OMS and EudraGMPD - a responsibility of your organisation

Regulatory Affairs (RA)
Written By Laila Frederiksen

OMS (Organisation Management Service) and EudraGMDP.

Shortly, all companies must check and maintain company data in EMA’s Organisation Management Service (OMS).

As of 28 January 2022 organisations must verify that their relevant locations (company name and location address details) are correctly recorded in OMS, when applying for a new/updated manufacturing or wholesale distribution autorisation with national competent authorities.

So, all companies are advised to check if their company has been set up correctly in OMS before 28 January 2022 to avoid delays in submissions.

This applies to all organisations on documents within EudraGMDP, including EU and non-EU manufacturers, importers and distributors of human and veterinary medicinal products and active substances.

—> For more information please contact: Laila Frederiksen

Laila Frederiksen
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