The European Medicines Agency, together with the European Member States and the European Commission, is preparing for the introduction of the new pharmacovigilance legislation in July 2012, which will bring the biggest change to the legal framework since the establishment of the Agency in 1995.

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.