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Activities with pathogens - apply for a permit

You require a permit if you wish to import pathogens

import pathogens into Germany,
export them from Germany,
store them,
dispense them or
want to work with them.

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

Certain persons or activities are exempt from the authorisation requirement:

Doctors, dentists and veterinarians who carry out microbiological tests for diagnostic purposes on their own patients
Persons who
- Carry out microbiological quality assurance work and
- have the necessary expertise and
- the competent authority exempts them from the authorisation requirement upon request
Employees who work under the supervision of a person who
- has a licence or
- are exempt from the authorisation requirement
certain procedures (e.g. sterility testing)

If you belong to one of the above-mentioned groups, please enquire with the competent authority before commencing work. You must notify them of the activity.

Responsible department

the Regional Council of Tübingen

Details

Prerequisite

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 degree with microbiological content and
- at least two years of full-time work with pathogens
You 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.

Procedure

You can apply for the licence informally in writing or in person at the responsible office. The competent authority provides forms on the Internet.

The authority will check your documents. You will then receive the required licence or a notice of refusal.

To prevent communicable diseases, it can restrict the licence

restrict the licence to certain activities or certain pathogens or
attach conditions to the licence.

Deadlines

You need authorisation from the authorities in good time to be able to notify your activity 30 days before the planned start.

Required documents

Proof of degree (e.g. diploma certificate, doctoral certificate)
Proof of expertise: certificate of two years of full-time professional activity with pathogens under the supervision of a person who holds the licence themselves
for proof of personal reliability:
- If resident in Germany:
  - Certificate of good conduct for submission to an authority
- For residence abroad:
  - Documents from your home country that prove your personal reliability

The competent authority may request further documents to verify your personal reliability.

Costs

EUR 50.00 - EUR 250.00 depending on expenditure

Processing time

The competent authority decides within three months.

Miscellaneous

If you have received authorisation to work with pathogens, you must also notify the competent authority of the first commencement of work.

Detailed information

For more information on the obligation to notify, see"Activities involving pathogens - notification of commencement of activity".

Legal basis

Infektionsschutzgesetz (IfSG):

§ 44 Erlaubnispflicht für Tätigkeiten mit Krankheitserregern
§ 45 Ausnahmen
§ 46 Tätigkeit unter Aufsicht
§ 47 Versagungsgründe, Voraussetzungen für die Erlaubnis
§ 53a Absatz 2 Entscheidungsfrist

Release note

machine generated, based on the German release by: Sozialministerium Baden-Württemberg, 03.03.2025