eSubmission PSUR XML Delivery File 07 November 2018 eSubmission PSUR XML Delivery File Changes introduced in v.14.0.0 and v.15.0.0 Presented by Hanna Palyszka on 31 August 2018

1. Upload of AR & Comments as word docs (SD-96935) For all new uploaded Assessments (both EU & Non-EU) in the PSUR Repository – these must now be in word format. PDFs will no longer be accepted. For Assessment Reports the first uploaded version must be in word format, <Refer to comment> Note: An exception to this is if any of the historic\the first versions of the AR had been previously sent as a PDF then the system will in this scenario allow for the upload in PDF format. For Comment Document Types the uploaded version must be in word format. 1 Training on updated eSubmission PSUR XML delivery files - 08 June 2018

2. All versions of AR that exist returned from search (SD-45839) When performing a Search for Assessment Reports (Preliminary\Updated) for a particular procedure. Users can now view all historic versions of the Assessment Report along with seeing the submitter and date received for each version. 2 Training on updated eSubmission PSUR XML delivery files - 08 June 2018

3. Hyperlink filenames to location in DREAM (SD-172959) When performing a search for any PSUSA for a particular procedure. The Document Types will now be displayed with a hyperlink to the physical location of the document. The user can mouse click the link. Once the link is selected the user is prompted to enter their DREAM login credentials and access the document directly from DREAM. This will allow for easier navigation to the documents. 3 Training on updated eSubmission PSUR XML delivery files - 08 June 2018

1. Entry of ‘period covered’ for PSUSA CAPs (1/2)(SD-130450) ) The coverage period is currently system calculated based on the data lock point and frequency. Users now have the ability to override the system calculated period and manually enter the period covered by entering a specific date range. This will provide more accurate data on the PSUSA submission and therefore allow for more efficient processing and Assessment of the PSUSAs. The latest range date will be the date valid for the next submission for that PSUSA. 4 Training on updated eSubmission PSUR XML delivery files - 31 August 2018

2. Entry of coverage period for PSUSA CAPs (2/2)(SD-130450) ) The notification sent to NCAs shall indicate if the Default coverage period has been overridden and the date ranges. Note: Screenshot taken from original requirement doc, update screenshot with real example 5 Training on updated eSubmission PSUR XML delivery files - 31 August 2018

Thank you for your attention 07 November 2018 Thank you for your attention Further information https://servicedesk.ema.europa.eu European Medicines Agency 30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact Note: This slide is OPTIONAL. It uses the 'Closing slide' layout. Delete if not needed. Follow us on @EMA_News