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 ...
PSUR Submissions in Single Assessment via EMA Gateway/ Webclient ...
PSURs submitted in accordance with the EURD list are subject to the EU PSUR single assessment (PSUSA) procedure. EMA carries out PSUSA procedures to ...
Wasif Sabir,. Kristiina Puusaari. 1.7. 11/11/14. Added the correct EMA routing ID and URL for create delivery file. Wasif Sabir. 2.0. 17/04/15.
The PSUR XML delivery file for EMA submission is introduced to harmonise the submission mechanism for all PSURs submitted to EMA and it ...
On the 26th of January 2015, the EMA introduced the pilot phase on the use of the XML delivery file for submissions of PSURs via the ...
EMA fully relies on the data contained in the XML delivery file.
A quick run through the status of the PSUR repository pilot at EMA.
Additionally, beginning 1 September 2015, companies will be required to use an XML delivery file to submit PSURs to EMA, as opposed to ...