Turkish Grand National Assembly Warning: You Are Viewing Act, The Parliamentary General Assembly Has Already Adopted. If It Does Not Include The Changes Made Later. Blood And Blood Products Act

Original Language Title: TÜRKİYE BÜYÜK MİLLET MECLİSİ Uyarı: Görüntülemekte olduğunuz Kanun, TBMM Genel Kurulunda kabul edildiği halidir. Varsa daha sonra yapılan değişiklikleri içermemektedir. KAN VE KAN ÜRÜN­LE­Rİ KA­NU­NU

Read the untranslated law here: https://www.tbmm.gov.tr/kanunlar/k5624.html

Law No. 5624

Acceptance Date: 04/11/2007


PART ONE Purpose, Scope and Definitions Purpose and scope

Article 1 (1) The purpose of this Act; blood, to regulate the procedures and principles related to blood components and products.
(2) of this Act; blood, blood components and their private legal persons and natural persons authorized to operate by the Ministry of products with institutions and organizations carrying out public services in this area.
(3) blood stem cell applications is beyond the scope of this Act.

Definitions Article 2 (1) of this Law;
A) Apheresis: the desired blood component to be obtained to be separated using a special device
b) The Minister of Health Minister,
c) Ministry: Ministry of Health,
d) Regional blood center in the region will be determined by the Ministry established, working in cooperation with the blood donation and transfusion centers in their respective regions, which have the capacity to meet the need for blood in the region is responsible, the most comprehensive unit can be made of all activities and transactions related to blood banking,
d) Service unit: transfusion center, blood donation center and regional blood center,
e) blood donors (donor): the party that whole blood or components of
f) blood donation (donation): Whole blood or blood components making process,
g) blood donation center : blood field from donors, working unit, depending on the region blood center operation direction
i) blood components: direct, apheresis or other methods that can be obtained whole blood, erythrocytes, platelets, plasma and cellular blood components such as granulocytes suspensions are
h ) blood products: blood obtained blood components and plasma products,
I) plasma products: treatment purposes all products obtained by treating human plasma
i) plasma products plant: from fresh frozen plasma, for therapy needed national and engaged in production in accordance with international standard facilities, which is made available separated proteins,
j) Complete blood: taken for transfusions from blood donors or processed to obtain new products and an appropriate mixed with anticoagulant agents and have not been subjected to any discrimination processing human blood ,
k) transfusion: Health problems due to the needs of the whole blood or blood components for transfusion to the patient,
l) transfusion center, except in emergency situations are not authorized to receive blood from donors for transfusion of blood or components obtained cross-comparison and should be heard by other tests using patient in order to prepare the unit refers
. SECTION

General Principles, Blood and Blood Products Committee

General principles Article 3 (1) of blood, blood components and products related to the general principles are as follows:
a) under this Act planning of services, implementation and monitoring of the matter is solely responsible and accountable for the Ministry.
B) blood donations are unpaid and voluntary basis in the supply of blood components and products. However, the financial provision to exempt does not mean that blood donors to encourage applications.

C) Blood, not reduce the danger of blood components and products to be taken in and given the donor and the recipient's health, protect against medical risk, it is essential for transfusion safely monitoring and transfusion after the donor and the recipient's done. Recipients must be reported and the complications that may arise in the transmitter. Blood, taking blood components and products, recording, analysis, processing, storing, making use, blood donation concerning the distribution and use of blood donors, prepare the organization, place of use and the buyer with all relevant data to be recorded in writing or electronically, and thirty years for storage is required. Blood donor questionnaire request form and the originals will be determined by the Ministry for not less than one year, representative samples of the blood samples taken from blood donors are kept for.
D) blood, blood components and transfusion or taken the responsibility of the physician and performed under the supervision of their products.
D) the production of plasma products collected in the country in order within the country and abroad to evaluate possible only with the permission of the Ministry. plasma product manufacturing in order to be brought from abroad is also subject to approval by the Ministry.
E) Services activities under this Act is required of those units open and operating executive in the framework of national and international quality assurance programs.
F) blood, blood components and those conducting the service products to protect personal information about donors to give to third parties, they are obliged to disclose to the press. This information will only be issued to the Ministry.
G) martial law and extraordinary circumstances, organizes within the framework of supply and the planning of the Ministry of the stored blood centers across the country will be necessary in case of mobilization and war materials needed for blood and blood products for them. Blood and Blood Products Committee

Article 4 (1) of the Ministry; blood, blood components and chaired by the relevant Ministry unit chiefs to provide scientific support that may be needed in the work to be done on the products of blood in the area for his work on blood products and blood banking distinguished experts, physicians or graduate in these matters for training persons composed of seven members appointed by the Minister of Blood and blood Products Committee is created.
(2) Blood and Blood Products Committee members shall be two years. The term of office ended on members be re-elected.
PART
Blood Supply and Use of Service Units
Services units
person authorized to service unit Article 5 (1) of blood supply and transfusion centers for use, blood donation centers and regional blood centers are established .
(2) the service units under this Act;
a) Regional blood center and blood donation center; Turkey Red Crescent Society and public institutions and organizations,
b) the transfusion center; Of this paragraph (a), as well as those listed in paragraph private legal persons and natural persons shall, in particular health care provider within the carrying emergency conditions,
c) the plasma product manufacturing facilities; public institutions and organizations and private legal entities and natural persons,
open, operate. PART FOUR

License, Inspection and Criminal Provisions
required to obtain licenses, audit and criminal provisions

Article 6 (1) Natural and legal persons, which will operate under the law, before starting its operations, obtain a license from the governor if the authorization of the Ministry or the Ministry and license the subject obliged to keep separate accounts and records for each activity. Real and legal persons determined to be licensed by the Ministry of amending the license, notarized copy of license and annual license fees for the accounting unit must pay will be determined by the Ministry of Finance.
(2) The Ministry supervises the activities of all types of service units or audited. The marketing authorization holder of persons; facilities, legal books and records available for the Ministry to control and clear and must provide the Ministry with any information and documents in a timely manner will require the Ministry.
(3) have taken the license does not remove the obligation to fulfill the requirements of this Act and other legislation. service units under this law, standards and operating procedures and principles regarding obliged to comply with the regulations to be made later by the Ministry.
(4) Inspections are taking to correct the deficiencies identified in the results, or the measures necessary, given time depending on the nature of the business or immediately desirable. The ministry's services should be addressed as needed, provided the related costs to be remedied if necessary in case of lack of necessary measures take ex officio. remedying deficiencies in this period does not eliminate the power to impose sanctions Ministry.
(5) licenses of those who died during the activities of the license requirements are taken back by the Ministry.
(6) with a license to take or operating outside the scope of the existing license of this Law Article 3 of the first paragraph of subparagraph (c) the storage of the mandatory documents and examples of eleven was banned from activity related to the governor's office who are found to store the new Turkish Lira administrative penalty is applied.
(7) in the audit;
A) Ministry who requested information is not timely or relevant governorship in thousands of New Turkish Lira administrative penalty is applied. The five thousand New Turkish Liras in case of repetition of the same act is an administrative fine.
B) Those who are suitably qualified staff to run the Ministry or the governor's office about five thousand New Turkish Lira administrative penalty is applied.
(8) of this Act the lives of people in the services covered and health that operate in a way that endangers the year was banned immediately operate up to five years in prison and fifteen hundred days will be punished with a judicial fine. These people will not be authorized for five years. In addition, technical and medical conditions that are found to be conferred shall be subject to the confiscation of blood and blood products.
(9) of the license is revoked or banned from operation of blood centers be confiscated in case of need to blood donation centers operated by necessary measures taken by the Ministry.
(10) knowing that such a disease or a risk of carrying diseases transmitted by blood way, in this case up to one year to three years in prison and five hundred days of storing blood that is given fined.




SECTION FIVE Miscellaneous Provisions


Regulation

Article 7 (1) transfusion center is planned to be established in this Act, the establishment of blood donation center and regional blood centers, equipment, identification of material and personnel standards, determination of working procedures and principles with their relations with each other, about the procedures and the quality assurance program will be implemented principles, values ​​to be licensed and principles and procedures for cancellation, the establishment of a plasma product manufacturing plant and operating principles with other matters, Blood and Blood products is determined by a regulation issued by the Ministry Board's working procedures and principles.

Removed provisions of the current Article 8 (1) and No. 2857 dated 23.06.1983 Blood and Blood Products Act is repealed.
Enforcement of the regulation and licensing of existing units
PROVISIONAL ARTICLE 1- (1) The regulations stipulated in this Law, the Ministry put into effect within six months. Regulations come into force until the existing arrangements shall continue to apply the provisions are not contrary to this Law.
(2) A and type B operating until the date of entry into force of this Act, the blood center blood stations and other service units, regulations a license in accordance with the lack of eliminating the types of activities within one year from the entry into force and must ensure compliance with this Act . During this time, without the permission of the Ministry under this Act can not be a new unit.

Enforcement Article 9 (1) This Law shall enter into force on the date of publication.

Execution ARTICLE 10- (1) This Law shall be enforced by the Council of Ministers.