MAHs are advised that due to system maintenance work the product refresh for the PSUR Repository will be stopped during the following planned dates, which are currently: 11th March to 18th March 2016 22nd March to 29th March 2016 As a consequence MAHs that make changes to data in Article 57 during these periods will be affected when searching for their products during the XML delivery file creation process. If you encounter issues with the submission of your initial PSUR we recommend that you wait until these days have passed; there are no planned submission deadlines until 20.04.2016 therefore a slight delay in submission will not impact your procedure start. If you encounter issues submitting supplementary information please await until the period is over and attempt to resubmit. Please inform your procedure manager (PM) of this and we will communicate with the assessment team accordingly. In those cases where you have an extensive response please highlight this to your PM in order to consider whether an alternative route of submission to the NCA should be considered.
