Resolved within the framework of the 12th Amendment to the German Drug Law (AMG), the rulings laid down in § 63b AMG were put into force to their full extent with the so-called "small-scale AMG amendment" in April 2005. This means that the regular, up-to-date reports on the safety of a drug described in § 63b, subsection 5 of the AMG referred to as Periodic Safety Update Reports or PSURs must also be drawn up for drugs and medicinal products that are authorised at national level in Germany, and these must be submitted to the regulatory authority at the specified intervals.

The preparation of PSURs ties up considerable human and financial resources within the industry without giving rise to any direct benefits in any other areas. A great deal of the information included in a PSUR is specific to the active substance, which means that the same general information has to be researched and processed by every authorisation holding company. The BAH WiDi therefore decided to offer a high-quality PSUR compilation service at a reasonable price.