Important Change for Entries in EudraGMDP Database

The new regulatory framework for veterinary medicinal products requires several changes to the EudraGMDP database. One important change is the integration of EudraGMDP into the 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.

For this purpose, EMA is organising a webinar (Integration of EudraGMDP and OMS - Webinar for industry).

The webinar for industry users will cover:

• Integration of EudraGMDP and OMS - implications for industry users;
• OMS services and activities;
• OMS change request process;
• customer service (EMA Service Desk)
• data quality management.