The Danish Medicines Agency cannot receive electronic adverse drug reactions via E2B in the period November 19th from 10:00 CET to November 24th

11 November 2020

Due to implementation of a new IT-system is it not possible for the Danish Medicines Agency to receive electronic adverse drug reactions (SUSARs) via E2B (DKMAEUDRA) in the period November 19th (10:00 CET) to November 24th 2020. Submissions to EVCTMPROD are not affected.

Reporting obligations are considered fulfilled if SUSARs are submitted to EVCTMPROD only in the period for DKMAEUDRA outage. SUSARs should be sent to The Danish Medicines Agency as soon as connectivity has been resumed. The Danish Medicines Agency will post information when systems are available for submission again.

Reporting of SUSARs via eForm is not affected by the outage.

Please note that the eForm is only targeted users not submitting via E2B and should therefore not be used for reporting via alternative means in the period.

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