Prepare for the new EudraVigilance obligations starting this November

Written by: Fleming. Team

Applicable to both marketing authorization holders and national competent authorities, new obligations regarding signal management and ADR reporting will come into force on November 22, 2017. This should end the transition period of the pharmacovigilance legislation from July 2012.


The new obligations concern the following four areas:


1. Signal management

Processes within signal management will be updated and described in detail in the upcoming revision of Guideline on good pharmacovigilance practices (GVP) Module IX – Signal Management (expected to be published at the end of this year).

2. ADR reports

For marketing authorization holders, there are a few important changes in electronic reporting requirements expected:

• Marketing authorization holders will be sending reports of suspected adverse drug reactions (with submissions under Regulation (EC) No. 726/2004 and/or Directive 2001/83/EC) directly to EudraVigilance. Afterwards, they will be re-sent to the relevant Member States.

• Instead of receiving them, marketing authorization holders will have to download ADR reports directly from EudraVigilance.

• Non-serious ADR reports from the EEA should be submitted to EudraVigilance within 90 days.

• Coming into force on 22 November 2017, the revised Guideline on good pharmacovigilance practices Module VI - Management and reporting of adverse reactions to medicinal products should be adhered to.

3. ICH E2B(R3) format

The current ICH E2B(R2) format will be replaced with the new ICH E2B(R3) format, influencing the content of ADRs. Used for the electronic exchange of ADRs, it will serve to improve the data quality.

4. Art 57 database

In order to comply with the new EudraVigilance obligations, all marketing authorization holders have to make sure that their data in the Art 57 database is always complete and up to date.