Activity with pathogens - Permit

  • Performance specification

    You require a licence 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, dispense them or work with them.

    There are exceptions to the authorisation requirement for the following groups of people or activities:

    • Doctors, dentists and veterinarians who carry out microbiological examinations for diagnostic purposes on their own patients
    • Persons who carry out work for microbiological quality assurance and possess the necessary expertise and who are exempted from the permit requirement by the competent authority upon application.
    • Employees working under the supervision of a person holding a permit or exempt from the permit requirement
    • certain procedures (e.g. sterility testing)

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

  • Requirements

    Permission to work with pathogens is granted to you if you

    • have the required expertise and
    • have so far proven to be reliable in terms of activity with pathogens.

    You can prove the required expertise by completing a degree in human, dental or veterinary medicine, pharmacy or a degree in natural sciences from a university of applied sciences or university with microbiological content and at least 2 years of full-time professional activity with pathogens.

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

    If the requirements are not fully met, a restricted licence may be issued.
     

  • Which documents are required?

    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 have a qualified electronic signature.

    Documents:

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

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

  • What are the fees?

    Fees are charged in accordance with the administrative cost regulations for the Ministry of Social Affairs and Integration (VwKostO-HMSI). The amount of the fee is calculated according to the time spent.

  • What deadlines do I have to observe?

    You need to obtain authorisation from the authorities in good time so that you can notify them at least 30 days before the planned date of commencement of work.

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

  • Legal basis

    - Section 44 Infection Protection Act (IfSG ) (authorisation requirement for activities involving pathogens)
    - Section 45 Infection Protection Act (IfSG ) (exceptions)
    - Section 46 Infection Protection Act (IfSG ) (activity under supervision)
    - Section 47 Infection Protection Act (IfSG ) (grounds for refusal, requirements for authorisation)
     

  • Applications / Forms

    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 first. Use the simulation for this purpose. In order to be able to make full use of the online application, you must first register with the online application procedure.

    Online application procedure of the Point of Single Contact Hesse

  • What else should I know?

    If you have been granted permission to work with pathogens, you must notify the competent body of the first commencement of the activity.


Start your request directly online

Who do I need to contact?

the health authority in whose area of responsibility your place of business or residence is located.

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

Responsible departments