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)
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.
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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
