Information - Services - Formalities by subjects - Preparations for business start-up - Erlaubnispflichtige und überwachungspflichtige Unternehmen - Infection control; application for a permit to work with pathogens. - Dienstleistungsportal Bayern

Description

A pathogen as defined by 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.

Activities involving pathogens that are not capable of reproduction, in particular those that have been killed, are not subject to the permit requirement. The same applies to activities with examination material that contains pathogens but which are not reproduced.

Work with pathogens does not only apply if pathogens are deliberately propagated, but also if foodstuffs are merely examined for the absence of pathogens and the possibility exists that potentially existing pathogens are propagated.

Permission from the competent authority is required for anyone who wishes to bring pathogens into the area covered by the IfSG, export them, store them, dispense them or work with them.

Permission is not required for anyone who works under the supervision of someone who has a permit or who, exceptionally, does not require a permit.

Prerequisites

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 completion of a degree in human, dental or veterinary medicine, pharmacy or the completion of a natural science technical college or university degree 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.

Deadlines

There are no deadlines to meet.

Required documents

• 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

Forms

Please select a location in "Localization" so that the address of the responsible authority can be filled in.

• Prefillable Form, Bavaria-wide: Tätigkeiten nach Infektionsschutzgesetz und Tierseuchenerregerverordnung - Genehmigungsanträge und Anzeigen

  Please note

  This form has to be signed and sent to the responsible authority. You can sign the form manually and send it by email/fax or sign the form electronically with your qualified electronic signature an send it by (secure) email. If the responsible authority has set up a De-Mail account, you can also send the form by De-Mail using an sender-confirmed message.

  • Antrag auf Erlaubnis für Tätigkeiten mit Krankheitserregern nach § 44 Infektionsschutzgesetz
  • Anzeige zur Aufnahme von Tätigkeiten nach § 49 Infektionsschutzgesetz
  • Antrag auf Erlaubnis für Tätigkeiten nach § 2 Tierseuchenerregerverordnung
  • Anzeige zur Aufnahme von Tätigkeiten nach § 6 Tierseuchenerregerverordnung
  • Änderungsanzeige gemäß § 5 Tierseuchenerregerverordnung
  • Änderungsanzeige gemäß § 50 Infektionsschutzgesetz

Fees

• An administrative fee shall be charged to the applicant, taking into account the administrative effort and time incurred and the importance of the matter (Cost Act - KG).

Legal bases

• Gesetz zur Verhütung und Bekämpfung von Infektionskrankheiten beim Menschen (Infektionsschutzgesetz - IfSG)

Remedy

administrative claim

Related issues

• Biological agents; notification of activities with biological agents