Laboratory animals: authorisations and enforcement
All projects involving the use of animals require prior authorisation from a body known as the Project Authorisation Board (formerly the Animal Experiment Board).
The procedures to be carried out on animals in the course of projects must be designed by a qualified individual. More information about qualification requirements is provided below.
Experimenting on animals requires a licence, more information on which is provided below.
Prior authorisation must be sought for any project involving the use of the following kinds of animals for education and training purposes that may cause the animals a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle:
- live non-human vertebrate animals
- foetal forms of mammals or birds as from the last third of their normal development
- independently feeding larval forms of fish
Authorisation is also required for projects that involve
- the creation of genetically modified animals or
- maintenance of a genetically modified animal line with clinical abnormalities.
No prior authorisation is required for
- projects that are likely to cause a level of harm lower than that caused by the introduction of a needle,
- euthanising animals in a humane manner,
- practices undertaken for the purposes of recognised animal husbandry,
- marking animals for identification purposes, or
- non-experimental clinical veterinary practices or veterinary clinical trials.
There is a simplified authorisation process for individual procedures that are likely to cause no more than moderate harm. Examples include experiments that only require the drawing of blood samples, euthanasia and teaching involving repetitive coursework.
Standard authorisation is required if a project consists of multiple components and procedures of differing levels of severity.
A project can be deemed to be ‘complex’ if processing the application requires an unusually large amount of work. Examples of complex projects include projects that consist of multiple experiments and sub-experiments involving a variety of procedures using several different species and strains of animals.
A separate form has been prepared for requesting changes to existing authorisations, such as adding a new procedure or a new animal species, increasing the number of animals involved or extending the period of validity of the authorisation.
The competent authority for approving short extensions, small increases in the number of animals involved or urgent changes is the Regional State Administrative Agency for Southern Finland (a processing fee of EUR 110 applies). A separate form has been prepared for requesting changes to existing authorisations.
Separate application forms have been prepared for seeking simplified, standard and modified authorisations in Finnish and Swedish. Applications must be submitted in Finnish or Swedish. Requests submitted in English are not considered. Instructions for filling in the forms are also available in English.
The forms are provided as Microsoft Word documents, and the address to send your form to is [email protected] You will receive confirmation of receipt once your message has been read.
You can ask for instructions from [email protected]
- Instructions for seeking project authorisation
- Instructions in English
- Instructions for requesting changes to existing authorisations
- Tips for applicants
- How to describe behaviour studies
- Codes for different scientific purposes
- Animals subject to project authorisation and animals to be included in EU statistics
- Severity of procedures – assessment and classification
- Animals taken from the wild
- Application of genetic engineering rules to the keeping and use of laboratory animals.
Project authorisations are usually granted for a period of three years. Five-year authorisations can be granted through the simplified procedure.
An officer is assigned to each request for authorisation within two or three weeks of receipt, at which point the officer also informs the applicant of an estimated processing time. It usually takes between three and five weeks from the receipt of a new application for the competent division of the Project Authorisation Board to review it.
Both the Regional State Administrative Agency’s officer and the Project Authorisation Board’s competent division may need to ask for more information from the applicant, which can lead to delays. The decision is issued within 40 working days of the date on which all pending questions have been answered by the applicant.
If you need a decision on your request urgently, mention this in your application and explain your reasons. The divisions of the Project Authorisation Board convene up to three times every month except in July, and applications are usually processed on a first-come, first-served basis.
Our processing fees are based on the Government Decree on Charges Payable for the Services of Regional State Administrative Agencies. The amount depends on the volume of work involved in processing each application.
Processing fees for project authorisations in 2021
- Simplified procedure: EUR 650
- Standard authorisation: EUR 1,080
- Complex projects: EUR 2,700
- Modifications that need to be reviewed by the Project Authorisation Board: EUR 325
- Modifications that do not need to be reviewed by the Project Authorisation Board (urgent changes, short extensions, small increases in the number of animals involved): EUR 110.
If you intend to continue your project for another three years, you need a new authorisation.
The Project Authorisation Board can extend existing authorisations by up to one year to allow a project to be completed. A two-year extension can be granted in special circumstances if, for example, a project’s schedule is tied to bird migration.
Requests to extend an existing authorisation must explain the reasons. Typical reasons why a project may not have progressed on schedule include maternity leaves, renovations in the facilities where animals are kept and difficulties with procuring laboratory animals.
The information to be provided in the non-technical project summary must be provided in connection with the project authorisation request. The objective of non-technical project summaries is to educate the general public about animal experimentation. Starting from 1 January 2021, the information is sent directly to the EU, which publishes the summaries in due course. More detailed instructions will be provided before the end of 2020.
A retrospective assessment is required of all projects involving procedures classified as ‘severe’. In some circumstances, the Project Authorisation Board can also order that a retrospective assessment be carried out on ‘moderate’ procedures.
If your authorisation stipulates that a retrospective assessment must be carried out, you have three months from the end of your project to perform one. Assessment forms are available from [email protected] From 2021 onwards, retrospective assessments will be regulated and published by the EU.
Operators who need a licence include, for example, universities and research centres that keep or use laboratory animals. Licensing is our way of making sure that the facilities, equipment and the way in which animals are looked after are in order. No animal experiments may take place until we have issued a licence.
You need a licence if you
- breed, sell or keep animals for scientific purposes or
- experiment on animals yourself.
If your operation involves genetically modified animals, you must also notify the Finnish Board for Gene Technology.
You also need a licence to perform experiments on animals
- in the wild,
- in a private cowshed,
- in a piggery, or
- in connection with veterinary practice.
1. Type up a description of your operation in your own words, making sure to include at least the information specified in section 27 of the Finnish Government Decree on the Protection of Animals Used for Scientific or Educational Purposes.
2. For each of the facilities and units that you use, provide details about
- your premises,
- your equipment,
- your tools,
- your staff,
- how you have provided for veterinary medical care and the designated veterinarian,
- the person in charge of each facility, and
- the members of your animal welfare body.
3. If you primarily operate in Southern, Southwestern, Western or Inland Finland, send your application to the Regional State Administrative Agency for Southern Finland ([email protected]). The competent licensing authority in Eastern and Northern Finland is the Regional State Administrative Agency for Eastern Finland ([email protected]).
The competent Regional State Administrative Agency will need to conduct an inspection on your premises before a licence can be issued.
You need to let the competent Regional State Administrative Agency know immediately of any material changes. You also need to notify us if you decide to close your business.
You can add more information to your licence and make changes to your details at any time by writing to your enforcement liaison officer.
The competent Regional State Administrative Agency appoints an enforcement liaison officer to regularly audit your operation. Your enforcement liaison officer can ask you to provide information about your operation at any time. Your enforcement liaison officer is also your point of contact for reporting violations of the laws or rules governing the keeping of animals and animal experimentation.
All members of staff must have their competence verified by a supervising officer before they can work with live animals independently. Several universities regularly run courses to boost staff’s skills in both Finnish and English. Regular training is vital for all staff members who work with animals.
The EU has prepared a common education and training framework for the protection of animals used for scientific purposes:
What are the competence requirements for different members of the team?
The “designer” of the project must be identified in the project authorisation request. The designer must hold a degree in a relevant academic subject and have received animal experimentation instruction appropriate to their role. If the instruction was given in Finland, there is no need to demonstrate competence separately. However, the designer must present proof of having completed the relevant animal experimentation courses upon request.
If the designer received their instruction abroad, their appointment to the role must be approved by the competent Regional State Administrative Agency. Only individuals whose foreign instruction matches that given in Finland can be approved to act as designers in Finland. A special form has been prepared for seeking recognition of competence. You can ask for the form by emailing [email protected] Evidence of the instruction received must be appended to the form. A processing fee of EUR 215 applies.
If an individual recruited to carry out procedures on animals received their instruction abroad, they must first be approved by the competent Regional State Administrative Agency. Only individuals whose foreign instruction matches that given in Finland can be approved to carry out procedures on animals in Finland.
A special form has been prepared for seeking recognition of competence. Evidence of the instruction received must be appended to the form. The form and the supporting documents can be sent by email to [email protected]
Any individuals responsible for taking care of animals or euthanising animals also need to be properly trained until they can demonstrate their competence in practice.
Topics that might interest you
Further information about animal experimentation
Website of the Finnish Board for Gene Technology (in Finnish)