Pathogens; application for permission for activities.
Anyone wishing to bring pathogens into the Federal Republic of Germany, export them, store them, dispense them or work with them requires permission from the competent authority.
A pathogen as defined by the Infection Protection Act is an agent capable of reproduction (virus, bacterium, fungus, parasite) or any other biological transmissible agent that can cause an infection or transmissible disease in humans.
Anyone wishing to bring pathogens into the area of application of the Infection Protection Act (IfSG), export them, store them, dispense them or work with them requires permission from the competent authority.
Work with pathogens is not only the case when pathogens are deliberately made to multiply, but also when foodstuffs are merely examined for the absence of pathogens and there is a possibility that potentially existing pathogens may be multiplied (e.g. laboratory diagnostic evaluation of PCR tests).
Activities involving pathogens that cannot be multiplied, in particular those that have been killed, are not subject to the permit requirement. The same applies to activities with test material that (possibly) contains pathogens, but these are not reproduced.
A permit is not required for anyone who works under the supervision of someone who has a permit or who, exceptionally, does not require a permit.
Exemptions from the permit requirement for certain groups of persons or certain activities are listed in Section 45 IfSG.
The permit is personal. It is a prerequisite that the applicant
- has the required expertise and
- has not proven to be unreliable for the activities for which the permit is requested.
The required expertise is generally demonstrated by
- a degree in human medicine, dentistry, veterinary medicine, pharmacy or a degree from a university or university of applied sciences with microbiological content and
- by at least two years of full-time work with pathogens under the supervision of a person holding a permit to work with pathogens.
Other full-time work 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 in the process.
The application for the permit is made via the online procedure at the government responsible for the place of business. Should you alternatively wish to submit a paper-based application, please contact the government responsible.
In addition to the permit, notification is also required: anyone wishing to take up activities involving pathogens for the first time must notify the competent authority (see under "Related topics").
You need to get the permission from the authority early so that you can notify the start of the activity at least 30 days before the scheduled date.
Please select a location in "Localization" so that the address of the responsible authority can be filled in.
An administrative fee is charged to the applicant, taking into account the time and material administrative expense incurred and the importance of the matter (Cost Act - KG). Depending on the individual case, the costs generally range from €50.00 to €300.00; this figure is provided for guidance.
Administrative court action
Responsible for editing: Bayerisches Staatsministerium für Gesundheit und Pflege
- Online transactions, Bavaria-wide
- Online transactions, locally limited
- Prefillable Form, Bavaria-wide
- Legal bases, Bavaria-wide
- Legal bases, locally limited
- Fees, Bavaria-wide
- Fees, locally limited