EudraGMDP to be integrated with EMA’s Organisation Management Service (OMS)

Regulations 2019/6 and 2021/16, Article 9(h)  |   05 October 2021 

As communicated by EMA:

“The new regulatory framework for veterinary medicines requires several changes to EudraGMDP. The most notable change is the integration of EudraGMDP with EMA’s Organisation Management Service (OMS).

From 28 January 2022, users of EudraGMDP from national competent authorities will no longer introduce organisational data (organisation name and location address details) directly into the relevant fields on the EudraGMDP database. Instead, they will select the relevant organisation name and location address details, including the legally registered address, of the manufacturers/importers/distributors from the Agency’s organisation dictionary (so-called OMS).

It is therefore necessary that all organisations currently regulated through EudraGMDP (which appear on documents within EudraGMDP, including EU and non-EU manufacturers, importers and distributors of human and veterinary medicinal products and active substances) are registered in OMS.”

The development of the database – the Manufacturers and Wholesale Distributors database (MWD) – started on 1 July 2021 and is currently in its test phase.

Status – EudraGMDP to OMS Integration (source: Veterinary Medicinal Products Regulation HIGHLIGHTS, European Medicines Agency, Issue 6, July 2021)

What is the Organisation Management Service (OMS)?

As per EMA 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 comprising organisation name and location address for organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers. “

OMS has published a Data Quality Standard and integrating EudraGMDP with OMS should ensure more reliable data in the system through the consistent use of organisation master data in EudraGMDP.

What does this mean for access to public data in EudraGMDP?

Our understanding is that “access will continue as before – no changes are foreseen”.  

Webinar

The EMA will organise a webinar on the OMS services for interested manufacturers, importers and distributors on 12 October 2021 at 14:00 – 16:30 CEST. Participants will have the chance to ask questions and seek clarifications on OMS services and activities.

Share

Share on linkedin
LinkedIn
Share on twitter
Twitter
Share on facebook
Facebook
Share on whatsapp
WhatsApp
Shopping Basket