They must ensure that their sites are registered in OMS. As of 28 January 2022, before applying for a new or updated manufacturing or wholesale distribution authorisation with national competent authorities, a correct registration in OMS is mandatory.

What makes this step necessary?

The new regulatory framework for veterinary medicines (Regulations 2019/6 and 2021/16 and Article 9(h)) thereof, requires changes to the EudraGMDP database. Those will become effective as of 28 January 2022.

EMA will organize 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. Interested participants should register by 5 October. The webinar will be recorded and published on EMA’s website later on.

EMA: OMS