In Germany, a general licensing requirement applies to activities involving pathogens. Any person acting in a responsible capacity who intends to import pathogens into Germany, export them, store them, distribute them, or work with them must obtain a license.

The term “pathogens” refers to reproducible pathogens (viruses, bacteria, fungi, parasites) or other biologically transmissible pathogens that can cause an infection or a communicable disease in humans.

Activities involving pathogens include, in particular:

• Experiments with pathogenic agents capable of reproduction,
• microbiological and serological tests to detect notifiable pathogens,
• the targeted enrichment or propagation of pathogens.

Exemptions from the permit requirement apply to the following groups of persons or activities:

• Physicians, dentists, and veterinarians who perform microbiological tests for diagnostic purposes on their own patients,
• persons who perform work related to microbiological quality assurance, possess the necessary expertise, and are exempted from the licensing requirement by the competent authority upon application,
• Employees who work under the supervision of a person who holds a license or is exempt from the licensing requirement
• certain procedures (e.g., sterility tests).

Further information on the topic of “Activities Involving Pathogens” can be found in the following services:

• Pathogens: Notification—Changes to Activities Involving Pathogens
• Pathogens: Notification — of the commencement of activities involving pathogens