Tätigkeit mit Krankheitserregern, Erlaubnis beantragen

• § 44 Gesetz zur Verhütung und Bekämpfung von Infektionskrankheiten beim Menschen (Infektionsschutzgesetz, IfSG) – Erlaubnispflicht für Tätigkeiten mit Krankheitserregern
• § 45 IfSG – Ausnahmen
• § 46 IfSG – Tätigkeit unter Aufsicht
• § 47 IfSG – Versagungsgründe, Voraussetzungen für die Erlaubnis
• Sächsisches Kostenverzeichnis (SächsKVZ), Anlage 1 zu § 1 lfd. Nr. 73 Tarifstelle 9 – Öffentlicher Gesundheitsdienst/Amtsärztliche Tätigkeiten

Authorisation for activities involving pathogens in accordance with Section 44 of the Infection Protection Act (IfSG)

Anyone wishing to bring, export, store, deliver or work with pathogens in Germany requires a licence from the competent authority in accordance with the Infection Protection Act (IfSG). This must be applied for.

Pathogens are defined as reproducible transmissible viruses, bacteria, fungi, parasites and the like that can cause infection or transmissible diseases in humans.

Exemptions from the licence requirement apply to doctors, veterinarians and dentists for certain microbiological tests and for certain procedures such as sterility tests. Anyone working under the supervision of persons who have a licence or are exempt from the licence requirement also does not require a licence.

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 request and provide you with expert advice.

• Single point of contact
  Amt24 information

• Certified copy of degree certificate (e.g. Bachelor's/Master's/Diploma certificate and diploma)
• for medical applicants additionally: licence to practise medicine and recognition as a medical specialist
• for natural science degree programmes additionally: proof of microbiological course content
• short professional CV and list of publications
• Information on the previous scope of work with human pathogens, stating the risk group
• Proof of at least two years of full-time work with pathogens under the supervision of a person who is in possession of a permit (in accordance with Section 19 BSeuchG or Section 44 IfSG) to work with pathogens - this confirmation should include the type and scope of the work carried out and specifically name the pathogens with risk group that were handled
• Copy of the licence according to § 44 IfSG of the supervising person
• Proof of reliability:
  • for self-employed persons: Certificate of good conduct
  • for employees: Assessment of the employer

Authorisation may be granted to persons who

• have the necessary expertise and
• have proven themselves to be reliable with regard to the activities for which the licence is being applied for.

The required expertise is fulfilled by a university degree in medicine, veterinary medicine or pharmacy or another natural science degree with microbiological content and at least two years of full-time work with pathogens under the supervision of a person who is in possession of a permit to work with pathogens.

from EUR 163.00 to 403.00

You must apply for the licence informally in writing to the competent authority.

none

Objection (details in the notification)