REMARKS: The main changes include the new definition of adverse reactions, Eudravigilance becoming the single receipt point for all pharmacovigilance information through the EU, the Pharmacovigilance Risk Assessment Committee, and strengthened PASS/PAES, and requirement of a risk management planning for all new medicines. The possible increase in PA(E)SS may be a concern in terms of access to appropriate data and so obtaining necessary authorisations without delays.

CONCLUSION: The new legislation will provide good vigilance practice standards with increased transparency of pharmacovigilance data. The communication will improve with the involvement of patient and public. With better access to real-life data, better protection of public health will be ensured. Keywords : pharmacovigilance legislation, pharmacoepidemiology, observational study, regulations, European Directive