Activities with pathogens permit
In Germany, there is a basic licensing requirement for activities with pathogens. Anyone who wants to bring pathogens to Germany as the responsible person, export them, store them, hand them over or work with them, needs a permit.
The term pathogens refers to reproducible pathogens (viruses, bacteria, fungi, parasites) or other biological transmissible pathogens that can cause an infection or a communicable disease in humans.
Activities with pathogens are in particular:
- experiments with reproducible pathogens,
- microbiological and serological tests for the detection of notifiable pathogens,
- targeted accumulation or multiplication of pathogens.
Exceptions to the permit requirement exist for the following groups of persons or activities:
- doctors, dentists and veterinarians who carry out microbiological examinations for the diagnosis of their own patients,
- persons who carry out microbiological quality assurance work and possess the necessary expertise and who are exempted from the authorisation requirement by the competent authority upon request,
- Employees who work under the supervision of a person who has a permit or is exempt from the permit requirement
- certain procedures (e.B. sterility tests).
Further information on the topic of "Activities with pathogens" can be found in the following services:
- Pathogens: indication - of the change in activities with pathogens
- Pathogens: indication - of the start of activities with pathogens
Who should I contact?
The responsibility lies with the district and the district-free city in whose district the activity is to be carried out.
This procedure can also be handled through a "point of single contact". The "Point of Single Contact" is a special service offered by the municipalities and the state for service providers.
- natural person
- has the necessary expertise, and
- has so far proved to be reliable in relation to the activity with pathogens for the exercise of which it is applying for permission.
- The required expertise is demonstrated 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.
Another full-time activity of at least two years in the field of bacteriology, mycology, parasitology or virology is also recognised as proof of expertise if equivalent expertise has been acquired.
If the conditions are not fully met, a restricted permit may be granted.
Which documents are required?
- Certified copies of training and study certificates
- Certificate of at least two years of full-time work with pathogens under supervision
- Certificate of good conduct
What are the fees?
Fees are payable in accordance with Annex 1 to § 1 paragraph 1 of the General Schedule of Fees of the State of Lower Saxony (AllGO) in accordance with No. 126.96.36.199.
What deadlines do I have to pay attention to?
Permission from the competent body is required as early as possible so that the start of work with pathogens can be reported at least 30 days before the planned date.
Processing Time: 3 Months§ 53a paragraph 2 sentence 1 Infection Protection Act (IfSG)
Applications / forms
The application must be submitted informally.
If the competent authority refuses to grant the permit, an action may be brought against this decision before the Administrative Court.
What else should I know?
Regardless of whether the activity requires permission or not, there is an obligation to notify. The activity may only be started when the notification is complete and after examination of the documents and the rooms the activity is not prohibited. Any significant change in the premises, activity, disposal or pathogen spectrum must be reported to the competent body.
Anyone who carries out an activity in accordance with §§ 44 et seq. of the Infection Protection Act (IfSG) is subject to official supervision in accordance with § 51 IfSG. Additional fees may apply for any necessary site visits and examinations.
Technically approved by
Lower Saxony Ministry of Social Affairs, Health and Gender Equality