Prepare for the new EudraVigilance obligations

Written by: Fleming. Team

On 22 November 2017, the launch of the new EudraVigilance System went live. Applicable to both marketing authorization holders and national competent authorities, new obligations regarding signal management and ADR reporting came into force.


The new obligations concern the following four areas:


1. Signal management

To be in line with the new GVP IX requirements, standalone notifications of signals detected in EudraVigilance should be sent to the EMA and competent authorities in Member States where the medicinal product is authorized. The standalone signal notification form should be used.

2. ADR reports

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

• Marketing authorization holders should send 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 now 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 previous ICH E2B(R2) format was replaced with the new ICH E2B(R3) format, influencing the content of ADRs. Used for the electronic exchange of ADRs, it should 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.


Make sure you comply with the new obligations with Shelley Gandhi, expert with over 20 years of experience in pharmacovigilance, at the upcoming Signal Management Throughout Products Life-Cycle: Pre to Post Authorization training (20 – 21 September 2018, Amsterdam, Netherlands).