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A permit in accordance with the Infection Protection Act is required if responsible persons wish to import pathogens into Germany, export them from Germany, store them, dispense them or work with them.

You require a permit in accordance with the Infection Protection Act if you, as the person responsible, wish to import pathogens into Germany, export them from Germany, store them, dispense them or work with them.

There are exceptions to the permit requirement for the following groups of people or activities:

• Doctors, dentists and veterinarians who carry out microbiological tests for diagnostic purposes on their own patients
• Persons who carry out work for microbiological quality assurance and have the necessary expertise and are exempted from the permit requirement by the competent authority upon request
• 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)

Note: Pathogens within the meaning of the Infection Protection Act are viruses, bacteria, fungi and parasites as well as any other biological transmissible agentthat can cause an infection or transmissible disease in humans.

You can submit the informal application in writing or in person.

If you submit the application in writing to the competent authority, it must be signed by hand or have a qualified electronic signature.

Documents:

• Tabular list of the academic education of the applicant
• Certified copy of the degree in medicine or natural sciences with microbiological content (e.g. diploma certificate, doctoral certificate)
• Confirmation of at least two years of full-time work with pathogens from the relevant employer
• Alternatively, proof of an equivalent activity to acquire the expertise
• If you are resident in Germany, you generally require a certificate of good conduct in accordance with Section 30 (5) of the Federal Central Criminal Register Act (Bundeszentralregistergesetz)
• If you are resident abroad, you will need documents from your home country to prove that you are personally reliable enough to perform the desired service.
• If applicable, license to practice medicine (doctor's license, see § 47 para. 4 IfSG)
• List of publications, if applicable
• Informal declaration of reliability in dealing with pathogens

When checking your personal reliability, the licensing authority may, in individual cases, request further documents in addition to the documents listed, which are suitable for making a statement about your personal reliability as an applicant.

You will be granted permission to work with pathogens if you

• have the necessary expertise and
• have proven to be reliable with regard to working with pathogens.

You can prove that you have the required expertise by completing 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 as well as at least two years of full-time 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.

If the requirements are not fully met, a restricted permit may be issued.

The amount of the fee is based on the time spent, but is at least EUR 125.00 (tariff item 3.4.1)

Application by submitting the required documents

A decision on the application must be made within 3 months. If the documents are complete, the processing time is usually 2-3 weeks.

You need permission from the authorities in good time so that you can notify the authorities at least 30 days before the planned date of commencement of activities involving pathogens.

The issued permit is valid nationwide. In addition to the permit, the first-time commencement of activities involving pathogens must be notified in accordance with Section 49 IfSG.

• You require a permit in accordance with the Infection Protection Act if you, as the person responsible, wish to import pathogens into Germany, export them from Germany, store them, dispense them or work with them.
• There are exceptions to the permit requirement for certain groups of people or activities.
• Note: Pathogens within the meaning of the Infection Protection Act are viruses, bacteria, fungi and parasites as well as any other biological transmissible agentthat can cause an infection or transmissible disease in humans.

The Mecklenburg-Vorpommern State Office for Health and Social Affairs is the responsible approval and monitoring authority.