EMA posts new Q&A on pharmacovigilance implementing rules
This article was originally published in SRA
The European Medicines Agency has issued an updated question and answer document on pharmacovigilance requirements for human drugs (EudraLex Volume 9A)1,2. The revised document (version 5.4), issued on 29 March, is applicable to all stakeholders exchanging individual case safety reports electronically within the European Economic Area.
The updated document supersedes version 3.2 published in October 2008 and contains new questions and answers (38 to 64) dealing with a range of pharmacovigilance issues. It explains, for example, what is requested in terms of re-testing when company databases are upgraded or modified and whether marketing authorisation holders are expected to update terms in the Medical Dictionary for Drug Regulatory Affairs (MedDRA) described in a submitted EU risk management plan with every release of the dictionary.
Also, it elaborates on what a marketing authorisation holder should do when the medicinal product manufacturer informs it about a reaction occurring with the concerned medicinal product. Specifically, it explains how the case should be handled when it occurs in a country where the MAH does not hold a marketing authorisation for the concerned medicinal product and whether the case should be considered for expedited/periodic reporting.
In the document, the EMA also explains what a company should do if it identifies valid individual case safety reports on internet websites, such as blogs and forums, but the minimum information for processing the cases is not available – for example, the country of the primary source is missing. In such situations, it explains what convention should be used for providing information regarding the country.
References
1. EMA, EudraLex – Volume 9A – Questions and answers on implementation: Version 5.4 (EMA/46003/2011), 29 March 2011, www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2011/03/WC500104368.pdf
2. EudraLex Volume 9A of The Rules Governing Medicinal Products in the European Union, Guidelines on Pharmacovigilance for Medicinal Products for Human Use, September 2008, http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf