Rubrik: Fachthemen

    Stufenplanbeauftragter and Qualified Person Responsible for Pharmacovigilance

    The German Medicinal Law (AMG) was preceded by the first comprehensive law on the commerce of medicinal products in 1961, which was implemented as a consequence of the Thalidomide tragedy [ 1 ]. Even though constituting a significant improvement, the German medicinal product legislation as of 1961 set very low standards compared to today, e.g. only preclinical data were required for obtaining marketing authorisation and instead of an application to/approval by a National Competent Authority (NCA), a formal registration was sufficient [ 2 ]. Good Manufacturing Practice (GMP), clinical trial regulatory framework as well as pre- and post-registration pharmacovigilance (PV) ...