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Law on the Application of Human Tissues and Cells
Law, OG 144 / 2012-3070 More 
CROATIAN PARLIAMENT
3070
Pursuant to Article 89 of the Constitution of the Republic of Croatia, I hereby
DECISION
DECLARING THE HUMAN TISSUES AND STATIONS APPLICATION LAW
I hereby declare the Law on the Application of Human Tissues and Cells, adopted by the Croatian Parliament at its sitting on 14 December 2012.
Class: 011-01 / 12-01 / 177
Reg. No: 71-05-03 / 1-12-2
Zagreb, December 19, 2012
The President
Of the Republic of Croatia
Ivo Josipović, Ph.D. r.
LAW
ON THE APPLICATION OF HUMAN TISSUES AND STATIONS
I. GENERAL PROVISIONS
Article 1
(1) This Law establishes the conditions for the donation, collection, taking, testing, processing, preservation, storage, distribution and application of human tissues and
cells (hereinafter referred to as tissues) from a living or deceased person (hereinafter referred to as a donor) in humans.
(2) The provisions of this Act relating to tissues shall also apply to cells, including hematopoietic stem cells from peripheral blood, blood from
umbilical cord and bone marrow.
(3) The provisions of this Act shall also apply to procedures for the donation, collection, collection and testing of tissues used in the manufacture of products.
intended for use in humans, which contain tissues or are produced from tissues.
(4) The provisions of this Act shall not apply to sex tissues and cells, tissues and cells of the embryo and fetus, blood and blood products, tissues used as
an autologous graft within the same surgical procedure, organs or organ parts if used in the human body for the same purpose as the whole organ, and
tissue collected during organ harvesting for the same organ transplant.
(5) Terms used in this Law and regulations adopted pursuant to this Act that have gender meaning, whether or not
used in the masculine or feminine gender, encompass male and female gender alike.
Article 2
This Act contains provisions which are in accordance with the following acts of the European Union:
- Directive 2004/23 / EC of the European Parliament and of the Council of 31 March 2004 setting quality and safety standards for gift-giving procedures,
the procurement, testing, treatment, storage, storage and distribution of tissues and cells of human origin (OJ L 102, 7.4.2004),
- Commission Directive 2006/17 / EC of 8 February 2006 implementing Directive 2004/23 / EC of the European Parliament and of the Council on certain technical
the requirements for the donation, acquisition and testing of tissues and cells of human origin (OJ L 38, 9.2.2006),
- Commission Directive 2006/86 / EC of 24 October 2006 implementing Directive 2004/23 / EC of the European Parliament and of the Council with regard to requests for
monitoring, reporting serious adverse reactions and occurrences and certain technical requirements related to labeling, processing, storage, storage and
the distribution of tissues and cells of human origin (OJ L 294, 25.10.2006),
- Commission Decision 2010/453 / EU of 3 August 2010 laying down guidelines for inspection conditions and control measures and for training and professional
the competence of tissue and cell inspectors provided for in Directive 2004/23 / EC of the European Parliament and of the Council (OJ L 213, 13.8.2010).
Article 3
Some terms within the meaning of this Act have the following meaning:
1. A cell is a single human cell or group of human cells that are not connected by connective tissue,
2. Tissue means all the constituent parts of the human body that are composed of cells,
3. The donor is the person from whom the cells or tissues are taken, whether taken during life or after death,
4. Donation means the donation of human tissues or cells for use in humans,
5. An organ is a differentiated part of the human body, made up of different tissues, which retains its structure, vascularization and ability to develop
physiological functions with a significant level of autonomy,
6. Collection means the organizational and professional procedures by which tissues and cells become available for use,
7. Taking is a medical procedure by which tissues and / or cells are taken from a donor,
8. Processing means any process associated with the preparation, handling, preservation and packaging of tissues and / or cells intended for human use,
9. Conservation means the use of chemicals, changes in environmental conditions or other conditions during processing to prevent or retard biological
or the physical decay of tissue or cells,
10. Quarantine is the process of isolating tissue, administrative and / or actual, until the decision to accept for use or destruction,
11. Storage means the maintenance of tissue and / or cells under suitable and controlled conditions until distribution,
12. Distribution means the transport and delivery of tissues and / or cells intended for use in humans,
13. Application means any process of using tissue and / or cells on or in humans,
14. A serious adverse event is any adverse event related to the taking, testing, processing, preservation, storage and distribution of tissues and cells, which would
could lead to the transmission of an infectious disease, death or life-threatening condition, powerlessness and / or incapacity of the recipient, or
the consequence of prolonging hospital treatment, pain or such conditions,
15. A serious adverse reaction is an adverse reaction, including an infectious disease, of a donor or recipient, related to the uptake or administration of tissue or cells
in humans, which causes death, presents a life-threatening risk of impotence and / or incapacity, ie resulting in hospital treatment, pain or
prolongs such conditions,
16. Monitoring of serious adverse events and reactions is a set of activities related to the detection, recording, research, evaluation, treatment and delivery
information on serious adverse events and reactions,
17. Tissue Bank is an organizational unit of a clinical hospital center for the purpose of performing the activity of processing, preserving, storing or distributing human
tissues and cells approved by the Minister of Health (hereinafter: the Minister),
18. Alogenic administration is the taking of cells or tissues from one donor and administration to another person,
19. Autologous administration is the taking and administration of cells or tissues by the same person,
20. Quality system means the organizational structure, defined responsibilities, procedures, processes and resources needed to implement the system.
quality management and its implementation, and includes all activities that contribute directly or indirectly to quality,
21. Standard operating procedures (SOPs) are written instructions describing all the steps of a specific procedure, including the materials and methods required, and
expected final outcome,
22. Traceability means the ability to locate and identify tissues and / or cells at any stage of the process from donation to administration or destruction, which
it also implies the possibility of identifying the donor, tissue bank, laboratory, or healthcare institution that participated in the procedures
related to tissues and / or cells as well as the ability to identify the recipient and the ability to find all relevant information pertaining to
produce and / or materials that come in contact with tissues and / or cells.
Article 4
(1) The donation, collection, taking, testing, processing, preservation, storage, distribution and administration of human tissues and cells from living or deceased persons
people may only be carried out in the manner and under the conditions prescribed by this Act.
(2) The procedures referred to in paragraph 1 of this Article must be carried out in accordance with the relevant professional recommendations and standards.
(3) The Minister shall prescribe the terms and conditions for the selection or assessment of the donor by ordinance.
Article 5
(1) When taking tissue from a deceased person, the utmost respect for the personal dignity of the deceased person and his or her family must be treated.
(2) Tissues taken from a deceased person must be administered in accordance with the rules of the medical profession.
Article 6
(1) In the event that there are more recipients of certain tissues than the tissues available, they are allocated taking into account their equitable availability,
recipients from the national waiting list and in accordance with transparent, objective and generally accepted medical criteria.
(2) The provision of paragraph 1 of this Article shall not apply to tissues for autologous use.
(3) The manner of maintaining the national waiting list, the conditions for selecting the most appropriate recipient and the procedure for allocating the tissues taken shall be prescribed by an ordinance
the minister.
Article 7
(1) For taken tissues, it is forbidden to give or receive any financial compensation, and to exercise other material gain.
(2) The provision of paragraph 1 of this Article shall not apply to payments that do not represent monetary gain or comparable benefit, in particular:
- reimbursement to living donors for lost profits or any other justified costs caused by tissue removal or related to necessary
health checks,
- justified reimbursement for the necessary health or technical services provided in connection with tissue collection,
- compensation in the event of excessive damage resulting from the removal of tissue from a living donor.
Article 8
All persons involved in the processes of collecting, taking, testing, processing, preserving, storing, distributing and administering tissue must take all
justified measures to reduce the risk of transmission of any disease to the recipient and to avoid any action that could affect safety and quality
tissues for application.
Article 9
(1) Personal information on tissue donors and recipients is a professional secret. Personal information about the donor is not allowed
recipient, and personal information about the recipient is not allowed to be given to the donor or the family of the deceased donor.
(2) The medical doctor of the recipient must be given insight into the donor's health information for a medically justified reason.
(3) The personal data referred to in paragraph 1 of this Article shall be collected, stored and communicated in accordance with special regulations governing the protection of professional secrecy.
and protection of personal information.
Article 10
(1) Tissue application is only allowed if the recipient has given written consent.
(2) The consent referred to in paragraph 1 of this Article must be an expression of the free will of the recipient, based on the appropriate, oral and written notification of nature,
the purpose and course of the intervention, the likelihood of its success and the common risks involved.
(3) For the recipient who is not legally capable or for a child, the consent referred to in paragraph 1 of this Article is given by his legal representative or guardian.
(4) The Minister shall prescribe the contents and the form of the consent letter referred to in paragraph 1 of this Article by an ordinance.
Article 11
(1) Following the taking and use of tissue, living donors and recipients shall be provided with health monitoring.
(2) The health care provider who has performed the procedure referred to in paragraph 1 of this Article shall notify the elected doctor of medicine of the completed procedure.
primary care of a living donor or tissue recipient.
(3) The elected doctor of primary health care medicine shall be obliged to enter the information referred to in paragraph 2 of this Article in the donor's health record,
that is, the recipient.
(4) The Minister shall prescribe the contents and form of the stationery of the notification referred to in paragraph 2 of this Article by an ordinance.
Article 12
When tissue is taken for human administration, it may be stored and used for a purpose different from that obtained for human consumption only if it is done in accordance with
the appropriate procedure for informing and giving written consent in accordance with the provisions of Articles 16, 22, 23 and 25 of this Law.
II. TAKING TISSUE FROM A LIVING GIFT
Article 13
(1) The necessity of treating the recipient with the tissue of a living donor shall be decided by the expert team of the health institution where the treatment procedure will be performed.
(2) The expert team referred to in paragraph 1 of this Article shall be appointed by the health institution.
Article 14
(1) All appropriate medical examinations and procedures must be carried out before tissue removal to assess and reduce the risk of mental and psychological
donor health.
(2) The Minister shall prescribe the manner and conditions for the selection and assessment of the health status of the living donor by an ordinance.
Article 15
Tissue should only be taken from an adult and an able-bodied person.
Article 16
(1) Tissue removal from a living donor shall be allowed only if the donor has given written consent to the procedure.
(2) Consent of the tissue donor applies only to the individual procedure and tissue.
(3) Consent must be an expression of the free will of the donor, based on the appropriate notice of the nature, purpose and course of the intervention, and the likelihood of its
performance and common risks.
(4) Before giving consent, the doctor of medicine is obliged to inform the donor of his rights prescribed by this Law, in particular the right to
unbiased advice on health risks, which is a doctor of medicine who will not participate in the uptake or administration of tissue, that is, not personal
recipient doctor.
(5) The consent referred to in paragraph 1 of this Article may not contain special conditions related to the recipient person.
(6) The donor may revoke his consent freely and at any time prior to the commencement of the taking procedure.
(7) The contents and form of the consent letter from paragraph 1 of this Article and the content of the letter of revocation of consent referred to in paragraph 6 of this Article shall be prescribed by the Minister.
regulations.
Article 17
By way of derogation from the provision of Article 15 of this Act, tissue may be collected from a child and from an adult who is not legally capable if filled.
all of the following conditions:
- that the recipient is the parent, brother or sister of the donor,
- there is no suitable donor available who is able to give written consent,
- the gift is intended to save the life of the recipient,
- the consent in writing of the legal representative or guardian of the donor or, in the absence thereof, of the ethics committee
the institution where the collection procedure will take place,
- that the potential donor does not object.
Article 18
The provisions of Article 17, subparagraphs 1 and 3 of this Act shall not apply to tissues if it is determined that their taking involves only minimal risk and
minimum load for the donor.
Article 19
By way of derogation from Article 15 of this Act, the collection of blood from the umbilical cord of a live child and the storage of hematopoietic stem cells are allowed
isolated from the same. The cells thus collected can be used for transplantation for both relatives and non-relatives.
Article 20
(1) Tissues remaining after the completion of individual therapeutic procedures intended for destruction may be taken and administered in accordance with the provisions of this
Of the law.
(2) By way of derogation from paragraph 1 of this Article, the tissue of a child and an adult who is not legally capable, remaining after the completion of individual therapeutic
procedures intended for destruction may be taken and applied in accordance with the provisions of Article 17, subparagraph 4 of this Act.
III. TAKING TISSUE FROM A DEAD DONOR
Article 21
Tissues of a deceased person may be taken for use in humans after they have been safely determined according to medical criteria and properly established.
death.
Article 22
(1) Tissues of a deceased person may be taken for use only if the donor for life has not given a written statement to the contrary.
(2) The written statement referred to in paragraph 1 of this Article shall be given by an adult legally capable person to the elected doctor of primary health care medicine, or
the Ministry responsible for health (hereinafter: the Ministry).
(3) By way of derogation from the provision of paragraph 2 of this Article, for adults who are not legally capable of writing the statement referred to in paragraph 1 of this Article,
solemnized by a notary public is given by the legal representative or guardian.
(4) The blind person, the deaf person who cannot read, the dumb person who cannot read and the deaf person makes the statement referred to in paragraph 1 of this Article in the form
a notarized act or two witnesses with a statement on the appointment of a legally capable person who will make a statement on his or her behalf that he opposes
donation of tissue.
Article 23
(1) The written statement referred to in Article 22, paragraph 1 of this Act shall be submitted by the elected doctor of primary health care medicine to the Ministry.
(2) A person may revoke his statement at any time.
(3) The written statement referred to in Article 22, paragraph 1 of this Act shall be stored in the Ministry and the data from the statement shall be entered in the register of non-donors.
(4) Non-donor information is a professional secret.
(5) The contents and form of the stationery, the manner and procedure of submission, the manner of keeping records, and the procedure for revocation of the statement referred to in Article 22, paragraph 1 of this Act
the Minister shall prescribe by ordinance.
Article 24
Tissues of a deceased person who is not a citizen of the Republic of Croatia, or who do not have a permanent residence permit in the Republic of Croatia, may be taken for
applications in humans when a spouse or parent, parent, adult brother, adult sister or adult child agrees in writing
deceased persons.
Article 25
Tissues of a deceased child and a deceased adult who is incapacitated may be taken for human use only in writing.
consent of both parents if they are alive or their legal representative or guardian.
IV. TISSUE COLLECTION, TESTING, PROCESSING, CONSERVATION, STORAGE AND TISSUE DISTRIBUTION SYSTEM
Article 26
(1) The collection, taking, testing, processing, preservation, storage and distribution of tissues may be carried out in accordance with the provisions of this Act only at
manner and under the conditions prescribed by the Minister by ordinance.
(2) The collection, taking, testing, treatment, preservation, storage and distribution of tissue may only be undertaken by a healthcare institution for which
carrying out these activities, in accordance with the provisions of this Act, the Minister's approval given.
(3) The approval referred to in paragraph 2 of this Article shall be granted separately for each type of tissue.
Article 27
Testing of donors for blood-borne diseases and immunogenetic testing of recipients and donors may be performed by the laboratory to which it is to be performed.
of these activities, in accordance with the provisions of this Act, given the approval of the Minister.
Article 28
The health institution or laboratory is obliged to establish a quality system based on the activity for which the Minister has been approved by the Minister.
appropriate professional guidelines appropriate to the activities they perform to ensure the quality and safety of tissues and procedures.
Article 29
(1) A health institution or a laboratory shall be obliged to appoint a responsible person and their replacement for each activity performed in accordance with
the provisions of this Act.
(2) The Minister shall prescribe the conditions regarding professional qualifications and the rights and obligations of the responsible person by an ordinance.
Article 30
(1) The Minister shall give the authorization for performing the activities referred to in Articles 26 and 27 of this Law by a decision stating that a health institution, ie
the laboratory fulfills the requirements of this Act for carrying out a specific activity with regard to space, professional workers, medical and technical equipment,
quality system and other conditions.
(2) The Minister shall grant the approval referred to in paragraph 1 of this Article for a term of four years.
(3) No appeal shall be allowed against the decision referred to in paragraph 1 of this Article, but an administrative dispute may be initiated.
(4) Conditions in respect of premises, professional staff, medical and technical equipment, quality systems and others, for carrying out the activities referred to in paragraph 1 of this
The Minister shall prescribe the Articles of Association.
Article 31
(1) The application for authorization for performing the activities referred to in Articles 26 and 27 of this Law shall be submitted to the Ministry.
(2) The request referred to in paragraph 1 of this Article must include:
a) name and headquarters of the health institution or laboratory,
b) personal data of the responsible person,
c) a description of the activity and the type of processes and tissues for which approval is sought;
d) a list of standard operating procedures for the required activity that provide a quality system with responsible persons,
e) the display of appropriate premises, equipment, workers and quality systems for the procedures for which approval is sought,
f) a statement of compliance with the conditions laid down.
(3) A health institution which has been approved by the Minister to carry out the activities of tissue processing, preservation, storage and distribution referred to in Article 26 of this
The Law is a tissue bank (hereinafter: the bank). The bank may also apply for authorization to pursue collection activities,
tissue sampling and testing.
(4) The health institution and the laboratory to which the authorizations for the activities referred to in Articles 26 and 27 of this Act have been granted shall be obligatory for each
to notify the Ministry of any change in the work and organization affecting the safety and quality of the tissue as soon as possible and within three days at the latest
the changes that have occurred.
Article 32
(1) The bank or laboratory, with the approval referred to in Article 30 of this Act, shall be obliged to enter into a written contract with a legal person for the performance of each
an activity that affects or may affect the quality and safety of the tissue processed in collaboration with that legal entity, and in particular if:
a) the bank entrusts the legal person with some stage of tissue processing,
b) the legal entity supplies materials and / or provides services that affect or may affect the quality and safety of the tissue, including tissue distribution services,
c) the bank provides services to a legal person,
d) the healthcare institution distributes tissues treated in a legal person.
(2) The contract referred to in paragraph 1 of this Article must contain precisely defined obligations and responsibilities of the legal person, as well as a detailed description of the procedures that
the subject of the contract.
Article 33
The Minister ex officio issues a decision on revocation of the authorization referred to in Article 30 of this Law if he / she determines that the health institution, ie
laboratory:
1. no longer fulfills the conditions referred to in Articles 26 and 27 of this Act,
2. fails to remedy the deficiencies established by the supervision within the prescribed period,
3. fails to comply with the provisions of this Act and the ordinances adopted pursuant to this Act.
Article 34
(1) A health institution or a laboratory, which is authorized to perform the activities referred to in Articles 26 and 27 of this Act, not later than 90 days before
the expiry of the authorization referred to in Article 30 of this Act may apply for renewal of the authorization.
(2) In addition to the request referred to in paragraph 1 of this Article, the health institution or laboratory shall submit the documentation referred to in Article 31 of this Act.
Article 35
(1) All hospital health care institutions are obliged to participate in the implementation of tissue donation procedures for deceased donors within the National
transplant program.
(2) Clinical health care institutions are obliged to appoint a person to perform the function of tissue coordinator at that institution.
(3) The coordinator referred to in paragraph 2 of this Article shall organize and coordinate the work within the health institution with regard to tissue collection.
(4) All hospital healthcare institutions are obliged to appoint a tissue coordinator whose scope of work is consistent with the level of participation of the institution in
implementation of the National Transplantation Program.
(5) The Minister's ordinance shall prescribe the duties and obligations of the coordinator, the conditions regarding professional qualifications and other conditions.
Article 36
(1) All health care institutions and healthcare professionals engaged in the activities of collecting, taking, testing, processing, preserving, storing,
tissue distributions and applications are obliged to cooperate with each other for the successful implementation, and scientific and professional improvement of these activities in
Republic of Croatia.
(2) All health care institutions and health care providers are obliged to continuously take appropriate measures in order to promote tissue donation.
V. FOLLOW-UP
Article 37
(1) With the approval referred to in Article 30 of this Act, a health institution or a laboratory shall ensure the traceability of all tissues from the donor to
of the recipient, in accordance with the conditions and manner prescribed by the Minister by ordinance.
(2) The health institution or laboratory referred to in paragraph 1 of this Article shall also ensure the traceability of all substances, objects and materials coming into
direct or indirect contact with tissue.
(3) Tissue establishments are obliged to ensure the traceability of tissue from distribution to recipient, and the traceability of all substances, objects and
materials that come into direct or indirect contact with the tissue in the application process.
Article 38
(1) A health institution or a laboratory, with an authorization to perform the activities referred to in Articles 26 and 27 of this Act, shall be obliged to apply
a unique identification system for each donor in which a unique code is assigned to each donation and to each tissue pack resulting from
gifts.
(2) All tissues must be labeled. The tag must include or enable linking to the bank's collection and receipt procedures
tissues, and the processes of tissue processing, storage, and distribution.
Article 39
(1) The health institution or laboratories shall be obliged to keep records that ensure traceability in all tissue procedures.
(2) The information shall be kept in electronic form and may also be recorded in writing.
(3) The data referred to in paragraph 1 of this Article shall be kept for 30 years after tissue application.
VI. IMPORTS AND EXPORTS OF TISSUES
Article 40
(1) Import and export of tissue may only be carried out by a bank approved by the Minister.
(2) Importation of tissue may only be carried out if:
a) there is a demonstrated benefit from the use of the intended tissue,
b) the purpose of the tissue is human application,
c) Tissue banks have no tissue available.
(3) Tissue export may only be carried out if:
a) Tissue banks in the Republic of Croatia have a sufficient amount of these tissues,
b) there is a medical reason justifying the export.
(4) The distribution of tissue from the Republic of Croatia to the Member States of the European Union may only be made under the conditions referred to in paragraph 3 of this Article.
(5) The approval referred to in paragraph 1 of this Article shall be given or denied by the Minister by a decision.
(6) No appeal shall be allowed against the decision referred to in paragraph 5 of this Article, but an administrative dispute may be initiated.
(7) The conditions and procedure for obtaining a permit for the import and export of tissue shall be laid down by the Minister in an ordinance.
(8) In the case of emergency situations for which the bank is unable to import tissue, the Ministry may approve a tissue establishment for health
direct tissue import.
Article 41
(1) Imports of tissues from countries not members of the European Union shall be prohibited.
(2) It is prohibited to import tissue collected, taken, tested, treated, preserved or stored in non-EU countries without
regardless of the country of distribution.
(3) Imports from countries not members of the European Union may be authorized in the event of an emergency.
(4) By way of derogation from paragraph 1 of this Article, it is permitted to import hematopoietic stem cells from non-EU countries for the purposes of the registry
voluntary hematopoietic stem cell donors.
Article 42
Tissues imported or exported must comply with the conditions laid down in this Law in terms of quality and safety.
VII. SURVEILLANCE
Article 43
(1) Supervision of the implementation and enforcement of this Act and regulations adopted pursuant to this Act, and supervision of professional work in
health institutions performing the procedures referred to in Article 1 of this Act and the laboratories referred to in Article 27 of this Law shall be subject to competent inspection
Ministries.
(2) Supervision tasks referred to in paragraph 1 of this Article shall be performed by senior inspectors, inspectors of the Ministry and other civil servants authorized to carry out this task.
control.
(3) Conditions regarding professional qualification, professional development and the manner of carrying out the supervision referred to in paragraph 1 of this Article by the inspector referred to in paragraph 2.
The Minister shall prescribe this Article with an ordinance.
Article 44
(1) Inspectors shall carry out regular supervision referred to in Article 43 of this Act at least once every two years.
(2) In carrying out inspection supervision, the inspector shall have the right and duty to:
1. order the pursuit of the activity in accordance with the conditions laid down in this Act and other regulations,
2. order the elimination of identified irregularities and deficiencies within the specified deadline,
3. prohibit the implementation of measures and actions that are contrary to law or regulation,
4. temporarily prohibit work in order to eliminate identified irregularities and defects,
5. prohibit the performance of the activities prescribed by this Law, if it is performed without the prescribed authorization,
6. order withdrawal from the application of tissue that does not meet the prescribed conditions,
7. declare tissue that does not meet the conditions of quality and safety unsuitable for human application and order its destruction,
8. prohibit the work of banks and laboratories that no longer meet the prescribed requirements in terms of space, workers, quality systems and medical and technical
equipment,
9. prohibit independent work by a healthcare professional who is not authorized to work independently,
10. prohibit the work of a health care institution and a health care professional who does not ensure the prescribed quality and safety of tissues and tissue application procedures
in humans,
11. propose to the competent chamber the implementation of the procedure with the aim of determining the need for additional professional training of the health care worker, ie
the need to repeat the proficiency test,
12. prohibit work and propose to the Chamber to withdraw the authorization for independent work of a health care professional,
13. refer the health care provider or health care associate for a health assessment in case of suspected loss
health ability to perform health care activity,
14. order the taking of other measures for which it is authorized by this Law and other regulation.
(3) If the identified deficiencies are not remedied within the specified period, the inspector shall prohibit the activity of the bank or the laboratory.
(4) If the inspector, in the course of carrying out inspection supervision, finds irregularities or breaches of regulations and is not authorized to act directly, he is obliged to
is to inform the competent state administration body about any irregularities or violations of the regulations, and to request to initiate proceedings and take action
prescribed measures.
Article 45
In addition to the regular inspection supervision referred to in Article 43 of this Act, inspectors shall also carry out extraordinary supervision in accordance with the Minister's order.
VIII. SERIOUS HARMFUL EVENT AND SERIOUS HARMFUL REACTIONS
Article 46
(1) Banks or institutions in which tissues are used are obliged to establish an effective and verified system for monitoring and reporting of serious adverse effects.
events and serious adverse reactions, and a system for withdrawal from the administration of tissues that have caused or may cause a serious adverse event or serious
adverse reaction.
(2) Any serious adverse event and serious adverse reaction of the bank or institution where tissues are applied shall be obliged in writing.
to notify the Ministry without delay, and to take without delay all available measures to reduce the damage caused by any serious
adverse event and serious adverse reaction and notify the Ministry in writing.
(3) The manner of monitoring serious adverse events and serious adverse reactions, the manner of keeping records and reporting deadlines of the Ministry shall prescribe
minister by ordinance.
(4) The Ministry shall be obliged to keep a register of serious adverse events and serious adverse reactions referred to in paragraph 2 of this Article.
Article 47
(1) The Ministry shall submit the annual report on the reported serious adverse events and serious adverse reactions to the European Commission by 30.
June of the current year for the previous year.
(2) The contents of the stationery of the annual report referred to in paragraph 1 of this Article, as well as the manner and procedure of submission by ordinance, shall be prescribed by the Minister.
IX. REPORTS AND RECORDS
Article 48
(1) Health care establishments with the approval referred to in Article 30 of this Act, or institutions where tissues are applied, are obliged to keep records of
the procedures referred to in Article 4, paragraph 1 of this Act.
(2) Records shall include at least information on the type and quantity of collected, tested, preserved, processed, stored, distributed or otherwise
the mode of disposal of the tissues, information on the origin and destination of the tissue, and information on the import and export of the tissue.
(3) The institution applying the tissues shall be obliged to inform the Ministry in writing of each type of tissue it uses, as well as the method of its application.
Article 49
(1) The bank or laboratory shall submit to the Ministry an annual activity report no later than June 30 of the current year for the previous year.
year.
(2) The report shall be published on the Ministry's website.
(3) The Minister shall prescribe the contents and the form of the printed matter of the report referred to in paragraph 1 of this Article by an ordinance.
Article 50
(1) The Ministry shall keep a register of tissue banks and laboratories with approval by type of activity for which they have been approved and by tissue type.
(2) The register referred to in paragraph 1 of this Article shall be on the Ministry's website.
(3) The register is part of the network of national registers of the Member States of the European Union.
Article 51
In implementing this Law, the Ministry shall also perform the following tasks:
- monitor the establishment and maintenance of a single information system for the activities of donation, collection, testing, processing, preservation, storage,
distribution of human tissues and cells,
- keep a register of tissue donors,
- maintains national tissue waiting lists where appropriate,
- keep records of tissue donors,
- cooperates with related foreign and international organizations,
- informs healthcare professionals and the public about the need for tissues, provides information on the conditions for tissue collection and transplantation, including questions
relating to consent, especially with regard to the taking of tissue from a deceased person,
- supervise the implementation and enforcement of this Act and regulations adopted pursuant to this Act, and supervise the professional work of banks, and
laboratory.
X. INFRINGEMENT PROVISIONS
Article 52
(1) A legal person shall be fined between HRK 70,000.00 and HRK 100,000.00 for a misdemeanor if:
1. acts contrary to Article 8 of this Law,
2. take tissue from a living donor for the purpose of application without the decision of the expert team of the health institution in which the procedure will be performed (Article 13),
3. before taking the tissue does not perform all appropriate medical examinations and procedures to assess and reduce the health and mental health risks
the donor (Article 14),
4. take tissue from a living donor contrary to the provisions of Article 15 of this Law,
5. fails to notify the Ministry of a serious adverse event or serious adverse reaction (Article 46).
(2) A responsible person in a legal person shall also be fined from HRK 5,000.00 to 10,000.00 for the offense referred to in paragraph 1 of this Article.
(3) A natural person shall also be fined from HRK 5,000.00 to 10,000.00 for an offense referred to in paragraph 1, items 1 to 5 of this Article.
(4) The perpetrator shall be punished for trying the offense referred to in paragraph 1, items 1 and 2 of this Article.
XI. TRANSITIONAL AND FINAL PROVISIONS
Article 53
The Minister shall issue the ordinances for the adoption of which are authorized by this Law within six months from the day this Law enters into force.
Article 54
Until the ordinance referred to in Article 53 of this Law enters into force, they shall remain in force, unless they are contrary to this Law:
1. Ordinance on the conditions relating to premises, professional staff and medical and technical equipment, quality systems and other conditions for performing the activity
tissue collection, storage and transplantation (Official Gazette 74/09),
2. Rulebook on the manner of reporting, the manner of keeping records and the deadlines for reporting serious adverse events and serious adverse reactions
(Official Gazette 67/09),
3. Ordinance on the manner of keeping medical records of the taking and transplantation of parts of the human body (Official Gazette 152/05),
4. Ordinance on the contents of the consent form of the recipient of parts of the human body (Official Gazette 84/07),
5. Ordinance on the content of the consent form of the living donor of parts of the human body (Official Gazette 84/07),
6. Ordinance on the method of keeping personal information of donors and recipients of parts of the human body for medical purposes (Official Gazette 141/05),
7. Rulebook on Information and Manner of Keeping Records of Possible Donors of Human Body Parts for Transplantation from a Dead Person (»
Gazette «, no. 188/03.),
8. Ordinance on the criteria for the allocation of parts of the human body and maintenance of the national waiting list (Official Gazette 152/05 and 84/07),
9. Ordinance on the method of storage and transport of parts of the human body intended for transplantation (Official Gazette 152/05),
10. Ordinance on the procedure for the allocation of allogeneic non-related hematopoietic stem cells and the operation of the registry of possible bone marrow donors (»
Gazette «, no. 151/05.),
11. Ordinance on measures to ensure the safety and quality of parts of the human body for medical use (Official Gazette 143/05 and 70/09),
12. Ordinance on the operation and supervision of health institutions or parts of health institutions with tissue banks (Official Gazette 1/06 and
44/07.),
13. Rulebook on the method of cooperation with related foreign and international organizations for the purpose of exchange of organs or tissues for transplantation
(Official Gazette 141/05 and 44/07),
14. Rulebook on the Content, Method and Procedure of Submission of the Form, and the Method of Keeping Records and the Procedure of Revocation of a Statement of Non-donation of Body Parts with
deceased persons (Official Gazette 111/07).
Article 55
Health institutions, that is, laboratories that have been authorized to perform taking activities prior to the entry into force of this Act,
the storage and transplantation of tissues referred to in Article 27a, that is, carrying out immunogenic processing and tests to determine the matching of recipient tissues and
of the donor referred to in Article 27b of the Act on the taking and transplantation of parts of the human body for the purpose of treatment (Official Gazette 177/04 and 45/09)
are to harmonize their work and business with the provisions of this Act within one year from the date of entry into force of this Act
Article 56
On the day this Act enters into force, the Law on Taking and Transplanting Parts of the Human Body for Healing (the Official Gazette,
no. 177/04. and 45/09.) in the section related to tissues and cells.
Article 57
This Law shall enter into force on the eighth day after its publication in the Official Gazette, with the exception of Article 47 of this Act, which shall enter into force on
accession of the Republic of Croatia to the European Union.
Class: 543-02 / 12-01 / 02
Zagreb, December 14, 2012
CROATIAN PARLIAMENT
The President
Of the Croatian Parliament
Josip Leko, Ph.D. r.
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