Organisation Management Service (OMS) - Integration in EudraGMDP
The new regulatory framework for veterinary medicinal products (Regulation 2019/6 and 2021/16, Article 9(h)) requires the following changes to the EudraGMDP database, which will be implemented from 28 January 2022:
- Integration of EudraGMDP into the Organization Management Service (OMS) of the EMA.
- Extension of the following two modules in EudraGMDP in relation to veterinary medicinal products:
- Wholesale Distribution Authorization (WDA)
- Active Pharmaceutical Ingredients Registration (API-Reg)
The most important change is the integration of EudraGMDP into OMS. As of January 28, 2022, national authorities will no longer be able to enter organizational data (organization or facility name and location) into EudraGMDP. Instead, the relevant organizational or company names and location data, including the legally (company register) recorded address of the manufacturer/importer/wholesaler/pharmaceutical intermediary, will be transferred from OMS. In the related documents for human and veterinary medicinal products as well as clinical investigational medicinal products and active substances (incl. operating license for manufacturing or wholesale, GMDP certificates,) the OMS data will also be transferred.
As of January 28, 2022, the national authorities can only make entries in EudraGMDP or create documents in this system if the relevant organizational data of the establishments are recorded in OMS. This concerns the following cases:
- First-time creation of documents in EudraGMDP, following an initial application (e.g. new manufacturing or wholesale permit).
- Renewal of existing documents (e.g. new version of the operating license, GMDP certificates issued in the course of a periodic inspection).
For this reason, it is necessary that all organizations that currently appear in EudraGMDP (whose permits / GMDP certificates are available in EudraGMDP), including manufacturers inside and outside the EU, importers and wholesalers of human and veterinary medicines, are registered in OMS.
Comprehensive information on OMS can be found here:
- OMS website
- SPOR portal
- Video tutorial: Overview of OMS
- Webinar for industry: Introduction to OMS services and activities
For any queries, please contact the EMA atvetchange.programme@ema.europa.eu.
