Activities with pathogens permit
In Germany, there is a basic permit requirement for activities with pathogens. Anyone who wants to bring pathogens to Germany as a responsible person, export them, store them, hand them over or work with them needs a permit.
The term pathogen refers to reproducible pathogens (viruses, bacteria, fungi, parasites) or other biological transmissible pathogens that can cause an infection or a communicable disease in humans.
In particular, the following are considered to be activities with pathogens:
- experiments with reproducible pathogens,
- microbiological and serological tests for the detection of notifiable pathogens,
- targeted accumulation or multiplication of pathogens.
Exceptions to the permit requirement exist for the following groups of persons or activities:
- Doctors, dentists and veterinarians who carry out microbiological examinations for the purpose of diagnosing their own patients,
- Persons who carry out work on microbiological quality assurance and possess the necessary expertise and are exempted from the authorisation requirement by the competent authority upon application,
- Employees who work under the supervision of a person who has a permit or is exempt from the permit requirement
- certain procedures (e.g. sterility tests).
Further information on the topic of "Activities with pathogens" can be found in the following services:
- Pathogens: Indication - of changes in activities with pathogens
- Pathogens: Indication - of the commencement of activities with pathogens
Who should I contact?
The responsibility lies with the district and the district-free city in whose district the activity is to be carried out.
This procedure can also be handled by a "Point of Single Contact". The "Point of Single Contact" is a special service offered by the municipalities and the state for service providers.
Requirements
- natural person
- has the necessary expertise, and
- has so far proven to be reliable with regard to the activity with pathogens for the exercise of which it applies for authorisation.
- The required expertise is demonstrated by:
- the completion of a degree in human, dental or veterinary medicine, pharmacy or the completion of a scientific college or university degree with microbiological content and
- a full-time occupation with pathogens for at least two years under the supervision of a person who is in possession of a permit to work with pathogens.
Another full-time activity in the field of bacteriology, mycology, parasitology or virology of at least two years is also recognised as proof of expertise if equivalent expertise has been acquired.
If the requirements are not fully met, the granting of a limited permit may be considered.
Which documents are required?
- Certified copies of training and study certificates
- Certificate of at least two years of full-time activity with pathogens under supervision
- Certificate of good conduct
What are the fees?
Fees are charged in accordance with Annex 1 to § 1 paragraph 1 of the General Fee Schedule of the State of Lower Saxony (AllGO) in accordance with No. 49.1.18.1.
Appendix 1 to § 1 paragraph 1 of the General Schedule of Fees (AllGO)
What deadlines do I have to pay attention to?
Permission from the competent authority is required as early as possible so that the commencement of activity with pathogens can be reported at least 30 days before the planned date.
Processing duration
Processing Time: 3 MonthsSection 53a (2) sentence 1 of the Infection Protection Act (IfSG)
Applications / forms
The application must be submitted informally.
Appeal
If the competent authority refuses to grant the permit, this decision may be appealed to the Administrative Court.
What else should I know?
Regardless of whether the activity is subject to authorisation or not, there is an obligation to notify. The activity may not be commenced until the notification is complete and, after examination of the documents and the premises, the activity is not prohibited. Any significant change in the premises, activity, disposal or pathogen spectrum must be reported to the competent authority.
Anyone who carries out an activity in accordance with §§ 44 et seq. of the Infection Protection Act (IfSG) is subject to official supervision in accordance with § 51 IfSG. Additional fees may apply for any on-site visits and inspections that may be required.
Technically approved by
Lower Saxony Ministry of Social Affairs, Health and Equality
