New EU Pharmacovigilance Legislation

New European Union (EU) pharmacovigilance legislation was adopted by the European Parliament and Council of Ministers in December 2010. Many of the new provisions contained in the legislation must be implemented within 18 months (by July 2012).

The incoming legislation is outlined in (1) Regulation (EU) No 1235/2010 and (2) Directive 2010/84/EU. Irish legislation to bring the Directive into law in Ireland is currently being prepared by the Department of Health.

The IMB is working with a wide range of stakeholders including the European Medicines Agency and other national regulators to prepare for the introduction of the new legislation. Patients, the pharmaceutical industry and healthcare professionals are also being consulted by the regulatory authorities to ensure effective implementation.

Why is the new legislation being introduced?
The new legislation, which amends existing legislation, is intended to further protect public health by strengthening the current European-wide system for monitoring the safety of medicines.

In particular, the new legislation aims to improve the pharmacovigilance system in the EU, making the reporting of adverse drug reactions (or side effects) easier and introducing special provisions for medicines that need additional monitoring. The legislation also aims to ensure that members of the public become better informed about the benefits and risks of taking medicines.

When are the new provisions contained in the legislation being introduced?
The European Medicines Agency has published (2 February 2012) a plan for implementation of the new pharmacovigilance legislation. The plan provides a summary of the activities the Agency will implement, in partnership with European Member States, during 2012 and those that it will focus on beyond 2012. Activities are grouped into four main topic areas reflecting the overall process for safety monitoring in the European Union.

Collection of key information on medicines
Better analysis and understanding of data and information
Regulatory action to safeguard public health
Communication with stakeholders

Patients and Public
The EU has published a Questions and Answers document detailing how the new pharmacovigilance legislation will ensure greater patient safety. The European Medicines Agency has also outlined the impact of the new legislation on EU citizens and patients.

Pharmacovigilance Information Day - 02 December 2011
The IMB hosted a Pharmacovigilance Information Day on Friday 2nd 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.

Further Information
Additional information will be added to this section of the IMB website in the coming months. To ensure you receive notification of important updates published on this website, please subscribe to our updates service (if you are not currently receiving website updates from the IMB).

Further information relating to the legislation is also available from the official EU website and from the European Medicines Agency website.

The Irish Medicines Board - www.imb.ie

New EU Pharmacovigilance Legislation