The new pharmacovigilance legislation, which came into effect in July 2012, was the biggest change to the regulation of human medicines in the European Union since 1995. On the 15th September 2015, Jelena Malinina, EFA EU Policy and Membership Officer attended the 9th Stakeholder Forum on the implementation of this new legislation.
The pharmacovigilance legislation has had significant implications for applicants and holders of EU marketing authorisations, as well as for patients, healthcare professionals and regulators.
During the forum, we had the opportunity to better assess the three operational years of the new EU pharmacovigilance system and to look for opportunities for the future. The main conclusion coming from all stakeholders attending the event, including patients and healthcare professionals was clear: the new EU pharmacovigilance system is in place but there is still room to simplify and put in place evaluation tools with patients, healthcare professionals and other stakeholders.