The delivery files are used to provide required metadata allowing the EMA to process the submissions. You can find the link to the tool to create the delivery file ...
foreseen in the Protocol on Ireland/NI. © European Medicines Agency | PSUR 1.17.5.0 ...
Send us a question Go to www.ema.europa.eu/contact Telephone +31
Use of the PSUR repository is mandatory for both centrally and nationally authorised medicines, whether they follow the EU single assessment or a purely ...
A quick run through the status of the PSUR repository pilot at EMA.
EMA fully relies on the data contained in the XML delivery file.
PSUR repository updated · Enter EMA routing ID (e.g. ESUBPROD) and your Routing ID (e.g. ESUBPTESTPROD123) · The XML delivery file will ...
As of 1 September 2015, companies should use the XML delivery file for all PSUR submissions to the EMA via the eSubmission Gateway/Web ...
Create a delivery file for submission by navigating to create delivery file screen. 2 .
XML delivery file is required; it is not possible to submit non-EU single assessment PSURs to the EMA using the file naming convention. 3.