Regulations of Application of the Ministry of Health and its public agencies, linked or dependent.
Ministry of Health
Basic Organic Structure of the Ministry
- Royal Decree 718/2024, of 23 July, which develops the basic organizational structure of the Ministry of Health (consolidated version containing subsequent modifications).
Territorial bodies
- Royal Decree 1746/2003, of 19 December, regulating the organisation of peripheral services of the National Institute of Health Management and the composition of the bodies involved in the control and monitoring of management. BOE 13-01-2004
Agencies attached to the Ministry
- Royal Decree 1275/2011, of 16 September , by which the State agency "Spanish Agency for Medicines and Health Products" and its Statute was adopted. BOE 23-09-2011
- Royal Decree 1825/2009, of 27 November , approving the Statute of the National Transplant Organization. BOE 28-11-2009
- Royal Decree 29/2000, of 14 January , on new forms of management of the National Institute of Health. BOE 14-01-2000. (Create the Committee on Participation and Guarantees of Citizenship and the Board Assistance)
- Law 7/2025, of 28 July, establishing the State Public Health Agency and amending Law 33/2011 of 4 October, General Public Health. BOE 29-07-2025
Other provisions
- Order SCO/3158/2003, of 7 November, by which the Rare Disease Research Institute. BOE 14-11-2003
- Order PRE/1952/2013, of 17 October, by which the Joint Research Institute of the National School of Health. BOE 24-10-2013
- Royal Decree 279/2016, of 24 June, on accreditation of Biomedical or health research institutes. BOE 05-07-2016
- Royal Decree 1113/2015, of 11 December, whereby thelegal regime of the Spanish Council of Drug Addiction and Other Addictions. BOE 01-01-2016
- Royal Decree 1091/2015, of 4 December, which creates and regulates the State Register of Rare Diseases. BOE 24-12-2015
- Royal Decree 1090/2015, of 4 December, regulating clinical trials involving medicinal products, Committees on Research Ethics with Medicines and the Spanish Registry of Clinical Studies. BOE 24-12-2015
- Royal Decree 69/2015, of 6 February, which regulates the Register of Specialized Health Care Activity. BOE 10-02-2015
- Royal Decree 640/2014, of 25 July, which regulates the State Registry of Health Professionals. BOE 14-08-2014 (Created in the tenth additional provision of the Law 16/2003 )
- Order SCO/3866/2007, of 18 December, establishing the content and structure of General Register of Health Centres, Services and Establishments of the Ministry of Health and Consumer Affairs. BOE 29-12-2007
- Royal Decree 124/2007, of 2 February, which regulates the National Register of Prior Instructions and the corresponding automated personal data file. BOE 15-02-2007
- Order SCO/932/2006, of 21 March, by which the Voluntary Registry of Bidders of the Ministry of Health and Consumer Affairs. BOE 01-04-2006
- Order SCO/393/2006, of 8 Februaryestablishing the organisation and functioning of National Bank of Cell Lines. BOE 18-02-2006
- Order SCO/564/2004, of 27 February, which establishes the system of coordination of alerts and emergencies of Health and Consumption. BOE 05-03-2004. (Create the Alert and Emergency Coordination Center (CCAES))
- Law 16/2003, of 28 May, of cohesion and quality of the National Health System.
- Royal Decree 294/1995, of 24 February, which regulates the Spanish Royal Pharmacopoeia, the National Form and the advisory bodies of the Ministry of Health and Consumer Affairs in this area. BOE 12-04-1995
- Royal Decree 415/1996, of 1 Marchestablishing the rules for the management of Spanish Red Cross. BOE 05-03-1996
Inter-administrative collegiate bodies
- Order SSI/1833/2013, of 2 October, which creates and regulates the Council of the Spanish Network of Agencies for the Evaluation of Health Technologies and Benefits of the National Health System. BOE 11-10-2013
- Law 14/2007, of 3 July, of Biomedical Research. BOE 04-07-2007 (Creates in its article 77 the Bioethics Committee of Spain)
- Royal Decree 1030/2006, of 15 September,establishing the common services portfolio of the National Health System and the procedure for its updating. BOE 16-09-2006 (Regulates in its article 9 the Committee on Benefits, Insurance and Financing)
- Royal Decree 182/2004, of 30 January, by which the composition of the Human Resources Commission of the National Health System. BOE 12-02-2004
- Order of 18 January 1996 approving the Rules of Procedure of the National Commission for the Rational Use of Medicines. BOE 19-10-2000
- Order of 14 April 1987, determining the composition and functions of Council of the Civil Order of Health. BOE 24-04-1987
Other organs
- Order SSI/1840/2012, of 13 August, which develops the composition and operating regime of the Advisory Board on Health. BOE 21-08-2012
- Royal Decree-Law 16/2012, of 20 Aprilurgent measures to ensure the sustainability of the National Health System and to improve the quality and safety of its services. BOE 24-04-2012 (See chapter IV. Article 4. Point eight. The one is created Advisory Committee on the Pharmaceutical Provision of the National Health System)
- Royal Decree 1302/2006, of 10 Novemberestablishing the bases for the procedure for the designation and accreditation of the centres, services and reference units of the National Health System. BOE 11-06-2006 (Creates in its article 4 the Committee for the Designation of Centres, Services and Reference Units)
- Law 16/2003, of 28 May, of cohesion and quality of the National Health System. BOE 28-05-2003 (Chapter X regulates the Interterritorial Council of the National Health System)
- Royal Decree 377/2003, of 28 Marchwhich regulates the procedure for processing and granting social assistance to people with haemophilia or other congenital coagulopathies who have developed hepatitis C as a result of having received treatment with clotting factor concentrates within the public health system. BOE 29-03-2003. (Creates in its Article 7 the Social Aid Assessment Committee (CEVHC))
- Royal Decree 1515/1992, of 11 December, regulating the composition and functions of the Advisory Committee on the National Health System. BOE 31-12-1992
- Resolution of 29 March 1989, of the General Secretariat for Health Care, creating the Growth Hormone and Related Substances Advisory Committee. BOE 20-05-1989