EU Telematics PIM _
 

PSUR Repository

_

Home

_

Human eSubmission

_
Veterinary esubmission
_

eSubmission CMB

_
CMB Documents
_

External Links

_

Systems:

_

Common Repository

_

eAF

_

CESSP

_
eASMF
_
ePMF
_
CESP
_

eSubmission Gateway & eSubmission Web Client

_

Delivery file UI

_

eSubmission Gateway

_

PAM submission form

_
PSUR Repository
_

Industry access

_
NCA access
_

eCTD

_

eCTD v4.0

_

EU Module 1

_

Paediatric submissions

_

SPOR

_

eSignatures

_
_

Previous News

27-11-2017

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.

09-10-2017

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.

05-10-2017

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.

27-06-2017

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.

20-06-2017

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.

20-02-2017

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.

16-02-2017

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.

10-10-2016

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.

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.

 

 

 
 

EMA
©1995-2018 European Medicines Agency | Disclaimer | For technical support, please visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here