EMA clarifies MAH obligations to record adverse events accessed through EudraVigilance

The European Medicines Agency (EMA) has published a note which clarifies the pharmacovigilance obligations of marketing authorisation holders (MAHs). The note provides information about when MAHs must record information regarding adverse events they access via EudraVigilance.

The new EudraVigilance system, which was launched on 22nd November 2017, means that the simplified (electronic) reporting of suspected adverse reactions related to medicines in the format of Individual Case Safety Reports (ICSRs) by national Competent Authorities (NCAs) and marketing authorisation MAHs to the EudraVigilance database became mandatory. Based on this simplification, NCAs and MAHs no longer have to report to each other directly, thus reducing duplicative reporting.

From 22nd November 2017 onwards, if an MAH finds a suspected adverse event linked to one their substances submitted by a national regulator to EudraVigilance, the EMA expects the company to record the details of the reaction. The EMA does not expect MAHs to retroactively screen the database for cases filed before 22nd November that are missing from their own systems. The EMA states that its rules do not stop MAHs from reconciling or adding old cases in the context of a safety assessment, such as the identification of a new risk.

In the note the EMA also clarifies the obligations a MAH faces when it sees a case uploaded to EudraVigilance by another manufacturer of a substance for which both companies hold a marketing authorisation. In this case, it is up to the MAH to decide whether they need to record details of the adverse event; the decision is based on what the MAH needs to do in order to comply with their pharmacovigilance obligations.

To view the note for clarification on recording by MAHs of information on suspected adverse reactions held in EudraVigilance, please click here.