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Pathogens; application for authorization for activities

Anyone wishing to bring pathogens into the Federal Republic of Germany, export them, store them, dispense them or work with them requires a permit from the competent authority.

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Supplement: Regierung von Oberbayern

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Regierung von Oberbayern - Sachgebiet 55.2 - Rechtsfragen Gesundheit, Verbraucherschutz und Pharmazie

Regierung von Oberbayern

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Maximilianstraße 39
80538 München

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80534 München

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Procedure details

A pathogen within the meaning of the Infection Protection Act (IfSG) 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 IfSG, export, store, dispense or work with them requires a permit from the competent authority.

Work with pathogens does not only apply if pathogens are deliberately caused to multiply, but also if food is only tested for the absence of pathogens and there is a possibility that potentially present pathogens will multiply (e.g. laboratory diagnostic evaluation of PCR tests).

Activities involving pathogens that cannot be reproduced, in particular pathogens that have been killed, are not subject to the permit requirement. The same applies to activities with test material that (possibly) contains pathogens but does not reproduce them.

A permit is not required for anyone working under the supervision of a person who has a permit or, exceptionally, does not require a permit.

Exceptions to the permit requirement for certain groups of people or certain activities are listed in Section 45 IfSG.

The permit is personal. The prerequisite is that the applicant

  • has the necessary 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, 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 two years of full-time work with pathogens under the supervision of a person who is licensed to 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.

  • Certificate of good conduct
    as proof of reliability
  • Certificate of competence
    by submitting certified copies of your training certificates and a certificate attesting to at least two years of full-time work with pathogens under supervision

The application for the permit is made via the online procedure at the government responsible for the place of business. Alternatively, if you wish to submit a paper-based application, please contact the government responsible.

An administrative fee is charged to the applicant, taking into account the time and effort involved and the importance of the matter (Kostengesetz - KG). Depending on the individual case, the costs generally range from €50.00 to €300.00; this information is provided as a guide.

You need permission from the authorities in good time so that you can notify the authorities at least 30 days before the planned start date.

In addition to the permit, notification is also required: anyone wishing to start working with pathogens for the first time must notify the competent authority (see "Related topics").

Administrative court action

Status: 23.05.2024
Editorially responsible for prodecure description: Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention
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