Tierversuche Genehmigung

§ 8 para. 1 Animal Protection Act (TierSchG)

§ 31 Animal Protection Experimental Animal Ordinance (TierSchVersV)

If you want to conduct animal experiments, you always need a permit from the competent authority before starting the experiment.

Animal experiments are interventions or treatments

• for experimental purposes on animals, if they may involve pain, suffering or harm to these animals,
• for experimental purposes on animals, which may result in the birth or hatching of animals that suffer pain, suffering or harm,
• for experimental purposes on the genetic material of animals, if they may involve pain, suffering or harm to the genetically modified animals or their carriers,
• carried out for the purpose of producing, obtaining, preserving or propagating substances, products or organisms, or

by which organs or tissues are removed in whole or in part for scientific purposes or which are carried out for the purpose of education, training or further education.

• Application for Approval or Notification of Animal Testing form.
• Non-Technical Project Summary (NTP) must include:
  • The purpose of the experiment,
  • the anticipated benefits,
  • the anticipated pain, suffering and/or harm,
• the animal species and animal numbers as well as the fulfillment of the requirements according to the Animal Protection Act (indispensable measure, alternative methods to animal experimentation, indispensability of the burden, sensory-physiological stage of development)
• Glossary of abbreviations and, if applicable, specific technical terms used in the text
• List of literature citations (if not included in the text)
• if applicable, form "Final evaluation of genetically modified breeding lines
• if applicable, form "Repeated use of primates
• Load table
• Score Sheet
• Recording sample according to § 9 Abs. 5 TierSchG
• if applicable, personal sheets
• Proof of training as well as knowledge and skills and animal experimental experience of the persons involved
• If applicable, forms "Information on Biometric Planning
• Statistical report
• Statement of the animal welfare officer
• If applicable, scientific assessments by independent third parties
• Other:
  • e.g. medication list etc.

• The test is essential and cannot be replaced by alternative procedures. It has not been carried out in this way before, and a gain in knowledge has been plausibly demonstrated.
• Personnel requirements are met: If you manage, plan and carry out animal experiments, you must demonstrate expertise, especially with regard to the stressful interventions and treatments, related to the intervention and the animal species
• the necessary facilities, equipment and other material resources are available
• for animal experiments carried out in laboratory animal facilities, a permit for the relevant animal species is required in accordance with the Animal Protection Act.

Is based on the respective administrative fee regulations of the state or on the fee statutes of the bodies responsible under state law.

After you have submitted the required documents, they will be checked for formal completeness. You will receive a formal confirmation of receipt. The application will then be submitted to the Commission for review at the next possible meeting. The opinion of the Commission will be taken into account accordingly in the examination by the competent authority. In addition, a statement from the responsible animal welfare officer will be obtained. Should any queries or need for clarification arise, you will be asked to comment on this in writing before a final decision is made.

The competent body shall notify you of a decision on the application within 40 working days from the date of receipt of an application that complies with the animal welfare requirements. The deadline may be extended once by up to 15 working days. The clarification of open questions also leads to an inhibition or suspension of the deadline. Even after the expiry of the above-mentioned deadline, the experimental project may not be started until a permit has been obtained.

Missing documents will be requested subsequently. The period until the decision on the application only counts from the time all required information is available.

You may not start the animal experiment until you have received the approval.

• Animal experiments that are required by law are subject to the simplified approval procedure.
• Experimental projects in which decapod crustaceans are used are subject to the notification requirement.

Objection (depending on state law, the objection may be excluded), administrative court action

• Apply for approval of animal experiments
• Animal experiments are generally subject to approval; animal experiments are interventions and treatments for experimental purposes on animals that may involve pain, suffering or harm to the animals
• There are special exceptions, which are only subject to notification.

• Application for approval or notification of animal testing,
• Final evaluation of genetically modified breeding lines,
• Loading table,
• Person sheet for a person to be involved in an animal experimentation project,
• Information on biometric planning,
• Form for the opinion of the animal welfare officer(s).