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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.
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.
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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