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A permit is required to carry out animal experiments

Before carrying out an animal experiment, a permit must be obtained from the competent authority in accordance with § 8 of the Animal Protection Act.

Animal experiments within the meaning of the Animal Welfare Act are interventions or treatments for experimental purposes

1. animals, if they are likely to cause pain, suffering or harm to those animals;

2. animals which may cause animals to be born or hatch, which suffer pain, suffering or harm, or

3. on the genetic material of animals, if they may be associated with pain, suffering or damage to the mutagenic animals or their carriers.

Animal testing also includes interventions or treatments that are not for experimental purposes, and

1. carried out for the manufacture, extraction, storage or propagation of substances, products or organisms;

2. removed in whole or in part by organs or tissues for scientific purposes:

(a) transplant the organs or tissues;

(b) to cultivate crops, or

(c) examine isolated organs, tissues or cells;

or

3. which are carried out for the purposes of education, training or further education,

insofar as one of the conditions specified in sentence 1 numbers 1 to 3 is met. The killing of an animal is not considered animal experimentation if it is done exclusively for the purpose of using its organs or tissues for scientific purposes.

The permit is granted in a simplified approval procedure in accordance with Section 8a of the Animal Protection Act if the experimental project is a project,

1. which has as its object exclusively animal experiments, the carrying out of which is expressly

(a) is required by law or regulation, by the pharmacopoeia or by a directly applicable act of the European Community or of the European Union;

b) is provided for in a general administrative regulation issued by the Federal Government or a Federal Ministry, or

c) is ordered by an authority or court on the basis of a law or a regulation or a directly applicable legal act of the European Community or of the European Union, or is required in individual cases as a prerequisite for an official decision,

2. which relates exclusively to animal experiments carried out on animals in the form of vaccinations, blood samples or other diagnostic measures in accordance with procedures that have already been tried and tested, and

(a) the detection of diseases, ailments, bodily injuries or physical ailments in humans or animals, or

(b) the testing of serums, blood preparations, vaccines, antigens or test allergens in the context of authorisation procedures or batch tests

or

3. which deals exclusively with animal experiments carried out in accordance with tried-and-tested

(a) for the manufacture, extraction, storage or propagation of substances, products or organisms, or

b) for diagnostic purposes

be carried out.

The application must contain all the necessary information in accordance with § 31 TierSchVersV (application according to § 8 TierSchG) or 36 TierSchVersV (application according to § 8a TierSchG). In addition, the following documents must be submitted as attachments:

Completed application form

Proof of qualifications of all contributors

Printout of the non-technical project summary (NTP) from the database "animaltestinfo" (except application according to § 8a TierSchG)

If necessary, final assessments of genetically modified lines

If applicable, score sheet (termination criteria)

If applicable, completed form for biometric planning for each partial experiment

If applicable, completed form for the use of primates

If applicable, completed form for the use of animals according to § 20, § 21 or § 22 TierSchVersV

If applicable, applications for exemptions

The opinion of the Animal Welfare Officer must be submitted separately by the Animal Welfare Officer.

If necessary, scientific assessments by independent third parties

Upon receipt of the application with all the necessary information, explanations and supporting documents, you will receive an acknowledgement of receipt from the competent authority. An examination will be carried out by the authority and, if necessary, a review will be made. Documents/information requested.

When deciding on the approval of animal experiments, the competent authority is supported and advised by a commission of experts, the "§ 15 Commission", consisting of representatives of animal welfare organisations and science.

Applications pursuant to Section 8a of the Animal Protection Act are subject to a simplified approval procedure.

After the examination, a decision will be made.

Application according to § 8 TierSchG: 40 working days from receipt of a complete application

Application according to § 8a TierSchG: 20 working days from receipt of a complete application

An extension of the processing deadlines is possible in each case by stating reasons.

The authorisation is granted for a limited period of time. A maximum duration of 5 years can be applied for.

Before submitting an application, an animal welfare officer must have been officially appointed.

Animal experiments on decapods are only notifiable.

An appeal against the decision may be lodged within one month of notification. The action must be lodged in writing with the competent administrative court or for the record of the clerk of the registry of that court. The action may also be brought with a qualified electronic signature by transmission via the court's Electronic Judicial and Administrative Mailbox (EGVP).

Forms/online services available: Yes

Written form required: Yes

Informal application possible: No

Personal appearance required: No