Reporting a Reaction to a Drug in the EU

In the European Union (EU), patients do not report directly to the Regulatory Authorities. The EU agency that is responsible for Drug Safety (Pharmacovigilance) is the European Medicines Agency (EMA), similar to the US Food and Drug Administration (FDA). Patients in the EU should report side effects to a medicine by informing their doctor or pharmacist. According to the EMA, these health care professionals can help put the information into the right medical context for further evaluation by the authorities, particularly if they suspect a serious or severe reaction. The EMA's goal is evaluate each case and when indicated take action, which

will involve warnings to the public and the medical community aimed at ensuring the safe use of a medicine and the prevention of future side effects. In extreme situations and, when justified, medicines have been removed from the market in order to protect public health. This is when the balance of risks outweighs benefits of the particular medicine. The EMA maintains a very informative website www.eudravigilance.ema.europa.eu