Re­port­ing Obli­ga­tions

Statutory reporting obligations are laid down in the German Medicines Act (AMG), the Transfusion Act (TFG), the Transplantation Act (TPG), the Infection Protection Act, and the Statutory Regulation on Animal Vaccines (Tierimpfstoffverordnung, TierImpfStV).

A part of these reports must be submitted to the Paul-Ehrlich-Institut (PEI).

Besides, there is the option of of voluntary reporting to the PEI, for example on suspected cases of adverse effects of medicines or a supply shortage of a human vaccine.

Updated: 03.08.2020