Paul-Ehrlich-Institut 产品代理

Vac­cines

Al­ler­gens

An­ti­bod­ies

ATMP

Blood Prod­ucts

Stem Cell Prepa­ra­tions

Tis­sue Prepa­ra­tions

Oth­ers (Hu­man Use)

Im­muno­log­i­cal Vet­eri­nary Medicines

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

Sera

Vaccines

Blood preparations

Tissues and tissue preparations

Allergens

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).