Paul-Ehrlich-Institut

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Of­fi­cial Du­ties

The Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, is responsible for the medicinal products listed below (section 77 of the AMG [Arzneimittelgesetz, German Medicinal Products Act]):

Human Medicinal Products

  • Sera
  • Vaccines
  • Blood preparations
  • Tissues and tissue preparations
  • Allergens
  • Advanced therapy medicinal products (gene therapeutics, somatic cell therapeutics, and tissue engineered products)
  • Xenogenic medicinal products
  • Genetically engineered blood components.

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is the competent authority for all other medicinal products.

Veterinary Medicinal Products

  • Immunological products for veterinary use, such as sera, vaccines, immunomodulators, tuberculins, and other immunological medicinal products for veterinary use.

The Friedrich-Loeffler-Institut (FLI) is responsible for products not designed for use in animals (diagnostic devices). All other medicinal products for veterinary use fall under the responsibility of the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL).

Official Duties

The Paul-Ehrlich-Institut fulfils the following duties for the medicinal products within its area of responsibility:

  • Authorisation of clinical trials for human use
  • Authorisation of field trials for products for veterinary use (= clinical trials in the field of veterinary medicine)
  • Processing of applications for marketing authorisations and subsequent applications (change notifications and variations regarding medicinal products for human and veterinary use) in the various national and European procedures
  • Federal testing and batch release for medicinal products. In special cases, the Paul-Ehrlich-Institut can also exempt certain medicinal products from federal batch testing.
  • Safety of medicinal products (pharmacovigilance)
  • Inspections
  • EU reference laboratory for in vitro diagnostic medical devices (IVDs)
  • Research in the fields of allergology, bacteriology, biotechnology, immunology, haematology, transfusion medicine, veterinary medicine, and virology
  • Reports relating to blood and tissue preparations for IVDs used in donor testing and preimplantation diagnostics
  • Advice for national, European, and international target groups concerning risk assessment and guideline development
  • Advice to applicants regarding scientific and procedural questions
  • Information for patients and consumers
  • The Center for Pandemic Vaccines and Therapeutics – ZEPAI – has the task of building up infrastructure to produce and distribute vaccines and therapeutics in and for Germany as quickly as possible in the event of a pandemic.

Updated: 29.02.2024