A special form of the marketing authorization application is laid down in Section 22(3)(1) of the German Medicines Act (AMG) and in Article 10a of Directive 2001/83/EC. Data for Modules 1 to 3 must therefore be submitted, but it is possible to replace results of the pre-clinical and clinical trials by detailed references to published scientific literature if it can be demonstrated that the active substances of a medicinal product in the claimed therapeutic indication have been in well-established medicinal use within the Union for at least ten years, with recognised efficacy and an acceptable level of safety. This evidence must be based on a detailed scientific bibliography covering all relevant preclinical and clinical aspects of the medicinal product. For this reason, this form of application is also referred to as a "bibliographical application".

In addition to the content, the nature of the literature sources is also decisive, as the submitted literature must be freely available in the public domain and published by a reputable source. Therefore, data from own preclinical and clinical trials may not be taken into account in the discussion of a bibliographic application. It must be stressed that assessment reports such as the EPAR for EU marketing authorisations or similar summary reports from competent authorities inside and outside the EU which are made publicly available by competent authorities for reasons of transparency cannot be considered. In addition, the applicant is obliged to include both positive and negative literature data in the evidence and to discuss any missing information controversially in order to adequately demonstrate the efficacy and safety of the medicinal product.