About the Legislation

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.

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

About the Legislation