To ensure a smooth transition from the pre-authorisation to the post-authorisation phase of the life-cycle of a medicinal product, it is the responsibility of the Marketing Authorisation (MA) applicant to have in place a robust Pharmacovigilance (PV) system for monitoring patient safety once the product is on the market. During clinical trials, patient exposure is limited and closely monitored, and there are very specific criteria for patients who are eligible to take part in the study. However, once the product is on the market and more widely available, patient exposure is much more widespr ..read more