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 have been effective since July 2012.

The legislation is outlined in (1) Regulation (EU) No 1235/2010 and (2) Directive 2010/84/EU. The legislation is accompanied by the implementing regulation which was published by the European Commission in June 2012. Implementing Regulation (EU) No 520/2012 provides details on the operational aspects for the new legislation.

Legislation to bring the Directive into law in Ireland was signed by the Minister for Health, Dr. James Reilly, on 25 July 2012. This legislation has been officially published in the Irish Statute Book and comprises:

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

The Irish Medicines Board - www.imb.ie

New EU Pharmacovigilance Legislation