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.
Operations with laboratory 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 scientific or educational 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 harmful phenotype.
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 according to the decree 564/2013 Annex 2,
- practices undertaken for the purposes of recognised animal husbandry,
- marking animals for identification purposes, or
- you won’t be performing other than standard treatment to animals in clinical veterinary medicine
- you are involved in clinical veterinary research that is needed for marketing authorisation for a veterinary medicinal product.
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 and, euthanasia, or teaching involving repetitive coursework.
Standard authorisation is required if a project consists of one or more subprojects and procedures of differing levels of severity.
A project can be deemed to be ‘extensive’ if processing the application requires an unusually large amount of work. Examples of extensive projects include projects that consist of large subprojects 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 separate form has been prepared for requesting changes to existing authorisations.
You can find the application forms and instructions for animal testing project authorisations in the Forms section at the bottom of this page. A new portal will be introduced during 2022, after which the applications must be sent electronically. Until the introduction of the portal, the applications must be sent on word-based forms to ella(at)avi.fi. The application forms are identical to the forms used in the portal. A non-technical project summary must be sent together with the application.
The applications must be submitted in Finnish or Swedish. However, the application for the approval of designer’s competence must be submitted in English.
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 section of the Project Authorisation Board to review it.
Both the Regional State Administrative Agency’s officer and the the Board section 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 sections 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
- Simplified procedure: EUR 845
- Standard authorisation: EUR 1,404
- Extensive projects: EUR 3,510
- Modifications that need to be reviewed by the Project Authorisation Board: EUR 423
- 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 143.
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 to get suitable animals.
You must send the non-technical project summary together with the application. The purpose of the summary is to provide the general public with information about animal experimentation. The summary is also used in the processing of the application.
Follow the instructions, when filling out the form. Pay attention to using plain English in the form. The information will be published in the ALURES NTS EU database of the European Union.
You can find the form and instructions for writing the non-technical project summary at the bottom of this page. The instructions are in English. The instructions in Finnish and Swedish will be published later.
You can draft the non-technical project summary for the excel form in the help file of the form in question, which is in word format. This makes completing the excel form easier. In the excel form, you must also select the language that you want to use in the form.
If your project involves procedures classified as ‘severe’, the Project Authorisation Board will order you to carry out a retrospective project assessment. For special reasons, a retrospective assessment may also be required for projects involving ‘moderate’ procedures.
You must carry out the retrospective assessment and submit the required information within three months of the project end. You can find the retrospective assessment form at the bottom of this page.
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 animal care are in order. No animal experiments may take place until we have issued a licence.
You need a licence if you
- breed, supply or keep animals for scientific purposes or
- experiments are done in your facilities
If your operation involves genetically modified animals, you must also notify the Finnish Board for Gene Technology.
You also need an operator 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 significant 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 Regional State Administrative Agency controls regularly your operation. You may be asked to provide information about your operation at any time. Inspector 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 named person before they can work with live animals. Several universities regularly run courses required for compentency 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 courses:
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 completed appropriate to their role. If the training was given in Finland, there is no need to demonstrate competence separately. However, the designer must present proof of having completed the relevant courses upon request.
If the designer received their training abroad, their competency must be approved by the Regional State Administrative Agency for Southern Finland. Only individuals whose training matches that given in Finland can be approved to act as designers in Finland.
Use the form for competence to request approval of the project designer’s competence. The form is in English. Certificates of completed studies must be appended to the request. The Regional State Administrative Agency charges a fee of EUR 280 for its decision on the matter.
The person must have species and procedure specific knowledge and skills for working with animals. These are acquired with special courses and practical training.
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)