Medicines can only be placed on the market in Germany if they have gone through an approval procedure in accordance with Section 21 of the Medicines Act. Based on the data submitted by the applicant pharmaceutical company, the field of application (indication), the type of administration and the dosage of the drug are then determined, among other things, as part of the approval process. In principle, a drug can only be prescribed at the expense of statutory health insurance if it is used in accordance with its approval. The off-label use of a medicinal product outside the area of application approved by the national and European regulatory authorities is referred to as off-label use. Off-label use in oncology in Germany is estimated at up to 60% of patients (Ludwig 2006). However, there is currently no empirical data to support these assessments. A distinction must be made between “classic” off-label use and recognized off-label use, which enables the approval-exceeding regulation in accordance with Section 35c (1) SGB V. In 2003, an expert group was set up at the Federal Institute for Drugs and Medical Devices (BfArM), whose task is to convey the "Assessment of the current state of scientific knowledge about the off-label use of certain drugs as a recommendation" to the G-BA (G-BA press release 2014). Resolutions on recognized off-label use only become legally binding if the pharmaceutical company and the Federal Ministry of Health agree. An example of recognized off-label use in oncology is fluorouracil (5FU), approved for the treatment of advanced colorectal cancer, gastric cancer, pancreatic cancer, and advanced and/or metastatic breast cancer (BCa). According to Section 35b Paragraphs 2 and 3 SGB V, 5FU was additionally approved for the adjuvant therapy of BCa. The recognized off-label use of 5FU has also been adopted into the S3 and Onkopedia guidelines, where adjuvant treatment of patients with 5FU-containing regimens is recommended.

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