Laboratory animals: authorisations and enforcement

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. 

Authorisation is sought in an electronic portal by using the Suomi.fi authentication. You will find a link to the portal and guidance on how to use it on this page in Finnish in the Online services section. In the Forms section you will find the forms in Word format, as well as instructions from the board that you may utilise in composing your application. Attach a citizen’s summary to your application.

Submit your application in Finnish or Swedish. However, an application for approval of a designer’s competence is 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 1,415
• Standard authorisation: EUR 2,360
• Extensive projects: EUR 5,925
• Modifications that need to be reviewed by the Project Authorisation Board: EUR 710
• 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 250.

• project designer’s competence EUR 480

• a separate fee is charged for the retrospective evaluation of the project permit, which is determined on the basis of the working hours used for the retrospective assessment, at a price of EUR 87 per hour.

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.

You must submit an application for a licence or a notification in the Suomi.fi service. You can find the link at the end of this page. In Suomi.fi, you can find information for managing the following licence matters:

• application for a licence
• application for an establishment approval
• notification of changes to a licence
• notification of changes to an establishment approval
• notification of termination of a licence
• notification of termination of an establishment approval.

You must submit notification of all major changes. You need an establishment approval to commission new facilities. Only a notification is required for personnel changes and minor facility changes. 

The Regional State Administrative Agency controls regularly your operation. You may be asked to provide information about your operation at any time. The Regional State Administrative Agency is also your point of contact for reporting violations of the laws or rules governing the keeping of animals and animal experimentation.

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.

You may request authorisation of competency in English in our Online service. You will find instructions and the needed information also in the links of the Forms section. Certificates of completed studies must be appended to the request. The Regional State Administrative Agency charges a fee of EUR 465 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. You can ask persons responsible for animal testing at universities about the training.