DeutschEnglish

EMA EudraVigilance Umstellungsphase

messages in brief |

Following the EMA Management Board confirmation and announcement in May 2017 that the database has achieved full functionality, the new version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions.


To allow for a smooth transition from the current to the new EudraVigilance system, a cutover (downtime) period of 10 business days i.e. from 8 to 21 November 2017 is required, where key functionalities of EudraVigilance will not or only partially be available.

  • The EudraVigilance registration system will not be available.
  • EVWEB, the application for electronic reporting of individual case safety reports (ICSRs) for authorised medicinal products and suspected unexpected serious adverse reactions (SUSARs) for products subject to investigation in clinical trials in the EEA, will not be available.
  • XEVMPD (Art.57 database) will not be available for the electronic submissions of data on medicines (Article 57).
  • The EudraVigilance Gateway will be partially available.


Please be aware:

 

  • During the downtime the sender organisation (MAH) stops the electronic submission of ICSRs to the Austrian Agency (BASG/AGES Medizinmarktaufsicht) as of 8 (00:00) November 2017.
  • The Austrian Agency will stop sending ICSRs to EVPM as of 8 (00:00) November 2017 and will stop sending Acknowledgements to MAHs as of 8 (00:00) November 2017.
  • Events/observations identified, which may affect the risk-benefit balance of a medicinal product during the cutover period, should be notified as emerging safety issue in accordance with GVP Module VI, and the Austrian national law via email to: P-PV-emerging-safety-issue@ema.europa.eu and to the competent authority in Austria via email (pharm-vigilanz@ages.at)
  • The sender organisation (MAH) should submit valid ICH E2B(R2) or ICH E2B(R3) safety messages to EudraVigilance (EVPM) when the gateway and the new EudraVigilance system is going live on 22 November within 2 business days. The reporting should follow the new simplified reporting rules.


Information for Sponsors of clinical trials:

Sponsors, who have already submitted the following form: “Ansuchen um Befreiung von der Meldungsverpflichtung über schwerwiegende Nebenwirkungen gemäß § 41e AMG an das Bundesamt für Sicherheit im Gesundheitswesen (BASG)” and send SUSAR reports directly to the the Pharmacovigilance Database of the European Medicines Agency (EudraVigilance-Clinical Trial Module) should stop sending SUSARS to EVCTM as of 8 (00:00) November 2017. SUSAR reports occurred in this time frame are to be submitted electronically by the sponsor to EVCTM after 22nd of November.

Sponsors, who have not submitted the waiver to BASG/AGES, should fulfill this obligation as soon as possible and SUSAR reports should be transmitted in CIOMS I format to:
Email: pharm-vigilanz@ages.at
or
Fax: +43 (0) 50 555 36207
or
Post:
BASG - Bundesamt für Sicherheit im Gesundheitswesen AGES - Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH Traisengasse 5 A-1200 Wien
Austria
Emails will be registered and acknowledged.

 

EMA Homepage
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/10/news_detail_002820.jsp&mid=WC0b01ac058004d5c1

 

Go Live Plan

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/09/WC500235774.pdf

Back