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.
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.
* 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