Activities with pathogens - apply for a permit

  • Performance specification

    You require a licence in accordance with the Infection Protection Act if you are the person responsible for

    • import pathogens into Germany,
    • from Germany,
    • store,
    • hand in or
    • want to work with them.

    The following are considered pathogens

    • Viruses,
    • Bacteria,
    • Mushrooms,
    • Parasites and
    • other agents that may cause infection or communicable disease in humans.

    Activities involving pathogens include, in particular

    • Experiments with pathogens capable of reproduction,
    • Microbiological and serological tests for the detection of reportable pathogens using process steps for the targeted enrichment or multiplication of pathogens;

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

    • Doctors,
    • Dentists and dental hygienists
    • Veterinarians;
    • Persons who
      • carry out microbiological quality assurance work and
      • have the necessary expertise and
      • the competent authority exempts from the authorisation requirement upon request;
    • Employees who
      • work under the supervision of a person who has a licence or is exempt from the licence requirement;
    • certain procedures, for example sterility tests;

    If you belong to one of the above-mentioned groups, please enquire with the authority responsible for you before starting work. You must register your activity there.

  • Requirements

    • You have the necessary expertise and can demonstrate this through
    • one of the following degrees:
      • Human, dental or veterinary medicine
      • Pharmacy
      • a degree in natural sciences from a university of applied sciences or university with microbiological content and
      • at least two years of full-time work with pathogens
    • They have so far proven to be reliable in dealing with pathogens.

    Note: Other full-time professional activities of at least two years in the fields of bacteriology, mycology, parasitology or virology also count as proof of expertise. The prerequisite is that you have acquired equivalent expertise.
     

  • Which documents are required?

    Proof of a degree:

    • Proof of completion of a degree in human, dental or veterinary medicine, pharmacy or
    • Proof of completion of a degree course in natural sciences at a university of applied sciences or university with microbiological content by means of semester certificates, examination certificates, licence to practise medicine or final examinations or exams

    Proof of activity:

    • Proof of two years of full-time work with pathogens under the supervision of a person with authorisation or
    • Proof of another two years of full-time professional work in bacteriology, mycology, parasitology or virology, if equivalent expertise was acquired in the process

    Proof of reliability:

    • Police clearance certificate (document type O)

  • What deadlines do I have to observe?

    You need authorisation from the authorities in good time before the start of your activity in order to be able to report your activity 30 days before the planned start.

  • Legal basis

  • What else should I know?

    All activities involving pathogens, including activities that do not require a permit, must be notified.


Responsible departments