Update to guidelines on good pharmacovigilance practices

18 décembre 2019 – New legislation for pharmacovigilance applies in the European Union (EU) since July 2012. In order to support its implementation, a set of guidelines for the conduct of pharmacovigilance in the EU has been developed. On 11 December 2019, a new chapter was added to the guidelines. The chapter aims to provide guidance to marketing authorization applicants and holders, competent authorities of Member States and the Agency regarding an appropriate pharmacovigilance for medicinal products that may be used by pregnant or breastfeeding women. Public consultation lasts until 28 February 2020. For further information, see here.