The Law Of Human Tissues And Cells And Organs, Medical Use

Original Language Title: Laki ihmisen elimien, kudoksien ja solujen lääketieteellisestä käytöstä

Read the untranslated law here: https://www.global-regulation.com/law/finland/646397/laki-ihmisen-elimien%252c-kudoksien-ja-solujen-lketieteellisest-kytst.html

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In accordance with the decision of Parliament: Chapter 1 General provisions article 1 (11 May 2007/547), the scope of this law: 1) in human tissues and cells, bodies, removing the use of the storage and treatment of human disease or injury;
1 (a)) transfer of organs intended for transplantation, testing, elinluovuttajan, and the description of the properties of the body, the extraction, transport and storage, in fact, the transfer of traceability and notification of serious adverse events and serious adverse reactions reporting; (12.4.2013/277) 2) in the context of the treatment of human disease, and tissues and cells to be mobilised, the storage and use of extraction, for medical purposes;
3) the donation of human tissues and cells intended for human applications, as well as for use in manufactured products derived from human tissues and cells, in respect of the acquisition, testing, processing, storage, and distribution, in fact the tissue establishment or on behalf of the Commission;
the use of human embryos and 4) other than for the purpose of fertilization treatment or medical research;
5) human bodies, tissues, cells and tissue samples to use for purposes other than those for which they have been disconnected from or recovered;
6 the use of medical education) died, and research activities.
In this Act, for the purposes of all human tissues and cells of human origin intended for use in the tissues and cells, including haematopoietic peripheral blood, umbilical and the bone marrow hematopoietic stem cells, reproductive cells from foetal tissues and cells and adult and embryonic stem cells.
Medicinal products containing human tissues and cells, and in the case of medical devices is the applicable law in the tissue and cell donation, procurement and testing.
This chapter shall not apply to (a) 6 of the tissues and cells used as an autologous graft within the same surgical procedure by the tissues or cells of the tissue or cell Bank, and no organs or parts of organs if it is used in the human body for the original purpose of the body.
Diagnosis, treatment or medical research to determine the cause of death as well as in the framework of the provision of the necessary equipment for removing bodies and tissues provides. Human tissues and cells used in medical research is, however, to meet the quality and safety requirements provided for in this Act.
Separately, also provides for the transfer of human blood and blood components for transfusion and testing, as well as blood and its components, processing, storage, and distribution. Separately, also provides for the use and storage of gametes, infertility treatment, as well as infertility treatments relating to compensation and fees.

1. (a) section (11 May 2007/547) the definitions in this law the following definitions shall apply: 1) differentiated part of the human body, the body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of; (12.4.2013/277) 1 (a)), a body of information in the description of the properties of the body, which are needed for the body to assess the compatibility of the transfer, recognition; (12.4.2013/277) 1 (b)), the description of the characteristics of the donor health information elinluovuttajan, which are necessary to evaluate its suitability for the person posting the organ donation; (12.4.2013/277) 2) tissue all the constituent parts of the human body;
3) individual human cells or groups of cells of human cells when not bound by each other by any form of connective tissue;
4) tissue establishment means a tissue bank or a unit of health care policy or any part thereof, or any other entity, where the human tissues and cells are undertaken processing, preservation, storage or distribution of, or is responsible for the acquisition or testing of tissues and cells;
5) quality system for implementing quality management organisational structure, responsibilities, procedures, processes and resources, including all direct and indirectly;
the use of human tissues or cells, 6) recipient and extracorporal applications;
7) autologous use cells or tissues removed from and applied in the same person by the tissue or cell bank;
8) occurs when a process by which tissue or cells are made available;
8 (a)) recovery "means the process by which the donated organs become available; (12.4.2013/277) 9) treatment to all measures relating to the organs, tissues, or cells in the preparation, manipulation, preservation and packaging; (12.4.2013/277) 10) preservation means the use of chemical agents, alterations in environmental conditions or other means during processing or in respect of the bodies from the extraction and ending with the transfer to prevent or slow down the organ, tissue or biological or physical deterioration of cells; (12.4.2013/277) 11) storage means maintaining the product under appropriate controlled conditions until distribution;
12) distribution: transportation and delivery of tissues or cells intended for human applications;
12 (a) of the traceability of the localisation and identification of the body) of the chain from donation to transplantation or disposal, in each stage, including the donor, recipient or recipients of the procurement organisation, identification, as well as body products and materials coming into contact with the localisation and identification of information; (12.4.2013/277) 13) serious adverse event: (a) the supply and transfer of the body) with any stage of the chain from the unwanted and unexpected situation, which may cause infectious disease, leading to the death of a patient or incapacitating conditions for patients or which results in, or or, to or of the disease or its prolongation;
(b)) of the tissues and cells to the procurement, testing, processing, preservation, storage or distribution of any of the undesirable situation that could lead to the transmission of a communicable disease, to death or invaliditeettiinsa or työkyvyttömyyteensä or, to lead his cause of hospitalization or illness, or;
(12.4.2013/277) 14) serious adverse reaction: a) the body of the unintended chain at any stage of the living that is associated with the donor or in the recipient associated with an unintended response, including a contagious disease that leads to death or life-threatening, disabling, or incapacitating conditions for patients or life-threatening or result in a hospital stay or an illness, or;
(b) the purchase or use of tissues and cells), in the donor or in the recipient associated with it an unintended response, including a communicable disease, which can be deadly or that is fatal, life-threatening illness or incapacitating conditions for patients or their extension;
(12.4.2013/277) 15) standard toimintaohjeilla written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product or result; (12.4.2013/277) 16) the transplantation Centre Helsinki University Central Hospital where transplantation is centered on the concentration of highly specialized medical care by the State and the organisation of the Council Regulation (336/2011). (12.4.2013/277), tissues and cells, the number 2, removing the Bodies alive from the donor transplant operations (11 May 2007/547) (11 May 2007/547) General conditions for the management of Human disease or injury can be in the body, the tissue or cells are removed from the donor, who has given their consent. Detached from the body, the tissue or cells removed can be stored for later use.
Body tissue or cells can be removed only if the removal does not cause any serious health risk and on the necessity for serious harm, if the recipient's address is not available for other equally effective treatment as a transplant, and if an appropriate body or tissue or cells are not available from the dead donor or if the results are expected to be significantly better than the results of the dead donor received.
The State of health of the Elinluovuttajan is accompanied by the body after the handover, to the supplier occur serious side effects, that may arise as a result of the donation, as well as to the quality and safety of donated bodies, as well as the factors which may affect the safety of the recipient can be detected, they can be notified in the manner provided for in this law, as well as to take other necessary measures to ensure the safety of the elinluovuttajan and of the consignee. (12.4.2013/277)
The receiver of the attending physician is not eligible to participate in the bodies and tissues, with the exception of bone marrow tissue for removing the closure.

section 3 (11 May 2007/547), the consent of the donor Organ, tissue or cell retrieval must be written, informed consent of the donor. The supplier has the right to withdraw their consent at any time, without giving reasons, before the body tissue or cell.

The donor must provide written consent to be given before the end of his statement on the importance of removing and the risks to himself and to the recipient, the results of the analytical studies and their potential tasks, the data protection officer of the registration and the data of the donor, the donor on the security measures for the protection of, as well as the fact that the donor may withdraw their consent at any time before. The donor, who is participating in the conclusion of the attending doctor, dismounting must be accounted for in person to the donor.
If the donor is a minor, or the legal age, which is not an illness, mental disorder or other reason unable to decide their treatment (incapacitated), the harvesting must be the written consent of their legal representative. Body tissue or cells are not, however, be removed from the person, if it is opposed. The donor the treating physician, who is involved in the termination, shall be (2) dismounting provided a statement in person to the donor's legal representative. Your doctor will need to find out the opinion of the minor or the vajaakykyisen of the donor to the extent that it is possible, taking into account the age of the donor and the level of development.

section 4 of the non-renewable tissue of the body, or the age of the person who will be able to decide on the management of non-renewable or nonrenewable, to dispose of the tissue just next of kin or other person close to the illness or injury.
Body or tissue removal will be in the field of Social Affairs and health for the authorisation and supervision of the Agency's permission. Article 5 (2009/778) a minor or incapacitated by the donor is a minor or incapacitated may disclose only part of the renewable renewable tissue or body siblings people threatening illness or injury treatment, if appropriate in the tissue or organ is not available from the dead or the sovereign ' from the donor. If the donor is a minor, who will be able to decide, in relation to the age and the development of standards for their care, the recipient can be in his immediate family or other close. Cells may disclose other than in the above situations, if the appropriate cells are not available from the dead or the sovereign ' from the donor.
Tissue or organ removal of the component will be in the field of Social Affairs and health for the authorisation and supervision of the Agency's permission. (2009/778), tissues and cells, the number 3, the bodies of the capture (11 May 2007/547) section 6 of the General conditions and limitations of the Organs, tissues and cells that are removed from the patient in the context of the diagnostic or treatment can be recovered and stored for medical use. (11 May 2007/547)
Items may only be used for the assisted reproductive technology treatment or medical research.

section 7 (11 May 2007/547) the patient's consent, and the other conditions of section 6 of the above, the recovery of the body referred to in subparagraph (1), the taking of tissue or cells recovered for the storage and use of the post should be the patient's written, informed consent. If the patient is incapacitated, or is not able to understand the importance of the European collection, therefore, must be the written consent of his legal representative. The patient or his legal representative has the right to withdraw their consent for any reason at any time prior to the final use of the cell, tissue or organ.
The patient is before the consent of the purpose of the recovery and the importance of the report, on the results of the analytical studies and their potential tasks, the data protection officer of the registration and the data of the donor, the donor on the security measures for the protection of, as well as the fact that the donor may withdraw their consent prior to the use of the tissue or cell in the body, in the final. The patient treating physician shall report in person to have the bodies recovered by the patient or his legal representative. When delivering the report recovered from tissues or cells can be also other health care professional.
If the organs, tissues or cells are recovered in the context of abortion or miscarriage, will be the activities of social services and health care industry for the authorisation and supervision of the Agency's permission. (12.4.2013/277), tissues and cells, the number 4, removing the bodies of the dead donor (11 May 2007/547), section 8 of the General conditions under which a dead person can be detached from the organs, tissues and cells, and they can be stored in the other person's illness or injury. (11 May 2007/547)
Death is noted by the Decree of the Ministry of Social Affairs and health.
The doctors, who say the death, are not eligible to participate in the activities of the organs, tissues and cells. (11 May 2007/547) (24.6.2010/653), the consent of the deceased human organs, tissues and cells can be removed, if the call is not known or if there is no reason to assume that the deceased during his lifetime, would have been opposed to the measure. If the deceased is a lifetime ban on the harvesting of kudoksiensa or blood cell, it brings with it, the action was not allowed to do. Before the dead man's organs, tissues or cells is removed, it is, as far as possible, to sort out the deceased's own lifetime the perception of bodies, blood cell kudoksiensa or removing section 8 for the purpose of subsection (1).
If the deceased is a minor, and due to the age and degree of maturity during his lifetime, he has not been able to detach, it brings with it, kudoksiensa or blood cell gets the organs, tissues and cells, except for his guardians have no objection to the measure.
If the age of the deceased is not an illness, mental disorder or for any other reason never been able to connect to the idea of removing the cells, tissues or organs, may be a measure to make, subject to his next of kin or other relatives, have no objection to it.

section 9 (a) (24.6.2010/653) to the next of kin of the deceased, the deceased's Statement or the nearby must be explained in the bodies, of the importance of the removal of cells and tissues and.

section 10 (11 May 2007/547) restrictions on the harvesting of Organs, tissues or cells shall not be removed, if it is harmful to the cause of death.
The harvesting of organs, tissues or cells must not be taken if the police investigation must be carried out to establish the cause of death and police opposition to removing the removing the cause of the death of the oikeuslääketieteellistä, or substantially more difficult.
Chapter 5 the autopsy medical research and teaching in the framework of the action under section 11, (30 November 2012/689) for research and teaching in the context of the conditions for the operation of the autopsies of dead bodies, as well as the recipients of the organs, tissues, cells, and other samples may also be used for any purpose other than to determine the cause of death related to medical research or education. Samples may also be transferred to biopankki (688/2012), as referred to in biopankkiin. The condition that the vehicles are: 1) the medical research Act (488/1999) vis-à-vis the competent Ethics Committee has delivered a favourable opinion with regard to the use of samples of the dead bodies and the transfer of the samples used in medical research, or biopankkiin; and (2)) in the field of Social Affairs and health, the authorisation and supervision of medicinal products, the Agency has authorized the use of corpses and samples for educational purposes.
If the Ethics Committee under paragraph 1, the opinion referred to in paragraph 1 is in the negative, Ministry of Social Affairs and health on the application for the authorisation and supervision of the Agency makes a decision.

Article 12 restrictions on the activities of the body of research and teaching may not be used, and the organs, tissues, or cells detached from the research or teaching, if it is harmful to the cause of the death of the detection, or in tissues or organs provided for in the law, removing the human cells for the treatment of illness or injury. Research or educational activities should not be taken if the police investigation must be carried out to establish the cause of death and police is opposed to taking up the operation. (11 May 2007/547)
Research and educational activity must be carried out with respect for the deceased and the deceased's appearance substantially change. Research and teaching activities may not engage in, if there is reason to believe that the deceased during his lifetime, would have been opposed to it.

section 13 of the body of the disclosure to the institution of the University of education the purpose of the anatomy can be a medical education to dispose of the body of the deceased, the purpose of the transmission of education is given his or her consent in writing during his lifetime.
Chapter 6 General provisions concerning the operation of (12.4.2013/277) (11 May 2007/547), tissues and cells, the origin, quality and security (12.4.2013/277) for the treatment of Human disease or injury or otherwise, the human body must be used only for the kind of human organs, tissues and cells, as well as of the quality and safety of manufactured products, which have been studied by appropriate methods and whose origin can be traced. (12.4.2013/277)
The imported organs, tissues and cells, as well as of the products may be used to treat human illness or disability or otherwise, of the human body provided for in this Act, if the only donor and release conditions are met.

section 15 (11 May 2007/547) to safeguard the quality of the health care business entity or any other entity, which carries out in this release, provided for in the law of capture or storage operations or with the use of this in accordance with the law with regard to the use of stored, recovered or human organs, tissues or cells must be appropriate to the activities and operation of the equipment as well as the necessary staff.

Tissue establishments operating conditions laid down in Chapter 6 (a). Out of the hospital and the Centre's activities, in addition to the requirements laid down in Chapter 6 (b). (12.4.2013/277) section 16 (11 May 2007/547) registers of Human organ and tissue transplantation for the treatment of disease or injury, helmet, recovered and stored tissues and cells of human bodies, as well as the safety and traceability of the removal, capture, storage and use of the control of the legality of the operation of a record to be kept. The data controller is the health care unit or any other unit that stores the human organs, tissues or cells for the treatment of human disease or injury, or in which they are used in organ and tissue transplantation. The controller is also the tissue establishment, to acquire, test, store, retain, or distributes tissue or cells. The Finnish Red Cross to keep a register of bone marrow tissue vapaaehtoisluovuttajista.
The name of the donor and the recipient shall be entered in the register, a personal identification number, or equivalent means of identification, the necessary contact information, the results of the study body tissue and cells, organs, tissues and cells of human origin from donor and recipient information, relating to the security of the information on the healthcare units, which are involved in the harvesting of the cells, tissues and organs, storage and use, the bodies, the tissues or cells to be used for purposes other than those for which they are recovered, the number of organ donors across Europe of the living and the dead the information transmitted or otherwise recovered, and the type and number of organs used, as well as information in the field of Social Affairs and health, the issuing of permits for the authorisation and supervision of the Agency's organs, tissues or cells, with the consent of the donor or the patient's irrotukselle and details of tissues and cells and organs, irrotukselle, or capture. (12.4.2013/277)
The information contained in the register are kept for 50 years from the death of the donor's death or, if there is no information as of the last 100 years, the registry entry. If a donor to withdraw their consent, the controller shall forthwith inform the Agency, the tissue or cells of the requested action. Donor information is in this case, remove the body or tissue transplantation registers, unless the law of the conservation of no other reason.
Transplantation Centre shall draw up an annual report on the activities of the organ transplantation referred to in this article. Transplantation Centre shall submit a report on the security and development of the pharmaceutical sector, which publishes an annual report on the activities relating to organ transplantation activities. (12.4.2013/277)
Tissue establishments from the register and the data contained in the above paragraph 9(3) of the aberrant retention period laid down in article 20 (i).

section 17 of the transfer of data from the register referred to in article 16, organ and tissue transplantation in the registers, as provided for in article 20 (i) tissue establishments, as well as other donors and the recipients of the amounts deposited in the register of the information received and documents relating to them are confidential. (11 May 2007/547)
Notwithstanding the provisions on secrecy, the controller is handed over to the secure use of the cells, tissues and organs, as appropriate in view of the information contained in the register to another healthcare entity or any other entity that participates in the activities referred to in subparagraph (1). The controller shall, on request, disclose the information contained in the register of the authority, which controls and monitors the activities provided for in this Act. Otherwise, the transmission of data is valid, what the Act on the openness of government activities (621/1999). (11 May 2007/547)
Notwithstanding the provisions on secrecy, the controller shall have the right to get the organs, tissues and cells are necessary for the safety and traceability of the information about the healthcare unit, or any other entity, that, having recovered, stores or the use of human organs, tissues, or cells, or take care of the donor or the recipient. (11 May 2007/547)
The information referred to in paragraph 2 and 3 shall not charge a fee.

section 18 (11 May 2007/547) and provided for in the economic prohibition of profit in this Act, the body, the use of the tissue or cell and the disposal of the body not to promise not to run to the donor or his successor. The bodies of the need for or, availability of advertising is prohibited, if it is with a view to offering or seeking financial gain or comparable advantage. (12.4.2013/277)
The vital need for the transfer to be based on this Act, referred to in body tissue or cell donor has the body, the tissue or cell harvesting and related to compensate for the loss of earnings caused by the necessary studies, entitled to a daily allowance as specified in the Health Insurance Act (12/2004). The day the money is carried out under section 7 of the Health Insurance Act, Chapter 8 of the full working days, notwithstanding. If an employer to pay salary for the period of incapacity, the right to a daily allowance as specified in section 4 of Chapter 7 of the law on health insurance provides. (24.6.2010/653)
The harvesting of the cells, tissues or organs, the procurement, storage, or use a participating health care unit or any other unit or the tissue establishment shall not undertake any activities provided for in this Act to pursue economic benefits. The health care unit or any other unit or service may, however, charge the processing of cells, tissues or organs to compensation, for carrying out the necessary studies, in order to ensure the safety of the transport and storage of other health care services or the website. Of these, the fee shall not exceed the amount of the costs of the provision of the service.

section 19 (2009/778) the use of tissues and cells and Organs, changed to people who live disconnected, recovered or stored in the body, the tissue or cell, which is not a medical reason to be able to use for its intended purpose, may be used for any other legitimate medical purpose, if you will, the consent of the donor. If the body, the tissue or cells is removed the application, or the consent of the legal representative of the vajaakykyisestä, you need to work with.
If the body, removing the tissue or cell or capture requires social and health for the authorisation and supervision of the Agency's permission, change in use requires, in addition to the consent provided for in paragraph 1, that the activity is in the field of Social Affairs and health for the authorisation and supervision of the Agency's permission, or in the case of medical research, or the transfer of the sample biopankki code biopankkiin, the Act on medical research Ethics Committee favourable opinion from the competent authority referred to in the. (30 November 2012/689)
Deceased person removed or stored in the body, the tissue or cell, which is not a medical reason to be able to use it for the purpose for which it was removed, may be used for medical research, and move the biopankkiin, if the intended use has been referred to in subsection 2, the positive opinion of the Ethics Committee, or any other medical use in health care and social services for the authorisation and supervision of the Agency. (30 November 2012/689)
If the Ethics Committee opinion referred to in paragraph 2 or 3 is in the negative, Ministry of Social Affairs and health on the application for the authorisation and supervision of the Agency makes a decision. (30 November 2012/689) under section 20 (30 November 2012/689) tissue samples of the intended purpose of the treatment or diagnostic changed due to photos taken with the tissue samples shall be made available, and used in medical research with the consent of the patient. If the person is a minor or incapacitated, consent will be to get his legal representative. If the consent of the person's death, it is not possible to obtain, samples can be used for medical research or transfer biopankki biopankkiin medical research referred to in the law referred to in the Act on a favourable opinion has been given by the Ethics Committee. If the presence of an unfavourable opinion of the Ethics Committee, Ministry of Social Affairs and health on the application for the authorisation and supervision of the Agency makes a decision. If there is reason to believe that the person was alive it would have objected to the use of näytteidensä research, samples shall not be transferred for biopankkiin. In addition to the transfer of the samples and the conditions of use are regulated in the processing of biopankki by law.
The treatment, diagnosis or cause of deaths due to the samples of the investigation may be disclosed to and used in medical research, method development, quality management and education to health care to the activities of an entity or other entity with the permission for the operation of which the sample was taken, if the samples to the release or not to process your personal data.
The treatment, diagnosis or medical research is therefore taken tissue samples may be handed over to and use the other person's identifying disease heredity only, if found it, from which the sample was taken, to give their consent. If the person is a minor or incapacitated, consent will be to get his legal representative. If the person is dead or it is a cause of death because of the reverse engineering on the website of the sample, the tissue sample, the disposition shall be ordered by the health care unit or any other unit, which for a tissue sample is taken, unless the deceased have this lifetime ban.

Treatment, diagnosis, cause of death because of the medical examination on reverse engineering or samples may be handed over to the biological parents for the Court or other authority be appointed by the research institution or for the identification of the dead, the police authority.
The treatment, diagnosis or cause of death because tissue samples taken from the investigation will not be made available or used for purposes other than those for which they have been taken, if it is detrimental to the implementation of the original purpose of the tissue samples.
6 (a) in the figure (11 May 2007/547) provisions concerning the operation of the tissue establishments and section 20 (a) (11 May 2007/547) the tasks of the tissue establishment to tissue and cell procurement, testing, processing, preservation, storage and distribution takes place in the tissue establishment or on behalf of the Commission. Tissue establishments shall ensure that quality and safety of tissues and cells to be appropriate, including the investigation of all in order to ensure the safety of donated tissues and cells. The tissue establishment shall also ensure that tissue and cell procurement, testing, processing, preservation, storage and distribution conditions are appropriate.

Article 20 (b) (2009/778) licensed and the announcement of the tissue establishment must have the security and development of the pharmaceutical sector. The approval can be attached to the scope of the activity of tissue establishments. Tissue establishments shall establish a substantial change in the Declaration of its activities in the security and development of the pharmaceutical sector, which will decide whether the change in the change.
Centre for the development of the pharmaceutical sector in the security and shall be issued on application having been made for the operation of the concession to the tissue establishment, to an association or any other equivalent group, entity or company, if the tissue establishment complies with the human tissue and cell donation, procurement, testing, processing, preservation, storage and distribution of quality and safety for the European Parliament and of the Council of Directive 2004/23/EC of the European Parliament and of the Council on the implementation of Directive 2004/23/EC for the donation of human tissues and cells , procurement and testing of as regards certain technical requirements for the Commission Directive 2006/17/EC of the European Parliament and of the Council on the implementation of Directive 2004/23/EC as regards traceability requirements, notification of serious adverse reactions and events, as well as for human tissues and cells for the coding, processing, preservation, storage and distribution of technical requirements of Commission Directive 2006/86/EC in accordance with the requirements. An application for a permit shall be in the tissue establishment staff, facilities, equipment, and supplies information on the donation of tissues and cells, as well as information on the procurement, testing, processing, preservation, storage and distribution procedures. In addition, an application for a permit shall contain the information, as well as the quality of the tissue establishment procedures relating to the safety and traceability of tissues and cells, as well as adverse events and reactions.

20 (c) of section (2009/778), the person in charge of the tissue establishment must have a responsible person, whose mission is to ensure the processing of tissues and cells, the provisions of this law and in accordance with the quality system at the tissue establishment, to make a notification under article 20 (g), as well as deliver a 20 (b) the granting of the authorisation referred to in article the data necessary for the safety and development of the pharmaceutical sector. The responsible person shall fulfil the human tissue and cell donation, procurement, testing, processing, preservation, storage and distribution of quality and safety for the European Parliament and of the Council of Directive 2004/23/EC in accordance with article 17.
Tissue establishments shall inform the Centre for the development of the pharmaceutical industry on safety and responsibility of the person referred to in subparagraph (1), and his sijaisestaan, as well as the shift of interest.

Article 20 (d) (11 May 2007/547) the staff of the human resources of the tissue establishment shall be qualified for their tasks and the staff must be organised on a regular basis with the proper training.

20 (e) of section (11 May 2007/547) the quality system the tissue establishment must be based on the principles of good practice and up to the quality of the system. The quality system shall contain at least the standard instructions do and other guidelines, training material, and the source works, notice forms, data, and information for donors of tissues and cells of the final use made of the data.

Article 20 (f) (11 May 2007/547) the traceability of the tissue establishment must have a system that allows all procured, processed, stored or distributed on their territory can be traced to tissues and cells from the donor to the recipient and vice versa. The traceability requirement also applies to all the relevant information about coming into contact with these tissues and cells and substances relating to the products.
Tissue establishments shall be assigned to each donation and to each of the unique code.

section 20 (g) (11 May 2007/547) notification of adverse events and reactions of the tissue establishment shall maintain a register of all came to the attention of the tissues or cells of the adverse events and reactions.
Tissue establishments shall notify, without delay, to the security and development of the pharmaceutical sector in their activities, as well as the use of tissues or cells on the procurement, testing, processing, preservation, storage and distribution of any serious adverse events and serious adverse reactions, which may affect the quality and safety of tissues and cells. The obligation to also be observed during or after clinical use to serious side effects that may be associated with the quality and safety of tissues and cells. (2009/778)
Tissues and cells, which have been the subject of a declaration referred to in paragraph 2, shall not be used, and such tissues and cells must be removed from the distribution. Such tissues and cells can be enabled, if a separate, on the basis of a report to demonstrate that they meet the requirements of this safety and quality standards provided for in the law.

20 h section (11 May 2007/547) tissue establishments and third-party contracting the tissue establishment can be technical, economic or productive factors, it requires and the safety of the pharmaceutical sector-and with the permission of the Centre to carry out specific actions to a third party. (2009/778)
Tissue establishments shall establish written agreements with a third party each time an external measure of the tissue establishment, the question is, which affects processed in cooperation with a third party to the quality and safety of tissues and cells.
The agreement referred to in paragraph 2 must be carried out, in particular, if: (a)) of tissue or cell processing to a third party to take care of or one of its stages;
(b)) where a third party provides goods and services that affect tissue or cell quality, or to ensure the security of their distribution;
(c)) where a tissue establishment provides services to a tissue establishment than to the other; or (d)) where a tissue establishment distributes tissue or cells processed by third parties.
The contract shall be the responsibility of the third party and the procedure to be followed.
Tissue establishments shall keep a list of agreements and provide, on request, copies of the contracts for security and development in the pharmaceutical sector. (2009/778), 20 (i) of section (11 May 2007/547) records and retention of tissue establishments shall keep a record of their actions. Shall be entered in the register in addition to the provisions of section 16 of the Ordinance, it procured, tested, preserved, processed, stored and distributed, or otherwise disposed of, and the type and number of tissues and cells. The register is also an important influence on the quality of your tissues and cells, as well as those relating to products and materials coming into contact with.
Tissue establishments shall be provided by the Centre for security and development in the pharmaceutical sector annual report on their activities. (2009/778)
Tissue establishments shall keep the data required for full traceability for a minimum of 30 years after clinical use. The data can be saved also in electronic form.
Register (s) referred to in subparagraph (1) of the data transmission shall apply by analogy to article 17.
Centre for the development of the pharmaceutical sector, security and keep a register of tissue establishments and of the measures to which a permit has been issued for each tissue establishment. The register is public. (2009/778), section 20 (j) (2009/778), the control and monitoring of tissue establishments and tissue establishments in the control and supervision of human tissue and cell donation, procurement, testing, processing, preservation, storage and distribution, as well as with regard to the quality and safety under the Ministry of Social Affairs and health and the development of safety-in the pharmaceutical sector.
The security and the development of the pharmaceutical sector will examine the tissue establishment on a regular basis, at least once every two years. The Centre may also, if necessary, check the website of the institution, if its activities are detected the use of tissues or cells on the quality or safety of the incident or serious side effect or if it is suspected that this has happened.

The inspector must give all tissue establishments, as well as at the premises of the tissue with the 20 h of the contract referred to in section (2) to have made a third-party. The inspection may take place in the premises of the pysyväisluonteiseen housing. The inspection must be requested by the Inspector, notwithstanding all the documents that are necessary for the implementation of the audit. The auditor shall be issued free of charge in his copies of the requested documents necessary for the implementation of the audit, as well as samples of substances and preparations at the separately in detail. The Inspector also has the right to take photos during the inspection. The auditor must audit Protocol.

section 20 k (11 May 2007/547) the inspection to The inspection referred to in article 20 (j) performing the Inspector may determine the shortcomings to be corrected. As a result of the order of the examination shall, without delay, to take the appropriate measures.

20 l section (2009/778) fees for security and development in the pharmaceutical sector, the Centre may charge a fee for 20 for the authorization referred to in paragraph (b) and (j) the checks referred to in article 20.

a 20 m section (2009/778) withdrawal of authorisation and a threat to the security and development of the fine in the pharmaceutical sector, the Centre may cancel the authorization number of the tissue establishment if inspection or control on the basis of the measure, it can be concluded that the body or the quality system meet the requirements laid down in the law.
The decision on the withdrawal of the authorization is to comply with the appeal.
In the pharmaceutical sector for the development of security and can set the penalty as a penalty (1113/1990), in the case where the conditions for the granting of authorisation: 1) are no longer met;
2) where a tissue establishment have failed to comply with the conditions attached to the approval of this law or in violation of, or its otherwise seriously jeopardize the safety of tissues and cells; or 3) article 20 (k) provisions adopted on the basis of the measures are not being taken.
6 (b) in the figure (12.4.2013/277) Out of the hospital and transplant centre in the provisions concerning the operation of the 20 's section (12.4.2013/277) Out of the hospital and transplant Donation hospital and transplant center in addition to the requirements provided for in this Act, the health care Act (221/2010) and specialized care (1062/1989).
Centre for the development of the pharmaceutical sector, security and maintain an up-to-date mailing list out hospitals and transplant center.
The State Council Regulation lays down rules on the organisation and of highly specialized medical care in transplantation.

20 o § (12.4.2013/277) Out of the hospital and transplant center functions Out of the hospital is to identify the possible death of the donor, the Agency said, identify and record any of the deceased referred to in article 9, a lifelong understanding of removing it brings with it, take care of the deceased, provided for in article 9 (a) of the nearby elinluovuttajan of the management and reporting, be responsible for the necessary additional studies for the transfer of the eligibility of the living body.
Transplantation Centre shall ensure that the quality and safety of the body are appropriate. Transplant Center is responsible for the transfer, as well as dismounting and the body accepts elinluovuttajan and selects the recipient. Transplant Center must be reviewed before proceeding with the transfer of the body of living and elinluovuttajan description is appropriate and that carried the bodies of the preservation, storage and transport conditions are appropriate.
Transplantation Centre shall ensure integrity during transport and transport the bodies of the time.
In the pharmaceutical sector for the development of security and provide more detailed provisions on the transport of the bodies of the quality and safety requirements for organs.

20 p section (12.4.2013/277) on the quality and safety of good practices relating to the Assignment of the hospital and transplant centre should be timely and the principles of good practice and the bodies of the chain from donation to transplantation or disposal, in accordance with the instructions covering all steps to ensure that: 1) donor identity;
2) donor (3) or section 9 of the registration of the consent of the engineer.
3 a description of the properties of the body and elinluovuttajan);
4) the fact that the staff meets the requirements laid down in article 20;
the preservation of the body, the proper reclamation of 5), transport, storage, packaging, and labelling;
6) the traceability of the body;
7) in compliance with the provisions on the protection of personal data;
8) the accurate, rapid and verifiable reporting of serious adverse events and reactions;
9) for the notification of serious adverse events and adverse effects.
In the pharmaceutical sector for the development of security and provide more detailed provisions on the principles of action of the commitment referred to in subparagraph (1) and guidelines.

20 q section (12.4.2013/277) personnel personnel directly involved in organ donation and transplantation must be on the quality and extent of the activities of the qualifications, training and expertise necessary to perform their duties. Out of the hospital and its staff shall be organised on a regular basis of the transplant Centre for appropriate training.

20 r section (12.4.2013/277) quality requirements for procurement on the procurement must be responsible for the medical condition of the doctor.
Recovery shall be carried out in operating theatres, which are designed, constructed, maintained and used in accordance with the relevant requirements and best medical practices.
Procurement of materials and equipment have to deal with sterilization and medical devices and that of the international, the European Union and in accordance with national regulations, standards and guidelines.

20 s section (12.4.2013/277) of the body and the description of the Elinluovuttajasta and elinluovuttajan properties of the body must be equipped with the necessary information relating to the disposal of before the transplant.
In order to obtain the information tasks, tests must be carried out in the laboratory, which is sufficiently qualified, trained and qualified staff and adequate facilities and equipment.
The Ministry of Social Affairs and Health decree, which details all the elinluovuttajista and the bodies of at least should be. Organ transplant can be performed, even if the minimum amount of information should not be available all the time limits provided for in this regulation, if the recipient of the benefit is greater than the risk, presumably because of the incompleteness of the information.
In the pharmaceutical sector for the development of security and provide more detailed provisions on the organ and donor characterisation of the relevant information should also work to get.

20 t section (12.4.2013/277) the traceability of the organ transplant center must be able to identify each of the donor and the recipient, as well as the body and trace all recovered in Finland, shared, and transferred to the bodies from the donor to the recipient and vice versa.
The traceability requirement also applies to all of the relevant information relating to such a body in contact with the products and the materials used.

20 the u section (12.4.2013/277) notification of adverse events and adverse effects of transplantation Centre shall maintain a register of all its organs in any reported adverse events which may affect the quality and safety of organs, as well as serious side effects.
Out of the hospital will inform the organ transplant center in all of its bodies, any reported adverse events which may affect the quality and safety of organs, as well as serious side effects.
Transplant Center must provide the security and the development of the pharmaceutical sector institutions, testing, characterisation, preservation, storage, and transport of the recovery, which may be associated with serious adverse events and serious adverse reactions, which may affect the quality and safety of organs.
The body, which was the subject of a notice referred to in this paragraph, shall not be used before it is drawn up in the written risk assessment. Such a body can be enabled, if on the basis of a risk assessment can be expected, that the benefits to the patient transfer is greater than the cost of the transfer.

20 v section (12.4.2013/277) Out of hospitals and transplant center to command and control the transfer of hospitals and transplant center transplant operations General command and control are under the Ministry of Social Affairs and health in health care and social services for the authorisation and supervision of the Agency, as well as the regional government agencies as specified in this or any other law.
Transfer of hospitals and transplant center control and control of the storage of bodies, testing, preservation, transport, handling, packaging, as well as the quality and safety requirements, notification of serious adverse events and serious adverse events reporting and management as well as the requirements of the Ministry of Social Affairs and health, under the security and development of the pharmaceutical sector.
In the field of Social Affairs and health for the authorisation and supervision of the Agency, the regional government agencies and pharmaceutical safety and Development Centre has the right to receive, free of charge, and the information necessary for the supervision, notwithstanding the assignment of hospital and transplant centre, State and municipal authorities, depending on the community, as well as other health-and sairaanhoitotoimintaa from the community or an institution.

20 x section (12.4.2013/277) verification of the transfer of hospitals and transplant centre


In the field of Social Affairs and health for the authorisation and supervision of the Agency, the regional government agency and to the security and development of the pharmaceutical sector has adopted on the basis of the provisions of this law and its provisions for the purposes of monitoring compliance with the right to inspect and out of the hospital and transplant center's facilities and activities, as well as the necessary documents.
The inspector must give all out at the premises of the hospital and transplant centre and the inspection must be requested by the Inspector, notwithstanding all the documents that are necessary for the implementation of the audit. The auditor shall be issued free of charge in his copies of the requested documents necessary for the implementation of the audit, as well as samples of substances and preparations at the separately in detail. The Inspector has the right to take photos during the inspection. The inspection must not be carried out in the premises used in the pysyväisluonteiseen housing.
In the field of Social Affairs and health, the Agency for the authorisation and supervision of the regional government agency or the security and development of the pharmaceutical sector shall be the submission of a copy of the inspection within 30 days of the inspection protocol for the supply of hospital or transplant center for information. The inspection shall be considered as terminated, when the inspection a copy of the Protocol is notified to the interested parties.
Out of the hospital and transplant center must start without delay, the necessary measures and shall inform the inspection shortcomings in health care and social services for the authorisation and supervision of the Agency, the regional government agency or the Organisation for security and development in the pharmaceutical sector, we must include all of the measures, the implementation of the timetable and the details within 30 days of the inspection report is given to the unit.

20 the y section (12.4.2013/277) and the application of less coercive measures in the field of Social Affairs and health, the Agency for the authorisation and supervision of the regional government agency or the security and development of the pharmaceutical sector shall prohibit the release hospital or transplant centre from pursuing their activities, on the basis of the audit or other enforcement action, if it can be established that the requirements laid down in this law, fill in the unit.
The decision on the ban appeal, must be respected subject to the appeal authority.
In the field of Social Affairs and health for the authorisation and supervision of the Agency, the regional Government Office and the Centre for the development of the pharmaceutical sector, security and can set the penalty as a penalty (1113/1990), if: 1) transfer or transplant center is a substantial violation of the provisions of this law or failed to comply with its otherwise seriously jeopardize the quality and safety of organs; or 2) 20 x of provisions adopted on the basis of the measures laid down are not being taken.
Chapter 7 miscellaneous provisions article 21 of the definition of the death of the man is dead, after all, his brain activity are permanently exhausted.

Article 21 (a) (30 November 2012/689) tissue samples to use in medical research in the field of Social Affairs and health, the authorisation and supervision of medicinal products, the Agency may authorise the treatment and the use of the diagnostic of tissue samples for medical research. The condition that the vehicles are: 1) the investigation is medically or socially significant;
2) medical research Act referred to the Ethics Committee has given a favourable opinion;
the necessary samples are not available for the 3) biopankista;
4) for research purposes is appropriate premises, equipment and staff;
5) research is named after the doctor responsible for research;
6) the individuals privacy is not compromised.
I promise to protect your privacy and can be attached to the protection of the rights of specific persons.
The health care unit shall be made available, in the field of Social Affairs and health, the Agency's decision for the authorisation and supervision of a doctor responsible for the examination of samples referred to in, if the person is not known to have näytteidensä for use in medical research.

section 22 (2009/778) in health care and social services for the authorisation and supervision of authorizations granted by the Agency for welfare and health, the Agency may grant the authorisation and supervision of section 4 of the Act and section 5 of the authorisation referred to in paragraph 2, if the conditions provided for in this Act removed the body, removing the tissue or cells, and has been the recipient of care.
In the field of Social Affairs and health, the Agency granted the authorisation and supervision of medicinal products provided for in article 7, article 11, paragraph 1, sub-paragraph (2) and section 19 of the licence referred to in paragraph 2 and 3, if the activities are presumed to be medically justified, for the operation of appropriate premises, equipment and staff, and is named after the doctor responsible for the activity. In the field of Social Affairs and health, the authorisation and supervision of medicinal products, the Agency may issue a permit for a specified period or until further notice. I promise can be attached to a specific activity of the organisation of working time. (30 November 2012/689) section 23 (2009/778), and social and health care sector for the authorisation and supervision of the Agency's cancellation of an authorisation issued by the health and social sector, the Office may provide for the authorisation and supervision of medicinal products provided for in article 7, article 11, article 19, paragraph 2 and 3 of article 20, as well as the activities referred to in article 21 (a) to suspend or withdraw the authorisation granted to the activities referred to in those paragraphs of the law, if the non-compliance with the rules in force or in operation, the conditions of authorization. (30 November 2012/689)
In the field of Social Affairs and health, the authorisation and supervision of medicinal products, the Agency may, if necessary, request to run an authorised institution of the premises and the activities referred to in subparagraph (1), as well as the supervision of the necessary documents for the inspection.
The decision on the withdrawal of the authorization is to comply with the appeal.

23 (a) section (2009/778) imports and exports of tissues and cells of tissues and cells to be imported to Finland and to export from Finland only the safety and development of the pharmaceutical sector in the Centre of a tissue establishment. The import and export of tissues and cells must be filled in by the law laid down in the quality, safety and traceability requirements.
Centre for the development of the pharmaceutical sector, security and may in exceptional circumstances grant the tissue establishment or other healthcare entity permission to the import or export of certain tissues and cells.

section 23 (b) (12.4.2013/277) for the transfer of the bodies referred to in the import and export of the body may be imported to Finland for the bodies referred to in the transfer and export from Finland only in the law for organ transplant center and its authorized health care operator.
The bodies of the European Union to a third country or for the import and export to a country not forming part of the Union, shall be permitted only if the organs can be traced from the donor to the recipient and vice versa, they meet the requirements of this Act correspond to those provided for in article 14 of the standards of quality and safety, as well as of the requirements laid down in paragraph 2 are complied with.

section 24 (2009/778) more detailed rules and regulations (12.4.2013/277) more detailed provisions on the conditions for granting the authorisations provided for in this Act, the information required in the application for authorisation, as well as on the implementation of this law, shall be provided to the State by means of a Council regulation.
Decree of the Ministry of Social Affairs and health shall be adopted, where necessary, more detailed provisions: 1) organs, tissues and cells, as well as tissue samples removal, capture, storage and use of the health care community and other departments;
2) healthcare units and other units, as well as the costs of tissue establishments;
3) referred to in article 16 of the organ and tissue transplantation registers, 20 (i) of article 20 and the tissue establishment as referred to in (i) referred to in section (5) of the medicine in the field of security and the Centre for the development of the register of tissue establishments, as well as the patient's document;
4) of the substantial change in the operation, which will require the development of pharmaceutical safety and authorisation;
5) pharmaceutical security and authorization given by the Centre for the development of and charges for its control, taking into account the State of payments by the law (150/1992) or under it;
6) the traceability of organs, tissues and cells; (12.4.2013/277) 7) the procedure for notification of adverse events and adverse effects;
8) out of hospitals, transplant center, and the inspection of tissue establishments, in particular with regard to the detailed content and the procedure for checking things, of the Protocol, its retention period and notification; (12.4.2013/277) 9) exceptional situations in which the safety and development of the pharmaceutical sector, the Centre may authorise the release of certain import or export of tissues and cells.
The activities falling within the scope of this Act, the necessary forms formulas shall be established in the security and of the Centre for the development of the pharmaceutical sector. (12.4.2013/277)
Centre for the development of the pharmaceutical sector, security and, where necessary, lay down more detailed rules: 1) on the implementation of the quality system for the content of the tissue establishment;
2) on the selection criteria for donors of tissues and cells;
3. to establish the required safety of tissues and cells) and their acceptable results;
4) the quality and safety of tissues and cells, the procedures for the procurement and handling, storage conditions and storage distribution as well as of the circumstances of the particular case.

section 25 (11 May 2007/547) penalty which intentionally 1) removed, having recovered or stores of the body, the tissue or cells without the consent or authorisation laid down in this Act,

2) to dispose of the removed, captured or stored by the body, this kind of tissue, such as blood cells or tissue sample, or use them without the consent of the authorisation provided for in this Act or the request, 3) to acquire, test, store, retain, or distributes tissue or cells without the authorization provided for in this Act or an agreement with the tissue establishment, 4) organs, tissues and cells for the notification of serious adverse events and reactions, (12.4.2013/277) 5) fails in legal institutions the traceability of tissues and cells, and to control the operation of the necessary personal safety or the maintenance of the register, 6) used in the treatment of the human or otherwise, in the human body such as organs, tissues or cells or products whose origin is not known or has not been examined for safety, 7) bring to Finland in the organs, tissues, or cells, that are removed or recovered contrary to the conditions laid down in this Act, or to bring to Finland, the donor organs , a State of the tissues or cells, whose legislation does not meet the conditions laid down in this Act, the traceability of tissues and cells, or by dismounting and 8) permission or paying for organs, tissues or cells to the donor or his representative to the premium for the bodies, tissues or cells must be condemned by human bodies, disconnecting, tissues and cells, medical use, subject to the Act to a fine for infringement of the provisions adopted in other parts of the Act provide for a more severe penalty.
The Act referred to in paragraph 5 of article 1, is to be punished as well, if it was gross negligence.

Article 26 (7.8.2015/1020) appeal the decision pursuant to this Act, with the exception of 20 (b), 20 m, 20 y, and the decisions referred to in article 23, may require an adjustment in the way the Administration Act (434/2003). The Inspector of this law and the decision referred to in article 20 (k) may require adjustment to the security and development of the pharmaceutical sector.
The adjustment to the requirement for a decision in the case referred to in articles 4 and 5, in fact, may not be appealed. The rest of the decision, as well as an adjustment to the requirement of this law 20 (b), 20 m, 20 y and the decision referred to in article 23, may be appealed by appealing to the Administrative Court as administrative act (586/1996).
The decision of the administrative law, 20 m, 20 y, and in the case referred to in article 23, the issue gets appealed to the administrative law. The rest of the decision may be appealed only if the Supreme Administrative Court grants leave to appeal.
This law, in accordance with article 20 (k) must comply with the decision of the appeal.
L:lla 1020/2015 amended section 26 shall enter into force on the 1.1.2016. The previous wording: article 26 (16 October 2009/778) appeal to The Inspector referred to in article 20 (k) is not allowed to apply for appealing to the change. The party concerned may make a written decision within 30 days following notification of the complaint to the security and development of the pharmaceutical sector. To make a claim for adjustment and reading on the subject, otherwise, the law (434/2003), on behalf of the Management Board. Complaint shall not prevent the implementation of the decision of the Inspector.
In the field of Social Affairs and health, the Agency and the authorisation and supervision of medicinal products for the field of security and an appeal is brought against a decision of the Centre for the development of appealing to as administrative act (586/1996).
This law, as referred to in article 4 and 5 of the Social Affairs and health in the industry for the authorisation and supervision of the Agency's decision may not be appealed.
Chapter 8, section 27, the date of entry into force and transitional provisions of the entry into force of this law shall enter into force on 1 September 2001.
This Act repeals the human organs and tissues was disconnected for medical use, the law of 26 April 1985 (355/1985) to later amended.
This Act required licences within one year of the entry into force of the law must be sought.
Before the entry into force of the law can be used to take the measures needed to implement the law.
THEY'RE 29/93/2000, Shub 2000 EV 168/2000 acts entry into force and application in time: 11 May 2007/547: this law shall enter into force on 1 June 2007.
Article 20 (b) of the Act referred to in the authorisation may be granted prior to the entry into force of the law.
Tissue establishments must apply for a 20 (b) an authorization referred to in article and shall forthwith inform the liability referred to in section 20 (c) of the person, and no later than 1 September 2007. The medicine must be resolved in the application for authorisation within six months of the submission of the application. In the case of an application for authorisation has been submitted before the entry into force of the law, the medicine shall be resolved within six months of the entry into force of the laws of the application.
In the circumstances referred to in paragraph (3) may, after the entry into force of the law, until the application has been resolved, continue to operate without a licence in accordance with the provisions of this Act.
The time limit referred to in paragraph 3, shall be calculated from the time the appropriate application with the report is delivered to the Medical institution. If the Agency with a report on the application ask the applicant for further, there is no extra time it takes to read a report on the provision of processing time.
Before the entry into force of the law can be used to take the measures needed to implement the law.
THEY 273/2006, Shub 57/2006, EV 284/2006 16 October 2009/778: this law shall enter into force on 1 November 2009.
Before the entry into force of the law can be used to take the measures needed to implement the law.
THEY'RE 166/2009 28/2009, Shub, EV 122/2009 24.6.2010/653: this law shall enter into force on 1 August 2010.
THEY 276/2009, Shub 13/2010, EV 94/2010 30 November 2012/689: this law shall enter into force on 1 September 2013.
In the field of Social Affairs and health, the Agency may issue the authorisation and supervision of medicinal products on the date of entry into force of this law had been in force under section 20 of the licence the use of tissue samples or the conditions laid down in the law until 1 January 2018, if medical research the necessary samples is not available in biopankista.
THEY'RE 86/2011, Shub 9/2012, EV 12.4.2013/277/78 of the 2012: this law shall enter into force on 1 may 2013.
THEY 198/2012/2013, EV, Shub 4 29/13, the European Parliament and of the Council directive 2010/53/EU (32010L0053); OJ L 207, 6.8.2010, p. 14.

7.8.2015/1020: this law shall enter into force on the 1 January 2016.
On appeal before the entry into force of this law shall apply to the Management Board on the date of entry into force of this law, the provisions in force.
THEY'RE 230/26/2014 2014, LaVM, EV 319/2014

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