Simplified Adverse Event Reporting in Europe – Are You Prepared for the Switch Over?

Since the introduction of the pharmacovigilance legislation in 2010, a commitment to a simplified approach to adverse event reporting was introduced by the EMA (Articles 107(3) and 107a(4) of Directive 2001/83/EC). This approach would only apply however following an independent audit of the EudraVigilance database.

Ad interim, the adverse reaction reporting is based on the provisions set out in Article 2(4), Article 2(5) and Article 2(6) of Directive 2010/84/EU and in line with national legislation and guidance where applicable. This is referred to as the so-called ‘Interim period’ which continues to be in place.

What Are The Interim Arrangements for Simplified Adverse Event Reporting?

The arrangements for adverse reporting in the so called ‘Interim period’ are detailed in both GVP module VI and in an EMA guidance document. Depending on the occurrence country, how an adverse event should be reported varies greatly. In Ireland for example, a serious adverse event should only be reported to the HPRA. In Belgium, it should only be reported to EudraVigilance. In Hungary it should be reported to both the NCA and to EudraVigilance.

Final Arrangements

Six months following the announcement of the successful outcome of the independent audit of EudraVigilance database, the so called ‘simplified reporting’ rules will apply henceforth. Current EMA estimates for the switch over put this at Q4 2017. What will the new rules mean for MAHs? Thankfully it means things do become much simpler – all ICSRs that occur in the EEA, be they serious or non-serious are simply reported to EudraVigilance according to the existing 15 and 90 day timeframes. MAHs no longer need to navigate the maze of country specific reporting requirements mandated during the interim period. For more information refer to the business process map in Figure 1.

Figure 1 – Business process map – Suspected adverse reaction reporting in EU – Final arrangements (Copyright European Medicines Agency. GVP Module VI)

Simplified Adverse Event Reporting


MAHs who use EVWEB should undergo training on EVWEB and the new ICH E2B(R3) format to familiarise with new functionalities and changes as there will be a new interface and improved functionalities. MAHs may use the E2B(R3) format for reporting of ICSRs to EV or continue to report based on the E2B(R2) format as no deadline has yet been established for discontinuation of R2.

If you would like assistance with this, then please get in touch.  Call us on 00353 52 61 76 706 or complete your details below and we will get back to you.

Further Reading from Acorn Regulatory

What Are Post-Marketing Surveillance Studies?

Post-marketing surveillance studies are defined in  Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised to obtain further information on a medicine’s safety or to measure the effectiveness of risk-management measures.  In this article, our Medical Manager, Dr. Danica Cvetkovic, looks at post-marketing surveillance studies and the link with Risk Minimisation Plans (RMP’s)

Read the article here.

Understanding MDR: 8 Important Changes

The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector.  The new regulations will bring about many changes compared to the current regulatory framework.  We look at the basics of the new MDR and the changes that will impact the device sector from May 26th, 2020. Read the full article here.

Need A WDA? Read Our Step By Step Guide

There has been significant growth in the number of companies seeking a Wholesale Distribution Authorisation (WDA) in recent years.  We have assisted many companies with every step of the process. Here, we outline a step by step guide for obtaining a WDA.  Read the full article here.

How To Prepare For A Pharmacovigilance Inspection

A pharmacovigilance inspection can be a daunting prospect for many companies.  Since 2002 we have worked with countless companies to guide them through their inspections. We look at the measures that your company can take to be prepared.  Read the full article here.

How To Complete A Type I Variation

Type I Variations to a Marketing Authorisation are surprisingly difficult.  The procedure that many people perceive to be a simple process can prove to be otherwise.  This article looks at how to complete a type 1 variation and we will consider:

  • common deficiencies
  • common validation issues
  • the challenges posed by the eAF
  • what to do when documentation is missing
  • how to handle GMP variations
  • what happens when a CEP is presented for an active substance instead of a GMP certificate

After reading this article you will be better placed to complete a Type I Variation to a Marketing Authorisation while avoiding the common pitfalls outlined below.  Read the full article here.

What Are The Initial Steps in Applying for a Marketing Authorisation?

We consistently receive questions regarding the steps required when applying for a marketing authorisation (MA).  In this article, we aim to provide a guide to assist companies applying for an MA

We have also provided a number of links throughout the article to relevant articles, authorities, organisations, and pieces of legislation to assist you.  Read the full article here.

KASA – What You Need To Know About Knowledge-Aided Assessment and Structured Application

What is KASA and how will it impact on getting a drug assessed by the US FDA?  We look at its ‘3 pillars’ and what it aims to be.  Importantly, we look at how the FDA believes it will change how drugs are assessed in the United States of America.

Read more about KASA here.

Pharmacovigilance Services

We offer a complete and comprehensive pharmacovigilance service to assist you in meeting your legal obligations as Marketing Authorisation Holder (MAH). Our pharmacovigilance consultants have significant experience in working with companies all over the world.

As a company that works with a global client base, we handle a wide range of pharmacovigilance related issues for client companies.  Some of the most frequently requested services that we offer are detailed below.  If we can assist you, then please get in touch with us.  Read more about our pharmacovigilance services here.

About the Author
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD