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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.

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
     
    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.

 

 

 
 

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