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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.

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.

News

25-07-2016

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.

Announcements

Announcement on the mandatory use of the PSUR repository New

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.

 

 

 

 

 
 

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