Before a medicinal product can be placed on the market it requires a marketing authorisation or registration. In order for these to be granted, the pharmaceutical entrepreneurs have to submit the corresponding applications. Depending on the nature of the project, different types of applications for marketing authorisation are available. The following pages provide information regarding the respective requirements.
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