EMA and EU-Commission – Topical News
Important Provisions of the New Pharmacovigilance Legislation – Part IV
RAin Dr. Brigitte Friese
Rechtsanwaltskanzlei Friese, Betzdorf/Sieg (Germany)
The review of the pharmacovigilance legislation contained in Regulation (EU) no. 1235/2010 and Directive (EU) No. 2010/84 has been the topic of the last 3 parts of this publication. In this final Part IV of this publication information is given on the roles and competences of the competent authorities in the Eudravigilance System and the pharmacovigilance procedures foreseen in the legal texts.
pharmind 2011, Nr. 5, Seite 854