Paul-Ehrlich-Institut

Ap­pli­ca­tion Ob­ser­va­tions

Currently, we offer more corresponding information only in German.

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfARM) and the Paul-Ehrlich-Institut (PEI) have issued recommendations, forms and instructions for the planning and implementation as well as the display of application observations (AWB). With the AWB database, the PEI offers information on displayed application observations.

Definition

AWB are examinations designed to gain insights into the use of authorised or registered medicinal products. They are a subgroup of non-interventional examinations within the meaning of § 4 (23) sentence 3 German Medicines Act (AMG). These non-interventional tests are defined as studies analysing evidence from the treatment of persons with medicinal products using epidemiological methods; The treatment, including the diagnosis and monitoring, does not follow a prescribed test plan, but only the medical practice. To the extent that the product is subject to authorisation or is subject to approval under § 21a (1) of the German Medicinal Products Act (AMG), this will be done in accordance with the requirements set out in the authorisation or the authorisation for its application.
AWB are not subject to approval. According to § 67 (6) of the AMG, however, the executing parties have to report to and submit to the competent higher federal authority. Pursuant to Section 67 (6) sentence 10 AMG, the competent higher federal authority shall make the advertisements and final reports transmitted to it publicly available on the Internet.

Updated: 04.09.2020