02/2022 - INTEGRATION OF EUDRAGMP WITH OMS
SInce 28/01/2022 the OMS system of EMA has been integrated in EudraGMP.
What is OMS?
OMS is the ‘Organisation Management Service’ database of the European Medicines Agency (EMA). This database provides a single source of validated organisation data.
What is EudraGMP?
EudraGMP is the database of EMA containing
- Manufacturing and Import Authorisations (MIA)
- Good Manufacturing Practice Certificates (GMP)
- Wholesale Distribution Authorisations (WDA)
- Good Distribution Certificates (GDP)
Based on the new published EU Regulation for Veterinary Medicines (regulation 2019/6), the OMS database will be integrated in the EudraGMP database.
What are the consequences?
If a competent authority needs to issue a new or updated license (MIA/WDA) or certificate (GDP/GMP), the competent authority will use the organization data as included in the OMS.
Therefore, if your company is not registered in the OMS, or the details are incorrect, it will not be possible to provide the requested license/certificate.
Which actions are required?
Manufacturers, distributors, importers and other companies holding a license/certificate should check from 28 January 2022 onwards whether their organization data have been correctly entered into the OMS:
No specific account is required to consult data in the OMS. If you wish to have the data amended, your organisation must be registered with the EMA and a data management role must be designated for Substances, Products, Organisations and References (SPOR)
Are you ready?
Have you checked if your company information is included correctly in the OMS? Do you need to change any details?
If required, we can help you!
Do not hesitate to contact us if you need further information!