The European Medicines Agency (EMA) has established the Organisation Management Service (OMS) to support regulatory activities in the entire European Union. The OMS manages master data for one of the four domains – substance, product, organisation and referential (SPOR) – in the context of pharmaceutical regulatory processes.
What the Organisation Management Service is for
The OMS provides a single source of validated organisation data that can be used as a reference to support EU regulatory activities and business processes.
It stores master data, including the name and location address, for organisations such as marketing authorisation holders, regulatory authorities and manufacturers. To establish master data, the OMS assigns unique identifiers (ID), referred to in the OMS as ‘Organisation_ID’ and ‘Location_ID’.
Within the OMS, organisations are categorised according to type (such as ‘Industry’, ‘Regulatory agency’ or ‘Educational institution’) and size (for instance ‘Micro’, ‘Small’ or 'Medium’).
The OMS does not define which role(s) an organisation plays, as this is context-specific. Only in a system linked to the OMS can a specific role – such as manufacturer of an active substance or marketing authorisation holder for a human or veterinary medicinal product – be assigned to an organisation included in the OMS.
Target group of the Organisation Management Service
Since 28 January 2022, companies such as yours must be registered in the EMA’s Organisation Management Service (OMS) database. While this was already mandatory for marketing authorisation holders, since 28 January 2022 this requirement also applies to Manufacturer’s and Import Authorisation (MIA) holders, including holders of GMP certificates, Wholesale Distribution Authorisation (WDA) holders, and importers, distributors and manufacturers of active substances used as starting materials in veterinary medicinal products (VET API REG).
Importance of the Organisation Management Service
The data used to grant the manufacturing authorisation, wholesale distribution authorisation, certificates and API registrations are the data on your organisation stored in the EMA’s database. In addition, your organisation can only be included in an application for the registration of a veterinary medicine or the modification of the marketing authorisation if it is registered in the OMS.
Check your data in the Organisation Management Service
For marketing authorisation holders it is important to check whether they are listed in the OMS and whether their data in the OMS are correct. Marketing authorisation holders must do this so that the Veterinary Medicinal Products Unit (BD) can create a new or modified manufacturing and/or distribution authorisation for veterinary medicinal products in the EudraGMDP database.
Only if the data in the OMS are correct will you be able to apply for a new or modified manufacturing authorisation, wholesale distribution authorisation, GMP certificate or veterinary API registration.
These applications must be submitted to the Veterinary Medicinal Products Unit.
The above applies to all manufacturers, importers and distributors of veterinary medicines (or active ingredients thereof) intended for the European market.
Also check if the data you use are correctly stated in the Organisation Management System
We recommend that you look up the organisations you use, such as the manufacturer for batch release and manufacturers of active substances, in the OMS to verify that their data are correctly stated there.
As the OMS is linked to multiple systems, including UPD, EVVET and EudraGMDP, it is important that the data for all the relevant organisations are correctly stated in the OMS. While this is obviously the responsibility of the organisations themselves, you can prevent potential problems by checking this yourself.
Link between the Organisation Management Service and EudraGMDP
The EudraGMDP database is linked to the EMA’s Organisation Management Service.
The integration of the database with the Organisation Management Service (OMS) means that EudraGMDP users of the national authorities obtain data concerning organisations and their locations from the OMS and no longer enter these details separately.
The link applies to, among other things:
- Manufacturer’s and Import Authorisations (MIAs);
- GMP certificates;
- Wholesale Distribution Authorisations (WDAs);
- VET API registrations (starting materials).
The integration ensures more consistency and therefore more reliable data.
It is therefore essential that all organisations that are currently regulated through EudraGMDP are also registered in the OMS. This will enable a link to be created between both systems.
More information on the Organisation Management Service and the link with EudraGMDP
The European Medicines Agency (EMA) has held a webinar on the OMS. To view this webinar, visit the EMA website and YouTube channel.
The EMA also has a number of other information sources available. More information is available from: Integration of EudraGMDP and OMS — Webinar for the industry | European Medicines Agency (europa.eu).
Detailed information about the OMS and its services for each organisation/users can also be found on the EMA’s website(s):