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eCTD Industry Update (20th March 2023)

March 20, 2023
/
onix

EMA:

Newsletter: CTIS newsflash – 17 March 2023

eSubmissions (eCTD):

17-03-2023

Common Repository Go-Live on 20th of March 2023 (relevant for NCAs only)

We are pleased to inform you that the next version of the Common Repository introducing the ‘Basic Authentication’ is going live on the 20th of March 2023 (originally planned for the 14th of March). This release improves security by modifying access to the Common Repository requiring all users to log in to the system to view/download submissions. Additionally, this release provides usability improvements mainly related to procedures containing Nationally Authorised Products

And

Common Repository UI and API and eSubmission Delivery File UI will be unavailable on Monday evening

Common Repository UI and API and eSubmission Delivery File UI will be unavailable on Monday evening Due to planned maintenance, Common Repository UI and API and eSubmission Delivery File UI will be unavailable on Monday evening, 20th of March 2023 between 17:30 and 20:30 (CET). For any further information, please contact Service Desk

And

Planned maintenance of the eSubmission systems on Saturday 25 March 2023

Planned maintenance of the eSubmission systems on Saturday 25 March 2023 The eSubmission systems are unavailable for planned maintenance and will be unavailable from Saturday 25th of March 2023 08:00 until 18:00 due to essential maintenance. For any further information, please contact Service Desk

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