Work Involving Pathogens – Apply for a Permit
Service description
You need a permit under the Infection Protection Act if, as the person in charge, you
- Importing pathogens into Germany,
- export from Germany,
- store,
- hand over or
- want to work with them.
The following are considered pathogens:
- Viruses,
- Bacteria,
- Mushrooms,
- Parasites and
- other agents that can cause infection or a communicable disease in humans.
Activities involving pathogens include, in particular:
- Experiments with pathogenic microorganisms capable of reproduction,
- microbiological and serological tests to detect notifiable pathogens using procedures for the targeted enrichment or propagation of pathogens;
Certain activities or individuals who perform microbiological tests for diagnostic purposes in connection with the immediate treatment of their own patients are exempt from the licensing requirement. These include:
- Doctors,
- Dentists, as well as
- Veterinarians;
- People who
- Perform microbiological quality assurance procedures and
- possess the necessary expertise and
- the competent authority, upon request, grants an exemption from the licensing requirement;
- Employees who
- work under the supervision of a person who holds a permit or is exempt from the permit requirement;
- certain procedures, such as sterility tests;
If you belong to one of the groups listed above, please check with the appropriate authority before starting your work. You must register your work with that authority.
Procedure
- You must apply for the permit from the authority with jurisdiction over you.
- The agency will review your documents. Afterward, you will receive either the requested permit or a notice of denial.
- To prevent communicable diseases, it may restrict the permit to certain activities or certain pathogens, or impose conditions on it.
Competent Authority
The relevant public health department
Prerequisites
- You possess the necessary expertise and can demonstrate it by:
- one of the following degrees:
- Human, dental, or veterinary medicine
- Pharmacy
- A degree in a natural science field from a university or university of applied sciences that includes microbiology, and
- at least two years of full-time work involving pathogens
- They have so far proven to be reliable when dealing with pathogens.
Note: Other full-time professional activities lasting at least two years in the fields of bacteriology, mycology, parasitology, or virology are also considered proof of expertise. The prerequisite is that you have acquired equivalent expertise through such activities.
What documents are required?
Proof of a college degree:
- Proof of completion of a degree in human medicine, dentistry, veterinary medicine, or pharmacy, or
- Proof of completion of a science degree program at a university of applied sciences or a traditional university that includes microbiology, as evidenced by semester transcripts, exam certificates, a license to practice medicine, or a final examination
Proof of Employment:
- Proof of two years of full-time work with pathogens under the supervision of a licensed individual, or
- Proof of other full-time, two-year work experience in bacteriology, mycology, parasitology, or virology, provided that equivalent expertise was acquired during that time
Proof of reliability:
- Certificate of Good Conduct (Document Type O)
What deadlines do I have to observe?
You must obtain permission from the authorities well in advance of starting your business so that you can file a notice of your business 30 days before the planned start date.
Legal basis
Legal remedy
Administrative Court Action
What else should I know?
All activities involving pathogens, including those that do not require a permit, must be reported.