This section of our website is updated regularly and includes new developments in Irish and EU pharmacovigilance practices and legislation. Details of current and past Public Consultations linked to the new EU pharmacovigilance legislation are also available. Industry stakeholders should visit the Guidance for Marketing Authorisation Holders section where all relevant regulatory documents and updates can be easily accessed.
European Medicines Agency publishes new and updated to Good Vigilance Practice guidelines
30/04/2013 - The European Medicines Agency has published new and updated Good Vigilance Practice guidelines on its website:
New guidelines
- GVP Module X Additional Monitoring
Note: Further information on additional monitoring is available here
Updated guidelines/supporting documents
- GVP Module VIII Post-authorisation safety studies – amended with practical clarifications
- GVP Module VIII Addendum I PASS Member States’ requirements
- GVP Annex II Templates PSUR Cover page
- GVP Annex V Abbreviations
European Medicines Agency publishes initial list of medicines subject to additional monitoring
25/04/2013 - The European Medicines Agency has published an initial list of medicines that will be subject to additional monitoring. These medicines will be identifiable by an inverted back triangle included in the package leaflet and in the summary of product characteristics (SmPC).
All medicines on the European Union (EU) market are carefully monitored and the inclusion of a medicine on the list does not mean that the medicine is unsafe. The purpose of the triangle is to actively encourage healthcare professionals and patients to report any suspected adverse reactions observed with the medicine, either because the medicine is new to the market or because there is a limitation to the data available on its safety.
Further information, including the list of medicines, a background document and the associated press release, is available from the European Medicines Agency website.
Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim period
European Medicines Agency publishes initial list of medicines subject to additional monitoring 25/04/2013 - The European Medicines Agency has published an initial list of medicines that will be subject to additional monitoring. These medicines will be identifiable by an inverted back triangle included in the package leaflet and in the summary of product characteristics (SmPC). All medicines on the European Union (EU) market are carefully monitored and the inclusion of a medicine on the list does not mean that the medicine is unsafe. The purpose of the triangle is to actively encourage healthcare professionals and patients to report any suspected adverse reactions observed with the medicine, either because the medicine is new to the market or because there is a limitation to the data available on its safety. Further information, including the , a and the associated , is available from the European Medicines Agency website.
09/04/2013 – The European Medicines Agency has published an updated version of the Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim period document. There are no changes to Irish reporting requirements.
European Medicines Agency publishes list of EU reference dates and frequency of PSUR submission
01/10/2012 – The European Medicines Agency has published the list of European Union reference dates and frequency of submission of periodic safety update reports (PSUR) known as the 'EURD list'. It provides a comprehensive list 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. Further supporting information including details on requesting amendments and an introductory cover note is also available.
National Legislation transposing 2010/84/EU now published
24/08/2012 - The national legislation transposing the EU pharmacovigilance legislation was signed by the Minister for Health, Dr. James Reilly, on 25 July 2012. This legislation has now been officially published in the Irish Statute Book and comprises of:
Update to Questions and Answers Document on Practical Transitional Measures for the Implementation of the Pharmacovigilance Legislation
30/11/2012 - The European Medicines Agency has updated it’s document addressing Questions and Answers on Practical Transitional Measures for the Implementation of the Pharmacovigilance Legislation.
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).
Good Pharmacovigilance Practices - Further Modules Published
13/12/2012 - The European Medicines Agency has published two further modules of the guideline on Good Pharmacovigilance Practices (GVP). The modules are:
26/07/2012 - The European Medicines Agency has released two further modules of the guideline on Good Pharmacovigilance Practices (GVP) for public consultation. The deadline for comments is 21 September 2012. The modules are:
(This consultation process is now closed.)
Summary of IMB reporting requirements for submission of Individual Case Safety Reports (ICSRs)
28/06/2012 - Further to publication of GVP Module VI on the European Medicines Agency (EMA) 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.
IMB Pharmacovigilance Information Day
02/12/2011 – 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.