NTO

legislation

RELATED ENACTMENTS

All the following regulations are published in the “Unified Automated System of Legal Information” (JASPI)
of Ministry of Justice of the Slovak Republic. References to individual documents can be found on MZ SR.

The Legislation:

Act No. 18/2018 Coll. on Data Privacy Policy / Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)

Act No. 576/2004 Coll. on health care, healthcare-related services and amendments and supplements of some laws

Act No. 578/2004 Coll. on healthcare providers, health workers and professional organizations in the health and on amendments and supplements to some laws

Act No. 300/2005 Coll. Penal Code as amended (selected provisions to organ trafficking – §159 and §160)

Act No. 282/2006 Coll.amending and supplementing Act No. 576/2004 Coll. on health care, healthcare-related services and amendments and supplements of some laws as amended and on amendments to some laws

Act No. 313/2012 Coll.amending and supplementing Act No. 576/2004 Coll. on health care, healthcare-related services and amendments and supplements of some laws as amended and on amendments to some laws

Act No. 122/2013 Coll. on the personal data protection and on amendments to some laws

Act No. 185/2014 Coll. amending and supplementing Act No. 578/2004 Coll. on healthcare providers, health workers and professional organizations in the health and on amendments and supplements to some laws, as amended and on amendments to some laws

Act No. 317/2016 Coll. on the requirements and procedures for removal and transplantation of human organs, human tissues and human cells and on the change and amendment of some laws (Transplantation Act)

Decrees and regulations:

REGULATION (EC) No 1049/2001 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 1394/2007 z 13. November 2007 on advanced therapy medicinal products and amending Directive 2001/83 / EC and Regulation (EC) No 726/2004 (Text with EEA relevance)

21/5000 Full text of the regulation:

Decree of the Ministry of Health of the Slovak Republic from December 20, 2004 no. 770/2004 Coll., which establishes the determining features of individual types of medical facilities Regulation of the Government of the Slovak Republic from 20.12. 2006 no. 20/2007 Coll. on the details of procurement, tissue and cell donation, the criteria for the selection of tissue and cell donors, the laboratory tests required for tissue and cell donors and the procedures for the procurement of cells or tissues and their acceptance by healthcare providers

Regulation of the Government of the Slovak Republic from 12. 12. 2007 no. 622/2007 Colllaying down the details of the processing, storage, storage or distribution of tissues and cells and the reporting and investigation of adverse reactions and events and the measures taken

Regulation of the Government of the Slovak Republic from 16. 4. 2014 no. 119/2014 Coll., which amends the Regulation of the Government of the Slovak Republic No. 20/2007 Coll. on the details of procurement, tissue and cell donation, the criteria for the selection of tissue and cell donors, the laboratory tests required for tissue and cell donors and the procedures for the procurement of cells or tissues and their acceptance by healthcare providers

Revenues and professional guidelines:

Professional guidance of the Ministry of Health of the Slovak Republic on the implementation of treatment replacing kidney function and on the implementation of extracorporeal elimination treatment no. 04386/2006, on: 12. 6. Bulletin 43-47 / 2006

Professional guidance of the Ministry of Health of the Slovak Republic on donation, procurement of human organs from the bodies of living and dead donors, on testing of donors and on the transfer of human organs to the recipient no. 28610/2006 – OZSO, on: 3.1.2007 Bulletin 1-5 / 2007

Decree of the Ministry of Health of the Slovak Republic no. 09812/2008-OL z 10.9.2008 on minimum requirements for staffing and material and technical equipment of individual types of medical facilities Bulletin 32-51 / 2008

Decree of the Ministry of Health of the Slovak Republic of 10. August 2009 amending the Decree of the Ministry of Health of the Slovak Republic no. 09812/2008-OL from 10. 9. 2008 on minimum requirements for staffing and material and technical equipment of individual types of medical facilities, as amended no. 25118/2008-OL from 10. 12. 2008 Bulletin 33 – 39/2009

Professional guideline of the Ministry of Health of the Slovak Republic, which regulates transport in connection with the program of procurement and transplantation of organs, tissues, cells no. 18864/2009-OZS, on: 3. 2. 2010 Bulletin 1-3 / 2010

Expert guidance of the Ministry of Health of the Slovak Republic, which regulates the allocation of harvested organs for transplantation purposes, the algorithm for selecting the recipient of the organ and the inclusion of patients on the waiting list for transplants no. 10098-1 / 2010-OZS, on: 15.3.2010 Bulletin 7-11 / 2010

Decree of the Ministry of Health of the Slovak Republic no. S09229-OL-2012 from 17. 12. 2012adjusting the details of organ and donor characteristics, marking of the transport container, record of harvested organs and record of transplanted organs Bulletin 39-40 / 2012 Decree of the Ministry of Health of the Slovak Republicč. S09602-OL-2012 from 17. 12 2012laying down the requirements for consent to the export of a tissue or cell outside the territory of the Slovak Republic and a model application for consent to the export of a tissue or cell outside the territory of the Slovak Republic Bulletin 39-40 / 2012

Decree of the Ministry of Health of the Slovak Republic no. 04114-OL-2013 from 24. 6. 2013amending the Decree of the Ministry of Health of the Slovak Republic no. S09602-OL-2012 from 17. 12. 2012, which lays down the requirements for consent to the export of a tissue or cell outside the territory of the Slovak Republic and a model application for consent to the export of a tissue or cell outside the territory of the Slovak Republic Bulletin 14/2013.