Inspections with the Participation of Paul-Ehrlich-Institut Experts

Pursuant to section 64 subsection 2 of the Medicinal Products Act (Arzneimittelgesetz, AMG), experts from the Paul-Ehrlich-Institut (PEI) should participate in inspections by the competent federal state authorities when such inspections involve products under the responsibility of the Paul-Ehrlich-Institut. Relevant inspections include:

• inspections for the granting of a manufacturing authorisation in accordance with section 13 of the AMG,
• inspections for the granting of an authorisation for the processing, preservation, testing, storage, or placing on the market of tissues or tissue preparations in accordance with section 20c of the AMG,
• Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) inspections within the framework of medicinal product monitoring in accordance with section 64 of the AMG (GMP and GCP inspections),
• inspections for the granting of an import authorisation in accordance with section 72 of the AMG,
• inspections in third countries outside the European Union (EU) or the European Economic Area (EEA) for the granting of certificates in accordance with section 72a of the AMG,
• inspections for the granting of import authorisations and certificates for tissues and specific tissue preparations in accordance with section 72b of the AMG.

Request for a Paul-Ehrlich-Institut Expert

The "Inspections of Biomedicines" Section at the Paul-Ehrlich-Institut centrally coordinates the participation of Institute experts in inspections by the federal state authorities. A special form has been made available in cooperation with the federal state authorities for the request of expert participation in an inspection by the respective federal state authority. Further information on inspection planning with the participation of experts from the Paul-Ehrlich-Institut can be found in the document "Organisation of cooperation with the Paul-Ehrlich-Institut: Participation of experts in inspections according to section 64 subsection 2 AMG".

The competent state authority will remain as the point of contact for the inspected facility, even if experts from the Paul-Ehrlich-Institut are involved in the inspection.

Contact

Section Inspections of Biomedicines
Email: inspektionen@pei.de

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