Key Benefits:
See the copyright notice Conditions of use .
In accordance with the decision of the Parliament:
This law provides for:
(1) removal, storage and use of human organs, tissues and cells for human illness or disability;
(1a) organs intended for transplantation, testing, characterisation, capture, preservation, storage, transport, transfer, traceability and serious adverse events, and Serious adverse reactions reported; (12/03/277)
(2) the capture, storage and use of organs, tissues and cells, in the course of the diagnosis and treatment of human beings, for medical purposes;
(3) the donation, procurement, testing, processing, preservation, storage of human tissues and cells intended for human use and human tissues and cells intended for human use; And the distribution of the tissue establishment or its mandate;
(4) the use of human embryos for purposes other than fertilisation or medical research;
(5) the use of human organs, tissues, cells and tissue samples for purposes other than those taken or recovered;
6) the use of a dead person for medical teaching and research activities.
For the purpose of this law, human tissues and cells are all tissues and cells intended for human use, including haematopoietic stem cells, germ cells, foetal tissues and cells from the umbilical and bone marrow, Cells as well as adult and embryonic stem cells.
In the case of medicinal products and medical devices containing human tissues and cells, the law shall apply to the donation, procurement and testing of tissues and cells.
Chapter 6 (a) of this Law shall not apply to tissues and cells used as autologous transplants in the context of the same surgical procedure without depositing tissues or cells in a tissue or cell bank, or in organs or parts of organs if they are used In the human body for the original purpose of the body.
Separation of the organs and tissues necessary for the diagnosis, treatment or medical examination and for the purpose of determining the cause of death shall be determined separately. However, the tissues and cells used in a medical study must meet the quality and safety requirements laid down in this law.
It also provides for the donation and testing of human blood and parts of the blood and parts of the blood and parts thereof, for the treatment, storage and distribution of blood and parts. It also provides for the use and storage of germ cells for fertilisation treatment, as well as compensation and payments in the case of fertilisation treatment.
For the purposes of this law:
(1) Body A differentiated part of the human body, consisting of various tissues and preserving its structure, blood vessels and its ability to develop a significant degree of autonomic physiological function; (12/03/277)
(1a) Description of the organ The recording of the body information necessary for the assessment of its suitability for transplantation; (12/03/277)
(1b) Description of the organ donor characteristics The donor's health information necessary for the assessment of whether the person is suitable for organ donation; (12/03/277)
(2) Tissue All constituent parts of the human body formed by cells;
(3) Cells Individual human cells or cell groups where the cells are not bound by any form of connective tissue;
(4) Tissue establishment A tissue bank, a health service unit, or any other unit or other unit carrying out activities related to the treatment, preservation, storage or distribution of human tissues and cells, or which is responsible for the procurement of tissues and cells; or Testing;
(5) Quality system The organisational structure, responsibilities, procedures, methods and resources required for the implementation of quality management, including all direct and indirect quality promotion measures;
(6) Use in humans The use of tissues or cells in the host person;
(7) Autologous use The removal of cells or tissues from human beings and their use in the same person without depositing them in a tissue or cell bank;
(8) Procurement The process through which the donated tissues or cells are made available;
(8a) Recovery operation The process by which the donated organs are made available; (12/03/277)
(9) Treatment Any measures relating to the preparation, manipulation, preservation or packaging of organs, tissues or cells that are transferred; (12/03/277)
(10) Preserved The use of chemical substances, changes in the environmental conditions and other means at which, in the course of the processing or in the case of organs, the recovery and the end of the transfer are intended to prevent or slow down the biological or Physical degradation; (12/03/277)
(11) In custody Keeping the product in appropriate controlled conditions until its distribution;
(12) Distribution The transport and supply of tissues or cells for use in humans;
12a) Traceability The localisation and identification of the body at each stage of the chain from donation to transplantation or disposal, including the identification of the donor, the procurement organisation, the consignee or the recipients, and with the body Locating and identifying information relating to products and materials coming into contact; (12/03/277)
(13) Serious adverse event :
(a) any unwanted and unexpected situation in relation to any stage in the chain between the donation and transfer of the body, which may result in the transmission of a contagious disease, to the death of the patient, or to endanger the patient's life, leads to the patient's death; Invalidity or incapacity for work, or cause hospitalisation or illness or their extension;
(b) any undesirable situation associated with the procurement, testing, processing, preservation, storage or distribution of tissues and cells, which may lead to transmission of the infectious disease, to the death of the patient or to endanger the patient; The spirit, leads to his invalidity or incapacity or causes hospitalisation or sickness or an extension of the disease;
(12/03/277)(14) With serious adverse effects :
(a) an unintended reaction, including contagious disease, to death or risk of death in a living donor or recipient linked to any stage of the chain between donation and transplantation in any part of the chain, Lead to invalidity or incapacity for work, or to cause hospitalisation or illness or their extension;
(b) the unintended reaction of the procurement or use of tissues and cells in the donor or in the recipient, including a communicable disease which may be fatal or endangering human life or leads to an invalidity, disability, or Cause hospitalisation or illness or their extension;
(12/03/277)(15) Standard operating guidelines Written instructions describing the stages of each procedure, including the substances and methods to be used and the expected end product or outcome; (12/03/277)
16) Transplantation centre The University Hospital of the Helsinki Region, where organ transplantation is centralised by a Council Regulation on the organisation and concentration of special medical care (186/2011) . (12/03/277)
In the case of human illness or injury, the organ, tissue or cells may be removed from the donor who has given his consent. The removed organ, tissue or detached cells may be stored for subsequent use.
Body, tissue or cells may be removed only if the removal does not cause a serious health risk to the donor and does not cause serious harm, if there is no other effective treatment available for the recipient, other than transplantation, and if appropriate The body or tissue or suitable cells are not available from the deceased donor, or if the results are expected to be significantly better than the results of the transfer from the deceased donor.
The health status of the organ donor shall be monitored after organ donation in order to give the donor the serious adverse reactions that may arise from donation and the quality and safety of the donated organ and the safety of the recipient. May be observed, reported in accordance with this law, and other necessary measures may be taken to ensure the safety of the donor and the recipient. (12/03/277)
The doctor treating the recipient shall not participate in the termination of organs and tissues, with the exception of removal of bone marrow tissue.
The removal of organs, tissue or cells must be the written, informed consent of the donor. The donor has the right to withdraw his/her consent at any time before removal of the body, tissue or cells.
Before giving his written consent, the donor shall report on the significance and risks of the removal to himself and the consignee, any analytical examinations and results thereof, the donor On data registration and data protection, on security measures applicable to the protection of the donor, and on the fact that the donor can withdraw his consent at any time prior to the release. The donor doctor who is involved in the decision on the release must report personally to the donor.
Where the donor is a minor, or an adult who is unable to decide on his treatment due to illness, mental illness or any other reason ( Impaired, ), the removal should be the written consent of his legal representative. However, organ, tissue or cells may not be detached if the person objects. The prescribing physician, who shall take part in the termination of the decision, shall be sent to the legal representative of the donor, as provided for in paragraph 2. The doctor shall also determine the opinion of the minor or the underperforming donor to the extent possible, taking into account the age and level of development of the donor.
A full-age person who is able to decide on his treatment may release a non-renewable body or a non-renewable tissue only for the treatment of his or her immediate family or other relatives.
The removal of organs or tissues must be authorised by the Agency for Social and Health Authorisation and Control. (16/10/2009)
A minor or a disabled person may only release recurrent tissue or part of a renewable body for the treatment of an illness or disability threatening the life of his sibling if the appropriate tissue or body is not available from a deceased or sovereign donor. If a donor is a minor who is able to decide on his or her age and level of development, the recipient may be close to or close to his or her immediate family. Cells may also be released in situations other than those referred to above, if suitable cells are not available from a deceased or fully-fledged donor.
The removal of the tissue or part of the body must be authorised by the Agency for Social and Health Authorisation and Control. (16/10/2009)
The organs, tissues and cells that have been removed from the patient in the course of diagnosis or treatment may be recovered and stored for medical use. (11.5.2007/547)
Alkias may only be used for fertility treatment or for medical research.
The collection and subsequent storage and use of the body, tissue or cells referred to in Article 6 (1) shall have a written, informed consent of the patient. If the patient is disabled or is unable to understand the meaning of the case, the procurement shall be subject to written consent of his legal representative. The patient or his legal representative shall have the right not to give his consent at any time prior to the final exercise of the body, tissue or cell.
Before giving consent, the patient shall be informed of the purpose and meaning of the procurement, the possible analytical examinations and results thereof, the registration of donor data and data protection, the donor And the fact that the donor can withdraw his consent before the final use of the body, tissue or cell. The doctor responsible for the patient shall report to the patient or the legal representative of the patient in person. When extracting tissues or cells, the reporting agent may also be another healthcare professional.
If organs, tissues or cells are recovered during pregnancy or abortion, the authorisation of the Agency for Social and Health Authorisation and Control should be performed. (12/03/277)
A dead person can be removed from organs, tissues and cells, and can be stored in order to treat another person's illness or disability. (11.5.2007/547)
Death must be established as laid down by the decree of the Ministry of Social Affairs and Health.
Doctors who say death are not allowed to participate in organs, tissues and cells. (11.5.2007/547)
The organs, tissues and cells of the dead person may be removed if they are not known or if there is no reason to believe that the deceased person had objected to the measure. If the deceased has prohibited the removal of his organs, tissues or cells, no action shall be taken. Before the organs, tissues or cells of the deceased person are removed, the deceased's own life-long view of the removal of organs, tissues or cells for the purpose provided for in Article 8 (1) shall, as far as possible, be established.
If the deceased is a minor, and in his/her age and level of development, he has been unable to form an understanding of the removal of his organs, tissues or cells, may remove organs, tissues and cells, unless his guardian objects.
If, in the absence of illness, mental health disorder or any other reason, the deceased person has not been able to form an opinion on the removal of organs, tissues or cells, the measure may be carried out, unless his/her immediate family or other close It.
A report on the removal and removal of organs, tissues and cells shall be provided to the next of the relatives or to any other person close to the deceased.
No organs, tissues or cells may be detached if it is harmful to the cause of death.
The removal of organs, tissues or cells must not be carried out if the police are required to carry out an investigation to determine the cause of death and the police are opposed to the removal or removal of any material which makes it more difficult to determine the cause of death in forensic medicine.
In the case of autopsies, bodies, tissues, cells and other specimens of organs, tissues, cells and other samples may also be used for medical purposes other than medical examination or education related to the cause of death. Samples may additionally be transferred to biobanks (19/08/2012) Of a dedicated biobank. The condition is that:
(1) Law on medical research (488/1999) The competent ethics committee has delivered a favourable opinion on the use of bodies and samples for medical examination or the transfer of samples to a biobank; and
2) The Agency for Social Affairs and Health has authorised the use of bodies and samples for educational purposes.
If the opinion referred to in paragraph 1 (1) of the Ethics Commission is negative, the Social and Health Authorisation and Control Agency shall take a decision on the application.
The body shall not be used or organs, tissues or cells to be released for research or teaching purposes, if it is harmful to the cause of death or to the removal of organs, tissues or cells provided for in this law to treat human illness or disability. No research or training activities may be undertaken if the police are required to investigate the cause of death and the police are opposed to taking action. (11.5.2007/547)
Research and teaching activities must be carried out with respect for the deceased and in such a way that the appearance of the deceased is not substantially altered. Research and teaching activities may not be conducted if there is reason to believe that the deceased had objected to it in his life.
The institution of the university anatomy may, for the purposes of medical education, dispose of the body for which the deceased person has given his or her consent in writing.
Human organs, tissues and cells and products produced from human organs, tissues and cells and products thereof whose quality and safety has been examined with appropriate methods and whose origin can be derived from human illness or disability. Tracking. (12/03/277)
The organs, tissues and cells produced on the ground, as well as products derived thereof, may be used for the treatment of human illness or injury or otherwise only if the conditions for the donor and the donation provided for in this Act are met.
The health care unit or any other unit carrying out the removal, recovery or storage activities provided for in this Act, or of human organs removed, recovered or stored in accordance with this law, Tissues or cells shall be provided with appropriate facilities and equipment and personnel necessary for the operation.
Requirements for the operation of tissue establishments are laid down in Chapter 6a. In addition, the requirements for the operation of the donor hospital and transplantation centre are laid down in Chapter 6b. (12/03/277)
The safety and traceability of organs, tissues and cells of human organs, tissues and cells removed and stored for the purpose of human illness or injury, as well as the legality of removal, recovery, storage, storage and operation Keep a register. The controller is a health care unit or other entity that stores human organs, tissues or cells for the treatment of human illness or injury, or where they are used for organs and tissue transplantation. The controller is also a tissue establishment that acquires, tests, processes, stores, preserves or distributes tissues or cells. The Finnish Red Cross may keep a register of voluntary donors of bone marrow tissue.
The register shall include the name of the donor and the consignee, identification number or other relevant identification number, contact details, research results on the body, tissue and cells, information on the safety of organs, tissues and cells, The donor and the recipient, information on the health care units involved in the removal, storage and use of organs, tissues and cells, information on the donation of organs, tissues or cells for use in other For the purpose of which they have been removed or taken, the living and Number of deceased organ donors, data on the type and number of organs recovered and transferred or otherwise used, as well as information on the authorisation of organs, tissues or cells by the Social and Health Authorisation and Control Agency; The release and/or consent of the donor or the patient to the removal or recovery of organs, tissues and cells. (12/03/277)
The data contained in the register shall be kept for 50 years after the death of the donor, or, if there is no information about death, 100 years after the last registration. If the donor withdraws his/her consent, the controller shall inform the entity that has received the body, tissue or cells. In this case, information on the donor must be removed from organ or tissue transplantation centres, unless there is any other law based on their retention.
The transplant centre shall report annually on organ transplants as referred to in this Article. The transplantation centre shall submit a report to the Agency for Safety and Development, which shall publish an annual activity report on organ transplantation. (12/03/277)
From the register kept by the tissue establishment and the information contained in paragraph 3 of the information contained in it, it is provided for in Article 20 i.
The records of the organ and tissue transplants referred to in Article 16 and in the register of tissue establishments provided for in Article 20 i, as well as other donors and recipients, and documents concerning them are confidential. (11.5.2007/547)
Without prejudice to the confidentiality rules, the controller shall, without prejudice to the safe use of organs, tissues and cells, shall disclose the information required to another health service unit or to another entity participating in the The activities referred to in the article. At the request of the controller, the information contained in the register shall also be disclosed to the authority which controls and supervises the activities provided for in this Act. The disclosure of information is otherwise in force, in the form of a law on public disclosure (18/09/1999) Provides. (11.5.2007/547)
Notwithstanding the provisions of confidentiality, the controller shall have the right to obtain information necessary for the safety and traceability of organs, tissues and cells from the healthcare unit or from any other entity to be removed, recovered, Storing or using human organs, tissues or cells, or treating the donor or recipient. (11.5.2007/547)
The transmission of the information referred to in paragraphs 2 and 3 shall not be charged.
The removal and use of the body, tissue or cells provided for in this Act and the donation of the body shall not be guaranteed or paid to the donor or his right-holder. Advertising concerning the need for or access to organs shall be prohibited if it is intended to provide or acquire an economic advantage or an advantage comparable to it. (12/03/277)
The donor of a body, tissue or cells referred to in this Act, based on a vital transfer requirement, shall have the right to compensate for the loss of the organ, tissue or cells and the necessary investigations related to it. Receive daily allowances as in the Health Insurance Act, (1224/2004) Provides. The daily allowance shall be made without prejudice to Section 7 of Chapter 8 of the Health Insurance Act. If the employer pays the salary from an invalid, the entitlement to the daily allowance is transferred to the daily allowance as provided for in Section 4 (2) of Chapter 7 of the Health Insurance Act. (24.6.2010/653)
The operation of organs, tissues or cells for removal, recovery, storage or use, or any other unit or tissue establishment shall not seek economic benefits from the activities provided for in this Act. However, the health care unit or any other unit or tissue establishment may collect compensation for the handling, transport, safety of organs, tissues or cells, carrying out the studies necessary to ensure safety and storage. From another healthcare unit or tissue establishment. The charge shall not exceed the cost of the production of the service.
Remunted, recovered or stored body, tissue or cell, which cannot be used for the purpose of the intended purpose, may be used for other legitimate medical purposes, provided that: Donor consent. If the body, tissue or cells are removed from a minor or a disabled person, the consent of the legal representative shall be required.
In addition to the consent provided for in paragraph 1, where a body, tissue or cell removal or recovery requires authorisation from the Agency for Social and Health authorisation, a change in the intended use shall be required in addition to the agreement provided for in paragraph 1. The authorisation of the authorisation and control agency, or in the case of a medical examination or the transfer of a sample to a biopanc for biopantic, the competent ethics committee referred to in the Law on Medical Research; Opinion. (30.11.2012/689)
A body, tissue or cell, whether or not released from a dead person, which cannot be used for medical purposes for the purpose for which it has been removed, may be used for medical research and transferred to a biobank if envisaged: Has received a favourable opinion from the Ethics Committee referred to in paragraph 2, or other medical uses, with the authorisation of the Social and Health Authorisation and Control Agency. (30.11.2012/689)
If the opinion referred to in paragraphs 2 or 3 of the Ethics Commission is negative, the Social and Health Authorisation and Control Agency shall take a decision on the application. (30.11.2012/689)
Tissue samples taken as a result of treatment or diagnosis may be donated and used in medical research with the consent of the patient. If the person is a minor or a disabled person, the consent shall be obtained from his legal representative. If it is not possible to obtain consent for the death of a person, samples may be used for medical examination or transferred to a biopantic biopsy referred to in the Law on Medical Research. The committee has delivered a favourable opinion. If the opinion of the Ethics Commission is negative, the Social and Health Authorisation and Control Agency shall take a decision on the application. If there is reason to believe that a person in his life had objected to the examination of their samples, the sample must not be transferred to the biopantic. In addition, the conditions for the transfer and processing of samples are laid down in the Biobanks Act.
Sampled samples taken as a result of treatment, diagnosis or death may be released and used for medical research, methodological development, quality management and education in the health care unit or other unit. With the permission of which the sample was taken if the personal data are not processed during the release or use of the samples.
Tissue samples taken as a result of treatment, diagnosis or medical research may be released and used to determine the hereditary condition of another person only if the sample from which the sample was taken gives its consent. If the person is a minor or a disabled person, the consent shall be obtained from his legal representative. If the person is dead or is involved in a tissue sample taken as a result of an explanation of the cause of death, the tissue sample shall be determined by the health care unit or any other unit for which the tissue sample has been taken, unless the deceased is present. In their lives, denied.
Sampled samples taken as a result of treatment, diagnosis, diagnosis of death or medical examination may be extradited to a technical service ordered by a court or other authority designated by a court or other authority, or To identify the deceased as a police officer.
Tissue samples taken as a result of treatment, diagnostic or death detection shall not be released or used for any purpose other than those taken if it interferes with the original purpose of the tissue samples.
The procurement, testing, processing, preservation, storage and distribution of tissues and cells are carried out in a tissue establishment or on its behalf. The tissue establishment shall ensure that the quality and safety of tissues and cells are appropriate, including the examination of all donated tissues and cells in order to ensure safety. The tissue establishment shall also ensure that the conditions for procurement, testing, handling, preservation, storage and distribution of tissues and cells are appropriate.
The tissue establishment shall be authorised by the Agency for the Safety and Development of the Medicinal Products. The authorisation may include conditions for the extent of tissue installation activities. The tissue establishment shall notify the relevant changes to the Centre for Security and Development in the pharmaceutical sector, which shall decide whether a change in the authorisation is required.
A pharmaceutical safety and development centre shall grant an authorisation for a written application for tissue establishments to the municipality, to the municipality, to the association, or to any other entity, or to an undertaking, if the tissue establishment meets: Directive 2004 /23/EC of the European Parliament and of the Council laying down quality and safety standards for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells And Council Directive 2004 /23/EC Implementing Commission Directive 2006 /17/EC concerning certain technical requirements for the donation, procurement and testing of human tissues and cells, and Directive 2004 /23/EC of the European Parliament and of the Council as regards: The Commission concerning traceability requirements, notification of serious adverse reactions and incidents and technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells Requirements under Directive 2006 /86/EC. The application for authorisation shall include information on the personnel, premises, equipment and equipment of the tissue establishment as well as information on procedures for the donation, procurement, testing, processing, preservation, preservation and distribution of tissues and cells. In addition, the application for authorisation shall include information on the quality system of the tissue establishment and the procedures for the safety and traceability of tissues and cells, as well as adverse events and adverse reactions.
The tissue establishment shall have a responsible person responsible for ensuring the treatment of tissues and cells in accordance with the provisions of this Act and the quality system in place in the tissue establishment, to make a declaration in accordance with Article 20g and Article 20b. To the Centre for Safety and Development in the pharmaceutical sector. The responsible person shall comply with the Directive of the European Parliament and of the Council laying down quality and safety standards for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells Qualification requirements in accordance with Article 17 of 2004 /23/EC.
The tissue establishment shall inform the Centre for Security and Development in the pharmaceutical sector of the responsible person referred to in paragraph 1 and his replacement as well as the replacement thereof.
The staff of the tissue establishment shall be suitably qualified for their duties and staff shall be regularly trained appropriately.
The tissue establishment shall have a quality system based on the principles of good practice. The quality system shall include at least standard operating instructions and other instructions, training material and source works, notification forms, data on donors, and information on the final use of tissues and cells.
The tissue establishment shall be equipped with a system whereby all tissues and cells procured, processed, stored or distributed can be traced from the donor to the recipient and vice versa. The traceability requirement shall also apply to all relevant information on products and substances entering into contact with such tissues and cells.
The tissue establishment shall assign a unique code to each donation and each related product.
The tissue establishment shall keep a list of all adverse events and reactions associated with its knowledge of tissues or cells.
The tissue establishment shall inform the Agency without delay of any serious adverse events related to the procurement, testing, processing, preservation, storage and distribution of tissues or cells, and Serious adverse reactions that may affect the quality and safety of tissues and cells. The reporting obligation also applies to the serious adverse reactions observed during or after clinical use, which may be related to the quality and safety of tissues and cells. (16/10/2009)
The tissues and cells for which a declaration referred to in paragraph 2 is made shall not be used, and such tissues and cells must be removed from distribution. Such tissues and cells may be introduced if a separate study shows that they comply with the safety and quality requirements laid down in this Act.
The tissue establishment may, subject to technical, economic or production factors, and subject to the authorisation of the Agency for the Safety and Development of Medicinal Products, arrange for individual actions to be carried out by the third party. (16/10/2009)
The tissue establishment shall enter into a written agreement with a third party whenever it is a non-tissue measure affecting the quality of tissues or cells treated with a third party; or Security.
The contract referred to in paragraph 2 shall be awarded in particular if:
(a) a third party conducts or any steps in the treatment of tissues or cells;
(b) the third party produces goods and services that affect the quality or safety of the tissue or cells, including their distribution;
(c) the tissue establishment provides services to another tissue establishment; or
(d) the tissue establishment shall perform the distribution of tissues or cells processed by a third party.
The agreement shall specify the third party's liability and the procedures to be followed.
The tissue establishment shall keep a list of the contracts it has concluded and, when requested, provide copies of contracts to the Agency for Safety and Development in the pharmaceutical sector. (16/10/2009)
The tissue establishment shall keep a register of its activities. In addition, the register shall indicate the type and quantity of the tissues and cells procured, tested, processed, preserved, stored and distributed or otherwise used for the purpose of Article 16 (2). The register shall also have a significant impact on the quality of the tissues and cells and on the products and substances involved.
The tissue establishment shall submit an annual report to the Agency for the safety and development of the pharmaceutical sector. (16/10/2009)
The tissue establishment shall keep the data required for full traceability at least 30 years after clinical use. The data may also be stored electronically.
The register referred to in paragraph 1 shall apply mutatis mutandis to the provisions of Article 17.
The Centre shall keep a register of tissue establishments and of the activities to which each tissue establishment has been authorised. The register is public. (16/10/2009)
The control and control of tissue establishments is part of the donation, procurement, testing, handling, preservation, storage and distribution of human tissues and cells, as well as the quality and safety requirements of the Ministry of Social Affairs and Health. Medical Security and Development Centre.
The Agency shall check the tissue establishment on a regular basis, but at least every two years. The Centre may also, where appropriate, check the tissue establishment where it is found to have a serious or serious adverse reaction to the quality or safety of tissues or cells, or if it is suspected that such a situation has occurred.
The inspector shall be admitted to all the premises of the tissue establishment and to the premises of the third party issuing the contract referred to in Article 20h (2). The inspection shall not be carried out in the premises used for permanent housing. The inspection shall, notwithstanding the provisions of confidentiality, present all documents requested by the inspector necessary for the purpose of carrying out the inspection. The inspector shall be given, free of charge, copies of the documents necessary for the examination of the inspection and samples of the substances and preparations in the office for further examination. The inspector also has the right to take photographs during the inspection. The inspector shall carry out the inspection.
The inspector carrying out the verification referred to in Article 20j may order the deficiencies identified to be corrected. As a result of the provision of the audit, the necessary measures shall be taken without delay.
The Agency may charge a fee for the authorisation referred to in Article 20b and the supervision referred to in Article 20j.
The Centre for the Safety and Development of Medicinal Products may suspend or revoke a tissue establishment if, on the basis of an inspection or control measure, it can be concluded that the institution or quality system does not comply with the requirements laid down by law.
The decision to withdraw the authorisation shall be taken in spite of the appeal.
The Centre for the Safety and Development of Medicine may impose a periodic penalty payment on the (1113/1990) Shall be provided if:
(1) the conditions for authorisation are no longer met;
(2) the tissue establishment has materially operated in contravention of this law or of the conditions attached to the authorisation or otherwise seriously jeopardises the safety of tissues or cells; or
3) No action has been taken under the provisions of Article 20k.
In addition to this law, the requirements imposed on the donor hospital and the transplant centre are laid down in the health legislation (1326/2010) And specialised care law (18/02/1989) .
The Centre for Security and Development in the pharmaceutical sector maintains an up-to-date list of donor hospitals and transplantation centres.
The decree of the Council of State provides for the organisation and concentration of transplants of special medical care.
The donor hospital shall identify any organ donor, identify death, identify and record the possible existence of a deceased person within the meaning of Article 9 to remove his organs, care for the deceased person referred to in Article 9a. , shall be responsible for the management of the donor and shall carry out the necessary additional studies on the viability of the transplant.
The transplant centre shall ensure that the quality and safety of the body are appropriate. The transplant centre shall be responsible for the removal and transfer of the organ and shall approve the organ donor and shall select the recipient. The transplant centre shall check prior to transplantation that the description of the organ and organ donor characteristics is appropriate and that the conditions of preservation, storage and transport of the transported organs have been appropriate.
The transplant centre shall ensure the integrity of organs during transport and the adequacy of the journey time.
The Agency shall provide more detailed provisions on the quality and safety requirements of organs for the transport of organs.
The activities of the donor hospital and transplantation centre shall be consistent with all stages of the chain of transplantation or disposal of organs and organs from donation to transplantation or disposal in order to ensure:
(1) the identity of the donor;
(2) registration of the consent of the donor in accordance with Article 3 or 9;
(3) a description of the organ and organ donor characteristics;
(4) that staff meet the requirements laid down in Article 20q;
(5) proper procurement, preservation, storage, packaging, transport and labelling of the body;
(6) traceability of the body;
(7) compliance with the provisions on the protection of personal data;
(8) accurate, rapid and reliable reporting of serious adverse events and reactions;
(9) management of serious adverse events and reactions.
The Agency shall provide more detailed provisions for the good policy principles and guidelines referred to in paragraph 1.
The personnel involved in organ donation and transplantation shall have adequate qualifications, training and expertise in relation to the quality and scope of the activity. The donor hospital and the transplant centre shall provide regular training to their staff.
The medical practitioner responsible for the recovery of organs must be a doctor.
Recovery shall be carried out in operating rooms designed and constructed and maintained and operated in accordance with the relevant requirements and best medical practice.
Materials and equipment used in the construction shall be handled in accordance with international, European Union and national rules, standards and guidelines for sterilisation and medical devices.
The donor and the organ must have the necessary data on the donation of organs before transplantation.
In order to obtain information, tests shall be carried out in a laboratory equipped with suitably qualified, trained and competent personnel and appropriate facilities and equipment.
The Regulation of the Ministry of Social Affairs and Health provides for at least the information on all organ donors and organs. The transplantation may be carried out even if all the minimum information provided for in the Regulation is not available if the expected benefit to the recipient is greater than the risk arising from the imperfection of the data.
The Centre for the Safety and Development of Medicinal Products shall provide more detailed provisions on which information relevant to the body and the donor's description should also be sought.
The transplant centre shall be able to identify each organ donation and related body and recipient, and to trace all organs recovered, distributed and transferred in Finland from the donor to the recipient and vice versa.
The traceability requirement shall also apply to all relevant information on products and materials coming into contact with such a body.
The transplant centre shall keep a list of any potentially related incidents that may affect the quality and safety of organs and serious adverse reactions.
The donation hospital shall inform the transplant centre without delay of any incident which may affect the quality and safety of organs, as well as serious side effects which may affect the quality and safety of organs.
The transplant centre shall inform the Agency of any serious adverse events and serious risks associated with the testing, characterisation, preservation, storage and transport of organs, Adverse reactions which may affect the quality and safety of organs.
The organ that has been notified under this Article shall not be used until a written risk assessment has been carried out. Such a body may be introduced if, on the basis of a risk assessment, it can be assumed that the benefit for the patient is greater than that resulting from the transfer.
General guidance and supervision of organ transplantation activities in donation hospitals and transplantation centres are under the responsibility of the Ministry of Social Affairs and Health for the Health and Safety Authors and for Regional Administrative Agencies, such as this or other The law provides.
The control and control of the donation hospitals and transplantation centre shall include the testing, preservation, storage, packaging, transport, other handling, and the relevant quality and safety requirements of organs, With regard to the reporting and management of adverse reactions and the traceability requirements under the Ministry of Health and Safety at the Ministry of Social Affairs and Health.
The Agency for Social and Health Authorisation, Regional Administrative Agencies and the Agency for the Safety and Development of Medicine shall have the right to receive, free of charge and without prejudice to the confidentiality rules, the information necessary for the purpose of monitoring from the donor hospital; and From the transplant centre, the State and the municipality, from a body governed by public law, as well as from a community or body pursuing health and medical care.
The Agency for Social and Health Authorisation, the Regional Administrative Agency and the Agency for the Safety and Development of the Medicinal Products Agency shall have the right to verify compliance with this law and the provisions and regulations adopted pursuant to it. The premises and activities of the donor hospital and the transplant centre and the necessary documentation.
The inspector shall be admitted to all the premises of the donor hospital and the transplant centre and shall, without prejudice to the secrecy provisions, present all documents requested by the inspector necessary for the purpose of carrying out the inspection. The inspector shall be given, free of charge, copies of the documents necessary for the examination of the inspection and samples of the substances and preparations in the office for further examination. The inspector shall be entitled to take photographs during the inspection. The inspection shall not be carried out in the premises used for permanent housing.
Within 30 days of the date of submission of the inspection, a copy of the inspection minutes shall be communicated to the hospital by the Agency, the Regional Administrative Agency or the Agency for Safety and Development of the Health and Development Agency, or To the transplant center. The inspection shall be deemed to have ended when the copy of the inspection protocol has been served on the parties.
The donor hospital and the transplant centre shall, without delay, initiate the necessary measures to remedy the deficiencies found in the inspection and shall inform the Agency, the Regional Administrative Agency, or The measures to be taken by the Agency for the safety and development of the pharmaceutical sector, the timetable and details of their implementation within 30 days of the notification of the inspection report to the operation unit.
The Agency for Social and Health Authorisation, the Regional Administrative Agency or the Agency for the Safety and Development of Medicinal Products shall prohibit the establishment of a hospital or organ transplant centre in the event of an inspection or any other control measure It can be concluded that the unit does not meet the requirements laid down in this Act.
The decision on the prohibition shall be complied with, in spite of the appeal, unless the appeal authority decides otherwise.
The Agency for Social Affairs and Health, the Agency and the Agency for the Safety and Development of Medicine may impose a periodic penalty payment on the (1113/1990) Shall be provided if:
(1) the donor hospital or transplantation centre has substantially acted in breach of the provisions of this law or otherwise seriously jeopardises the quality and safety of organs; or
2) No action has been taken under the provisions of Article 20 x.
Man is dead when all his brain functions are permanently depleted.
The Agency for Social and Health Authorisation and Control may authorise the use of tissue samples taken as a result of treatment and diagnosis in medical research. The condition is that:
(1) is medically or socially significant;
(2) the Ethics Committee referred to in the Law on Medical Research has delivered a favourable opinion;
(3) the necessary samples are not available from a biopank;
(4) adequate facilities, equipment and personnel are available for research;
(5) a doctor responsible for research has been appointed;
(6) the protection of the privacy of persons is not compromised.
I promise that more detailed conditions can be attached to the protection of individuals' privacy and rights.
The health care unit may donate the samples referred to in the decision of the Agency for Welfare and Health to the doctor responsible for research if the person is not known to oppose the use of their samples for medical purposes. Research.
The Office for Social and Health Authorisation and Control may grant the authorisation referred to in Article 4 (2) and Article 5 (2) if the conditions for removal provided for in this law are met and the removal of the body, tissue or cells is the recipient 's Treatment is justified.
In accordance with Article 7 (3), Article 11 (1) (2) and Article 19 (2) and (3), the Office for Social and Health Authorisation and Control shall grant the authorisation provided for in Article 7 (2) and Article 19 (2) and (3) if the activity is to be considered to be medically justified. The facilities, equipment, personnel and operations have been designated by the corresponding doctor. The Agency for Social and Health Authorisation and Control may grant an authorisation for a limited period or for an indefinite period. I promise that more specific conditions can be attached to the organisation of activities. (30.11.2012/689)
The Office for Social and Health Authorisation and Control may order the suspension or withdrawal of the activities referred to in Article 7 (3), Article 11, Article 19 (2) and (3), Article 20 (1) and Article 21a If the operation does not comply with the provisions in force or the permit conditions. (30.11.2012/689)
The Agency for Social and Health Authorisation and Control may, where appropriate, order the inspection of the premises and the activities referred to in paragraph 1 and the documentation required under the supervision of the authorised establishment.
The decision to withdraw the authorisation shall be taken in spite of the appeal.
The tissues and cells may be imported into Finland and exported from Finland only to a tissue establishment licensed by the pharmaceutical safety and development centre. The quality, safety and traceability requirements laid down in this law must be met by the tissues and cells that are produced and exported.
In exceptional circumstances, the Agency may authorise the tissue establishment or any other health care unit to import or export certain tissues and cells.
The organs intended for transplantation may be imported into Finland and exported from Finland only to the transplant centre within the meaning of this Act and to the healthcare operator authorised by it.
Imports from a country outside the European Union or exports from outside the Union shall only be authorised if the organs can be traced from the donor to the recipient and vice versa, fulfil the equivalent quality and quality laid down in this law, Safety requirements and the requirements laid down in Article 14 (2) are complied with.
More detailed provisions on the conditions for granting authorisations laid down in this Act, the information required in the application for authorisation and the implementation of this law are laid down by a decree of the Council of Ministers.
The Decree of the Ministry of Social Affairs and Health lays down, where appropriate, more specific provisions:
(1) the organisation of the removal, recovery, storage and operation of organs, tissues and cells and tissue samples in health care units and other units;
(2) reimbursement of costs for health care units and other units and for tissue establishments;
3. In the register of organs and tissue transplants referred to in Article 16, in the register of tissue establishments referred to in Article 20i (1) and in the Register of the Centre for the Safety and Health of the Development Centre referred to in Article 20i (5); On labelling and on the labelling of medical records;
(4) the essential changes to the operation which require a modification of the authorisation granted by the Agency for the Safety and Development of the Pharmaceutics;
(5) The fees charged by the Agency for the authorisation and supervision by the Agency for the authorisation and supervision of the medicinal product, taking into account the provisions of the State contribution law (150/1992) Or by virtue of its provisions;
(6) the traceability of organs, tissues and cells; (12/03/277)
(7) the procedure for notification of adverse events and reactions;
(8) the inspection of the hospitals, the transplant centre and tissue establishments, in particular the matters to be taken into account, the precise content of the verification procedure and the Protocol, its retention period and notification; (12/03/277)
(9) exceptional situations where the pharmaceutical safety and development centre may authorise the import or export of certain tissues or cells.
The formulae for the forms necessary for activities falling within the scope of this Act shall be laid down by the Order of the Agency for Safety and Development in the Pharmaceutical Sector. (12/03/277)
The Centre for the Safety and Development of Medicinal Products may, where appropriate, lay down more detailed provisions:
(1) the content and implementation of the tissue establishment quality system;
(2) selection criteria for the donor of tissues and cells;
(3) the studies required to establish the safety of tissues and cells and their acceptable results;
(4) quality and safety requirements for tissues and cells, procurement procedures, storage conditions, storage conditions, and distribution conditions.
Every intention.
(1) remove, recover or store organ, tissue or cells without the consent or authorisation provided for in this Act;
(2) extradite, recovered or stored, such tissue, such cells or tissue samples, or use them without the consent, authorisation or request provided for in this Act;
(3) acquisition, testing, processing, preservation, preservation or distribution of tissues or cells without authorisation or agreement with tissue establishments provided for in this Act;
(4) neglecting the reporting of serious adverse events and reactions in organs, tissues and cells, (12/03/277)
(5) neglecting the maintenance of the traceability and safety of organs, tissues or cells provided for in this law, or the maintenance of the necessary identity register;
(6) use human or otherwise human organs, tissues or cells, or products manufactured from them whose origin is not known or whose safety has not been studied;
(7) bring Finnish organs, tissues or cells that have been removed or recovered in contravention of the conditions for the transferor provided for in this Act, or to the Finnish organs, tissues or cells from a State whose legislation is not equivalent to this The conditions laid down by law for the removal and traceability of organs, tissues or cells, or
(8) authorisation or payment to the donor of organs, tissues or cells or to his right-holder for the removal of organs, tissues or cells;
Must be condemned Concerning the infringement of the human organs, tissues and cells for medical use Fine, unless the law provides for a heavier penalty in the rest of the law.
The act referred to in paragraph 1 (5) shall also be punishable if it is committed with gross negligence.
The decision taken pursuant to this law, with the exception of the decisions referred to in Articles 20b, 20 m, 20 y and 23, may require an adjustment to the administrative law (2003) Provides. The decision referred to in Article 20 (k) of this Act shall require an adjustment from the Agency for Safety and Development in the pharmaceutical sector.
In the case referred to in Articles 4 and 5, the decision to amend the requirement shall not be appealed against. The decision to amend the objection and to the decision referred to in Articles 20 (b), 20 m, 20 and 23 of this Act shall be subject to appeal by the appeal to the administrative court in accordance with the administrative law (18/06/1996) Provides.
In the case referred to in Article 20 m, 20 y and 23, the administrative right shall be subject to appeal as laid down by the Law on Administrative Law. An appeal against any other decision of the administrative court may be lodged only if the Supreme Administrative Court grants an appeal.
The decision taken pursuant to Article 20k of this Act must be complied with in spite of the appeal.
L to 10/2015 Article 26 shall enter into force on 1 January 2016. The previous wording reads:
The decision of the inspector referred to in Article 20k shall not be appealed against. Within 30 days of receipt of the decision, the interested party may make a written reply to the Agency for Security and Development in the pharmaceutical sector. Otherwise, administrative law shall apply for the purpose of making and handling the adjustment (2003) . The requirement of an adjustment shall not prevent the enforcement of the inspector's decision.
The decision to amend the decision of the Social and Health Authorisation and Control Agency and the Agency for the Safety and Development of Medicinal Products shall be as follows: (18/06/1996) Provides.
The decision of the Agency for Social Security and Health referred to in Articles 4 and 5 of this Act shall not be subject to appeal.
This Act shall enter into force on 1 September 2001.
This Act repeals the Law of 26 April 1985 on the removal of human organs and tissues to medical use (355/1985) With its subsequent modifications.
Operating authorisations required by this law shall be submitted within one year of the entry into force of the law.
Before the law enters into force, measures may be taken to implement the law.
THEY 93/2000 , StVM 29/2000, EV 168/2000This Act shall enter into force on 1 June 2007.
The authorisation referred to in Article 20b may be granted before the law enters into force.
The tissue establishment shall apply for the authorisation referred to in Article 20b and shall notify the responsible person referred to in Article 20c by 1 September 2007 at the latest. The application for authorisation shall be submitted within six months of the date of submission of the application. If an application for authorisation has been made before the law enters into force, the application shall be submitted within six months of the entry into force of the law.
In the situations referred to in paragraph 3, the tissue establishment may, after the entry into force of the law, until the application has been settled, continue its activities without authorisation in accordance with the provisions of this Act.
The period referred to in paragraph 3 shall be calculated from the time when the appropriate application, together with the necessary explanations, has been submitted to the Medical Service. If the Agency requests an additional explanation from the applicant as a result of the application, no further explanation shall be given for the period during which the application is submitted.
Before the law enters into force, measures may be taken to implement the law.
THEY 273/2006 , StVM 57/2006, EV 284/2006
This Act shall enter into force on 1 November 2009.
Before the law enters into force, measures may be taken to implement the law.
THEY 166/2009 , StVM 28/2009, EV 122/2009
This Act shall enter into force on 1 August 2010.
THEY 276/2009 , StVM 13/2010, EV 94/2010
This Act shall enter into force on 1 September 2013.
Pursuant to Article 20 (1), the Social and Health Authorisation and Control Agency may authorise the release or use of tissue samples under Article 20 (1) until 1 January 2018, provided that: The samples for medical examination are not available for biopanc.
THEY 86/2011 , StVM 9/2012, EV 78/2012
This Act shall enter into force on 1 May 2013.
THEY 198/2012 , StVM 4/2013, EV 29/2013, Directive 2010 /53/EU of the European Parliament and of the Council (32010L0053); OJ L 207, 6.8.2010, p. 14.
This Act shall enter into force on 1 January 2016.
In the case of appeals before the entry into force of this Act, the provisions in force at the time of entry into force of this Act shall apply.
THEY 230/2014 , LaVM 26/2014, EV 319/2014
