EMA: Q&As from webinar on EudraGMDP/OMS for veterinary medicines
The European Medicines Agency (EMA) has published a 13-page Q&A including 87 questions and answers from a webinar held on the topic of integrating EudraGMDP and OMS (Organisation Management Services) into the new regulatory framework for veterinary medicines.
According to the 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).
Before applying for a new/updated manufacturing or wholesale distribution authorisation with national competent authorities, organisations have to verify that their relevant locations are correctly recorded in OMS. This applies to all organisations which appear on documents within EudraGMDP, including EU and non-EU manufacturers, importers and distributors of human and veterinary medicinal products and active substances.
The Q&A covers all questions that came up during the webinar.
Source:
EMA: Integration of EudraGMDP and OMS - Webinar for industry
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