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Pharmacovigilance system: Eudravigilance Downtime

The EMA Eudravigilance system will be unavailable from 8 November to 21 November 2017.

VMD

Following on from the EMA notification stating that the Eudravigilance Veterinary Production system will be unavailable from 8 November to 21 November 2017; VMD would like to remind you of what has been agreed with the EMA.

EVWeb Users

During the downtime period, no reports should be submitted via EVWeb.

Do not use paper reports, all reports must be kept and reported electronically within the week following the downtime, from 9am on 22 November to 29 November 2017.

During the downtime period, if any urgent safety issues are identified, you should contact us directly by phone 01932 338427 or Adverse.Events@vmd.defra.gsi.gov.uk

Gateway Users

During the downtime period, EMA has stated that gateway to gateway transmission, between MAHs and NCAs will continue to operate as normal, and it is only transmission to the EMA which will not operate.

Therefore during this period, we would request that all MAHs using the gateway system continue to submit reports to the VMD, and VMD will continue to send reports to you. However, we recommend that each MAH send 1 or 2 reports at the start of the downtime, and then contact us by phone or email to confirm that the reports have been successfully received before submitting any further reports, to ensure that the system is working as expected.

If you have any questions, please contact the VMD Pharmacovigilance team on 01932 338427 or Adverse.Events@vmd.defra.gsi.gov.uk.

Further information is available from EMA.

Published 18 October 2017