European Economic Area [EEA]

Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one of two paths - the decentralised procedure, or the centralised procedure. In some cases in Europe, the centralised procedure is mandatory.

EudraVigilance is an EU web-based information system, designed to manage safety report data created by the European Medicines Agency (EMA) containing adverse reaction reports (ADRs) for medicines authorised in the EU.

Safety communication is put in place to communicate adverse reactions or any safety findings to regulators, healthcare providers and patients. Safety communications are provided by marketing authorisation holders and health authorities, and may include restrictions, contraindications, dose limitations, warnings, and recommendations.