New Changes in XML Delivery Files for eSubmission v3.4.0.0 by EU Agency
In the latest update for eSubmission Web Client XML delivery files, various enhancements have been introduced including the ability for users to enter related sequence numbers, identify if a Risk Management Plan is included, provide CAP names, indicate Brexit-related procedures, select procedure numbers for clinical data submissions, and add multiple procedure numbers for post-authorisation CAP submissions.
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Presentation Transcript
eSubmission Web Client XML delivery files Changes introduced in v3.4.0.0 An agency of the European Union Presented by Hanna Palyszka on 06 March 2018
1.Related sequence number Users can now optionally enter the related sequence number for most types of Human submissions. This allows for easy cross referencing of related submissions. 1 1 Training on updated eSubmission Gateway XML delivery files - 08 March 2018
2. Identify if RMP included Users can now identify whether a Risk Management Plan is included for the following type of submissions: MAA Variation Type IB Variation Type II Extension PAM Renewal 2 2 Training on updated eSubmission Gateway XML delivery files - 08 March 2018
3. Other CAPS where same change applies Users can now provide the name of any CAPs for which the same changes are being applied outside of the procedure. This is applicable to the following types of submissions: Variations Type IB Variations Type II 3 3 Training on updated eSubmission Gateway XML delivery files - 08 March 2018
4. Brexit related procedures Users can indicate if the change is a Brexit related procedure. This is applicable to initial submissions for the following submission types: Variations Type IA (H & V) Variations Type IAIN (H & V) Variations Type IB (H & V) Variations Type II (H & V) Transfer MA (H & V) Notification 61-3 (H only) 4 4 Training on updated eSubmission Gateway XML delivery files - 08 March 2018
4. Clinical data Select procedure number Users can now select from a predefined list of procedure number to reference the submission. This is applicable for the following clinical data submissions types. Clinical data publication-FV Clinical data publication-RP 5 5 Training on updated eSubmission Gateway XML delivery files - 08 March 2018
5. CAPS - Add multiple procedure numbers Users can now add multiple procedure numbers from a predefined list to reference the submission. This is applicable for all post authorisation CAP submissions when the submission unit is closing. 6 6 Training on updated eSubmission Gateway XML delivery files - 08 March 2018
6. Addition of type of Renewal Users can now specify the length of the renewal by selecting the radio button. This is applicable for all initial renewal submissions. 7 7 Training on updated eSubmission Gateway XML delivery files - 08 March 2018
7. ASMF Select procedure number Users can now select from a predefined list of procedure number to reference the submission. This is applicable for all ASMF submissions types. 8 8 Training on updated eSubmission Gateway XML delivery files - 08 March 2018
8. Vnees New Validation set Users can now select from a new validation set for Veterinary Vnees submissions. This includes: VNeeS (pharmaceutical product) v.2.5 VNeeS (immunological product) v.2.5 9 9 Training on updated eSubmission Gateway XML delivery files - 08 March 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 Follow us on @EMA_News
