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 Protection Experimental Animal Ordinance.
The application must
- demonstrate in a scientifically substantiated manner that the prerequisites of § 8 Para. 1 Sentence 2 No. 1 Letters a and b of the Animal Protection Act (TierSchG) are fulfilled,
- to demonstrate that the requirements of § 8 para. 1 sentence 2 nos. 2 to 5 of the Animal Welfare Act (TierSchG) are fulfilled,
- to demonstrate that the requirements of Section 8, Paragraph 1, Sentence 2, Nos. 6 to 8 of the Animal Welfare Act are met.
The application must be accompanied by a summary of the experimental project with the information required by Section 41, Paragraph 1, Sentence 2 of the Animal Protection Experimental Animal Ordinance.
According to § 8 paragraph 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 of the Animal Protection Act are met,
- the desired result is not sufficiently known despite exhaustion of the accessible information possibilities or the verification of a sufficiently known result by a duplicate or repeat experiment is indispensable,
- the responsible head of the experimental project and his deputy have the required professional qualification, in particular with regard to the supervision of the animal experiments, and there are no facts which give rise to doubts about their reliability,
- the necessary premises, equipment and other material resources comply with the requirements of the Ordinance on Animal Experiments for the Protection of Animals,
- the personnel and organizational requirements for the performance of the animal experiments, including the activities of the animal protection officer, are met,
- the keeping of the animals complies with the requirements of § 2 of the Animal Protection Act and the Ordinance on Experimental Animals for the Protection of Animals and their medical care is ensured,
- compliance with the regulations of § 7 para. 1 sentence 2 no. 1 and § 7a para. 2 nos. 4 and 5 Animal Welfare Act can be expected, and
- compliance with expertise requirements, regulations on pain relief and anesthesia of animals, regulations on the re-use of animals, prohibitions and restrictions on the use of animals, regulations on the avoidance of pain, suffering and damage after the purpose of the animal experiment has been achieved, regulations on the prevention of the death of an animal under the effect 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 to be followed after completion of the animal experiment, and that the animal experiment is carried out in as environmentally compatible a manner as possible, can be expected and
- the keeping of records in accordance with Section 9 (5), first sentence, can be expected.
The approval notice shall contain the name of the head of the experimental project and his deputy, an indication of the facilities or establishments or the location at which the experimental project will be carried out, a decision on whether and at what point in time the experimental project is to be retrospectively evaluated, and, if necessary the ancillary provisions to be attached to the approval and, if the competent authority deviates in its decision from the scientifically substantiated statements pursuant to Section 31 (1) sentence 2 number 2 and the scientific assessments pursuant to Section 31 (3), an explanation of the reasons, without prejudice to the requirements under administrative procedure law for substantiating an administrative act.
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