This year has been important in the area of pharmacovigilance in the European Union. It has seen the application of new rules that were agreed in 2010. This month there will be a further amendment of the legislation which is expected to fully apply by the end of 2013.
All medicinal products in the EU are subject to strict testing and assessment of their quality, safety and efficacy before being authorised for marketing. Once a medicinal product has been authorised, its safety continues to be monitored to ensure that action is taken to ensure public health when there are adverse reactions that present an unacceptable level of risk. This monitoring is called pharmacovigilance.
The EU pharmacovigilance system is one of the most advanced and comprehensive systems in the world. It represents a robust and transparent system to ensure a high level of public health protection throughout the EU.
Now patients across the EU can report directly online or by post to their national authority adverse reactions they have experienced. Next year, they will see the inclusion of a ‘black symbol’ in the information about medicines that are under additional monitoring, for example those containing a new pharmaceutical ingredient. Patients, doctors, nurses and other health practitioners will be particularly encouraged to report any adverse reactions to these medicines.
The legislation on pharmacovigilance is a part of the EU regulation on medicines that assures the safety of medicines across the EU.
