Tätigkeiten mit Krankheitserregern – Erlaubnis beantragen

If you want to bring pathogens to Germany, export them, store them, hand them over or work with them, you need a permit from the competent authority in accordance with the Infection Protection Act.

You require a permit in accordance with the Infection Protection Act if you, as the person responsible, wish to import pathogens into Germany, export them from Germany, store them, hand them over or work with them.

Pathogens are defined as viruses, bacteria, fungi, parasites and other agents that can cause an infection or transmissible disease in humans.

Activities involving pathogens include in particular

• Experiments with pathogens capable of reproduction,
• microbiological and serological tests to identify pathogens that must be reported,
• targeted enrichment or multiplication of pathogens.

Certain persons or activities are exempt from the authorization requirement:

• Doctors, dentists and veterinarians who carry out microbiological tests for diagnostic purposes on their own patients

• Persons who

• carry out work for microbiological quality assurance and
• have the necessary expertise and
• the competent authority exempts them from the licensing requirement 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.g. sterility tests)

If you belong to one of the above groups, please contact your local health authority before starting work. You must notify them of the activity.

Proof of a degree:

• certified proof of completion of a degree in human, dental or veterinary medicine, pharmacy or
• certified proof of completion of a degree course in natural sciences at a university of applied sciences or university with microbiological content (proof of microbiological course content by means of semester certificates, examination certificates, license to practice medicine or final examination/exam)

Proof of employment:

• Proof and written confirmation of at least two years of full-time professional activity with pathogens of the risk groups applied for (from RG III, naming the pathogens concerned) under the supervision of a person who holds a permit to work with pathogens, but at least the RG applied for. The written confirmation of the permit holder must clearly state the two-year (month and year) full-time activity. Also activities with the requested risk group.

Proof of reliability:

• Police clearance certificate (document type O)

• 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 professional activity with pathogens of the risk groups applied for (from RG III, naming the pathogens concerned) under the supervision of a person who is in possession of a permit to work with pathogens, but at least the RG applied for.
• They have 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.

• You apply for a permit from the authority responsible for you
• The authority checks your documents. You will then receive the desired permit or a notice of refusal.
• To prevent communicable diseases, it may restrict the permit to certain activities or certain pathogens or attach conditions to it.

You need permission 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.

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

Administrative court action

• Activities with pathogens Permit
• Importing, exporting, storing, dispensing or working with pathogens requires a permit under the Infection Protection Act
• there are exemptions from the permit requirement for certain groups of people or activities
• personal permits are issued if the required expertise and reliability are present
• Responsible: Thuringian State Office of Administration - Department 550

Thuringian State Office of Administration - Department 550