News Category: Regulatory news
The EMA integrated the Organisation Management Service (OMS) with the EudraGMDP database on 28 January 2022. Manufacturers and wholesalers must now ensure that the following details are registered in OMS:
The HPRA cannot issue documents, such as MIAs, WDAs, Active Substance Registrations, GMP or GDP certificates, on the EudraGMDP database if the above details are not registered in OMS.
The EMA will hold webinars to assist manufacturers and other stakeholders using OMS. For more information and to register, visit the EMA webpages listed below.
10 March 2022 – OMS and RMS services and activities
This webinar is aimed at industry users. See the EMA website for more information – Introduction to OMS and Referentials Management Service (RMS) services and activities.
18 March 2022 – Using the SPOR application interface
This webinar is aimed at technical audiences. See the EMA website for more information – Requesting access to and using EMA's substance, product, organisation and referential (SPOR) application programming interface (API).