Inspections with the Participation of PEI-Experts
According to Section 64 (2) Medicinal Products Act (MPA), experts from the Paul-Ehrlich-Institut (PEI) should participate in inspections of the competent authorities of the federal states. These include
- inspections for the granting of a manufacturing license in accordance with Section 13 MPA
- routine inspections according to Section 64 MPA (e.g. GMP- and GCP-inspections)
- inspections for granting a license for the processing, preservation, testing, storage or placing on the market of tissues or tissue preparations in accordance with Section 20c MPA
- inspections for granting import permits pursuant to Section 72 MPA
- inspections in third countries (outside the EU or the EEA) for granting certificates pursuant to Section 72a MPA or 72b MPA
- inspections for the granting import permits of tissues or tissue preparations pursuant to Section 72b MPA
Request for a PEI Expert
Our Section "Inspections of Biomedicines" also functions as a coordination unit for the participation of PEI-experts in inspections of the competent authorities of the federal states. As agreed upon with the competent authorities of the federal states, a special application form is available to facilitate the request for participation of PEI-experts. Details for the planning of inspections with the participation of PEI-experts can be found in the document "Organisation of cooperation with the PEI: participation of PEI experts in inspections according to Section 64 (2) MPA".
The competent authority of the federal state remains the contact point for the inspected site, even when PEI experts are involved in the inspection.
Section Inspections of Biomedicines