Social Authority

Apply for permission to work with pathogens

If you want to import pathogens into Germany, store them, hand them over, work with them or export them from Germany, you need a permit.

Detailed description

You need a permit if you are a responsible person who

  • to Germany,
  • from Germany,
  • keep,
  • hand in or
  • want to work with them.

Pathogens are

  • viruses,
  • Bacteria,
  • Mushrooms,
  • parasites and
  • other agents that can cause infection or communicable disease in humans.

Activities involving pathogens include in particular:

  • Experiments with reproducible pathogens,
  • microbiological and serological tests to identify notifiable pathogens using process steps for the targeted enrichment or multiplication of pathogens;

You must apply for a permit from the competent authority. To prevent communicable diseases, the competent authority may restrict your permit to certain activities or certain pathogens or attach conditions to it.

 

Information

Prerequisites

  • You have the required expertise through one of the following degrees:
    • human, dental or veterinary medicine
    • Pharmaceutical sciences college or university degree with microbiological content and
    • at least two years of full-time work with pathogens or
    • another full-time activity of at least two years in the fields of bacteriology, mycology, parasitology or virology in which you have acquired equivalent expertise.
  • So far, they have proven to be reliable in dealing with pathogens.

Documents required

  • Proof of a degree (semester certificates, examination certificates, license certificate or final examination or exam)
    • human, dental or veterinary medicine, pharmacy or
    • Proof of completion of a scientific college or university degree with microbiological content
  • Proof of activity, for example through
    • Proof of two years of full-time work with pathogens under the supervision of a person with permission or
    • Proof of another two-year full-time job in bacterio-, myco-, parasito- or virology, if equivalent expertise was acquired
  • Proof of reliability through a police clearance certificate (certificate type O)

Please note

You must report all activities involving pathogens, including those that do not require a permit, to the responsible authority.



Certain activities or persons who carry out microbiological diagnostic tests for the direct treatment of their own patients are exempt from the requirement for a permit. These include:

  • doctors,
  • dentists
  • veterinarians
  • People who
    • Carry out microbiological quality assurance work and
    • have the necessary expertise and
    • the competent authority has exempted from the permit requirement upon application
  • Employees who work under the supervision of a person who has a permit or is exempt from the permit requirement.
  • certain procedures, such as sterility tests.

If you belong to one of the groups mentioned above, please contact the responsible office before starting work. You must report the activity there.

Deadlines

You need permission from the authorities in good time before you start your activity so that you can report your activity 30 days before the planned start.

Procedure

  • You apply for permission from the authority responsible for you.
  • The responsible authority will check your documents.
  • You will receive written permission or a rejection notice.

Processing time

The competent authority will decide within three months.

Fees

272.00 EUR

Legal basis

§ 44 Infection Protection Act


https://www.gesetze-im-internet.de/ifsg/__44.html


§ 45 Infection Protection Act


https://www.gesetze-im-internet.de/ifsg/__45.html


§ 46 Infection Protection Act


https://www.gesetze-im-internet.de/ifsg/__46.html


§ 47 Infection Protection Act


https://www.gesetze-im-internet.de/ifsg/__47.html


§ 49 Infection Protection Act


https://www.gesetze-im-internet.de/ifsg/__49.html

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Keywords: Permission for activities with pathogens Permission for activities with genetic engineering Permission for activities according to the Infection Protection Act

Last updated: 14.02.2026