|
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).
Since 16 April 2025, 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.
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.
05-08-2025
PSURs cannot be submitted without IRIS-affiliated contact after 1
September 2025
As of 1 September 2025, Marketing Authorisation Holders (MAHs) will no longer be
able to create PSUR submissions if the primary contact indicated in the PSUR submission
form does not have an IRIS account affiliated with the MAH of the product.
To ensure business continuity, we strongly encourage all MAHs to verify that
their contacts meet this requirement well in advance of the deadline.
Please note the following:
- For Centrally Authorised Products (CAPs): For any
type of procedure with CAPs, it is a CAP Person authorised for communication
with the Agency (referred in section 2.4.3 of the application form).
- For non-CAPs: For PSURs with non-CAPs, the MAH
contact associated with the email address as indicated in the PSUR
submission form (and NOT in the cover letter)
when generating the delivery file.
All key actions and instructions for updating product contacts and
requesting IRIS access are explained in the PDF document available at this page, which also includes an overview
of training resources for MAHs for using IRIS and EMA service desk
triage guidelines for support requests.
If you have questions outside of the above or require further assistance,
please raise a ticket through the EMA Service Desk.
12-06-2025
Planned maintenance of PSUR systems and Important notification
Due to planned maintenance, the PSUR Repository (Industry access) will not be available
today between 18:00 and 19:30.
For any further information, please contact EMA Service Desk
Reminder: Due to planned maintenance, the PSUR Repository (Industry
access) will not be functional
during 20 - 22 June 2025. During this downtime, the PSUR packages that
are submitted through the EMA gateway
will not be processed. During the week 23 - 27 June
2025, the PSUR Repository and the PSUR submissions will be
closely monitored, and even though all the potential scenarios were carefully
considered, unforeseen disruptions could occur during this
week.
To avoid any delays in sending the PSUR packages, it is highly recommended to submit the
packages a few days before the 20th of June 2025.
For further details, please follow the EMA Service Desk and
eSubmissions.
03-06-2025
Planned maintenance of PSUR systems - Important notification
Due to planned maintenance, the PSUR Repository (Industry access) will not be functional
during 20 - 22 June 2025. During this downtime, the PSUR packages that are submitted
through the EMA gateway will not be processed.
During the week 23 - 27 June 2025, the PSUR Repository and the PSUR submissions will be
closely monitored, and even though all the potential scenarios were carefully considered,
unforeseen disruptions could occur during this week.
To avoid any delays in sending the PSUR packages, it is highly recommended to submit the
packages a few days before the 20th of June 2025.
For further details, please follow the EMA Service Desk
and eSubmissions.
22-05-2025
Planned maintenance of eSubmission systems on 23 May 2025, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on
Friday 23 May 2025, between 18:00 and 19:00: PSUR Repository (relevant for NCAs only).
For any further information, please contact EMA Service Desk
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
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
|
|
| 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 |
|
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 |
|
| 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.
|
