The Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines is responsible for the medicinal products listed below (pursuant to Section 77 AMG [Arzneimittelgesetz, German Medicines Act]):
Human Medicinal Products
- Blood preparations
- Tissues and tissue preparations
- Advanced therapy medicinal products (gene therapeutics, somatic cell therapeutics, and biotechnogically manipulated tissue 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-Institute (FLI) is responsible for products not designed for the use in animals (diagnostic devices) (pursuant to Section 2, Statutory Veterinary Vaccines Regulation [Tierimpfstoff-Verordnung]), and all other medicines for veterinary use are under the responsibility of the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL).
For the groups of medicinal products and in its area of responsibility, the PEI fulfils the following duties:
- 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 in the field of medicines for human and veterinary use) in the various national and European procedures
- Official testing and release of batches for the medicinal products.
- In special cases, the PEI can also exempt certain medicinal products from official batch testing.
- Safety of medicinal products (pharmacovigilance)
- Research in the fields of allergology, bacteriology, biotechnology, immunology, haematology, transfusion medicine, veterinary medicine, and virology.
- Reports relating to blood and tissue products
- Advice for national, European, and international target groups concerning the assessment of risks and the development of guidelines
- Advice to applicants of marketing authorisations and clinical trials in scientific and procedural questions
- Information for patients and consumers