Abstract
Background Germany has a long tradition of switch and has long been considered one of the most liberal countries in terms of the
release of modern active substances from prescription, the so-called switch. In the period 2000–2016, a total of more than 30 active
ingredients – partly in different dosage strengths, dosage forms or indications – were released from prescription status in Germany. Of
these, almost half can be described as “innovative” switches. Recently a significant decline of filed switch proposals can be noted, with
only a few being successful.
Methods Reflecting that the German switch procedure is barely mentioned in the literature it is the aim of this article to describe
the German approach. The legal framework in the national and European Legislation are assessed as well as the experience of the author and
his predecessor over more than 35 years of membership in the German Switch Committee were described.
Results Although the German switch procedure is based on European legislation a successful switch application demands insights in the
national particularities. The process is complex and partly intransparent. After a phase of restraint there are positive developments
recently particularly the possibility for a scientific advice in pre-submission meetings.
Key words
switch - procedure - prescription - non-prescription - reclassification - switch expert committee - Germany
