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.
The use of the PSUR Repository is mandatory as of 13 June 2016. All PSURs for products authorised in Europe must now be submitted to the PSUR Repository (PSURs for products authorised under Art. 58 are excluded). There should be no PSUR submissions directly to the National Competent Authorities from 13 June 2016 onwards.
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.
Essential maintenance to computer applications
PSUR and Gateway File Handler will be affected between 07:00 and 08:00 on Wednesday, 31 January 2018 due to essential maintenance to EMA’s computer systems.
Essential maintenance to computer applications
The PSUR Repository will be impacted by essential maintenance to SPOR data services between Wednesday evening 29th November and Friday, 1 December 2017 for industry users sending non-EU single assessment PSURs and for the NCA users performing searches in the non-EU single assessment area of the PSUR Repository. Additionally, on the PSUSA module, search attribute ‘MA authorisation type’ is also unavailable during this period. Other searches should work.
MAHs should please note that if you have submission deadline for non-EU single assessment PSUR on Friday 1 December, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.
The PSUR Repository will be impacted by essential maintenance to SPOR data services on Thursday evening 12th and Friday 13th October 2017 for industry users sending non-EU single assessment PSURs and for the NCA users performing searches in the non-EU single assessment area of the PSUR Repository. Additionally, on the PSUSA module, search attribute ‘MA authorisation type’ is also unavailable during this period. Other searches should work.
MAHs should please note that if you have submission deadline for non-EU single assessment PSUR on Friday 13th October, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.
The EMA is launching an updated version of the EudraVigilance on 22 November 2017. In preparation for this update, there will be a downtime period for the Article 57 database (EXVDMP). During the scheduled downtime from 8th-21st of November 2017 it will not be possible to amend or add product/substance data in Article 57. This will impact the PSUR Repository as the product selection for the PSUR submissions is linked to Art. 57. It will not be possible to update/amend product data for the creation of the XML delivery files during this downtime period.
The EMA strongly recommends that MAHs, with a PSUR submission date falling during the scheduled downtime (8 to 21 November 2017), carefully review the list of products available through the PSUR Repository xml delivery file user interface to ensure availability of the products included in the relevant procedures and make plans to create the xml delivery file and submit their PSUR prior to the 8 November. Alternatively, if an earlier submission cannot be accommodated MAHs are encouraged to review the availability of products and correctness of the entries in the XML delivery file user interface.
The MAHs should contact the EMA service desk to request a late submission ID in order to submit initial PSUSAs after the due date. There is no need to request late submission ID for subsequent submissions, such as responses.
Essential maintenance to computer applications on Tuesday afternoon
PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 15:00 and 17:00 on Tuesday, 27 June 2017. Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release on 27th June 2017 will not work following the deployment of the new version.
Essential maintenance to EMA computer applications affecting PSUR Repository on Saturday, 24 June
PSUR/eSubmissions Web User Interface (to create the delivery file) will be intermittently unavailable between 09:00 and 19:00 on Saturday, 24 June due to essential maintenance. EMA’s gateway will remain available for all communities throughout and any files submitted during that time will be put in a queue for processing once the deployments have been completed.
If you have any questions, please contact the EMA Service Desk.
An updated version of the PSUR Repository is now available. This release provides ability to indicate if RMP is included in the submission for Centrally Authorised Products. Additionally defect fixes and improvements to the PSUR Repository notifications have also been implemented. Details are available in the updated NCA and MAH User Guides and the updated Release Notes.
Essential maintenance to PSUR Repository.
PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07.00 and 09.00hrs on Monday, 20 February 2017. However, the Axway gateway will be available for all communities and any files submitted during that time will be put in a queue for processing when the deployments will be completed.
An updated version of the PSUR Repository has been made available on Thursday 6th October 2016. This release improves the product availability for the submission of responses. More details on the release can be found from the updated release notes.
An updated version of the PSUR Repository to create XML delivery files for submissions via the eSubmission Gateway and the Web Client is now available. This new version will introduce changes in line with the updated EU Module 1 Specification v3.0 and v3.0.1. The updated delivery files are also used for eCTD submissions created using eCTD specification version 2.0.
Announcement on the mandatory use of the PSUR repository New
PSUR Repository Bulletin
Previous Repository Bulletins are available here.
* 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.