OBJECTIVES: In 2011 was introduced the early benefit assessment with the new pharmaceutical restructuring act (AMNOG) in Germany. Only new launched pharmaceuticals were assessed since this date. At the beginning of June were the first calls by FJC of drugs which made available for the market before 2011. The objection is to show relevant criteria for calling a launched product and to analyze which issues and consequences are possible in the AMNOG process. METHODS: In the first step was described the political situation before and after the AMNOG and the potential criteria for a call of launched drugs prior the law. Afterwards it was shown the dossier development and assessment, hearing, G-BA decision and price negotiation. There were demonstrated possible issues and differences between assessments of new and launched products in this procedure. RESULTS: There is only a small time frame for dossier development and assessment. Manufacturers and concerned institutions have to plan and prepare in early expected time. Pharmaceuticals mostly admitted for more than one indication, why there could be a high number of clinical trials available. The assessment of prior 2011 launched drugs is very difficult, because there was a retrospective change of frame conditions. The main criteria for a call are the market volume and revenues, remaining patent protection and the expected assessments of competitors, triggered by admission of new drugs in next time. CONCLUSIONS: In the next years can be expected, that G-BA will be assess more pharmaceuticals from indications that have a great influence for costs in German health care. The methods and criteria have to be discussed with all involved parties.