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Signal Management in the European Union

The European Medicines Agency (EMA), together with the regulatory authorities in the Member States and marketing authorisation holders are responsible for detecting and managing safety signals.

Safety signals can be detected from a wide range of sources, such as spontaneous reports, clinical studies and scientific literature. The EudraVigilance database is an important source of information on suspected adverse reactions and signals.

EMA - Questions & answers on signal management

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GVP Module IX

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PRAC - Pharmacovigilance Risk Assessment Committee

PRAC recommendations on safety signals

Each month, the European Medicines Agency publishes an overview listing all safety signals discussed during the latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting and the recommendations given for each of them. The overview includes PRAC recommendations for centrally and nationally authorised medicines.

PRAC recommendations for regulatory action (i.e. amendment of the product information) are submitted to:

Marketing-authorisation holders are expected to take action according to the recommendations. They should monitor the information on this page regularly to keep informed about the PRAC recommendations concerning their products.

The presence of a safety signal does not mean that a medicine has caused the reported adverse event. The adverse event could be a symptom of another illness or caused by another medicine taken by the patient.

The overview of PRAC recommendations is published after each month's CHMP and CMDh meeting. The first list was published in October 2013 and lists the recommendations from the September 2013 PRAC meeting. A cumulative list of all signals discussed at the PRAC since September 2012 is also available below.

Starting from the January 2015 PRAC meeting, the Agency now publishes recommendations for updates of product information translated into all official European Union (EU) languages.

The Agency publishes these translations in all official EU languages, as well as Norwegian and Icelandic, in the table below after review of their quality by the national regulatory authorities in the EU Member States.

Marketing-authorisation holders can use these translations to update their product information.

The Agency expects this initiative to accelerate the implementation of changes to product information and to ensure consistency across EU countries, thus leading to better information for patients on their medicines.