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Inspections

Besides marketing authorisations, official batch release testing and authorisation of clinical trials, official duties of the Paul-Ehrlich-Institut (PEI) also include inspecting the actual conditions prevailing at pharmaceutical companies.

The PEI is the competent authority for conducting inspections within the scope of

  • processing marketing authorisation applications (at a national and a European level), quality-related and for the purpose of monitoring the adherence to Good Clinical Practice (GCP inspections),
  • the European Plasma Master File certification procedure,
  • national authorisations of clinical trials,
  • monitoring of pharmacovigilance systems (systems for identifying, assessing, understanding, and preventing adverse reactions) at a national and a European level.

In addition, experts of the PEI support inspections of the competent Land authorities within the scope of granting manufacturing and import authorisations and within the scope of routine monitoring.

In general, inspections are carried out in close cooperation between PEI employees and employees of the competent Land authorities.

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