Centralised Procedure: Organisation Management Service (OMS) now mandatory

Recommendation

17/18 September 2024

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The European Medicines Agency (EMA) regularly updates the "Questions & Answers (Q&A)" documents on its website relating to centralised marketing authorization procedures. Now, a Q&A document exclusively on "Organisation Management Service (OMS)" has been published on the EMA's eSubmission website.

The Q&A document "OMS mandatory for CAPs from November 1st onwards" first draws attention to the fact that the use of OMS data in centralised procedures has been mandatory since 01 November 2021. Originally, this implementation obligation was set for the end of September, as you could read recently in Update of the Q&A Documents on the topic "Centraled Procedures".

The questions document presents the most important information on the "Organisation Management Service (OMS)" in a condensed form and explains the new requirements associated with the mandatory use of OMS during the registration and change notification submission process in a question-and-answer style in the four main points

• General
• About OMS 
• About Use of OMS data in Centralised Procedure applications and 
• About Use of OMS data in eAFs

In addition, the EMA website provides general information on the Organisation Management Service (OMS).