Pursuant to the German Medicinal Products Act (Arzneimittelgesetz, AMG), the competent federal state authority decides in consultation with the Paul-Ehrlich-Institut (PEI) on the granting of various authorisations for products that are the Institute's responsibility. In addition to the participation of experts from the Paul-Ehrlich-Institut in inspections by the competent federal state authority, a consultation with the higher federal authority can also take place independently of inspections. An example of these consultations are decisions on extending a manufacturing authorisation in accordance with section 13 subsection 4 AMG for products such as blood preparations, tissue preparations, and vaccines.
If you are an inspector at a German competent federal state authority and would like to arrange a consultation, please use the form "Requests to arrange a consultation with the Paul-Ehrlich-Institut" and send it directly by email to the contact address below. If you know the name of the expert or assessor responsible for the product at the Paul-Ehrlich-Institut, please CC their email address.
Email: eSubmission@pei.de
The request for participation of a Paul-Ehrlich-Institut expert in an inspection is made via a separate application process. Information and the associated application form can be found under "Inspections with the Participation of Paul-Ehrlich-Institut Experts".
Requests to arrange a consultation with the Paul-Ehrlich-Institut – independent of inspections (Word form, German only)
Inspections With the Participation of Paul-Ehrlich-Institut Experts
Updated: 13.11.2025
