Activities with pathogens Permission Unfortunately this specification of service has not yet been completely translated.

In Germany, there is a basic obligation to permit activities with pathogens. Anyone who wants to bring pathogens to Germany, export, store, surrender or work with them as the responsible person requires a permit.

The term "disease" refers to pathogens (viruses, bacteria, fungi, parasites) or other biological transmissible pathogens that can cause infection or a communicable disease in humans.

Activities with pathogens include in particular:

  • Experiments with propropagating pathogens,
  • microbiological and serological examinations for the detection of notifiable pathogens,
  • targeted enrichment or propagation of pathogens.

Exceptions to the authorisation requirement apply to the following groups or activities:

  • doctors, dentists and veterinarians who carry out microbiological examinations for diagnostics in their own patients,
  • persons carrying out work on microbiological quality assurance and possessing the necessary expertise and exempted from the authorisation requirement by the competent authority on request;
  • Employees working under the supervision of a person who has a permit or is exempt from the authorisation requirement
  • certain procedures (e.B. sterility tests).

For more information on "Activities with pathogens", see:

  • Pathogens: Notification - the change of activities with pathogens
  • Pathogens: Notification - the commencement of activities with pathogens
  • certified copies of proof of education and studies
  • Certificate of at least two years of full-time work with pathogens under supervision
  • Certificate of leadership

The application must be made informally.

Preconditions

  • natural person
    • has the necessary expertise, and
    • has so far proved to be reliable in relation to the activity of pathogens for which it applies for permission.
  • The necessary expertise is demonstrated by
    • the completion of a degree in human, dental or veterinary medicine, pharmacy or the completion of a university of science or university with microbiological content, and
    • a full-time professional activity with pathogens for at least two years under the supervision of a person in possession of permission to work with pathogens.

Another full-time activity in the field of bacteriology, mycology, parasitology or virology for at least two years is also recognised as evidence of expertise if equivalent expertise has been acquired.

If the conditions are not fully met, a limited permit may be granted.

Hints

Irrespective of whether the activity is subject to authorisation or not, there is an obligation to notify. The activity may not be commenced until the notification is complete and, after examination of the documents and premises, the activity is not prohibited. Any significant change in the premises, activity, disposal or range of pathogens must be reported to the competent authority.

Anyone who carries on an activity in accordance with Section 44 et seq. of the Infection Protection Act (IfSG) is subject to official supervision in accordance with Section 51 of the IfSG. Additional fees may apply for any necessary site visits and inspections.

  • Section 44 et seq. Infection Protection Act (IfSG)
  • Section 51 Infection Protection Act (IfSG)

Related Links

  • Section 44 et seq. Infection Protection Act (IfSG)

Responsible for the content
No information available

Last update or date of publication
13.09.2018