Tätigkeit mit Krankheitserregern - Erlaubnis

• § 44 Infection Protection Act (IfSG) (permit requirement for activities with pathogens)
•§ 45 Infection Protection Act (IfSG) (exceptions)
• § 46 Infection Protection Act (IfSG) (activity under supervision)
• § 47 Infection Protection Act (IfSG) (grounds for refusal, requirements for permission)
 

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

Exceptions to the permit requirement exist for the following groups of persons or activities:

• Doctors, dentists and veterinarians who carry out microbiological tests for diagnostics on their own patients
• Persons carrying out microbiological quality assurance work and possessing the necessary expertise and, upon request, exempted from the authorisation requirement by the competent authority
• 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)

Hint: Pathogens within the meaning of the Infection Protection Act are viruses, bacteria, fungi and parasites as well as other pathogens that can cause an infection or communicable disease in humans.
 

You can submit the informal application in writing or in person.

If you submit the application in writing to the competent authority, it must be signed by hand or provided with a qualified electronic signature.

Data:

• Proof of graduation (e.g. diploma certificate, doctoral certificate) in certified copy
• Proof of competence: Certificate of 2 years of full-time occupation with pathogens by the employer concerned
• For proof of personal reliability:
  • If you are resident in Germany, you usually need:
    • Certificate of good conduct
  • If you reside abroad, you will need documents from your home country proving that you have the personal reliability to perform the desired service.

When checking personal reliability, the authorising authority may, in individual cases, request further documents in addition to the documents listed, which are suitable for making a statement about your personal reliability as an applicant.
 

You will be granted permission to work with pathogens if you:

• possess the necessary expertise, and
• have so far proven to be reliable in terms of working with pathogens.

You can prove the required expertise by completing a degree in human, dental or veterinary medicine, pharmacy or the completion of a scientific college or university degree with microbiological content as well as at least 2 years of full-time work with pathogens.

Another full-time professional activity in the field of bacteriology, mycology, parasitology or virology for at least 2 years will also be recognised as proof of expertise if you have acquired equivalent expertise.

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

There are fees according to the administrative costs regulation for the business area of the Ministry of Social Affairs and Integration (VwKostO-HMSI). The amount of the fee is calculated according to the time required.

You need permission from the authorities at an early stage so that you can notify the start of the activity at least 30 days before the planned date.

The authority shall decide on the application within a period of 3 months.
 

If you have received permission to work with pathogens, you must notify the competent authority of the first start of the activity.

the health authority in whose jurisdiction your business premises or residence are located.

You can also complete the procedure electronically via the Point of Single Contact.

A separate platform has been developed for online applications. On the so-called service platform you can submit your applications electronically and much more! You are welcome to get your own impression of the application in advance without registering beforehand. To do this, use the simulation. In order to make full use of the online application, you must first register with the online application process.

Online application procedure of the Point of Single Contact Hesse