Paul-Ehrlich-Institut

Tis­sue Vig­i­lance

Tissue vigilance provides safety when using tissues and tissue preparations. Tissues and tissue preparations are medicinal products according to the German Medicinal Products Act (Section 4 § 30 AMG).

Reporting System in Germany

The German Medicinal Products Act (AMG) states that the holder of an authorisation or approval for tissue preparations must report any suspicion of a serious event and a serious adverse reaction immediately to the competent higher federal authority (Section 63i AMG).

Updated: 04.05.2020