Veterinary Medicinal Products Regulation: link between EudraGMDP database and OMS
A number of things are going to change in relation to the EudraGMDP database in the field of veterinary medicinal products. This is a consequence of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), which is coming into effect on 28 January 2022. For example, the database will be linked to the EMA's OMS system, which is used to link data on marketing authorisation holders.
The integration of the database with the Organisation Management System (OMS) means that, as of 28 January 2022, EudraGMDP users of the national authorities will obtain data of organisations and their locations from the OMS and will no longer enter them separately.
The result of that change will soon be evident in a variety of documents. As regards veterinary medicinal products this means MIAs (manufacturing authorisations), GMP certificates, WDAs (wholesale authorisations) and VET API registrations. The integration will lead to more consistency and therefore more reliable data.
It is therefore essential that all organisations which are currently regulated via EudraGMDP are registered in the OMS. This will enable a link to be created between both systems. The European Medicines Agency (EMA) has set up a project with this goal in mind.
For marketing authorisation holders it is important to check, as from 28 January 2022, whether they are listed in the OMS and whether the data it contains is correct. Marketing authorisation holders must do this so that the Veterinary Medicinal Products Unit (BD) can create a new or amended manufacturing and/or distribution authorisation for veterinary medicinal products in the EudraGMDP database.
Webinar with more information
The EMA also has a number of other information sources available. More information is available from: Integration of EudraGMPD 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):
- The OMS website
- SPOR portal
- Video tutorial: Overview of the OMS
- Webinar for the industry: Introduction to OMS services and activities