Prerequisites
- Permission or exemption or release
- There is no risk to public health. This is primarily due to...
- Suitable rooms or facilities are available for the type and scope of the activities and
- The conditions for safe disposal are met.
Documents required
- certified copy of the permit under the Infection Protection Act, if it was issued by another authority, or information on exemption from the permit requirement
- Information on the type and scope of the intended activities
- Information on disposal measures:
- Listing or naming of the pathogens
- Description of disposal routes and disposal procedures for infectious waste
- Information on the condition of the rooms and facilities:
- Submission of the floor plan with functional designation of the rooms, i.e., naming of the floor, depiction of the access routes,
- Naming of laboratory rooms for microbiological work,
- Description of the function of the laboratory rooms.
- Description of the demarcation from other areas in which no activities involving biological agents of the specified risk group are carried out.
- An assessment of the hazards and the assignment of activities to a protection level
- Description of the room furnishings and layout. A detailed description of the workspaces is required, in particular a description of surfaces, laboratory tables, installations, ventilation systems, windows, and desks.
- Description of the supply and disposal areas, the ancillary rooms, the possible animal stalls and the technical equipment.
- Preparation of a list of laboratory equipment with location details, in particular a description of the steam sterilizer, which serves the disposal of biological materials.
- Information on maintenance, effectiveness checks and description of waste containers for the disposal of microbiological waste.
- Description of protective measures:
- Evidence of protective measures for targeted and untargeted activities with biological agents in laboratories
- Representation of the marking of workplaces, in particular the placement of doors, collection containers and furnishings with the biohazard symbol.
- Submission of the operating instructions
- Submission of the hygiene plan
- Information on the presence of an animal barn
Please note
You may only begin working with pathogens if there is no risk to public health.
All activities involving pathogens, including those that do not require a permit, must be reported.
The activity may only commence once the notification is complete and, after examination of the documents and the premises, the activity is not prohibited.
You need a permit from the relevant authority if you wish to bring, export, store, transfer, or work with pathogens in Germany. Pathogens are defined as replicating, transmissible viruses, bacteria, fungi, parasites, and similar organisms that can cause infection or communicable diseases in humans.
Generally, anyone working with pathogens needs a permit. Certain exceptions to this permit requirement may apply.
- Doctors
- Dentists
- Veterinarians
, who conduct microbiological examinations for diagnostic purposes on their own patients
Any significant change must be reported to the responsible authority immediately. The cessation or resumption of activity must also be reported.
The competent authority prohibits activities involving pathogens if there is a risk to public health, in particular because
suitable premises or facilities for the type and scope of activities are not available or
The conditions for the safe disposal of the pathogens are not met.
Deadlines
The activity must be reported at least 30 days before the intended commencement of the activities.
The activity may only commence once the notification is complete and the activity is permitted after examination of the documents and the premises.
