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Tätigkeit mit Krankheitserregern, Veränderungen anzeigen

Sachsen 99003021218000 Typ 2/3

Inhalt

Leistungsschlüssel

99003021218000

Leistungsbezeichnung

Activity with pathogens, indicate changes

Leistungsbezeichnung II

Activity with pathogens, indicate changes

Leistungstypisierung

Typ 2/3

Begriffe im Kontext

nicht vorhanden

Leistungstyp

nicht vorhanden

SDG Informationsbereiche

nicht vorhanden

Lagen Portalverbund

nicht vorhanden

Einheitlicher Ansprechpartner

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Fachlich freigegeben am

nicht vorhanden

Fachlich freigegeben durch

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Teaser

If you carry out activities involving pathogens, you must notify the competent authority immediately of any changes that occur.

Volltext

Notification of changes in the performance of activities involving pathogens in accordance with Section 50 of the Infection Protection Act (IfSG)

If you carry out activities involving pathogens, you must notify the competent authority immediately of any changes that occur.

In particular, you must report

  • significant changes in the type and scope of the activity, the nature of the rooms and facilities or the disposal measures
  • the cessation of activities involving pathogens
  • the resumption of activities involving pathogens

Please note! You must always notify the changes even if the activity with pathogens does not require a licence; however, if you are working under the supervision of another person, there is no obligation to notify.

Single point of contact

You can use the service of the Single Point of Contact for this procedure. They will guide you through the procedure, take care of correspondence with all the authorities responsible for your matter and provide you with expert advice.

Erforderliche Unterlagen

  • informal written notification of change
  • Documents relating to the changes, such as
    • Room plans with a detailed spatial description focussing on the mobile and technical equipment of the respective laboratory (or drawn into the site plan) including
      • (Safety) workbenches, incubators, shelves, autoclave,
      • Sinks, available hand wash basins and
      • Locations of any touch-free disinfectant, soap and disposable towel dispensers, eye showers and so on,
    • Information on existing ventilation technology
    • current hygiene plan/cleaning/disinfectant plan
    • Operating instructions
    • Disposal plan
  • Permit to carry out the activity (copy) or information on exemption from authorisation

Voraussetzungen

  • You have a licence to work with pathogens and have notified us that you are taking up this activity for the first time, or
  • You are carrying out an activity with pathogens that does not require a licence

Kosten

none

Verfahrensablauf

Compose your written notification of change informally in writing or (if available here via Amt24) on the form provided.

  • Depending on the reason for the change, your notification must contain the following information:
    • Changes in the type and scope of activities
    • Changes to the disposal measures
    • Changes in the nature of the premises and facilities
    • Changes to the exemption from authorisation
    • Information on the cessation or resumption of an activity involving pathogens
  • Complete the form in full and attach any necessary evidence and documents.
  • Submit the notification of change to the competent authority.
If there is a risk to public health, the competent authority will prohibit the continuation or resumption of activities involving pathogens. This is particularly the case if no suitable rooms or facilities are available for the activities or if the conditions for safe disposal are not met.

Bearbeitungsdauer

nicht vorhanden

Frist

Notification of changes: immediately, i.e. without undue delay

Weiterführende Informationen

nicht vorhanden

Hinweise

nicht vorhanden

Rechtsbehelf

objection (details in the notification)

Kurztext

nicht vorhanden

Ansprechpunkt

nicht vorhanden

Zuständige Stelle

nicht vorhanden

Formulare

nicht vorhanden