News about GMP/cGMP

29.09.2021

EUDRAGMDP: EMA with important information for all users

EUDRAGMDP: EMA with important information for all users

As communicated by the EMA, the EUDRAGMDP database will be „merged“ with EMA’s Organisation Management Service (OMS). This is an important change to be aware of for all manufacturers, importers and distributors of human and veterinary medicines whose information is recorded in EUDRAGMDP.


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


 

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