Update on Medicines Subject to Additional Monitoring Requirements and Texts for Inclusion in Product Information on ADR reporting
IMB reporting requirements for submission of Individual Case Safety Reports (ICSRs)
Further to publication of GVP Module VI on the European Medicines Agency website on 25 June 2012, please note that the following national adverse reaction reporting requirements will apply from July 2012 until the end of the transitional period (within six months of the functionalities of the Eudravigilance database being announced by the Agency).
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Adverse Reaction Report Type
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Source
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Reporting requirements during Transitional period
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Serious Irish
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HCP
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Continue to submit to IMB only within 15 days^
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Consumer
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Submit to IMB only within 15 days^
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Non-serious Irish
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HCP
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No direct submission to IMB required*
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Consumer
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No direct submission to IMB required*
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Serious non-Irish
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HCP
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No direct submission to IMB required*
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Consumer
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No direct submission to IMB required*
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Non-serious non-Irish
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HCP
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No direct submission to IMB required*
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Consumer
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No direct submission to IMB required*
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^Please note that the IMB will forward all Irish serious cases received directly to EudraVigilance. During the transitional period, MAHs should not report these Irish serious cases to EudraVigilance as this will lead to duplicate reporting.
*Reports to EudraVigilance and other NCAs should be submitted in accordance with the European Medicines Agency document on Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim arrangements.
Questions and Answers Document on Practical Transitional Measures for the Implementation of the Pharmacovigilance Legislation
The European Medicines Agency has released a document addressing Questions and Answers on Practical Transitional Measures for the Implementation of the Pharmacovigilance Legislation (most recently updated on 30 November 2012).
This document applies to all medicinal products for human use regardless of the route of authorisation.
The questions and answers in this document represent the view of the European Medicines Agency and Member States and have been subject to consultation with the European Commission. It is recommended that the information is read in conjunction with Commission questions and answers on transitional arrangements (see European Commission website).
European Medicines Agency publishes list of EU reference dates and frequency of PSUR submission
The European Medicines Agency has published (1 October 2012) the list of European Union reference dates and frequency of submission of periodic safety update reports (PSUR) known as the 'EURD list'. This is a comprehensive listing of active substances and combinations of active substances contained in medicinal products subject to different marketing authorisations, together with the corresponding Union reference dates, frequencies for submission of PSURs and related data lock points.
The EURD list is available from the European Medicines Agency website. Additional supporting information is also available including details on requesting amendments and an introductory cover note.
Information on changes to required documentation for renewals
Some changes to required documentation for renewals apply as a result of Directive 2010/84/EU. Additional guidance in this regard is available as follows:
IMB Pharmacovigilance Information Day
The IMB hosted a Pharmacovigilance Information Day on Friday 2 December 2011. The event was organised specifically to address the implementation of the new European pharmacovigilance legislation.
In addition to presentations from IMB staff members, representatives from the European Medicines Agency, the UK’s Medicines and Healthcare products Regulatory Agency and the European Organisation for Rare Diseases (EURORDIS) also addressed the audience.
The presentations are available to download and will be of particular interest to those dealing with pharmacovigilance of human medicinal products including both marketing authorisation holders and healthcare professionals.