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The use of EMA’s Organisation Management Services (OMS) data is extended

Use of EMA standardized organizational information (OMS, Organisation Management Services) becomes mandatory in application forms related to marketing authorisations. The latest (v1.25.0.0) application form version has been published on 1 October 2021 and the use of the form and OMS information is mandatory from 1 November 2021. The next application form version v1.26.0.0 will be published in December 2021 and will completely lack the free text field for organizational data.

At the end of February 2022, the organizational information for the EudraGMDP database (a database of manufacturing and wholesale licences, GMP and GDP certificates) comes directly from EMA’s OMS database. All license holders in EudraGMDP must ensure that they are registered with the OMS database by January 28, 2022. Fimea reminds that the OMS database must also contain the organisation information of Finnish wholesalers.