Use of organisation data from OMS in EudraGMDP
Applicants of manufacturing and importation authorisations, wholesale dealer's authorisations and API registrations must register their organisation data in the EMA’s Organisation Management Service (OMS) before they can apply to the Danish Medicines Agency for company authorisations and company registrations. In OMS, all registered companies (organisations) receive so-called OMS IDs that uniquely identify the company. These OMS IDs must be submitted with any application for the concerned company authorisations and company registrations.
Organisation data in EudraGMDP
The EMA introduced the use of OMS IDs in EudraGMDP on 28 January 2022. This means that companies must be registered in OMS before they can appear on a EudraGMDP document. The Danish Medicines Agency regularly uploads authorisations, registrations and certificates to EudraGMDP, and submitting the companies’ OMS IDs is mandatory to be able to upload these documents.
Companies must therefore register and maintain their organisation data in OMS prior to submitting applications for a manufacturing and importation authorisation, wholesale distribution authorisation or API registration to the Danish Medicines Agency.
Organisation data in OMS
Companies already holding a manufacturing and importation authorisation, wholesale distribution authorisation and API registration will automatically have registered in OMS with their company details from EudraGMDP. New companies must submit a request to the EMA for registration in OMS.
Companies should check if their organisation has been registered correctly in OMS before applying for an update to their authorisation or registration. Relevant company employees should therefore obtain an EMA account and request “SPOR user roles”, which will enable them to request changes to their organisation data in OMS.
Read more about SPOR and OMS user registration via the link to the EMA website at the bottom of the page.
Changes to organisation data in OMS
Changes to organisation data must be updated in OMS before applying for the change to the Danish Medicines Agency. If, for example, a company moves or a new site is added to it, the company must submit a change request to the EMA for registration of the new location in OMS. When the EMA approves such change request, the company will receive a new OMS LOC ID for the new location. This ID is to be stated in the application to change the authorisation or registration. If a company changes its name, this must also be registered in OMS before the variation application can be submitted to the Danish Medicines Agency.
Note: A change to the organisation data in OMS does not automatically change authorisations, registrations and certificates in EudraGMDP. Changes to authorisations and registrations become effective only when the Danish Medicines Agency approves the variation application and submits updated information to EudraGMDP. Once issued, certificates are normally not changed.
Note that the transfer of a site is not handled as a change of location in OMS; instead it is handled as a request for a new location.
The EMA normally handles requests within 5 to 10 working days.
The OMS is a standardised register of companies in the pharmaceutical area. The OMS register is accessible to all and aims to ensure reliable and unambiguous data about companies in the EU and third countries. The OMS will make it easier for authorities and companies to exchange data on companies, e.g. for application purposes or when presenting data in the various EU databases such as the EudraGMDP database.
Read more about OMS on the EMA website.
Read more about SPOR user registration on the EMA website. Questions about user registration should be submitted to the EMA.
The OMS database is accessible at: https://spor.ema.europa.eu/omswi/#/
The tab “Documents” contains important guidance documents on the database such as
- C - OMS Data Quality standards
- E - OMS Change Requests
Note that the document E – OMS Change Requests also applies to the registration of new companies in OMS.
You can also learn more about OMS in this video tutorial:
- Overview of OMS (see especially module 03 on change requests to OMS)