Bundesportal | Activities with pathogens Permission

More Information

Publisher

Brandenburg

Contact

The government service telephone number 115 – your point of contact for questions related to the federal, state and local.

Monday through Friday from 8:00 to 18:00 (and beyond these times in some regions).

Call 115 now

Government service telephone number calls are charged at local rates.

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, dispense them or work with them.

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

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 are exempted from the permit requirement by the competent authority 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)

Note: 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 transmissible 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 have a qualified electronic signature.

Documents:

Proof of degree (e.g. diploma certificate, certificates if applicable, doctoral certificate) in the form of a certified copy; if you have completed a degree course in the natural sciences at a university of applied sciences or university with microbiological content, the microbiological content of the course must be briefly described informally
Proof of expertise: certificate of two years of full-time work with pathogens from the relevant employer (copy of the permit to work with pathogens from the person under whose supervision the applicant worked full-time)
For proof of personal reliability:
If you are resident in Germany, you will need a certificate of good conduct.
If you are resident abroad, you will need documents from your home country proving that you are personally reliable enough to perform the desired service.
Curriculum vitae
License to practice medicine

When checking your personal reliability, the authorizing 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.

Online procedure possible: no

Written form required: yes

Personal appearance required: no

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Preconditions

You will be granted permission to work with pathogens if you have the necessary expertise and have proven to be reliable in terms of working with pathogens.

You can prove that you have 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 as well as at least two years of full-time work with pathogens.

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

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

Hints

The issued permit is valid nationwide and is a prerequisite for the notification of the commencement of activities with pathogens.

Residence in the state of Brandenburg is a prerequisite for processing the application.

According to the Fees Act for the State of Brandenburg (GebBbg) in conjunction with the Fee Schedule of the Ministry of Labor, Social Affairs, Health, Women and Family (GebOMASGF), the fee for issuing a permit for activities with pathogens pursuant to Section 44 IfSG is EUR 330 according to tariff item 7.8.5.1.

Basis for legal action

§ 44 Infektionsschutzgesetz

§ 45 Infektionsschutzgesetz

§ 46 Infektionsschutzgesetz

§ 47 Infektionsschutzgesetz

§ 49 Infektionsschutzgesetz

Commentary and collection of regulations on the Infection Protection Act, e.g. by Bales, Baumann, Schnitzler, Verlag Kohlhammer in the respective current version

Procedure

You will receive information about the documents to be submitted for the application processing by e-mail

The documents to be submitted by you must be sent to the State Office for Occupational Safety, Consumer Protection and Health, Health Department, G2 Health Reporting/Infection Protection Division, in 15806 Zossen, Wünsdorfer Platz 3.

Deadlines

You need the permit from the authorities in good time so that you can notify the authorities of any activities involving pathogens at least 30 days before the planned date.

The application can only be processed once the complete documentation has been submitted.

Processing time

Promptly up to max. 3 months

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