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    Changes in reporting adverse drug reactions to Eudravigilance

    08.12.2017
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    Responsibilities of Marketing Authorisation Holders

    MAHs need to submit electronically to EVPM information on all serious suspected adverse reactions that occur in the Union and in third countries within 15 days following the day on which the MAH concerned gained knowledge of the event.

    MAHs need to submit electronically to EVPM information on all non-serious suspected adverse reactions that occur in the Union, within 90 days following the day on which the MAH concerned gained knowledge of the event.

    There is no need to additionally notify the State Agency of Medicine.

    There will be no changes to the reporting of SUSARs during clinical trials.