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Law on Blood and Blood Products
Law, OG 79 / 2006-1916 More 
CROATIAN PARLIAMENT
1916
Pursuant to Article 88 of the Constitution of the Republic of Croatia, I hereby
DECISION
ON THE DECLARATION OF THE LAW ON BLOOD AND BLOOD PREPARATION
I hereby declare the Law on Blood and Blood Products, adopted by the Croatian Parliament at its session of 30 June 2006
Class: 011-01 / 06-01 / 30
Reg. No: 71-05-03 / 1-06-2
Zagreb, 5 July 2006
The President
Of the Republic of Croatia
Stjepan Mesic, v. r.
LAW
ON BLOOD AND BLOOD PREPARATIONS
I. GENERAL PROVISIONS
Article 1
This Act regulates the supply of blood and blood products to the population of the Republic of Croatia, which includes the system of social,
group and individual measures and activities in the field of planning, collecting and testing blood and producing, storing and distributing blood
of the preparation.
The provisions of this Act shall not apply to the supply of medicinal products from human blood or human plasma.
Article 2
The terms in this Law have the following meaning:
1. "blood" means blood collected from a blood donor into an anticoagulant solution for processing into blood products for transfusion or for
further processing,
2. "blood donor" means a person who donates blood or a blood component,
3. "blood recipient" means a person who receives blood or a blood product for medical purposes,
4. "blood component" means the portion of blood collected from a donor (erythrocytes, leukocytes, platelets, plasma),
5. "blood preparation" means any therapeutic preparation for transfusion treatment produced from human blood or a blood component,
6. "plasma derivative" means a therapeutic composition or drug produced from human plasma,
7. "autologous transfusion" is a form of transfusion treatment in which the blood donor and the recipient are the same person and to whom it is administered
previously taken and stored blood or a blood preparation,
8. "Certified health institution" means a health institution / part of a health institution that performs blood and blood collection and testing
ingredients, regardless of their purpose and their processing, storage, distribution and dispensing when intended for transfusion
treatment,
9. "hospital transfusion unit" means an organizational unit of a hospital healthcare institution that stores and dispenses blood and blood products, and which may
to carry out testing of markers of blood transmitted diseases, immunohematological and molecular tests of patients and pregnant women, diagnostics and
hemostatic disorders therapy, supervision of transfusion treatment and other hospital transfusion diagnostic and therapeutic
procedures,
10. "serious adverse event" means an adverse event related to the collection, testing, treatment, storage, distribution or transport of blood and
blood products, which could lead to death or danger of damage to the patient's health, or resulting in hospital
the treatment of persons, their morbidity or their extension,
11. "serious adverse reaction" means an unpredictable response from a blood donor or patient related to the collection or transfusion of blood or blood
preparations, which are deadly, life-threatening, cause damage to the health of the patient or result in hospital treatment
the person, their morbidity or who prolongs them,
12. "release of a blood product" means the withdrawal of a blood product from quarantine status by the use of systems and procedures to ensure
that the final product meets the release specification,
13. "distribution" means the distribution of blood products to authorized healthcare institutions, hospital transfusion units and other
institutions for manufacturers of blood and plasma drugs,
14. "total blood safety monitoring" means a series of organized surveillance procedures aimed at preventing harmful or unexpected
events or reactions of the donor or recipient of blood or minimize it,
15. "health inspection" means supervision over the application and enforcement of this Act and the regulations adopted pursuant to this Law.
Of the Act, as well as the supervision of professional work in authorized healthcare institutions in accordance with established standards.
II. SOCIAL CARE FOR INSURANCE OF EFFECTIVE, QUALITATIVE AND INHERENT BLOOD PREPARATIONS
Article 3
The Republic of Croatia, in the provision of social care for the health of its inhabitants throughout its territory, provides the conditions for supply
population with effective, quality and harmless blood products.
Article 4
Republic of Croatia its rights, obligations, tasks and goals in the field of supplying the population with effective, quality and harmless
blood products accomplish:
- planning of the need to treat patients with medicines produced from human blood,
- promoting the principle of self-sufficiency in the supply of blood to the population through voluntary and unpaid donation,
- ensuring the conditions for raising public awareness of the need for blood collection and the use of blood products,
- providing funds throughout the Republic of Croatia for the harmonization of blood collection and testing procedures; and
production, storage and distribution of blood products with scientific and technological development achievements,
- establishing and ensuring the development of a health information system for the field of transfusion medicine in the Republic
Croatia,
- ensuring the development of scientific activity in the field of transfusion medicine,
- providing conditions for the education of healthcare professionals in the field of transfusion medicine.
III. AVAILABILITY OF BLOOD PREPARATIONS
Article 5
In order to ensure the availability of blood products for all health care institutions, the required number is determined by the transfusion network
authorized health institutions for the territory of the Republic of Croatia, or units of regional (regional) self-government.
Article 6
The network of transfusion activities is determined by the basic network of healthcare activities in accordance with the Law on Health Care.
Article 7
The planning, collection and testing of blood and the production, storage, distribution or dispensing of blood products may be performed by
a health institution, that is, a part of a health institution that has been approved by the Minister for performing one of these activities
competent for health (hereinafter: the Minister) in accordance with the provisions of this Act (authorized health institution).
Article 8
The approval referred to in Article 7 of this Act, at the request of the health institution, shall be given by the Minister by a decision declaring that the health care
the institution is eligible for a particular activity.
No appeal shall be allowed against the decision referred to in paragraph 1 of this Article, but an administrative dispute may be instituted against that decision.
An authorized healthcare institution operating the blood production business must employ a responsible person -
doctor of transfusion medicine specialist with at least five years of work experience in the field of that specialty that is
responsible for the collection, testing, processing, storage, distribution and dispensing of blood products in accordance with this Act.
More detailed conditions regarding premises, professional staff and medical and technical equipment for performing the activities referred to in Article 7 of this Law, with
the previously obtained opinion of the competent chamber shall be prescribed by an ordinance by the Minister.
Article 9
The Minister ex officio issues a decision revoking the authorization referred to in Article 7 of this Act if he determines that the authorized health
institution:
- no longer fulfills the conditions from Article 8 of this Law,
- does not comply with the provisions of this Act and the ordinances adopted pursuant to this Act.
IV. PERMITS TO PERFORM TRANSFUSION ACTIVITIES
Article 10
Blood collection and testing and production of blood products in the Republic of Croatia may only be performed by an authorized health care provider
institution authorized to carry out these transfusion activities.
The permit referred to in paragraph 1 of this Article shall be given or denied by the Minister by a decision which is not allowed to appeal, but is appealed against.
solutions can be initiated by an administrative dispute.
Article 11
The application for the permit referred to in Article 10 of this Law shall be submitted to the Minister and shall contain:
- name and headquarters of the health institution,
- personal data of the responsible person in the institution,
- personal data of the person responsible for the transfusion activity in the institution,
- a list of procedures and activities for which a license is sought,
- documentation describing the system of activity and quality with responsible persons,
- display of appropriate premises and equipment for the procedures / jobs for which the permit is requested,
- the results of external quality control.
Article 12
The permit referred to in Article 10 of this Law shall be granted for a period of five years for all or only some of the procedures in blood collection and testing, that is,
production of blood products.
Article 13
Authorized health institution not later than 90 days before the expiry of the permit for performing the collection and testing procedure
blood, that is, the production of blood products may apply for a license renewal.
The provisions of Articles 10 and 11 shall apply mutatis mutandis to the procedure for renewal of the authorization to perform the procedures referred to in paragraph 1 of this Article.
of this Act.
Article 14
For a change in blood collection and testing procedures, or the production of blood products that may affect their blood
Effectiveness, quality and harmlessness, the authorized healthcare institution must immediately seek the approval of the Minister.
The approval referred to in paragraph 1 of this Article, at the request of the authorized health institution, shall be issued by a decision of the Minister.
No appeal shall be allowed against the decision referred to in paragraph 2 of this Article, but an administrative dispute may be instituted against that decision.
V. BLOOD TESTING
Article 15
Authorized healthcare providers licensed to perform blood testing procedures must test any blood or blood dose collected
ingredient.
The Minister shall prescribe the manner and conditions of testing, in the ordinance at least:
–ABO and Rh D blood type,
- The following blood-borne diseases:
–HIV1 / 2, hepatitis B, hepatitis C and syphilis.
VI. QUALITY ASSURANCE OF BLOOD AND BLOOD PREPARATIONS
Article 16
Authorized health care institutions are obliged to establish a quality assurance system for transfusion activities.
More detailed standards for the organization of the quality assurance system referred to in paragraph 1 of this Article, in accordance with the requirements of internationally recognized ones
standards in the field of transfusion medicine and scientific and technological development, the ordinance is prescribed by the Minister.
To ensure the quality of blood and blood products, all persons involved in blood collection and testing, production, storage and distribution
blood products must be appropriately trained, with the obligation of continuing professional training in accordance with
the law.
Article 17
When performing the transfusion activity, authorized health care institutions are obliged to keep records whose form and content
the Minister shall prescribe.
The data from the records of the authorized health institution are obliged to submit to the Croatian Institute for Transfusion Medicine in the manner and in the
the deadlines prescribed by the ordinance referred to in paragraph 1 of this Article.
The Croatian Institute for Transfusion Medicine is obliged to keep the data from the records referred to in paragraph 1 of this Article for at least 15 years.
Article 18
The Croatian Institute for Transfusion Medicine submits data from the Ministry responsible for health (hereinafter: the Ministry)
the records of authorized health institutions determined by the ordinance issued by the Minister.
The manner and deadlines for submission of data from the records of authorized health institutions shall be determined by the ordinance referred to in paragraph 1 of this Article.
The Ministry is obliged to establish and maintain a uniform system of data storage referred to in paragraph 2 of this Article.
VII. MONITORING HARMFUL EVENTS
Article 19
Traceability and labeling system for each blood product produced from the donor to the patient and vice versa throughout
States is a set of procedures and measures that can be indisputably identified by each individual blood donor, dose taken, produced
blood preparation and patient.
The traceability and labeling system for blood products should be in line with international traceability and labeling systems
ensuring the traceability of blood products internationally.
Authorized healthcare institutions are obliged to apply the traceability and labeling system in performing all the activities referred to in Article 7 of this
Of the law.
The system of traceability and labeling of blood products, with the previously obtained opinion of the competent chamber, shall be prescribed by an ordinance by the Minister.
Article 20
Croatian Institute for Transfusion Medicine is obliged to establish a single national system for reporting harmful and unexpected
events and reactions related to:
- collecting and testing blood, and producing, storing and distributing blood products that could affect their blood
efficiency, quality and harmlessness,
- the use of blood products in case of doubt about their effectiveness, quality and harmlessness.
The system of documentation, classification and assessment of the severity of adverse and unexpected events and reactions must allow for international
data exchange.
Any serious adverse event and serious adverse reaction shall be mandated in writing by an authorized healthcare institution.
report to the Croatian Institute for Transfusion Medicine and the Ministry.
Authorized healthcare providers are required to establish an effective and proven system of withdrawal from blood products that are
cause or may cause a serious adverse event or a serious adverse reaction.
Article 21
Healthcare facilities that administer blood products for transfusion treatment are required to establish a system for reporting serious
adverse events and serious adverse reactions within the institution.
Any serious adverse event and serious adverse reaction referred to in paragraph 1 of this Article shall be obliged by the health institution without
to notify the Croatian Institute of Transfusion Medicine and the Ministry in writing.
Article 22
The register of serious adverse events and serious adverse reactions referred to in Articles 20 and 21 of this Act shall be kept by the Croatian Institute for Transfusion
medicine.
Article 23
Ordinance on the monitoring of serious adverse events and serious adverse reactions referred to in Articles 20 and 21 of this Law, with previously obtained
the opinion of the competent chamber, is passed by the Minister.
VIII. EXPORTS AND IMPORTS OF BLOOD AND BLOOD PREPARATIONS
Article 24
Blood and blood products must not be exported from the Republic of Croatia.
The Minister may exceptionally, in the case of natural disasters and other emergencies, as well as in cases of emergency,
medically justified need to approve the export of blood and blood products.
In the case referred to in paragraph 1 of this Article, testing in accordance with Article 15 of this Act shall be ensured.
Article 25
Blood and blood products must not be imported into the Republic of Croatia.
The Minister may exceptionally, in the case of natural and other emergencies, as well as in cases of emergency, medically
justify the need to approve the importation of blood and blood products.
The imported blood and blood products must meet the conditions prescribed by this Act and testing in accordance with Article 15 must be ensured.
of this Act.
IX. INSURANCE OF THE QUALITY AND INJURY OF BLOOD AND BLOOD PREPARATIONS
Article 26
The promotion and organization of the donation of blood and blood components in the Republic of Croatia are based on the principles of voluntary, free,
anonymity and solidarity.
For the blood or blood component taken, it is forbidden for the donor to provide financial compensation.
For a given blood or blood component, the donor may not receive any monetary compensation.
Article 27
Donors of blood and blood components may only be adults who are identified by the doctor of medicine referred to in Article 29, paragraph 2 of this Act
absence of medical reasons that could cause damage to the health of the provider or patient.
By way of derogation from paragraph 1 of this Article, in the case of an autologous transfusion, the donor of the blood or blood component does not have to be an adult.
Article 28
The person who approaches the donation of blood or blood component must be informed about possible reactions during blood collection, the extent of testing
blood and protect personal information.
The information referred to in paragraph 1 of this Article shall be given by the medical doctor referred to in Article 29, paragraph 2 of this Act, who shall also request the information necessary for the
an assessment of the person's suitability for donating blood or a blood component.
Article 29
Prior to each donation of blood or blood component, the doctor of medicine is obliged to examine the person who approaches the donation.
The medical doctor performing the examination of the person accessing the appointment is designated by the responsible person of the authorized health care institution referred to in the article
8, paragraph 3 of this Law.
The Minister shall prescribe the scope of the examination referred to in paragraph 1 of this Article and the criteria for selecting the provider.
Article 30
Prior to each donation of blood or blood component, the person accessing the donation must give consent for the voluntary blood or blood donation
ingredients.
The consent referred to in paragraph 1 of this Article shall be given in writing and must be an expression of the free will of the provider, based on the appropriate
notifications of the purpose of the administration and common risks.
The contents of the consent form referred to in paragraph 1 of this Article shall be prescribed by an ordinance by the Minister.
Article 31
The Croatian Institute for Transfusion Medicine maintains a register of blood donors.
In the register referred to in paragraph 1 of this Article, particulars shall be given of persons who may not temporarily or permanently be blood donors.
Article 32
The blood donor registry must be part of the national transfusion information system.
The registry must be accessible to all health facilities that collect blood.
Funds for keeping the register are provided in the state budget.
Article 33
The blood donation and blood components are promoted in the territory of the Republic of Croatia by the Croatian Institute for Transfusion Medicine and the Croatian
Red cross.
Promotional activities should be continuous and consistent with the need for sufficient quantities of blood and blood products in the area
throughout the Republic of Croatia throughout the year.
Article 34
A unique annual plan of blood donation actions for the Republic of Croatia is adopted by the Croatian Institute for Transfusion Medicine and the Croatian Red
cross based on anticipated blood supply needs of all healthcare facilities.
Article 35
The Minister shall prescribe the conditions regarding the premises and equipment to be fulfilled by the organizer of blood donation operations.
X. DATA PROTECTION
Article 36
Medical information on the blood donor, including the information referred to in Articles 15 and 28 of this Act shall be confidential and shall be protected from
unauthorized access.
Article 37
Personal information about providers is a professional secret.
The personal data referred to in paragraph 1 of this Article shall be kept and communicated in accordance with special regulations governing the protection of professional secrecy and
protection of personal data.
XI. HEALTH-INSPECTION
Article 38
Supervision of the implementation and enforcement of this Act and regulations adopted pursuant to this Act, as well as supervision of professional work in
authorized health institutions are conducted by the ministry - health inspection.
Health inspection activities referred to in paragraph 1 of this Article shall be performed by health inspectors and other civil servants
in accordance with a separate law.
Article 39
Health inspectors shall carry out regular inspections referred to in Article 38 of this Act at least once every two years.
In the event of a serious adverse event, the health inspector will carry out an urgent inspection.
Article 40
In carrying out the inspection supervision referred to in Article 39 of this Law, the health inspector shall have the rights and duties:
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 actions contrary to this Law and other regulations,
4. temporarily prohibit the work of an authorized health care institution if it does not meet the requirements regarding workers, equipment and premises,
5. prohibit the work of a legal person if it is engaged in the planning, collection and testing of blood, ie production, storage, distribution and
issuing blood products without the Minister's approval,
6. prohibit the work of a legal entity if it engages in the collection and testing of blood, ie the production of blood products without a license for
performing a specific activity,
7. order the withdrawal from circulation of blood products that do not meet the conditions prescribed by this Law and other regulations,
8. declare a blood product found not to comply with the prescribed standards for hazardous waste and order it
disposal,
9. order the taking of other measures for which it is authorized by this Law and other regulations.
XII. PENALTY PROVISIONS
Article 41
A legal person shall be fined in the amount of HRK 70,000.00 to HRK 100,000.00 for the offense if:
1. plans, collects and tests blood or produces, stores or dispenses blood products without the Minister's approval (Article 7),
2. collects or tests blood or produces blood products without the Minister's permission (Article 10),
3. export blood or blood products from the Republic of Croatia contrary to Article 24 of this Law,
4. import blood or blood products into the Republic of Croatia contrary to Article 25 of this Law.
A responsible person in
to a legal person.
A natural person shall also be fined in the amount of HRK 5,000.00 to HRK 15,000.00 for the offense referred to in paragraph 1 of this Article.
The perpetrator shall be punished for attempting the offense referred to in paragraph 1 of this Article.
Article 42
An authorized health institution will be fined in the amount of HRK 70,000.00 to HRK 100,000.00 if:
1. does not inform the Croatian Institute for Transfusion Medicine and the Ministry of any serious adverse event and serious adverse reaction
(Article 20 (3)),
2. fails to protect confidential medical information about the blood donor from unauthorized access (Article 36).
A responsible person in
to a legal person.
Article 43
The authorized health institution shall be fined in the amount of HRK 30,000.00 to HRK 50,000.00 if:
1. in the case of changes in the procedures for the collection or testing of blood, or the production of blood products that may affect them
Efficiency, quality and harmlessness do not require the approval of the Minister (Article 14, paragraph 1),
2. does not keep the prescribed records when performing the transfusion activity (Article 17, paragraph 1)
3. fails to submit the data from the records within the prescribed deadline to the Croatian Institute for Transfusion Medicine (Article 17, paragraph 2);
4. provides compensation for the blood collected (Article 26, paragraph 2),
5. take blood from a minor or adult contrary to Article 27 of this Law,
6. fails to inform the person who approaches the blood or blood component about possible reactions during blood collection, the extent of blood testing and
protection of personal data (Article 28),
7. fails to perform the prescribed examination of the person who accesses the donation of blood or blood component (Article 29),
8. take blood or blood component without the prescribed consent of the donor (Article 30).
A responsible person in
to a legal person.
A fine in the amount of HRK 3,000.00 to HRK 7,000.00 for a misdemeanor referred to in paragraph 1, points 5, 6, 7 and 8 of this Article shall also be imposed on the doctor.
medicine in a licensed healthcare facility.
The perpetrator shall be punished for attempting the offense referred to in paragraph 1, items 4, 5 and 8 of this Article.
Article 44
A fine of HRK 30,000.00 to HRK 50,000.00 shall be imposed on the Croatian Institute of Transfusion Medicine for an offense if
does not submit the data from the records of authorized health institutions to the Ministry within the prescribed period (Article 18, paragraph 1).
A responsible person in the amount of HRK 3,000.00 to HRK 7,000.00 shall also be fined for the misdemeanor referred to in paragraph 1 of this Article.
Croatian Institute for Transfusion Medicine.
Article 45
A fine in the amount of HRK 1,000,000 to HRK 5,000.00 shall be imposed on an individual if he or she receives blood or a blood component for a given day.
financial compensation (Article 26 (3)).
XIII. TRANSITIONAL AND FINAL PROVISIONS
Article 46
The Minister shall adopt the ordinances authorized by this Law within six months from the day this Act enters into force.
Of the law.
Article 47
Health care institutions that have been granted a permit to exercise on the basis of regulations in force until the day this Act enters into force
transfusion activities are obliged to harmonize their work and business with the provisions of this Act and the ordinances adopted on the basis of this
Of the Act within six months from the entry into force of the ordinance referred to in Articles 8 and 16 of this Act.
Article 48
With the entry into force of the ordinance referred to in Article 46 of this Act, the Ordinance on Blood and Blood Ingredients (Official Gazette, No.
14/99).
Article 49
This Law shall enter into force on the eighth day after its publication in the Official Gazette.
Class: 500-01 / 05-01 / 04
Zagreb, 30 June 2006
CROATIAN PARLIAMENT
The President
Of the Croatian Parliament
Vladimir Seks, c. r.
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