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E-reporting / «Pharmacovigilance»

In relation to the release of new EudraVigilance functionalities we would like to inform you that as of 22.11.2017 are valid the following electronic reporting rules:

  • 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.
  • MAHs need to use the EVWEB functionalities to gain access and download ICSR reports reported by NCA to the EVPM.

After 22.11.2017 there will be no changes to the reporting of SUSARs during clinical trials until the application of the Clinical Trial Regulation. Sponsors of clinical trials should follow the current SUSAR reporting principles set out in the Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’) (2011/C 172/01).

More information on the following link:

EudraVigilance


Contact details:

Responsible person for EudraVigilance at the BDA:

Violeta Getova, MScPharm

Pharmacovigilance and Clinical Trials Department

+359 2 89034 91

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