Pathogens: Commercial handling - Permission

Diseases with pathogens must be reported to the health authority.

Activities with pathogens (for example, in laboratories) can become a source of infections and communicable diseases. Therefore, special attention is paid to them.

In principle, all persons who work with pathogens, want to store, dispense or export them require a permit from the competent authority. There are exceptions to the permit requirement only where it is expressly regulated by the Infection Protection Act, such as doctors, dentists or veterinarians who are entitled to practice their profession independently.

"Working with pathogens" includes in particular:

  • experiments with reproducible pathogens,
  • microbiological and serological tests for the detection of notifiable pathogens,
  • targeted accumulation or multiplication of pathogens.

Pathogens within the meaning of the Infection Protection Act (IfSG) are reproducible pathogens (viruses, bacteria, fungi, parasites) or other biological transmissible pathogens that can cause infection or communicable disease in humans.

The conditions for the granting of a licence are the reliability of the activities applied for and proof of the necessary expertise by:

  • the completion of a degree in human, dental or veterinary medicine, pharmacy or the completion of a scientific university of applied sciences or university degree with microbiological content and
  • at least two years of full-time work with pathogens under the supervision of a person who is in possession of permission to work with pathogens.
  • certified copies of the required evidence of formal qualifications,
  • certificate of at least two years of full-time work with pathogens under supervision,
  • Certificate of good conduct.

Informal application

Hints

No permission is required for the exceptions specified in § 45 IfSG.

A permit is also not required for anyone who works under the supervision of the person who has a permit or, exceptionally, does not require a permit.

Regardless of whether the activity requires permission or not, there is an obligation to notify. In addition, any significant change in the premises, activity, disposal or pathogen spectrum must be reported to the competent authority.

§§ 44 et seq. Act on the Prevention and Control of Infectious Diseases in Humans (Infection Protection Act - IfSG).

Related Links

  • §§ 44 ff. IfSG

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