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 |