The European Medicines Agency informs stakeholders on the introduction of new pharmacovigilance legislation

The European Medicines Agency has published a new implementation plan detailing the activities of the new pharmacovigilance legislation scheduled for implementation in 2012 and those activities which will be the focus beyond 2012. With the new legislation, any patient in European Member States will be able to report suspected adverse drug reactions to his or her national medicines authority.

The introduction of the new pharmacovigilance legislation in July 2012 will bring the biggest change to the legal framework since the establishment of the European Medicines Agency in 1995. Therefore, the Agency and European Member States are preparing for fundamental changes in pharmaceutical legislation. Over the next five months, the Agency will finalise its preparations for the inaugural meeting of the new Pharmacovigilance Risk Assessment Committee (PRAC), planned for 19 July 2012. The Agency already announced in December that during 2012, it will focus on the implementation of this new legislation.

In addition, the Agency will continue to inform stakeholders of the ongoing implementation process through its website and stakeholder meetings. This will include consultation and guidance on new or revised processes, information on transitional arrangements for the pharmaceutical industry, and information on how patients and healthcare professionals can be involved in the detection and management of safety issues in European Member States. This information will complement the implementing measures being finalised by the European Commission.

Any patient in the EU will be able to report suspected adverse drug reactions to his or her national medicines authority with the new legislation. Furthermore, the new pharmacovigilance legislation will significantly increase the transparency of all pharmacovigilance activities of the Agency and the European Member States. The Agency will cooperate with the Member States on providing information to patients on direct reporting during 2012.