The European Medicines Agency (EMA) has published the European Union regulatory network incident management plan for medicines for human use.
This plan which has been in operation since September 2009, explains how the European Medicines Agency, the European Commission and medicines regulatory authorities work together in the EU Member States to ensure that the most appropriate actions are taken across the EU whenever incidents (new events or information) arise concerning human medicines. It covers medicines authorised centrally, nationally and through the decentralised and mutual-recognition procedures.
Although incidents may relate to quality, efficacy or safety concerns, they usually involve issues related to pharmacovigilance, such as new safety hazards. However, they can also involve issues related to both safety and quality concerns. In addition, situations such as supply shortages caused by manufacturing or good-manufacturing-practice (GMP) compliance problems also fall within the scope of the incident management plan.
The plan covers both the proactive continuous monitoring of incidents that may have an impact on public health as well as actions taken in more extreme situations, when crises are managed in a reactive manner. It also describes how information is exchanged across the EU whenever new information on medicines arises.
It has recently been amended to reflect the provisions in the 2010 pharmacovigilance legislation, with the version published today being adopted formally by the Heads of Medicines Agencies in June 2012.
Source EMA Press Release