Pharmacovigilance and Risk Assessment Committee [PRAC]

Risk management is important in medicines development and pharmacovigilance in order to avoid crisis situations and harmful consequences. There are various kinds of risk; risk management strategies must assess and minimise these, and balance them with the benefits of the medicine being developed.

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.

Pharmacovigilance is the practice of detecting, understanding, and preventing adverse events or any other medicine-related problem.

Medicine shortages can occur for many reasons and may impact patients in different ways.