Applying for approval of animal experiments

Source: BUS Rheinland-Pfalz

If you would like to carry out animal experiments, you generally 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 be associated with pain, suffering or harm to these animals,
for experimental purposes on animals that may lead to the birth or hatching of animals that suffer pain, suffering or harm,
for experimental purposes on the genetic material of animals if they may cause pain, suffering or harm to the genetically modified animals or their carriers,
which are carried out for the production, extraction, storage or propagation of substances, products or organisms, or

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

Once 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 Commission's opinion will be taken into account by the competent authority during the assessment. In addition, an opinion is obtained from the responsible animal welfare officer. If there are any questions or need for clarification, you will be asked to comment on this in writing before a final decision is made.

The test is essential and cannot be replaced by alternative methods. 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 provide evidence of expertise, in particular with regard to the stressful interventions and treatments, in relation to the intervention and the animal species
the necessary facilities, equipment and other material resources are available
For animal experiments that are carried out in laboratory animal facilities, a permit for the relevant animal species is required in accordance with the Animal Welfare Act.

Application form for approval or notification of animal experiments
The non-technical project summary (NTP) must contain
- the purpose of the experiment,
- the expected benefit,
- the expected pain, suffering and/or harm,
the animal species and animal numbers as well as the fulfillment of the requirements according to the Animal Welfare Act (indispensable measure, alternative methods to animal testing, indispensability of the stress, sensory-physiological developmental stage)
Glossary of abbreviations and any specific technical terms used in the text
List of literature citations (if not included in the text)
Form "Final assessment of genetically modified breeding lines", if applicable
Form "Repeated use of primates", if applicable
Stress table
Score sheet
Recording template according to § 9 para. 5 TierSchG
Person sheets, if applicable
Proof of training, knowledge, skills and animal experimentation experience of the persons involved
If applicable, "Information on biometric planning" forms
Statistical report
Statement from the animal welfare officer
Scientific assessments from independent third parties, if applicable
Other documents:
- e.g. medication list etc.

The competent authority must notify you of a decision on the application within 40 working days of receipt of an application that complies with animal welfare regulations. The deadline can be extended once by up to 15 working days. The clarification of open questions also leads to a suspension of the deadline. Even after the deadline has expired, the experimental project may only be started once approval has been granted.

Applying for approval of animal experiments

Process flow

Requirements

Which documents are required?

What are the fees?

What deadlines do I have to pay attention to?

Processing duration

Legal basis

Applications / forms

Appeal

What else should I know?

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