday 23 April 2025, between 18:00 and 20:00.
For any further information,
please contact EMA Service Desk.
14-03-2025
Planned maintenance of eSubmission systems on 17 March 2025, 18:00 CET
Due to planned maintenance, the Common Repository Web User Interface and API (relevant for NCAs only) and PSUR Repository Web User Interface and API (relevant for NCAs only) will not be available on Monday 17 March 2025, between 18:00 and 22:00
For any further information, please contact EMA Service Desk.
07-03-2025
Planned maintenance of PSUR Repository API on 7 March 2025, 18:00 CET
Due to planned maintenance, the PSUR Repository API (relevant for NCAs only) will not be available on Friday 7 March 2025, between 18:00 and 19:00.
For any further information, please contact
EMA Service Desk.
26-02-2025
Planned maintenance of eSubmission systems on 4 March 2025, 18:00 CET
Due to planned maintenance, improvements in the Delivery File User Interface and for the Multi Factor Authentication go-live in Common Repository (relevant for NCAs only) and PSUR Repository (relevant for NCAs only), the following eSubmission systems will not be available on Tuesday 4 March 2025, between 18:00 and 22:00: Common Repository (Web User Interface and API), PSUR Repository (Web User Interface and API), Gateway Filehandler, Delivery File User Interface.
For any further information, please contact
EMA Service Desk.
And
Planned maintenance of PSUR Repository (Industry access) on 28 January 2025, 18:00 CET
Due to planned maintenance, the PSUR Repository (Industry access) will not be available on Friday 28 February 2025, between 18:00 and 20:00.
For any further information, please contact
EMA Service Desk.
13-01-2025
Planned maintenance of eSubmission systems on 14 January 2025, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Tuesday 14 January 2025, between 18:00 and 19:30: Gateway XML delivery file user interface, Gateway Filehandler, PSUR Repository Web-UI.
For any further information, please contact EMA service desk.
04-12-2024
Planned maintenance of eSubmission systems on 5 December 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Thursday 5
December 2024,
between 18:00 and 24:00: Gateway XML delivery file user interface, Gateway Filehandler, Common
Repository Web-UI
and API, PSUR Repository Web-UI (both NCA and industry access) and API.
The maintenance includes various improvements and implementations:
- Common Repository Web-UI - technology modernisation
- Gateway XML delivery file user interface - various improvements and integrations for
retrieval of data (e.g. procedures) from the internal EMA case management system (IRIS)
- Gateway XML delivery file user interface - minor changes related to the new variation regulation (e.g.
renaming of the submission mode from "IG" to "super-grouping")
Updated documentation will be published on the relevant pages of the
eSubmission website.
For any further information, please contact EMA Service Desk.
28-10-2024
Planned maintenance of eSubmission systems on 24 October 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Thursday 23 October 2024, between 18:00 and 20:00: Gateway XML delivery file user interface, Gateway Filehandler and PSUR Repository XML delivery file UI (relevant for industry only).
Previously created delivery files will continue to work. For any further information, please contact EMA Service Desk.
01-10-2024
Planned maintenance of eSubmission systems on 8 October 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Tuesday 8 October 2024, between 18:00 and 20:00: Gateway XML delivery file user interface, Gateway Filehandler and PSUR Repository Web-UI (relevant for NCAs only).
The maintenance includes the aligning of the VNeeS submission format to 3.1, where applicable, and other small improvements.
Previously created delivery files will not continue to work, please use the new version of the Gateway XML delivery file after the maintenance has completed.
Updated documentation will be published on the relevant pages of the eSubmission website. For any further information, please contact EMA Service Desk.
11-06-2024
Planned maintenance of the PSUR Repository (NCAs only) on 18 June 2024, 18:00 CET
Due to planned maintenance, the PSUR Repository NCA UI and PSUR Repository NCA API will not be available for approximately 1 hour on Tuesday, 18 June 2024, after 18:00 CET. The maintenance is related to a technical upgrade and will not result in any changes of the features and functionalities of the system.
05-12-2023
Survey for PSUR Repository (open until Monday, 18 December 2023)
In light of an ongoing application study at the European Medicines Agency, we are gathering feedback on the PSUR Repository.
By completing this short 2-3 minutes survey, you help us understand if the application addresses your user needs.
May we kindly ask you to complete this survey by Monday, December 18th? The link to the survey can be found here: PSUR Repository User Survey.
We highly appreciate your input.
04-07-2023
A new version of the PSUR Repository NCA UI is now available
An updated version of the PSUR Repository NCA UI is now available. The new version of the PSUR Repository NCA User Interface provides a technical update only. Following the update, the PSUR Repository NCA UI has slightly different look and feel, however, there are no changes to the features and functionality of the system.
User Guidance and the Release Notes were updated and they can be found in the "User Documents" section of the page.
28-06-2023
PSUR Repository (NCA UI) Go-live 3rd July 2023
We are pleased to inform you that an updated version of the PSUR Repository NCA UI is going live on the 3rd of July 2023.
The new version of the PSUR Repository NCA User Interface provides a technical update only. Following the update, the PSUR Repository NCA UI will have slightly different look and feel, however, there are no changes to the features and functionality of the system.
For the completion of the deployment, the PSUR Repository NCA User Interface will be unavailable on Monday evening 3rd of July 2023 between 18:30 and 19:30 (CET).
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.
Announcements
Announcement on the mandatory use of the PSUR repository
PSUR Repository Bulletin
Previous Repository Bulletins are available here.
User Documents
* Presentations and webinars have been developed during the transitional period, prior to the mandatory use of the system and may refer to national submission requirements. All users should note that the use of the PSUR Repository is now mandatory and all PSURs must be submitted to the PSUR Repository only. The national submission requirements no longer apply. PSURs submitted directly to National Competent Authorities only will be excluded from the PSUR assessment procedure.
PSUR Repository user registration form for NCA users |
Repository user registration |
| MAH PSUR Repository User Guidance document |
MAH user guide (14.06.2022) |
| NCA PSUR Repository User Guidance document |
NCA user guide (03.07.2023) Updated |
| How to send submissions via the Web Client – User Guide |
User guide (22-06-2020) |
| PSUR Repository FAQ document |
Frequently Asked Questions |
| Mandatory use Questions and Answers document for MAHs |
MAH Q&As (24.0.2016) |
| Release Notes |
Release notes (30.06.2023) Updated |
| PSUR repository presentation on changes on Brexit related changes – v.1.17.3.0 |
Presentation (15.12.2020) |
| PSUR Repository training for MAHs and NCA on new functionality –v1.17.0.0* |
Presentation (09.06.2020) |
| PSUR Repository training for MAHs and NCA on new functionality –v1.16.0.0* |
Presentation (09.10.2019) |
| PSUR Repository training for MAHs on new functionality – v1.07.00* |
Presentation(25.07.2016) |
| PSUR Repository training for MAHs on new functionality – v1.06.00* |
Presentation (17.05.2016) |
| PSUR Repository interactive Q&A session with MAHs – v1.06.00* |
Presentation (24.05.2016) |
| PSUR Repository training for MAHs on new functionality – v1.04.00* |
Presentation (14.10.2015) |
| PSUR Repository interactive Q&A session with MAHs – v1.04.00* |
Presentation (28.10.2015) |
| PSUR Repository for MAH - New functionality v1.03.00 |
Presentation (12.08.2015) |
| PSUR Repository interactive Q&A session with MAHs – v1.03.00 |
Presentation (10.09.2015) |
| How to submit to PSUR Repository - existing Gateway users |
Presentation |
| How to submit to PSUR Repository – New Gateway users |
Presentation |
| Slides and the Q&A from 21 May webinar |
Slides and Q&A's |
| Formatted table template |
Download |
EudraVigilance system downtime – impact on PSUR Repository and the eAF |
Document (05.10.2017) |
Multimedia Tutorials
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| PSUR Repository training for MAHs on new functionality – release v1.07.00) |
Multimedia webinar (25,07.2016) |
| Webinar on the mandatory use of the PSUR Repository for MAHs |
Multimedia webinar (13.06.2016) |
| Webinar on the mandatory use of PSUR Repository for NCA users |
Multimedia webinar (13.06.2016) |
| PSUR Repository training for MAHs on new functionality – release v1.06.00)* |
Multimedia webinar (17.05.2016) |
| PSUR Repository – interactive Q&A session for NCAs on new functionality – release v1.06.00* |
Multimedia webinar (26.05.2016) |
| PSUR Repository training for NCA users on new functionality – release v1.06.00 * |
Multimedia webinar (17.05.2016) |
| PSUR Repository training for MAHs on new functionality – release v1.04.00) |
Multimedia webinar (14.10.2015) |
| PSUR Repository training for NCA users on new functionality – release v1.04.00 |
Multimedia webinar (15.10.2015) |
| PSUR Repository interactive Q&A session with MAHs – release v1.04.00 |
Multimedia webinar (28.10.2015) |
| PSUR Repository training for MAHs on new functionality (v1.03.00) |
Multimedia webinar (12.08.2015) |
| PSUR Repository training for NCA users on new functionality (v1.03.00) |
Multimedia webinar (13/08/2015) |
| PSUR Repository interactive Q&A session with MAHs – release v1.03.00 |
Multimedia webinar (10.09.2015) |
| How to submit PSURs training for existing Gateway users |
Multimedia webinar |
| How to submit PSURs training for new Gateway users |
Multimedia webinar |
| How to submit to PSUR Repository – pilot training for MAH |
Multimedia webinar |
| Pilot training for NCA users |
Multimedia webinar |
| Technical Documents |
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Automated two-way exchange of documents held in the PSUR Repository between NCA systems and the PSUR Repository to reduce administrative burden for NCAs |
Specifications of the PSUR Repository API - (17.10.2016) |
Supplementary Specification |
Additional email notifications specification |
| Who to contact |
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| MAH Gateway user registration |
https://servicedesk.ema.europa.eu |
| NCA User registration |
https://servicedesk.ema.europa.eu |
| Gateway submission related technical issues |
https://servicedesk.ema.europa.eu |
| All questions related to the PSUR Repository, submission of PSURs, non-procedural issues with PSUSA and questions related to training, user guide or documentation on this page |
https://servicedesk.ema.europa.eu |
| PSUR procedural questions for the EU Single Assessment coordinated by the Agency.1 |
PSUR procedural guidance Q&A |
1.Please note that procedural questions on non-EU single assessment procedures conducted only in one Member State must be addressed to the relevant National Competent Authority.
As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period.
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