Tierversuche; Beantragung einer Genehmigung

Anyone wishing to carry out experiments on vertebrates or cephalopods requires approval of the experimental project by the competent authority.

The application for approval of an experimental project must be submitted in writing to the Government of Upper Bavaria (for the administrative districts of Upper Bavaria, Lower Bavaria and Swabia) or to the Government of Lower Franconia (for the administrative districts of Lower Franconia, Middle Franconia, Upper Franconia and Upper Palatinate) in accordance with Section 31 or Section 36 (simplified approval procedure) of the Animal Welfare Experimental Animal Ordinance.

The application must

• provide scientific justification that the requirements of Section 8 (1) sentence 2 no. 1 letters a and b of the Animal Welfare Act (TierSchG) are met,
• demonstrate that the requirements of Section 8 para. 1 sentence 2 nos. 2 to 5 TierSchG are met,
• demonstrate that the requirements of Section 8 para. 1 sentence 2 nos. 6 to 8 TierSchG are met.

The application must be accompanied by a summary of the experimental project with the information specified in Section 41 (1) sentence 2 of the Animal Welfare Experimental Animal Ordinance.

According to Section 8 (1) TierSchG, approval may only be granted if

• it is scientifically substantiated that
  • the requirements of Section 7a (1) and (2) Nos. 1 to 3 TierSchG are met,
  • the intended result is not sufficiently known despite exhausting the available information options or the verification of a sufficiently known result by a duplicate or repeat test is essential,
• the responsible head of the experimental project and his deputy have the necessary professional qualifications, in particular with regard to the supervision of animal experiments, and there are no facts that give rise to concerns about their reliability,
• the necessary premises, facilities and other material resources meet the requirements of the Animal Welfare Experimental Animal Ordinance,
• the personnel and organizational requirements for carrying out the animal experiments, including the activities of the animal welfare officer, are met,
• the animals are kept in accordance with the requirements of Section 2 TierSchG and the Animal Welfare Experimental Animal Ordinance and their medical care is ensured,
• compliance with the provisions of Section 7 para. 1 sentence 2 no. 1 and Section 7a para. 2 nos. 4 and 5 TierSchG can be expected and
• compliance with expertise requirements, regulations on pain relief and anaesthesia of animals, regulations on the re-use of animals, prohibitions and restrictions on use, regulations on the avoidance of pain, suffering and harm after the purpose of the animal experiment has been achieved, regulations on the prevention of the death of an animal under the influence of the experiment or on the avoidance of pain and suffering in the event of the death of an animal and regulations on the procedure after completion of the animal experiment and the most environmentally friendly conduct of the animal experiment can be expected and
• the keeping of records in accordance with Section 9 para. 5 sentence 1 can be expected.

The notice of approval shall specify the head of the experimental project and his/her deputy, the facilities or establishments or the location at which the experimental project is to be carried out, a decision on whether and at what point in time the experimental project is to be assessed retrospectively and, where applicable the ancillary provisions with which the authorization is provided and, if the competent authority deviates in its decision from the scientifically substantiated explanations pursuant to Section 31 (1) sentence 2 number 2 and the scientific assessments pursuant to Section 31 (3), an explanation of the reasons, notwithstanding the requirements under administrative procedure law for the justification of an administrative act.