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The Law On The Protection Of Animals Used For Scientific Or Educational Purposes

Original Language Title: Laki tieteellisiin tai opetustarkoituksiin käytettävien eläinten suojelusta

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Law on the protection of animals used for scientific or educational purposes

See the copyright notice Conditions of use .

In accordance with the decision of the Parliament:

Chapter 1

General provisions

ARTICLE 1
Purpose of the law

The purpose of this law is to ensure that animals are kept and used for scientific or educational purposes only for the necessary and important reasons.

In addition, the purpose of the law is to ensure that animals are used for scientific or educational purposes as low as possible and that the animals are subjected to as little pain, suffering, distress or lasting harm as possible.

ARTICLE 2
Scope

This law shall apply:

(1) when using or increasing live cephalopods or vertebrates for scientific or educational purposes; and

2) to raise these animals for the purpose of donating their organs or tissues for scientific or educational purposes.

For the purposes of this law, the animal shall be treated as a larval form of larvae, as well as a mammalian foetus during the last third of its normal development. For the purposes of this law, an individual shall also be treated as an individual in an earlier stage of development, if it is likely to experience pain, suffering, distress or lasting harm after having achieved that Development phase.

This law shall apply even if pain and pain are removed from the animal and prevent suffering and lasting harm to anaesthesia, analgesia or any other method.

ARTICLE 3
Scope of application

This law shall not apply to:

1) non-experimental terrestrial methods;

(2) clinical veterinary methods other than those used for experimental purposes;

(3) clinical veterinary studies necessary for the marketing authorisation of a veterinary medicinal product;

(4) the procedures followed for the treatment of conventional animals;

(5) the methods used to identify the animal as a priority;

(6) methods which are unlikely to cause equal or greater pain, suffering, distress or lasting harm than pain, suffering, distress or lasting harm caused by needle puncture in accordance with good veterinary practice.

§ 4
Relationship with other legislation

Unless otherwise provided for in this Act or by virtue of this Act, or otherwise provided under this Act, the use, treatment, treatment and treatment of animals used for scientific or educational purposes shall be followed in accordance with animal protection law. (247/1996) Or pursuant to it.

Genetic engineering measures for the application of genetic engineering to animals (377/1995) . The transport of animals is provided for in Council Regulation (EC) No 1/2005 on the protection of animals during transport and related operations and amending Directives 64 /432/EEC and 93 /119/EC and Regulation (EC) No 1255/97, and The Law on the transport of animals (19/2006) . The use of animals for cosmetic products is governed by the law on cosmetic products (2011) . In addition, the capture, possession and killing of wild animals is laid down in the Nature Conservation Act (1096/1996) And hunting law (615/1993) . Clinical trials on veterinary medicinal products are laid down in (185/1987) .

§ 5
Definitions

For the purposes of this law:

(1) Project A work programme with a defined scientific or educational objective, including at least one measure;

(2) The measure :

(a) any use of animals for experimental purposes, for other scientific or educational purposes in such a way that the animal may suffer from a pain comparable to the feeling of needle puncture in accordance with at least good veterinary practice; Pain, suffering or lasting harm; and

(b) any activity intended or likely to result in the formation or establishment of a genetically modified or other animal or the establishment and maintenance of a genetically modified animal line in such a way that the animals may be Pain, suffering, distress or lasting harm; the procedure begins with an individual animal when the animal is started to be prepared for use in a procedure, and ends when observations from a living animal have been killed;

(3) Breeder Any natural or legal person who raises the animals referred to in Article 16 (1) for use in projects or for the use of their tissue or organs for scientific or educational purposes or to increase other animals; Primarily for the purposes mentioned above;

(4) Supplier, Any natural or legal person who is not an educator who sells, distributes, distributes or otherwise dispose of animals for use in projects or for the use of their tissue or organs for scientific or educational purposes; A natural or legal person who occasionally sells or extradite an individual animal or a minor number of animals for use in the project or for the use of tissue or organs for scientific or educational purposes;

(5) User A natural or legal person who carries out projects;

(6) Operator Breeder, supplier and user;

(7) Institution All types of installations, buildings, construction groups and other facilities controlled by the operator in connection with the activities covered by this law; and

(8) The principle of replacement, reduction and refining The principle that the use of animals is intended to be replaced by other methods wherever possible; if animals are to be used, they shall be used as low as possible without jeopardising the purpose of the project, and The cause of pain, suffering, distress and lasting harm is sought at the lowest possible level.

However, the measure referred to in paragraph 1 (2) shall not be regarded as:

(1) the killing of an animal by a qualified person using approved methods; or

(2) the breeding of genetically modified animals or animals with spontaneous mutation after the establishment of the animal line where conversion or mutation does not give rise to pain, distress and pain, as a result of at least a needle puncture in these animals; Suffering or lasting harm.

Chapter 2

Requirements for the operator

ARTICLE 6
General requirements

The operator shall take into account the specific needs and characteristics of each species in the treatment of the animals.

The operator shall have adequate facilities, equipment and equipment for the activities to be carried out. In addition, the design and operation of the operator's premises, equipment and equipment shall be such that the projects may be carried out in the most appropriate manner and with a limited number of animals and in such a way that the animals are As little as possible pain, suffering, distress or lasting harm.

The operator shall have an appropriate veterinary service for the veterinary, health and medical care of the animals.

More detailed provisions on the management of animals, the premises required for the operation and the organisation of veterinary services are laid down by a decree of the Government.

§ 7
Staff

The operator shall have the quality and extent of the activity taking into account the number of qualified personnel required.

The operator shall designate a person who is familiar with the activities in accordance with this law and in accordance with the requirements laid down in this law ( Person responsible for the operation ). The person responsible for the activity shall ensure that the activity is carried out in accordance with the prescribed and prescribed requirements. The operator shall ensure that the person responsible for the activity is able to carry out his or her duties in accordance with legal acts and permit conditions.

The operator shall designate one or more persons responsible for the installation in each establishment, with the task of:

(1) responsible for the control of animal welfare and care;

(2) ensure that information on animals kept in the establishment is available to staff working with animals; and

(3) ensure that staff are adequately trained and qualified to carry out their duties.

The operator shall have access to the designated veterinarian for veterinary and animal welfare and treatment advice. However, if it is necessary for the species or other comparable reasons to be considered to be more appropriate, advice on welfare and treatment may be provided by other suitably qualified experts. The designated veterinarian and expert shall have expertise in the use of animals for scientific or educational purposes. The use of animals as referred to in Article 8 (1) for scientific purposes must have been carried out by the designated veterinarian and expert.

More detailed provisions on the tasks of staff will be laid down by a Council regulation.

§ 8
Training and qualification requirements for staff

The project may be designed by a qualified person who has completed a higher education qualification, who has completed a university or university syllabus or the use of animals approved by the Southern Finland Regional Administrative Agency. Studies for scientific or educational purposes.

The Southern Finland Regional Administrative Agency shall, upon application, approve a person who has not completed the necessary studies in Finland to design projects in Finland. As a condition for approval, the studies carried out correspond to the studies referred to in paragraph 1.

Persons who take measures, treat or terminate animals shall be provided with sufficient knowledge and skills to carry out the task before entering into it.

The decree of the Council of State provides for the content and completion of the studies referred to in paragraph 1. More detailed provisions on training and qualification requirements for staff are laid down by a Council regulation.

§ 9
Hyvinus group

The operator shall designate a welfare group comprising at least the person or persons responsible for the institution referred to in Article 7 (3), the designated veterinarian or other qualified expert referred to in Article 7 (4) and the operator At least one representative of the study. However, the welfare group is not required if the activity is small and the operator fulfils the obligations imposed on the welfare group by other means.

The welfare group shall be responsible for:

(1) staff advice on animal welfare issues;

(2) development and inspection of animal welfare surveillance, reporting and monitoring;

(3) monitoring project development and results for animal welfare; and

(4) deciding on the donation of an animal used or intended to be used in the project, or on a return to the appropriate management system.

The advice and advice given by the welfare group shall be kept a record. Records shall be kept for at least three years after the last entry.

More detailed provisions on the role of the Welfare Group are laid down by the Government Decree. More detailed provisions on the composition and accounting of the welfare group may be laid down by a Council regulation.

ARTICLE 10
Accounting and statistics on animals

The operator shall keep records:

(1) the species and quantities of animals which have been raised, acquired, supplied, used in the procedure, the names and addresses of the suppliers and recipients of the animals, and the dates on which the animals are: Acquired, delivered, released or disposed of elsewhere;

(2) the origin of animals;

(3) veterinary medicinal products; and

4) for the species and quantities of dead and dead animals and their known causes of death.

Upon request, the operator shall draw up statistical information on the information referred to in paragraphs 1 and 4 of paragraph 1 and transmit it to the Regional Administrative Agency of Southern Finland.

In addition, the operator, which is a user, shall keep records of the projects to be carried out and provide statistics on the animals used and the actual severity of the measures taken to them. The premises shall be submitted annually to the Regional Administrative Agency of Southern Finland within three months of the end of the calendar year.

Records and statistics shall be kept for at least five years after the last entry therein.

More detailed provisions on the content, maintenance and storage of accounting and statistics are laid down by the Government Decree. The decree of the Council of State provides for animal species for which individual records must be kept.

Chapter 3

Project and measure

ARTICLE 11
Replacement of the project and measure by other methods

The project may only be carried out if, in practice, it is not possible to use any other scientifically reliable method or testing strategy that does not require the use of a live animal.

The project shall not use more animals than is required to achieve its purpose. The project and the measure must be replaced, partly if it is possible to achieve the desired result, by another scientifically sound method which does not require the use of a live animal, or by a method in which the total number of animals or Pain, suffering, distress and lasting harm to the animals can be reduced.

ARTICLE 12
Project purpose

The project may only be carried out for the following purposes:

1) basic research;

2) translational or applied research with the aim of any of the following:

(a) prevention, prevention, diagnosis or treatment of human, animal or plant disease, disease or other disorder or their effects;

(b) the assessment, detection, regulation or modification of human, animal or plant life functions; or

(c) animal welfare and improvement of the conditions of production animals;

(3) for the purposes of any of the objectives referred to in paragraph 2, in the context of the testing of medicinal products, food, feed and other substances or products, in the context of the testing of their quality, efficiency and safety;

(4) protection of the environment due to human or animal health or welfare;

(5) research aimed at preserving species;

(6) forensic studies; and

(7) teaching in higher education or skills acquisition, maintenance or upgrading.

ARTICLE 13
General principles of measure

The measure may only be carried out by the project. The measure shall be carried out by an animal with the least ability to experience pain, suffering, distress or lasting harm. The measure shall be selected and carried out in such a way as to minimise pain, suffering, distress or lasting harm to the animal, and that the project is likely to result in a reliable result.

Measures shall be prohibited which involve severe pain, suffering or distress, which is likely to be long-term and cannot be alleviated. Exceptions may be made for exceptional and scientifically justified reasons as referred to in Article 55 (3) of Directive 2010 /63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes only. The measure must not be performed to investigate the animal's pain or pain cover.

Death as the end point of the measure must be avoided and must be replaced by an early and human endpoint. If death is not prevented, the procedure must be designed to lead to the death of as few animals as possible.

More detailed provisions on the selection of animals used in the procedure are laid down by a Council Regulation. More detailed provisions on the choice of measures and the reduction of pain, suffering, suffering and lasting harm to the animal may be adopted by a Council regulation.

ARTICLE 14
Use of stone removal

The pain, suffering, distress or lasting harm caused by the measure to the animal shall always be alleviated by any means necessary for the purpose of the measure, unless the pain, suffering, distress or permanent harm caused to the animal Equal to or greater than the measure itself.

Measures involving severe injuries that may cause severe pain must not be performed without anaesthesia.

Without adequate anaesthesia or analgesia, animals may not be given a medicine that prevents or limit the animals from expressing pain.

Details of the use of anaesthesia and analgesics may be laid down by a Council Regulation.

§ 15
Stability classification of measures

The pain, suffering, distress and lasting harm to the animal shall be assessed before it takes place. The severity of the measure is determined by the level of pain, pain, suffering or permanent disadvantage that an individual animal is expected to experience during the procedure. The severity of the measures shall be assessed in the project application application referred to in Article 24 and shall be determined in the project category referred to in Article 25.

The severity classes of the measures are:

1) no recovery;

2) mild;

(3) moderate; and

4) serious.

The decree of the Council of State lays down more precise provisions for the inclusion of measures in the stability classes.

Chapter 4

Animals

ARTICLE 16
Requirement for target breeding and origin of animals

The project must always seek to use animals grown for scientific purposes or for educational purposes ( Target bred animal ). Subject to Article 26 (3), the animals commonly used in projects shall be target-raised. The decree of the Council of State provides for more detailed provisions on animal species which must be target-grown.

Subject to Article 26 (3), the project shall not use:

(1) animals of animal species found loose or wild in isolation; and

2) animals caught in the wild.

Where an animal is made available for use in a project other than an educator or supplier, the intended use of the animal shall be reported to the donor.

§ 17
Catching the animal from nature

Where, pursuant to Article 26 (3), an animal is authorised under Article 26 (3), only a person with sufficient knowledge of fishing gear and sufficient skills to deal with the animal shall be caught. The application shall be used to use a procedure approved in abrasive action which does not cause avoidable pain, distress, distress or lasting harm to the animal.

More detailed provisions on the capture of the animal and the qualifications of the animal in question may be issued by a decree of the Council.

ARTICLE 18
Identification of animals

The animal shall be marked or identifiable. The decree of the Council of State lays down more precise rules on the labelling and identification of animals.

§ 19
Reuse of the animal

Subject to Article 26 (3), a new measure may be reintroduced for an animal to which one or more measures have already been taken, including an animal for which no measure has yet been taken, only if:

(1) Whereas previous measures have actually been subject to mild to moderate severity;

(2) it can be demonstrated that the general health and well-being of the animal have been fully restored;

(3) the following measure does not fall within the severity category; and

4) is in accordance with the guidance of the designated veterinarian referred to in Article 7 (4), taking into account the entire life cycle experience of the animal.

§ 20
Stopping the animal

The animal shall end as much pain, suffering and suffering as possible.

An animal shall be killed without delay if there are symptoms or changes in its behaviour, vitals or outdoor appearance, which suggest that it can be inferred to experience severe pain, distress or suffering in the abruse of the experiment, Cannot be removed by medication or by other measures.

An animal shall be killed at the end of the procedure if it is likely that it will continue to suffer moderate or severe pain, suffering, distress or lasting harm.

The veterinary surgeon or other qualified person shall decide on the killing of the animal. A qualified person shall mean a person who has sufficient knowledge of the health and well-being of the animal concerned, as well as the pain, pain and suffering he is experiencing.

The animal shall be killed at the premises of the operator unless it is a project carried out under field conditions.

If an animal is not stopped after completion of the operation, the welfare of the animal must be taken care of and must receive the care it needs. More detailed provisions on the culling of animals are laid down by the Government Decree.

Chapter 5

Authorisation for the exercise of the activity

ARTICLE 21
Operating authorisation and application

The operator must be authorised to carry out the activities of the Regional Administrative Agency of Southern Finland or the East Finland Regional Administrative Agency ( Operating authorisation ).

An application for an authorisation shall be submitted to the Regional Administrative Agency of Southern Finland where the applicant has its registered office in the territory of the Southern Finland, South-West Finland or Western and Finnish Regional Administrative Agency, and from the Regional Administrative Agency of the East Finland, if the applicant has its registered office: In the territory of the regional administrative office of eastern Finland, Northern Finland or Lapland.

The application for authorisation shall indicate the information referred to in Articles 6, 7 and 9. More detailed provisions on the content of the application for authorisation are laid down by the Government Decree.

§ 22
Issue of an action permit

An action permit shall be granted if:

(1) the applicant has access to appropriate facilities, equipment and equipment for its activities;

(2) the applicant has appropriate staff at his disposal;

(3) the veterinary service required for operation is organised in accordance with Article 6 (3); and

(4) other requirements laid down in this Act or by virtue of that law are fulfilled.

An action permit may also be granted for a limited period.

An inspection body shall be inspected before the authorisation is granted.

ARTICLE 23
Changes in staff and activities

The operator shall immediately inform the regional administrative authority which granted the operating authorisation of the replacement of the persons referred to in Article 7 (2) to (4). The operator shall immediately inform the Regional Administrative Agency of the Southern Finland of the replacement of the persons referred to in Article 25 (2).

An application for an authorisation shall be repeated if there is a significant change in the activity or structure of the facility which may adversely affect the welfare of the animals. The cessation of activities shall be notified without delay to the Regional Administrative Agency which granted the authorisation.

Chapter 6

Authorisation of the project

§ 24
Project authorisation and application

The project may only be carried out with the permission of the project board ( Project authorisation ).

An application for a project application shall be submitted, including:

1) a project proposal indicating the justification for the project and the use of the animal project as provided for in Articles 11 to 14;

(2) an estimate of the severity of the measures included in the project;

(3) a generic summary of the project; and

4. The name of the person responsible for carrying out the project.

More detailed provisions on the content of the application for a project application are laid down by a Council Regulation.

ARTICLE 25
Granting of the authorisation

Project authorisation shall be granted if:

(1) the operator, which is a user, is authorised to act;

(2) the project is carried out for the purposes of Article 12;

(3) the project designer is qualified in accordance with Article 8 (1);

(4) the project is justified from the point of view of science or education or required by law;

(5) the benefits expected for humans, animals or the environment are considered to be ethically acceptable to animals in relation to their project;

(6) the project has been designed in such a way that measures can be taken in the most humane and environmentally friendly manner; and

(7) the other requirements concerning the use of the animal provided for by this law or by the animal provided for in this Act are met.

The project shall determine the severity categories referred to in Article 15 of the measures contained in the project. The project is designated by the person responsible for carrying out the project.

The project may also be granted as a series of projects if the projects are carried out to meet the requirements of the legislation or where the projects are used for productive purposes or for diagnostic purposes with established methods. Project authorisation may be granted for a maximum period of five years.

§ 26
Conditions and derogations to be granted in Chapter

The conditions for the protection of animals during the project may be subject to conditions for animal welfare in the project.

The project agreement may provide that the retrospective assessment referred to in Article 29 shall also be carried out for a project involving a category of serious classified measures, if necessary:

(1) the scale of the project or the number of measures;

(2) the number of animals used in the project or the unconventional species; or

3) for other similar reasons.

A derogation may be granted in the project category:

(1) the requirement to raise the objective of Article 16 (1) if there is a reasonable scientific need for the derogation;

(2) Article 16 (2) (1), if a particularly important need for studies on animal health and welfare, on the environment or on serious threats to human and animal health is necessary and scientifically justified, That the purpose of the project can be achieved only through the use of an animal belonging to an animal species which has not been met or has been feral;

(3) the prohibition of Article 16 (2) (2) if it is scientifically justified that the purpose of the project cannot be achieved by using the target-raised animal; and

(4) in accordance with Article 19 (1), where exceptional circumstances so require; a derogation may be granted only on condition that the animal has not been used more than once in a procedure involving severe pain, suffering or equivalent suffering, and That the veterinarian will inspect the animal before reuse.

More detailed provisions on the content of the authorisation decision may be adopted by a Council Regulation.

§ 27
Amendment of the authorisation

Authorisation to carry out the project in a derogating manner shall be applied to the project board. The application shall indicate the reasons for the modification of the project.

Notwithstanding the provisions of paragraph 1, the Regional Administrative Agency of Southern Finland may grant an authorisation for minor changes to the project if:

(1) it is strictly necessary for the continuation of the project and it is not possible without compromising the purpose of the project to bring the project drawback or to the section of the project, and the modification of the project may not result in such a measure A change in severity class which is more harmful to the animal; or

2) it is a short-term extension of the project authorisation or a small increase in the number of animals used.

The Office of the Region of Southern Finland shall inform the project board of any changes to the authorisation.

ARTICLE 28
Exemption, release and return of an animal used or intended for the project

The project authorisation may allow the release of the wild animal used in the project to release into the wild if:

(1) the health of the animal allows it;

2) the release does not present any risk to human or animal health or the environment; and

3) It is expected that the animal will adapt to the wild life without difficulty.

The welfare group may decide on the release or restitution of an animal used or intended for the purpose of the project if:

(1) the health of the animal allows it;

(2) there is no risk to human or animal health or the environment arising from the release or return of the animal; and

3) It is expected that the animal will adapt to the new conditions.

Where appropriate, the animal shall gradually adapt to its new management system or to its habitat prior to its release, return or release.

Before deciding on an application for the release of an animal, an application for authorisation shall, where appropriate, be requested by the opinion of the Agency for Life, Transport and the Environment, in whose territory the animal is to be released into the wild. Where appropriate, the Agency shall consult the other authorities.

More detailed provisions on the conditions for adaptation, extradition, return and release of animals may be laid down by a decree of the Council of Ministers.

§ 29
Background assessment

A retrospective assessment shall be carried out for all projects using apes and for projects involving serious classified measures. The project's retrospective assessment shall assess:

1) how the objectives of the project have been achieved;

(2) the harm to animals, including the numbers and species of animals used and the actual severity of the measures; and

(3) all aspects that may contribute to the implementation of the principle of replacement, reduction and refining.

The Southern Finland Regional Administrative Agency shall carry out a retrospective assessment of the projects. Within three months of the completion of the project, the holder of the project authorisation shall provide the Agency with the information necessary for the retrospective assessment.

The Southern Finland Regional Administrative Agency shall forward the results of the retrospective assessment referred to in paragraph 1 to the holder of the project authorisation and the project board.

More detailed provisions on the information to be provided for the retrospective assessment and the assessment of the matters referred to in paragraph 1 may be adopted by a Council Regulation.

Chapter 7

Project Restoration

ARTICLE 30
Setting-up and composition of the project return municipality

The project board is set up by the Government of the Ministry of Agriculture and Forestry for five years at a time. The Board shall be composed of the Chairperson and the Vice-Chair and the 16 other members and their personal alternates. The composition of the panel shall take account of the balanced representation of the different parts of the country in the exercise of the activities provided for in this Act. The Board operates within the framework of the Southern Finland Regional Administrative Agency.

The Chairperson and the Vice-Chairperson of the Board shall have a master's degree in law or a higher education degree suitable for the post. The members and alternates of the Board must be known to be adept and experienced in scientific knowledge of the use of animals, four of which should represent the expertise of scientific research, four scientific Expertise, four veterinary expertise and four expertise on animal protection work or ethical issues for animals used for therapeutic purposes.

The project board is divided into four sections. The Board of Directors shall designate the members and alternates to the Chambers in such a way as to have a balanced representation of the expertise of the various fields of the Board. The Board shall appoint a Chairperson and a Deputy Chairperson.

The Project Restoration has the right to consult external experts.

ARTICLE 31
Preparation and handling of cases by the Board

The proceedings of the Board or its Division shall be prepared by the Regional Administrative Agency of the Southern Finland, which shall also be presented. The Board or its section shall be convened by the Chairperson of the Board or of the Chamber or, in the absence thereof, of the Chairperson.

A decision on a permit application for a project shall be submitted no later than 40 working days after the submission of all necessary information to the Regional Administrative Agency of Southern Finland. The Regional Administrative Agency of the Southern Finland shall, without delay, send the applicant a notification of the applications received and the 40 working days within which the decision will be taken. If it is justified by the complexity or the multidisciplinary nature of the project, the deadline for the decision may be extended by 15 working days. The Southern Finland Regional Administrative Agency shall inform the applicant of the extension of the time limit and its justification before the expiry of that period.

A protocol to the meeting of the panel and its section shall be signed by the President and the Secretary of the Assembly. The decisions of the Board or its section shall be signed by the President and the rapporteur.

More detailed provisions on the internal division of labour, the handling of cases and other activities are laid down in the Rules of Procedure, which the Ministry of Agriculture and Forestry confirms.

The President of the Board and its sections, as well as the other members and alternates, shall be subject to the provisions of criminal law relating to criminal law when dealing with the matters referred to in this Act. Liability for damages is governed by the law on damages (1999) .

ARTICLE 32
Decision-making

In order to carry out the project, the Project Restoration Division or, if it is not unanimous, the project board of the project. If the Chamber does not permit the project to be completed, the project shall be decided upon by the project office.

There shall be a quorum when the chairperson of the meeting and at least eight other members or alternate members are present. A quorum shall be quorum when the chair of the meeting and three other members or alternates are present.

If there is a difference of opinion on the resolution of the project board, the vote shall be taken. The proposal for a decision by the majority will be supported by the majority of the proposals and by the vote the President-in-Office of the Council.

The Board of Appeal shall decide on the economic and other matters relating to the internal management of the Board. The order of business may also be delegated to the Vice-President and the rapporteur.

§ 33
Board staff

The Agency shall have full-time rapporteurs and office staff to be recruited by the Regional Administrative Agency of Southern Finland. The rapporteur's qualification is an appropriate higher education qualification and a good understanding of the use of animals for scientific and educational purposes.

Chapter 8

Authorities and their tasks

§ 34
General control and control

General guidance and supervision of the implementation of this law are part of the Ministry of Agriculture and Forestry.

ARTICLE 35
Supervisory authorities

The responsibility for monitoring and supervising compliance with this law and of the provisions and regulations adopted under it is carried out by the Southern Finland Regional Administrative Agency in the area of the Southern Finland, South-West Finland and Western and Inland Regional Administrative Agency, and East Finnish regional government agency in the area of the regional administrative office of eastern Finland, Northern Finland and Lapland.

The regional administrative offices of Southern Finland and Eastern Finland may also be assisted by other regional administrations.

§ 36
Some of the tasks of the Southern Finland Regional Administrative Agency

In addition to the tasks of the Regional Administrative Agency in Southern Finland, the Agency shall:

(1) collect and communicate electronically to the public on the use of animals for scientific or educational purposes;

(2) publish the non-technical summaries of the project authorisations granted and ensure their updating when the projects have been assessed retroactively; and

(3) ensure the necessary support services for the Advisory Board and the Advisory Board referred to in Article 53.

Chapter 9

Control

ARTICLE 37
General principles of control organisation

The activities of operators shall be subject to regular and regular monitoring. Controls shall be intensified where there is doubt that the operator's activity or body does not comply with the requirements laid down or laid down in this Act.

ARTICLE 38
Control plan

The regional administrative offices of Southern Finland and Eastern Finland shall draw up an annual control plan for the organisation of controls. The control plan shall indicate the checks to be carried out, the types of control points and the frequency of their inspection. In addition, the plan shall set out the criteria for the risk assessment of the target types and the criteria for the assessment of the implementation of the plan.

More detailed provisions on the control plan and its content may be adopted by a Council regulation.

ARTICLE 39
Right to information

The Ministry of Agriculture and Forestry and the Authority shall have the right to obtain the information and documents necessary for the control and inspection referred to in this law from the operator, the holder of the project authorisation and the public authorities, and From the community of projects.

The right of access shall also apply to information which is necessary for the purposes of supervision which, in the form of information on private or Community trade, occupation or economic status, or in the knowledge of private personal circumstances, would otherwise be Secretly confidential.

ARTICLE 40
Inspection and attendance rights

The supervisory authority referred to in Article 35 shall have the right to carry out checks required to verify compliance with this law and the provisions adopted pursuant to it and to the premises in which this law takes place. Or where, in the case of animals intended for action, animal feed or beverage or beverage, material, equipment, equipment, equipment, equipment or operations, Documents or information. However, the inspection shall not be carried out in a permanent housing condition.

The Regional Administrative Agency of Southern Finland and the Regional Administrative Agency of the Eastern Finland have the right to be present when carrying out the project and carrying out the measure. In addition, the agencies have the right to be present at the meeting of the project board.

ARTICLE 41
Right to sampling

The Authority shall have the right, where appropriate, to take the necessary samples of the animals, animal feed and drink and the substances used for the purposes of the exercise of the checks.

ARTICLE 42
European Union inspectors

Articles 39 to 41 provide for the right of scrutiny and information of the Finnish authority, as well as the right of access to samples, including those of the European Union. If the inspection is carried out by an inspector of the European Union, the Authority shall cooperate with this.

ARTICLE 43
Disclosure of confidential information

Law on public authorities' activities (18/09/1999) Notwithstanding the obligation of professional secrecy or compliance with the provisions of this Act or of the provisions adopted pursuant thereto, the financial position, business or professional secrecy of the private or Community nature, or On private personal circumstances to hand over:

(1) to the authorities responsible for compliance with this law for the purpose of carrying out their duties under this law;

(2) Prosecution, police and customs authorities (450/1987) Chapter 5 of Chapter 5 , in order to investigate the crime;

(3) the foreign institutions and inspectors referred to in the legislation of the European Union or of Finland, which are binding on Finland, when required by European Union law or agreement.

ARTICLE 44
Official assistance

The Authority shall have the right to obtain administrative assistance from the police and customs authorities for the performance of their duties under this Act and the provisions adopted pursuant thereto.

ARTICLE 45
Register of operators

Operators shall be subject to a register of supervision and control planning.

The Southern Finland Regional Administrative Agency and the Eastern Finland Regional Administrative Agency shall record the following information:

(1) Law on the information system of the rural economy (284/2008) Identification details referred to in paragraph 2;

(2) the species covered by the activity;

(3) the date of commencement of operations and the operating permits issued;

(4) whether the operator is an educator, supplier or user within the meaning of Article 5 (1);

(5) the name and contact details of the person responsible for the operation, the persons responsible for the institution referred to in Article 7 (3) and the designated veterinarian referred to in Article 7 (4) and any other qualified expert; and

6) cessation of activities.

The information contained in the register of operators shall be stored in the information system provided for in the Act on the information system of the EAFRD. The registry shall be governed by the law referred to above, unless otherwise provided in this Act.

ARTICLE 46
Project Register

The Southern Finland Regional Administrative Agency shall keep a register of project figures for monitoring and control planning and for statistical purposes. The register shall contain the following information:

1) the institution of the user in which the project is carried out;

(2) the project authorisation number and the name of the authorisation holder and the name of the person responsible for the project referred to in Article 25 (2);

3) the purpose of the project;

(4) the species used in the project and the number of animals per species;

(5) the planned start and end of the project;

6. The severity categories of the measures;

(7) whether a retrospective assessment of the project is required; and

8) information on retrospective assessment.

The data shall be deleted from the register three years after the end of the deadline set for the project. However, if the project is to be assessed retrospectively, the data shall be deleted only when three years have elapsed since the completion of the retrospective assessment.

The Ministry of Agriculture and Forestry and the Regional Administrative Agency of Southern Finland and the Eastern Finland Regional Administrative Agency shall have the right to use the register to the extent required for their duties. The collection and storage of personal data and the use and disclosure of the data entered in the register shall be subject to the provisions of the Personal Data Act (523/1999) And the law on public authorities' activities.

Chapter 10

Administrative constraints and sanctions

§ 47
Prohibitions, regulations and emergency measures

Where the inspection referred to in Article 40 or otherwise finds that the exercise of the activity has not complied with the relevant provisions or provisions or permit conditions for the performance of the project, the Authority shall: Prohibit the operator or the holder of the project authorisation from continuing or repeating a procedure contrary to the provisions, provisions or conditions of authorisation, or to impose on the quality of the case within a sufficient time limit to fulfil its obligations.

As an emergency measure, the Authority may, by way of derogation from paragraph 1:

(1) to terminate or to order the immediate killing of an animal to be used in the project if the animal's behaviour, functions or the appearance of the animal present symptoms or changes which suggest that it can be extrapolated to the abruse of the animal. Unforeseeable strong pain, suffering or distress and cannot be removed by medication or by other measures;

(2) to terminate or order the immediate cessation of an operation other than the animal referred to in paragraph 1, if the animal welfare reasons are necessarily so called for.

Where the decision referred to in paragraphs 1 or 2 makes the supervisory authority referred to in Article 35 (2), the decision shall be notified without delay to the competent authority referred to in Article 35 (1). The measures referred to in paragraph 2 shall be taken at the expense of the operator.

ARTICLE 48
Withdrawal of the authorisation

The Regional Administrative Agency of Southern Finland or the Regional Administrative Agency of the Eastern Finland may withdraw the project authorisation if the implementation of the project has materially infringed the provisions of the project, the provisions or the terms and conditions of the project and have not been remedied. Within a reasonable period set by the Authority.

The Southern Finland Regional Administrative Agency shall withdraw the project authorisation if, on the basis of Article 55 of Directive 2010 /63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes, the European Commission is required to do so.

If the project authorisation is withdrawn, the operator shall terminate the animals used in the project or carry out any other action approved by the competent regional management agency in order to remedy the situation so that the welfare of the animals is not adversely affected.

ARTICLE 49
Withdrawal of authorisation

The Regional Administrative Agency may withdraw its authorisation if the operator is in a material breach of the requirements or conditions of authorisation laid down in this law or in the animal protection law or under them, or where the operation no longer: Fulfil the conditions for the authorisation and the operator fails to correct the deficiencies within a reasonable period set by the Authority.

Where an operating licence is withdrawn, the animals kept at the establishment must be stopped at the operator's expense, transferred to another operator's establishment, or else approved by the competent regional management agency So that animal welfare is not adversely affected.

§ 50
Threat and commissioning

The Regional Administrative Agency of Southern Finland and Eastern Finland may impose a penalty or a threat of a penalty payment as referred to in Article 47.

The periodic penalty payment shall not be imposed on a natural person as an effect of the reporting obligation if the person concerned is suspected of a criminal offence and the information relating to the subject matter of the suspected criminal offence.

The penalty payment and the threat to be made shall be laid down in the (1113/1990) .

ARTICLE 51
Penalty provision

Every intention or carelessness

(1) fails to apply for an authorisation as referred to in Article 21 (1);

(2) carry out a project without the authorisation referred to in Article 24 (1) or in breach of the conditions laid down in the authorisation;

(3) the acquisition or use of animals by animals in breach of the conditions laid down in Article 16 (1) to (3);

(4) infringes the obligation to identify animals laid down in Article 18;

(5) re-use the animal in breach of Article 19;

(6) fails to comply with the obligation to end the animal provided for in Article 20 (1) to (3) or to terminate the obligation referred to in Article 20 (6) or to terminate the animal other than the authorised killing method;

(7) infringes the obligation to keep accounts or to draw up statistics provided for in Article 10;

(8) infringes the notification requirement laid down in Article 23 (1); or

(9) infringes the prohibition or order issued pursuant to Article 47;

Shall be condemned, unless the law provides for a heavier penalty in the rest of the law, Infringement of the law on the protection of animals used for scientific or educational purposes Fine.

Any violation of a penalty or an obligation imposed by the penalty imposed by this law may be waived for the same offence.

ARTICLE 52
Provisions referring to penalties

The penalty for the offence of animal protection is laid down in Article 54 of the Animal Protection Act.

The punishment for the crime of animal welfare is laid down in criminal law (39/1889) Articles 14, 14a and 15.

Chapter 11

Outstanding provisions

ARTICLE 53
Advisory Board for the protection of animals used for scientific or educational purposes

In the case of the Regional Administrative Agency of Southern Finland, the Advisory Board for the protection of animals used for scientific or educational purposes. The aim of the Advisory Board is to promote the implementation of the principle of replacement, reduction and refining. The Council of State sets the Advisory Board for five years at a time.

The role, composition and organisation of the Advisory Board are laid down by a decree of the Government.

ARTICLE 54
Payments

A fee shall be charged to the State for the performance of the authority and the project board. The fees shall be determined in accordance with the provisions of the State Payment Act (150/1992) Provides.

ARTICLE 55
Premiums and reimbursement of costs

The President, the Vice-President and the members of the Project Restoration Refund shall be remunerated and reimbursed on the basis of the criteria laid down by the Ministry of Agriculture and Forestry.

ARTICLE 56
Appeals appeal

Any decision taken by the authority and the project board pursuant to this Act shall be appealed to the administrative court, as in the case of administrative law (18/06/1996) Provides. An appeal to the decision of the administrative court shall be lodged only if the Supreme Administrative Court grants an appeal. The appeal for a fee referred to in Article 54 shall apply to what is laid down in the State payment law.

A decision under this law may provide that, in spite of the appeal, the decision is to be complied with, unless the appeal authority decides otherwise.

The appeal against a decision taken under this law concerning animal welfare must be treated as a matter of urgency.

Chapter 12

Entry and transitional provisions

ARTICLE 57
Entry into force

This Act shall enter into force on 1 August 2013.

This law repeals the law on laboratory animals (2006) (hereinafter ' the Repealed law . Regulation of the Ministry of Agriculture and Forestry of the Ministry of Agriculture and Forestry on Animal Health (1920/2006) Remain in force, however.

Before the law enters into force, action can be taken to enforce the law.

ARTICLE 58
Transitional provisions

A person who, under the law of the repealed law, has acquired or maintained the validity of the animal tests, shall be considered qualified to design projects and take measures.

Within three months of the entry into force of this Act, a laboratory animal body approved under the repealed Law shall, within three months of the entry into force of this Act, notify the competent authority referred to in Article 21 (1) of this Law:

(1) whether animals are kept for breeding, supplying or using them for scientific or educational purposes;

(2) the name and contact details of the person responsible for the operation;

(3) the names and contact details of the persons responsible for the establishment referred to in Article 7 (3) of this Act; and

4) the composition of the welfare group referred to in Article 9 (1) of this Law.

The rules and permit conditions applicable upon entry into force of this Act shall apply to animal testing issued under the repealed Law if the animal test is completed by 1 January 2018. An animal test which has been authorised before the entry into force of this Act and which ends after 1 January 2018 shall comply with this law by 1 January 2018 at the latest.

At the time of entry into force of this Act, the animal testing board in operation will continue its activities as a project returnees until the project board is set up.

THEY 150/2012 , MmVM 2/2013, EV 52/2013, European Parliament and Council Directive 2010 /63/EU (32010L0063); OJ L 276, 20.10.2010, p. 33