According to GVP Module VI section VI.C.2.2.8. marketing authorisation holders are encouraged to receive and collect all adverse events/adverse drug reports, irrespective if the license for a medicinal product is withdrawn or not, and report them to EMA.
06. How long is there an obligation to continue collection and submission of spontaneous ADR reports after a marketing authorisation of the suspect product was withdrawn?
Last updated: December 17, 2021