• Print

Regulations

Consult all autonomic-level, national and European regulations related to the donation and transplant of organs, tissues and cells.

  • Order of 3rd of January 1984, which creates the register of renal patients (DOGC núm. 402, de 27.01.1984).
  • Order of 16th of August 1984, which modifies the Order of 2nd of January 1984 on the authorisation of health centres extracting and implanting human organs (DOGC num. 462, de 22.08.1984).
  • Order of 26th of May 1994, which creates the Catalan Organization of Transplants as a program attached to the Health Area of the Catalan Health Service (DOGC num. 1907, de 10.06.1994).
  • Order of 5th of July 1994, which authorizes health centres to perform transplants of hematopoietic progenitor cells (DOGC núm.1922, de 18.07.1994).
  • Order of  8th of July 1994, which creates the Hematopoietic Progenitor Cell Transplant Advisory Commission (DOGC num. 1922, de 18.07.1994).
  • Order of 30th of January 1997, which creates the Corneal Transplant Advisory Commission (DOGC num. 2337, de 24.02.1997).
  • Order of 30th of January 1997, which creates the Organ and Tissue Procurement for Transplant Advisory Commission (DOGC num. 2337, de 24.02.1997).
  • Law 37/1997, of 18th of February, which creates a register of Hematopoietic Progenitor Cell Transplants (DOGC num. 2337,  24.02.1997).
  • Order of 6th of May 1997, which modifies the Order of  8th of July 1994, creating the Hematopoietic Progenitor Cell Transplant Advisory Commission (DOGC num. 2396, de 22.05.1997).
  • Order of 24th of December 1997, which creates the Vascular Tissue Procurement and Transplant Advisory Commission (DOGC num. 2565, de 27.01.1998).
  • Order of 11th of June 1998, which modifies Order of 30th of January 1997, which creates the Corneal Transplant Advisory Commission (DOGC num. 2666, de 23.06.1998).
  • Order of 14th of December 1999, which creates the Procurement and Transplant of Bone Marrow Tissue Advisory Commission (DOGC num. 3040, de 22.12.1999).
  • Law 260/2000, of  31st of July, which deploys the structure and central organization of the public Catalan Health Service, attached to the Catalan Organization of Transplants  in the Health Service (DOGC num. 3200, de 08.08.2000).
  • Order SSS/250/2002, 1st of July, which regulates computerised files which contain personal data, in the area of the Catalan Health Service. This order regulates, among others, the register of donors and patients awaiting transplant, the register of patients awaiting hematopoietic progenitor cell transplants from non-related donors, the register of cardiac transplants, the register of hepatic transplants and the register of renal patients. (DOGC num. 3678, de 16.07.2002).
  • Order SSS/270/2003, of 26th of May, through which the Hepatic transplant register advisory commission was created and which regulated mandatory collection and transmission of the Catalan hepatic register data.
  • Orden SSS/271/2003, of 26th of May, through which the Cardiac transplant register advisory commission was created and which regulated mandatory collection and transmission of the Catalan cardiac register data.
  • Order SLT/560/2006, of 21st of  November, modifies the Order of 30th of January1997 which set up the Organ and Tissue Procurement for Transplant Advisory Commission. (DOGC num. 4770, de 28.11.2006).
  • Order SLT/135/2011, 10th of June, which establishes in 2011, the prices of renal transplant activities and the extraction of organs for centres and health establishments providing services through contracts or agreements with the Catalan Health Service (DOGC núm. 5907, de 27.06.2011).
  • Regulation 04/2015 of Catalan Health Service which establishes the operational framework and responsibilities in tissue donation. Coordination mechanisms and action plan.
  • Law 30/1979, of 27th of October, wich dictates the arrangements for organ extraction and transplant (BOE núm. 266, de 06.11.1979).
  • Order of 24th of June 1987 on anti HIV detection tests, in the area of procurement, extraction, transplant, graft or implant of human organs (BOE num. 167, of 14.07.1987).
  • Transposition of Order SCO 3461/2003, evaluation, authorization, register and dispensing of pharmaceutical specialities and other medications for human use manufactured industrially.
  • Royal decree 223/2004 which regulates clinical trials of medicines (BOE num. 33, of 07/02/2004).
  • Royal decree 2183/2004 which develops and regulates the authorization regime of pharmaceutical laboratories and medical importers and the quality guarantee of  industrial manufacture (BOE num. 274, of 13/11/2004).
  • Law 29/2006 of guarantees of rational use of medicines and health products (BOE num. 178, of 27/07/2006).
  • Law 14/2007 of  bio-medical research (BOE num. 159, de 04/07/2007).
  • Royal decree 1591/2009, of  16th of October, which regulates health products and which refers to the prohibition of commercial distribution of tissues of human origin, in particular lyophilized bone marrow tissue, up till now distributed by companies authorized by the European Agency for Medicines (BOE num. 268, de 06.11.2009).
  • Royal decree 1527/2010 which regulates the Guarantee Commission for the Donation and Utilization of Human Cells and Tissues and the register of research projects.
  • Royal decree 1723/2012, of 28th of December, which regulates procurement activities, clinical use and territorial coordination of human organs destined for transplant, and establishes quality and safety requirements (BOE num. 313, of 29.12.2012).
  • Royal decree–law 9/2014, 4th of July, on setting standards of quality and safety for donation, procurement, testing, processing, preservation, storage and distribution of human cells and tissues and approving the coordination and operation rules for being used in humans (BOE nº. 163, of 05/07/2014).
  • Order SSI/2396/2014, December 17th, which establishes the basis of the quality and security Program for human organ procurement and transplant and information procedures for interchange with other countries (BOE núm. 308, de 22/12/2014).
  • Royal decree-law 318/2016, 5th of August, approving the authorization procedure for conducting promotional and advertising activities of donation of human cells and tissues (BOE num. 206, of 26.08.2016).
  • Ethical Aspects of Human Tissue Banks (Group on Ethics in Science and New Technologies. European Commission, 21st of July, 1998).
  • Additional protocol to the Convention on human rights and biomedicine concerning transplantation of organs and tissues of human origin. Strasbourg, 24.01.2002.
  • Directive 2003/63 on medicines for human use.
  • Directive 2003/94 Correct practice in manufacture of medicines for human use and medicines in research for human use.
  • Regulation 726/2004 which establishes community procedure for the authorization and control of medicines for human and veterinary use and which creates the European Agency of Medicines.
  • Directive 2004/23/CE of the European Parliament and the Council, of 31st of March, related to the establishing of quality and safety norms for donation, procurement, evaluation, processing, preservation, storage and distribution of human cells and tissues.(DOUE, de 07.04.2004).
  • Directive 2005/28 on good clinical practice regarding medicines in research for human use, as well as requirements to authorize manufacture or importation of these products.
  • Directive 2006/17 which applies Directive 2004/23 for the donation, procurement, evaluation, processing, storage and distribution of human cells and tissues.
  • Regulation 1394/2007 on medicines for advanced therapies.
  • Directive 2009/120 which establishes a community code on medicines for human use, in all aspects of advanced therapy.
  • Directive 2010/45/UE of the European Parliament and Council, 7th of July 2010, on quality and safety regulations for human organs destined for transplant (DOUE, de 06.08.2010).
  • Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (OJ L 93, 9.4.2015, p.43)
  • Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (OJ L 93, 9.4.2015, p. 56).