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EU Clinical Trials Information System training programmes22.01.2021Notification for marketing authorisation holders (hereinafter - MAH): date of approval of variations, updated after comments received29.10.2020Updated guidance on clinical trial management in the context of COVID-19 pandemic07.10.2020

Information for marketing authorisation holders: date of approval of variations30.09.2020Updated Guidance on DCPC - submission of the text and communication plan05.08.2020Updated Guidance on Additional risk minimisation measures (aRMM) - submission of educational materials 05.08.2020

Information for marketing authorisation holders: EMA finalises opinion on presence of nitrosamines in medicines10.07.2020Guidance on clinical trial management in the context of COVID-19 pandemic28.04.2020Procedural guidance during COVID-19 pandemic20.04.2020

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