The PSUR Repository is now available and it offers a secure electronic submission point for Marketing Authorisation Holders (MAH), streamlining the Periodic Safety Update Report (PSUR) submissions for the pharmaceutical industry. It will act as a common storage place for PSURs, PSUR Assessment Reports (ARs), comments and final outcomes, with a secure access for NCAs and the European Commission. The PSUR Repository supports both the PSUR Single Assessment Procedure (PSUSA) as governed by the EURD list and the single, pure NAP procedures where the active substance is only authorised in one Member State.
PSUR submissions to the Repository will be made using the eSubmission Gateway/Web Client with an additional XML delivery file included in the submission package. The Agency has developed a dedicated user interface for the creation of the Repository specific XML delivery file. This delivery file can be used to provide the required metadata allowing the EMA to process the PSUR. You can find the link to the tool to create the delivery file from here. When a submission to the PSUR Repository is made using the XML delivery file, the use of the manual filenaming convention to provide the metadata, is no longer obligatory. The XML delivery file must be provided within the submission package (i.e. in the relevant ZIP file). The Agency encourages applicants to use guidance provided in Annex 3 of the PSUR filenames for repository submissions when using the XML approach.
At the moment, both the filenaming convention and the XML delivery file approach can be used to send the metadata along with the PSUR submissions. However, submissions sent without XML delivery file, will be validated using the existing filenaming convention and will only be placed in the Agency’s general submission review tool and the Common Repository, i.e. not in the PSUR Repository. The Agency will phase out this dual approach and therefore strongly recommends users to switch to the XML deliver file option at their next opportunity.
It is essential that all MAHs, who have not previously used the eSubmission Gateway / Web Client, should register to use the submission tools 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.
The Agency will be making the use of the XML delivery file mandatory from 1 September 2015 for all PSUR submissions via the Gateway or Web Client. The statement of intent for the mandatory use can be found here
During the period between the system becoming available and its mandatory use, the current submission rules for the PSURs of Nationally Authorised Medicinal Products (NAPs) included in PSUSA procedures or single, pure NAP PSURs must be followed.
From 1 September 2015 all PSURs submissions should be sent with an XML delivery file. After this date, it will no longer be possible to send PSUR submissions using the existing filenaming convention. The exclusive use of the PSUR XML delivery file for PSUR submissions is introduced to harmonise the submission mechanism for all PSURs and it will apply to all types of PSUR and PSUR supplementary information submissions. This excludes PSURs for Art. 58 (WHO) procedures. New
PSUR Repository v01.06 Go Live between 9:00 am and 9:00 pm UK time on Saturday 14th May 2016
Version 01.06 of the PSUR Repository will be made available for both MAHs and NCAs on 14th of May 2016. This release provides important improvements to the system prior to the start of the mandatory use on 13th June 2016. The release also provides fixes for defects that have been identified during simulated mandatory use. While the new version is made available the system will not be able to process new submissions. The PSUR Repository will be unavailable for MAH and NCA users between 9:00 am and 9:00 pm UK time on Saturday 14th May 2016.
A series of trainings and Q&A sessions have been scheduled in preparation for the upcoming PSUR Repository release v1.06.00 and for the mandatory use.
The industry representatives are encouraged to register for the training by sending contact details to eSubprogofficer@ema.europa.eu. NCA representatives will receive an invitation from EMA without a need to register.
PSUR Repository Bulletin
Week commencing 09 May 2016
- Version 01.06 of the PSUR Repository will be made available for both MAHs and NCAs on 14th of May 2016. The new release provides change requests further enhancing the system; for example the ability for MAHs to create delivery files for late submissions and improved connection to eSubmission Gateway meaning that the routing ID’s will be automatically detected during the submission process. NCAs will benefit from improved notifications and business rules within the PSUR Repository as well as the ability to reject technically invalid eCTD submissions. The release also provides fixes for defects that have been identified during the switch on phase. While the new version is made available the system will not be able to process new submissions. Submissions will be received via the eSubmission Gateway however they will only be made available in the PSUR repository once the deployment is finalised. The PSUR Repository will be unavailable for MAH users to create xml delivery files and for NCA user access between 9:00 am and 9:00 pm UK time on Saturday 14th May 2016. Applicants should endeavour to make their submissions outside of the scheduled downtime to avoid potential issues with their submissions.
- Version 01.06 will mark the transition of the PSUR Repository project into its maintenance phase, with the PSUR Repository Advisory Group (PRAG) becoming a Maintenance Group of the EU Telematics governance structure (PSUR Repository Maintenance Group (PRMG)). The role of the PRMG will remain in line with the current role of PRAG in that they will be supporting system maintenance/improvements and change management. If any NCAs or MAHs that are not already represented in the PRAG wish to join the newly formed PR maintenance group please contact Kristiina Puusaari (Kristiina.email@example.com).
- We are pleased to announce that following a call for interest to Head of Medicines Agencies to establish a group of NCA Communication Contact points for the PSUR Repository, the vast majority of NCAs have named their representatives. The role of the NCA Communication Contact points will be to facilitate the cascade communications regarding the PSUR Repository implementation, promote visibility of training materials at national level, act as an internal and external advocate promoting the changes brought about by the mandatory use of the PSUR Repository and to identify any training or communication gaps which need to be escalated for EMA for further action. We are in the process of setting up a kick-off meeting with the newly established group, and will communicate timing in the upcoming days. We would already like to thank those colleagues from the NCAs that will be collaborating with us in this new role during the upcoming months.
Previous Repository Bulletins are available here.
The system is now available and it is now possible to submit PSURs to the PSUR Repository. The delivery files required for the submissions can be created here.
The system is also available to all registered NCAs for pilot use here
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.